Roadmap Instructions

The Alberta Clinical Research Roadmap is an interactive navigator outlining the steps to setting up and conducting a clinical health research study within Alberta.

Use the Roadmap by expanding any section below to find specific steps as well as helpful supports such as tools
and services.

Use the Glossary to find definitions for clinical research terminology.

Use the FAQs to find answers to frequently asked about themes in clinical research.

Use the Search bar at the top of the Roadmap to expand all areas relevant to a chosen topic (ie. Informed Consent).

Use the Contact Us feature to contribute a tool, service or resource to the Alberta Clinical Research Roadmap or provide feedback.

Steps with a hollow border can be completed concurrently with other hollow border steps.

CONCEPT

The study is in the ‘concept’ or ‘idea’ stage. The goal is to identify a focused, answerable question that addresses a gap, contributes to the body of knowledge, enhances health services and/or delivery, and improves patient care or outcomes.
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    Clinical Health Research Terminology

    The language of clinical health research can be confusing. However, many resources have been developed that can help you navigate this process. You can access our online Glossary above, or click on the resources tab below to see what else is available to help you with your project.

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    Question

    What is my research question?

     

    A good research question is essential the to research process. It should be clear and concise, and be broad enough to solve a complex problem, however, focused enough to identify the issue(s) that the researcher will address.

    ALBERTA CHILDREN'S HOSPITAL RESEARCH INSTITUTE (ACHRI) - UNIVERSITY OF CALGARY

    Region: Calgary

    Service: Formulating research questions and hypotheses.

    Eligibility: ACHRI Members

    Contact:  khchaput@ucalgary.ca or (403) 210-7066

    More Information: Research Methods and Statistics Support

     

    ALBERTA HEALTH SERVICES (AHS) RESEARCH FACILITATION

    Region: Alberta

    Service: Research study methods including research question refinement.

    Eligibility: Available to PIs with AHS and SCN endorsed projects

    Contact: research.facilitation@ahs.ca

    More Information: Visit the AHS Research Facilitation webpage

     

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service: Study design

    Eligibility: University of Alberta Researchers

    Contact: (780) 492-8525 or 1-877-876-9888

    More Information: Visit the EPICORE Centre website

     

    THE METHODS HUB

    Region:  Calgary

    Service: The Methods Hub is a group of dedicated health researchers who have expertise and provide education in methodology.

    Eligibility: Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information:  The Methods Hub website

     

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    Engagement

    Who will be impacted by the results of the study?

    Individuals who will be affected by or interested in a project are engaged early on in the planning stages of a project, the resulting study can be more meaningful or impactful.  

    Identify the individuals or groups whom the outcome of the project would be relevant, consider how they may be impacted by the study, what information or input would be helpful and how those end users will be engaged. 

    An end user, can be a healthcare professional, patient/public, or policy maker.

    ALBERTA SPOR SUPPORT UNIT (AbSPORU) - PATIENT ENGAGEMENT PLATFORM

    Region: Alberta

    Service: Project refinement and feasibility, project support, mobilization and matching, assessment, orientation and engagement, facilitation and mentorship, guidance with patient compensation, and evaluation of patient engagement activities.

    Eligibility: Application via the AbSPORU Portal

    Contact: Robyn Laczy, Program Coordinator, rlaczy@athabascau.ca or laczy@ualberta.ca, (780) 492-9695

    More Information:  AbSPORU Patient Engagement Platform

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: Consultation to explore the possibility engaging patients or other non-academic stakeholders. Facilitation of the process of engagement to ensure that the methodological, organizational and ethical principles of research are respected and applied. Support of trainees through the PaCET (Patient and Community Engagement Training) Program.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our website 

     

     

    Alberta SPOR SUPPORT Unit - Patient Engagement Platform for resources on patient engagement.

    Clinical Trial Diversification Better Practices - Topic 2: Information about touch points where a patient may be involved and implementing a patient engagement strategic plan.

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    Research Team

    What is a Research Team?

    Research teams work together towards a research goal. Ideally the research team has a diverse range of technical and administrative skills who can be from within or outside an organization.

    Assess the balance and composition of the team in terms of skills, expertise and other contributions appropriate to achieving the research goal. A balance can include having individuals with bigger picture thinking, detailed individuals, and ability to work with others. While not all team members may be involved throughout the study, i.e. a biostatistician, it is important to identify the team members from the start.

    The principal investigator can delegate tasks as part of a study appropriate to the education and experience of an individual. Any tasks that are not delegated are the responsibility of the principal investigator. The principal investigator cannot delegate oversight as he or she holds the ultimate responsible for the study including conduct and financing. Each team member must have appropriate training and experience to perform their delegated duties.

    Examples of team members may include a research coordinator/assistant, statistician, data entry personnel, co-investigators, research nurse, etc.

    ICH GCP E6 Consolidated Document 2.8

    ”Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service:  Research Coordination

    Eligibility:  UofA Researchers

    Contact:  (780) 492-8525 or Toll Free 1-877-876-9888

    More Information:  EPICORE Centre - Edmonton

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: Gain access to a highly skilled team of research coordinators to help manage your study. Services available include:

    • Participant screening, recruitment, consent, assent and visit scheduling
    • Administering questionnaires, data collection, sample collection, data entry
    • Liaising with lab, pharmacy, diagnostic imaging, and other facilities as needed
    • Maintaining regulatory documents
    • Assisting with study close-out and archiving study documentation

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or visit our Study Management web page.

     

    CURRICULUM VITAE (CV)

    The Curriculum Vitae (CV) is an essential document which should be included in the files of the investigator/institution and sponsor, before the trial formally starts, and updated as per study requirements. The CV is the foundation upon which trial related tasks can be delegated as it highlights the individual’s personal details, education, employment history, professional association(s), and related experience. Members of a professional association are to only perform those duties allowed within his/her designated scope of practice according to provincial regulations and their place of employment.

    Other CV templates exist including the Canadian Common CV3. We provide here an abbreviated CV for those individuals with or without an extensive academic research background who may not already have an existing CV.

    ACRC Abbreviated CV

     

    TRANSCELERATE CV TEMPLATE

    Many TransCelerate members (industry/sponsors) have begun using the CV Template. While each member makes its own decision about whether to implement, the expectation is that the significant efficiencies available to both sponsors and sites will lead to widespread adoption, especially as TransCelerate membership grows and sponsors amend existing SOPs.

    TransCelerate CV Template

    TransCelerate CV Guidance

    TransCelerate CV FAQs

     

    DELEGATION OF RESPONSIBILITY LOG

    The ‘Delegation of Responsibility Log’ is a source document that records the names, initials, signatures and responsibilities of all participating staff throughout the course of the trial. The log meets the ICH GCP guidelines and helps ensure there is a clear understanding of the delegated tasks among research staff.

    ACRC Delegation of Responsibility Log

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    Intellectual Property

    Intellectual Property refers to creations of the mind in a form that can be shared or enables others to recreate or manufacture them. Examples include: inventions, new technologies, new brands, software code, novel designs, and unique processes. Trademarks, copyright, trade secrets, patents and industrial design patents are all forms of intellectual property.

    In order to protect your intellectual property, it is important to consider what types of intellectual property may exist in your research, program or clinical trial prior to a public disclosure (presentation, conference, publication).

    If you think your study may result in the need to protect intellectual property, it is necessary to begin this process early in your study. Services are available at both University of Alberta and University of Calgary to help you with this endeavour.

     

    INNOVATE CALGARY

    Region: Calgary

    Service: Innovate Calgary provides advice and consultation regarding intellectual property, including ways to protect and disseminate your research. Services include; technology patentability assessment; market assessment; patent preparation, filing and prosecution; guidance and registration for copyrighted works and trademark filing. To access these services, please visit our website to submit an invention disclosure form.

    Eligibility: UCalgary Researchers

    Contact: ipm@innovatecalgary.com

    More Information:  Innovate Calgary

     

    TEC EDMONTON

    Region: Edmonton

    Service: Technology Management specialists will advise you on Intellectual Property (IP) options, protection, licensing and commercialization strategies.

    Eligibility: UofA Researchers

    Contact: Connect with TEC, info@TECedmonton.com

    More Information:  TEC Edmonton

DEVELOPMENT

Designing the study and identifying the research team. Once the research question has been formulated, the development stage involves identifying the target study or data population; where the research will be conducted, what is collected and how; research method and analysis; and who is involved and/or the expertise to be consulted.
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    Study Design/Protocol Development

    What should be included in the study protocol? How will your study be carried out?

    A research protocol is the document that describes in detail the plan for your study including the objectives, study design, methodology, analysis and resources. Making sure the protocol is developed to the fullest and contains the key elements promotes high quality research and eases obtaining regulatory approvals.

     

    How many participants will you need? 

    Consideration should be given as to the appropriate sample size (e.g. number of participants in each treatment group) required to ensure that your study will have sufficient statistical power.  Engaging a statistician during the writing of the research protocol would be helpful for describing the rationale and evidence for the number of participants needed for the study.

    ALBERTA CHILDREN'S HOSPITAL RESEARCH INSTITUTE (ACHRI)

    Region:  Calgary

    Service:  Project Planning and Development - Formulating research questions and hypotheses

    Eligibility:  ACHRI Members

    Contact:   research4kids@ucalgary.ca

    More Information: Alberta Children's Hospital Research Institute

     

    ALBERTA HEALTH SERVICES - RESEARCH FACILITATION

    Region:  Alberta

    Service:  Proposal Development

    Eligibility:  AHS Researchers

    Contact:   research.facilitation@ahs.ca

    More Information: AHS - Research Facilitation

     

    ALBERTA SPOR SUPPORT UNIT (AbSPORU) - METHODS SUPPORT & DEVELOPMENT PLATFORM

    Region:  Alberta

    Service:  Advice on developing proposals/protocols

    Eligibility:  Alberta-based

    Contact:  spor@albertainnovates.ca

    More Information/To Apply: AbSPORU - Methods Support and Development Platform

     

    ALBERTA SPOR SUPPORT UNIT (AbSPORU) - PATIENT ENGAGEMENT PLATFORM

    Region:  Alberta

    Service:  Advice on involving patients in protocol development

    Eligibility:  Alberta-based

    Contact:  spor@albertainnovates.ca

    More Information/To Apply:  AbSPORU - Patient Engagement Platform

     

    EPIDEMIOLOGY  COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service:  Design/Methods

    Eligibility:  UofA Researchers

    Contact:  (780) 492-8525 or Toll Free 1-877-876-9888

    More Information:  EPICORE Centre - Edmonton

     

    LOIS HOLE CLINICAL RESEARCH UNIT

    Region: Edmonton

    Service: Discuss specifics and requirements with the Women’s Health research nurses and/or Women’s Health manager(s) while the study is in the design phase (if applicable).

    Eligibility: Researchers who require access to Women's Health patients (labour and delivery, antepartum, postpartum, gynecology, operating rooms and/or ambulatory care), their families or staff members of the Lois Hole Hospital for Women (LHHW) at the Royal Alexandra Hospital.

    Contact: shauna.littlefair@ahs.ca, winnie.savard@ahs.ca, alberta.pasco@ahs.ca

    More Information: Lois Hole Clinical Research Unit Webpage

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: WCHRI offers assistance with qualitative research design and can conduct a small set of pilot interviews and focus groups (to support research design).

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our Qualitative Research webpage

    PROTOCOL TEMPLATE

    The SPIRIT 2013 Statement provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol. The recommendations are outlined in a 33-item checklist and figure.

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    Regulatory Binder

    The regulatory binder tracks and contains the essential documents for a study. It is to be available for inspection during a monitoring or audit visit and must be kept up-to-date at all times.

     

    ICH GCP E6 8. Essential Documents for the Conduct of a Clinical Trial - Health Canada

    "Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.

    Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected."

    NORTHERN ALBERTA CLINICAL TRIALS AND RESEARCH CENTER (NACTRC)

    Region: Edmonton

    Service:  Provides regulatory binder tab template.

    Eligibility:  University of Alberta Researchers

    Contact: Complete the NACTRC Contact Form

    More Information: For more information on this service you must have an account with NACTRC, login to your account and click on "PI Resources".

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: Gain access to a highly skilled team of research coordinators to help manage your study. WCHRI Research coordinators are knowledgeable in all regulatory aspects of a clinical research study and can help you set-up and maintain your regulatory binder in a manner that will be compliant with all regulatory authorities.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or visit our Study Management web page.

    REGULATORY BINDER TABS

    A regulatory binder contains the study-specific information and regulatory documentation and is recommended for all intervention trials regardless of funding. To help you organize your essential documents, the ACRC has developed a possible option on how to organize your regulatory binder.

    Regulatory Binder Tabs

    These new templates may be fully customized for specific study needs and come with a Guidance Document for tips on usage and best practice.

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    Data Collection

    What will the study measure/capture? 

    Quantitative research measures quantity or size with data variables as the counts, observations and measurements that can differ from individual to individual over time.   

    Qualitative research examines the "what?", "why?", and "how?". Qualitative methodology includes field observation, in-depth interviews, focus groups, and document analysis.

     

    How will the study measure/capture the data?  

    An essential element for any research study involves how the data will be collected, stored, and analyzed. High quality data can be gathered with the development of structured, organized data collection plans and forms. 

     

    What documents should be developed to assist in data collection?

    Case report forms (CRFs) are the tools used for collecting participant data from the study sites.  CRFs ensure that data is collected in a standard format, either in paper or electronic form. CRFs  should accurately reflect the data specified by the protocol. They are essential documents, and as per good clinical practice should be on file before the trial formally starts.

     

    What should be considered while developing a data collection plan? 

    Having quality data collection methods can enhance the validity and reliability of study data. The outcome of a study can be impacted by careful attention to; 

    -How data is acquired and recorded 

    -Choice of data collection methods

    -Use of reliable, valid data collection instruments

    -Clarity of the description of data collection methods in the study protocol

     

     

     

     

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    ALBERTA CHILDREN'S HOSPITAL RESEARCH INSTITUTE (ACHRI) - UNIVERSITY OF CALGARY

    Region: Calgary

    Service: Directing sample size calculations and analysis planning. Identifying appropriate biostatistical analysis methods for a given research project.

    Eligibility: ACHRI members

    Contact: Contact Dr. Katie Chaput: khchaput@ucalgary.ca , or (403) 210-7066 with a description of your research support needs.

    More Information: ACHRI Research Methods and Statistics Support

     

    ALBERTA HEALTH SERVICES (AHS) RESEARCH FACILITATION

    Region: Alberta

    Service: Research study methods, research question refinement, study design, sample size calculations, analysis plan.

    Eligibility: Available to PIs with AHS and SCN endorsed projects

    Contact: research.facilitation@ahs.ca

    More Information: Visit the AHS Research Facilitation page for more information.

      

    ALBERTA SPOR SUPPORT UNIT (AbSPORU)

    Region: Alberta

    Service: Dataset feasibility, Biostatistical plan development, Case volume estimates, Sample size calculations, Pilot data extraction, Preparation of data access agreements, Data extraction, Data linking and merging, Generation of control groups.

    Eligibility: AbSPORU Portal Applicants

    Contact: spor@albertainnovates.ca

    More Information: AbSPORU Data Platform

     

    COVENANT HEALTH DATA & DECISION SUPPORT

    Region: Alberta

    Service: Data and Decision Support is a corporate centralized analytics, reporting and decision support service specializing in reporting relating to clinical care. Data and Decision Support analysts are able to draw from a variety of clinical databases to create reports regarding clinical processes and outcomes. To make a request contact their Data & Decision Support and complete a request form.

    Eligibility: Alberta Researchers with a Research Agreement with Covenant Health

    Contact: dataanddecisionsupport@covenanthealth.ca or 780-735-2726 

    More Information: Visit the Data & Decision Support webpage

     

    THE METHODS HUB

    Region:  Calgary

    Service: The Methods Hub is a group of dedicated health researchers who have expertise and provide education in methodology.

    Eligibility: Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information:  Visit The Methods Hub website

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: REDCap setup and support, database setup and configuration, identifying statistical methods best suited to answer specific research questions, calculating sample sizes and power, assisting with study design and protocol development, developing a statistical analysis plan, developing randomization schedules, analyzing data and interpreting results, setting up tables and graphs for presentations, and reviewing statistical sections of funding applications and manuscripts.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our website 

    DATA COLLECTION CONSIDERATIONS

    Consideration should be made as to the;

    -practicality, validity and reliability of data collection tools.

    -Levels of measurement (data types, ex. categorical data, quantitative data) of the data collected over the length of a study to determine the type of statistical analysis that will be required for the data.

    -Types of data variables (ex. outcome variables, predictor variables, and co-variables).

     

    DEFINING DATA VARIABLES

    Resources that exist to help researchers identify and define data variables include; 

    Statistics: Power from Data! (2001) archived at Statistics Canada

    Alberta SPOR Support Unit Provincial Services (Patient-Oriented Research)

     

    MEASURING QUALITY

    The Agency for Healthcare Research and Quality (AHRQ) has developed an array of health care decision making and research tools that can be used by program managers, researchers, and others at the Federal, State and local levels. The Quality Indicators (QIs) are measures of health care quality that make use of readily available hospital inpatient administrative data. The current AHRQ QI™ modules expand HCUP QIs. The QIs can be used to highlight potential quality concerns, identify areas that need further study and investigation, and track changes over time.

    The current AHRQ QI modules represent various aspects of quality: Prevention Quality Indicators, Inpatient Quality Indicators, Patient Safety Indicators, and Pediatric Quality Indicators.

    The AHRQ QIs are used in free software distributed by AHRQ. The software can be used to help hospitals identify quality of care events that might need further study. The software programs can be applied to any hospital inpatient administrative data. These data are readily available and relatively inexpensive to use.

     

     

    DATA COLLECTION PACKAGE

    The ACRC Data Collection Package provides several examples of Case Report Forms (CRFs) which can be customized to collect study-specific participant information.

    Attached are several samples of common types of case report forms. Each may be modified to meet the needs of the specific study protocol:

    The following templates may be helpful to the study staff in following the flow of study assessments and procedures through a particular study visit. For the purpose of these flowsheets, we have populated the samples with examples related to a stroke study. These templates can be customized for each visit, relevant to your study:

    These templates may be fully customized for specific study needs and come with a Guidance Document for tips on usage and best practice.

    Manage your research projects online

    REDCap is a secure, web-based application for building and managing online research projects. It uses an intuitive, streamlined process for rapidly developing data entry forms in support of many types of research projects, such as surveys, chart reviews, clinical trials, longitudinal cohort studies and more.

    Using REDCap significantly improves data quality and security. It also eliminates the need to develop other project databases, which can be expensive and time consuming.

    Key Features of REDCap: ​​

    • Secure and web-based – input research data from anywhere in the world with secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption.
    • Multi-site access – REDCap projects are managed by the Principal Investigator and their research team, so access can be extended to collaborators from multiple sites and institutions.
    • Fast and flexible - simple form design tools allow you to create a production-level database quickly, often in less than one day.
    • Quality assurance – built-in tools allow for automated data management, such as data validation, branching, and stop actions.
    • Import Data – easy tools for importing data from external sources to begin a study or to provide mid-study uploads.
    • Export Data – simple data export functions support multiple file formats (SPSS, STATA, SAS, Excel, etc.); including downloadable data dictionary.
    • Scheduling – use the built-in project calendar and scheduling module to organize events and participant appointments.
    • Ad Hoc Reporting - create custom queries for generating reports to view or download.
    • Randomization – create or link to randomization schemes
    • Mobile app – the iOS and Android REDCap mobile applications allows data to be collected offline via tablets and smartphones.
    • Local – REDCap servers are locally hosted at the University of Alberta and University of Calgary – so your data stays in Alberta!

    REDCap FOR UNIVERSITY OF ALBERTA AFFILIATED RESEARCHERS

    Through collaboration with the Women and Children's Health Research Institute (WCHRI), the Faculty of Medicine & Dentistry, and the Northern Alberta Clinical Trials and Research Center (NACTRC), this important research support is available to researchers in Edmonton and surrounding areas. Initial project setup and training sessions are provided free of charge.

    Regulated Clinical Trials

    WCHRI, in collaboration with the Maternal Infant Child & Youth Research Network (MICYRN), maintains a validated instance of REDCap for use in Health Canada regulated investigator-initiated clinical trials. This instance of REDCap will meet regulatory requirements for electronic data systems and includes an appropriate set of standard operating procedures (SOPs). A $250/year system access fee is charged for use of the validated version. If your investigator-initiated clinical trial requires a clinical trial application (CTA) with Health Canada, use of the validated instance of REDCap is strongly recommended.

    Additional Support Services

    For project teams who have available funding and require additional support services, WCHRI, Alberta SPOR SUPPORT Unit, and EPICORE Centre are available to provide a number of value-added services including database development and data management

     

    REDCap FOR UNIVERSITY OF CALGARY AFFILIATED RESEARCHERS

    Located in the Cumming School of Medicine at the University of Calgary, the Clinical Research Unit (CRU) offers research data support to University researchers as a faculty-wide resource.

    The CRU at the University of Calgary is a vendor for the Electronic Data Capture platform REDCap, a browser-based application designed to support various types of research endeavours, including clinical studies, trials and surveys. With the growing need to facilitate processes surrounding clinical and translational research databases, REDCap is becoming a highly lucrative tool in the Academic Research Community. The platform is free, secure, and easy to learn with a comprehensive set of training materials at your fingertips. Depending on your research project needs, REDCap has mirrored interfaces for either de-identified or secure data collection. The CRU provides access to both of these under two separate instances: Self-Serve or Supported — meaning we can either grant credentials for independent use, or take on a project requiring support in areas of database design, management and analytics. Data security and integrity are always a priority , so all REDCapdata is stored in the University's high performance computing hub and backed up daily. 

    For more information please contact:  cru@ucalgary.ca

    Additional Support Services

    For project teams who have available funding and require additional support services the Clinical Research Unit is available to provide a number of value-added services including database development and data management.

     

     

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    Data Management

    What is your plan for the study data?

    Identifying the source and availability of data as well as how the data will be collected, stored and analyzed, and the inherent limitations therein will help to ease study start-up. 

    At this stage of study development, all possible sources of data should be considered. Confirmation and clarification of data sources will be performed as part of the study feasibility stage.

    Example questions to ask include:  Are study staff eligible for research access to data repositories (Netcare, EMR, etc.)?

     

    What is the difference between a Clinical Trial Management System (CTMS), Electronic Medical Records (EMR), Electronic Health Records (EHR) and a Electronic Data Capture System (EDC)?

    Electronic health records (EHRs), electronic medical records (EMRs) and personal health records (PHRs) are similar terms but have different definitions and distinct purposes. At Canada Health Infoway, the terms are defined as follows:

    • Electronic Health Record: An electronic health record (EHR) refers to the systems that make up the secure and private lifetime record of a person's health and health care history. These systems store and share such information as lab results, medication profiles, key clinical reports (e.g., hospital discharge summaries), diagnostic images (e.g., X-rays), and immunization history. The information is available electronically to authorized health care providers.
    • Electronic Medical Record: An electronic medical record (EMR) is an office-based system that enables a health care professional, such as a family doctor, to record the information gathered during a patient's visit. This information might include a person's weight, blood pressure and clinical information, and would previously have been hand-written and stored in a file folder in a doctor's office. Eventually the EMR will also allow the doctor to access information about a patient's complete health record, including information from other health care providers that is stored in the EHR.[1]

    A Clinical Trail Management System (CTMS) is typically used by a pharma company, a ARO, or CRO to manage, multiple clinical trials or clinical trial sites. A CTMS will help provide oversight of key clinical trial activities and allow up-to-date reporting. 

    Electronic Data Capture (EDC) is the process of collecting clinical trial data into a permanent electronic form. Note: Permanent in the context of these definitions implies that nay changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual enter of case report form (CRF) data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [2]

     

    REDCaP:

    REDCap is an electronic data capture system designed to support data capture for research studies.

    Click on the Services button below on how to get access to REDCap for both UofA and UofC researchers.

    ALBERTA CHILDREN'S HOSPITAL RESEARCH INSTITUTE (ACHRI) - UNIVERSITY OF CALGARY

    Region: Calgary

    Service: Directing sample size calculations and analysis planning. Identifying appropriate biostatistical analysis methods for a given research project. Planning biostatistical analysis with ongoing direction and oversight. Directing data cleaning and preparation. Leading integrated interim data analysis techniques. Directing and overseeing interim analyses, power projections and providing decision support (Trials). Assisting with interpretation and appropriate reporting of biostatistical and epidemiologic results. Conducting advanced analyses. Contextualizing results and analyses in current state of knowledge.

    Eligibility: ACHRI members

    Contact: Contact Dr. Katie Chaput: khchaput@ucalgary.ca , or (403) 210-7066 with a description of your research support needs.

    More Information: ACHRI Research Methods and Statistics Support

     

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service: Database development, Case report forms, Data entry, Data management, Quality Assurance, and Data Analysis.

    Eligibility: University of Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information: Visit the EPICORE Centre website

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Biostatistics consultation and support, REDCap support, database setup and configuration, data management planning, data validation and query management, data coding, and data reporting.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our website 

    Manage your research projects online

    REDCap is a secure, web-based application for building and managing online research projects. It uses an intuitive, streamlined process for rapidly developing data entry forms in support of many types of research projects, such as surveys, chart reviews, clinical trials, longitudinal cohort studies and more.

    Using REDCap significantly improves data quality and security. It also eliminates the need to develop other project databases, which can be expensive and time consuming.

    Key Features of REDCap: ​​

    • Secure and web-based – input research data from anywhere in the world with secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption.
    • Multi-site access – REDCap projects are managed by the Principal Investigator and their research team, so access can be extended to collaborators from multiple sites and institutions.
    • Fast and flexible - simple form design tools allow you to create a production-level database quickly, often in less than one day.
    • Quality assurance – built-in tools allow for automated data management, such as data validation, branching, and stop actions.
    • Import Data – easy tools for importing data from external sources to begin a study or to provide mid-study uploads.
    • Export Data – simple data export functions support multiple file formats (SPSS, STATA, SAS, Excel, etc.); including downloadable data dictionary.
    • Scheduling – use the built-in project calendar and scheduling module to organize events and participant appointments.
    • Ad Hoc Reporting - create custom queries for generating reports to view or download.
    • Randomization – create or link to randomization schemes
    • Mobile app – the iOS and Android REDCap mobile applications allows data to be collected offline via tablets and smartphones.
    • Local – REDCap servers are locally hosted at the University of Alberta and University of Calgary – so your data stays in Alberta!

    REDCap FOR UNIVERSITY OF ALBERTA AFFILIATED RESEARCHERS

    Through collaboration with the Women and Children's Health Research Institute (WCHRI), the Faculty of Medicine & Dentistry, and the Northern Alberta Clinical Trials and Research Center (NACTRC), this important research support is available to researchers in Edmonton and surrounding areas. Initial project setup and training sessions are provided free of charge.

    Regulated Clinical Trials

    WCHRI, in collaboration with the Maternal Infant Child & Youth Research Network (MICYRN), maintains a validated instance of REDCap for use in Health Canada regulated investigator-initiated clinical trials. This instance of REDCap will meet regulatory requirements for electronic data systems and includes an appropriate set of standard operating procedures (SOPs). A $250/year system access fee is charged for use of the validated version. If your investigator-initiated clinical trial requires a clinical trial application (CTA) with Health Canada, use of the validated instance of REDCap is strongly recommended.

    Additional Support Services

    For project teams who have available funding and require additional support services, WCHRI, Alberta SPOR SUPPORT Unit, and EPICORE Centre are available to provide a number of value-added services including database development and data management

     

    REDCap FOR UNIVERSITY OF CALGARY AFFILIATED RESEARCHERS

    Located in the Cumming School of Medicine at the University of Calgary, the Clinical Research Unit (CRU) offers research data support to University researchers as a faculty-wide resource.

    The CRU at the University of Calgary is a vendor for the Electronic Data Capture platform REDCap, a browser-based application designed to support various types of research endeavours, including clinical studies, trials and surveys. With the growing need to facilitate processes surrounding clinical and translational research databases, REDCap is becoming a highly lucrative tool in the Academic Research Community. The platform is free, secure, and easy to learn with a comprehensive set of training materials at your fingertips. Depending on your research project needs, REDCap has mirrored interfaces for either de-identified or secure data collection. The CRU provides access to both of these under two separate instances: Self-Serve or Supported — meaning we can either grant credentials for independent use, or take on a project requiring support in areas of database design, management and analytics. Data security and integrity are always a priority , so all REDCap data is stored in the University's high performance computing hub and backed up daily. 

    For more information please contact:  cru@ucalgary.ca

    Additional Support Services

    For project teams who have available funding and require additional support services the Clinical Research Unit is available to provide a number of value-added services including database development and data management.

  5. 5

    Ethics Requirements

    What are the ethical requirements of my study? What types of studies require an research ethics board review and approval?

    The type of research project proposed will determine the ethical requirements of the study.

    Not all studies involving humans require ethical review, although many clinical health research studies do require ethical review. 

     

    What is health research?

    Health research involves human subjects, their health information, and/or research involving their biological samples, such as blood or tissue.

    • Because health research exposes people to risk, at least in part, for the benefit of others, it must show that it lives up to high ethical standards set out in the Tri-Council Policy Statement (TCPS2) before it even gets off the ground.
    • It's the job of research ethics boards to also ensure that the research projects being considered comply with relevant regulations, guidelines, and ethical principles.
    • Alberta’s research ethics boards have the responsibility of adhering to a piece of legislation called the Health Information Act of Alberta.

      

    What are the Research Ethics Boards in Alberta?

    There are three such boards in the province that are able to review studies that use health information. Each of these boards has specific requirements for submission of an application for ethics approval and each provide guidance and templates to aid in your submission process.

    1. The Health Research Ethics Board (HREB) housed at the University of Alberta;
    2. The Conjoint Health Research Ethics Board (CHREB) housed at the University of Calgary; and
    3. The Health Research Ethics Board of Alberta (HREBA) housed at Alberta Innovates – Health Solutions. 

    If you are unsure which Research Ethics Board is appropriate for review of your study, find a guidance document here

     

    What is classified as non-research by research ethics boards and not subject to ethics board review? 

    According to the TCPS2, quality assurance, program improvement initiatives, or any other systematic investigation meant to inform change in only local practice or policy is not considered research and is not subject to research ethics board review. That, however, doesn’t mean these types of projects are without ethical risk.

     

    How do I determine ethical risks in a quality assurance or program improvement project?  

    • In an effort to use an objective (though not definitive) standard to facilitate considerations, it is recommended that researchers/project leads run their project through the ARECCI Ethics Screening Tool. The distinction is made primarily based upon the intended use of the results despite similarities in methodology. Receiving a competitive research grant award indicates that the project is research (per item #1 on the ARECCI Screening Tool). Of note, studies which involve both clinical research and QI/program evaluation must have the clinical research portion reviewed by the relevant REB.
    • For projects that are categorized as Quality Improvement (QI) or program evaluation, researchers/project leads can use the ARECCI Ethics Guidelines to help identify and integrate the appropriate ethics consideration into the project. Consultation with expertise in project ethics is recommended and should be done prior to involving participants as ethics approval cannot be granted for research already undertaken. This expertise may include:
      • the REB to confirm if the project falls outside the REB's mandate or should be submitted for REB review, or
      • QI and evaluation consultants with projects ethics review training to confirm if the project requires that type of review. 
    •  See A pRoject Ethics Community Consensus Initiative (ARECCI) for more information.

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service: Quality Assurance

    Eligibility: University of Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information: Visit the EPICORE Centre website

    ARECCI Ethics Guidelines

    The Health Research Ethics Board (HREB) housed at the University of Alberta;

    The Conjoint Health Research Ethics Board (CHREB) housed at the University of Calgary; and

    The Health Research Ethics Board of Alberta (HREBA) housed at Alberta Innovates – Health Solutions. 

    TCPS2: CORE - Tutorial

    A pRoject Ethics Community Consensus Initiative

    CMA Code of Ethics

    Quality Management in Clinical Research - University of Alberta

    ARECCI ETHICS GUIDELINES AND SCREENING TOOL

    The ARECCI Ethics Screening Tool and a set of guidelines have been developed to help researchers distinguish the ethics requirements of a quality improvement or program evaluation study.

    INFORMED CONSENT TEMPLATES

    Each ethics board has templates in order to facilitate development of informed consent forms:

    Conjoint Health Research Ethics Board/University of Calgary (CHREB)

    Health Research Ethics Board/University of Alberta (HREB)

    Health Research Ethics Board of Alberta (HREBA): Cancer Committee (CC)

    Clinical Trials Committee (CTC)

  6. 6

    Informed Consent

    What type of consent will be required for my study?

    The informed consent process is one of the most important elements of clinical research. Properly written Informed Consent Forms (ICFs) should be considered early in study development and can help your ethics review process go more smoothly.

    Any research project involving human participants requires Informed Consent. Properly developed informed consent forms (ICFs) will help smooth out the process of Ethics Approval and is an integral part of any Research Study. Depending on the type of research you are doing and the target population, different types of consent forms may need to be developed.

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service:  Research Coordination staff who can help develop ICFs.

    Eligibility:  UofA Researchers

    Contact:  (780) 492-8525 or Toll Free 1-877-876-9888

    More Information:  EPICORE Centre - Edmonton

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: WCHRI offers Research Coordination staff which can help you develop your ICFs for either a clinical trial or investigator initiated study.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our website 

  7. 7

    Study Materials

    What documents, forms, spreadsheets, or other materials will be required to carry out the study?

    The forms associated with the study (i.e. Case Report Form, participant recruitment material) should reflect your research question and your data collection requirements.  

    Considerations include the type of form, how the information on the form will be used and who will be providing the information for the form.

    Care should be taken to ensure enough information is gathered on the form as to have utility but also that the forms are organized, purposeful, clear and professional. 

    Any study materials that will be seen by a patient must be approved by the REB. 

    0

    ALBERTA CHILDREN'S HOSPITAL RESEARCH INSTITUTE (ACHRI)

    Region:  Calgary

    Service:  Developing/redesigning methods to achieve research objectives and maximize scientific outputs and clinical/population impact, Directing database design and coding, data collection and management.

    Eligibility:  ACHRI Members

    Contact:   research4kids@ucalgary.ca

    More Information: Alberta Children's Hospital Research Institute

     

    ALBERTA HEALTH SERVICES (AHS) RESEARCH FACILITATION

    Region: Alberta

    Service: Research study methods including study design.

    Eligibility: Available to PIs with AHS and SCN endorsed projects

    Contact: research.facilitation@ahs.ca

    More Information: Visit the AHS Research Facilitation page for more information.

      

    ALBERTA SPOR SUPPORT UNIT (AbSPORU) - METHODS SUPPORT & DEVELOPMENT PLATFORM

    Region: Alberta

    Service: The AbSPORU Methods & Development Platform can help with developing innovative methods for using data, developing Ideas for innovative tools to conduct patient-oriented research, developing methodology, advice on data collection methodology, and training on novel methodologies.

    Eligibility: Application via the AbSPORU Portal

    Contact: spor@albertainnovates.ca

    More Information:  AbSPORU Methods Support and Development Platform

     

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service:  Design/Methods

    Eligibility:  UofA Researchers

    Contact:  (780) 492-8525 or Toll Free 1-877-876-9888

    More Information:  EPICORE Centre - Edmonton

     

    THE METHODS HUB

    Region:  Calgary

    Service: The Methods Hub is a group of dedicated health researchers who have expertise and provide education in methodology.

    Eligibility: Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information:  Visit The Methods Hub website

     

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: Administering questionnaires, data collection, sample collection, data entry.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our website 

  8. 8

    Investigational Product Accountability

    Investigational products must be tracked and accounted for throughout the conduct of the trial. To ensure the integrity of the investigational product, the product is to be inspected and recorded by lot number upon receipt; temperature conditions monitored and recorded during storage; quantity, lot number and to whom product was dispensed to recorded; and record of destruction or return to the sponsor upon completion or request by the sponsor.

    DRUG DEVELOPMENT AND INNOVATION CENTRE

    Region: Edmonton

    Service: Our team works closely with industry or academia partners to design and create the next generation of therapeutic drug delivery.  The Center provides specialized prototypes of novel and conventional dosage forms through testing and production of clinical trial materials takes place in its pharmaceutical test laboratory and Heath Canada licensed cleanroom. The Centre’s unique infrastructure allows clinical testing support to take place from study design to the finished product. 

    Eligibility: University of Alberta Researchers

    More Information: Visit the DDIC webpage

    INVESTIGATIONAL PRODUCT ACCOUNTABILITY PACKAGE

    The Investigational Product (IP) Accountability Package - accurate record keeping ensures that investigational products, including drugs, devices and natural health products are completely accounted for and that they are not used incorrectly. This process documents all aspects of the receipt, storage, use and disposal of investigational products. The responsibility for investigational product accountability lies with the investigator/institution, at the trial site[1].

     The Investigational Product Accountability Package contains examples of:

    These new templates may be fully customized for specific study needs and come with a Guidance Document  for tips on usage and best practice.

    [1] ICH Guidance E6, Good Clinical Practice: Consolidated Guideline

FEASIBILITY

The research, project protocol, or proposal is close to final and in this stage, it is assessed whether the necessary resources including access to patients/data and other resources, are in place to successfully conduct the study/project.
  1. 1

    Budgeting and Funding

    How is your study being supported?

    Identifying whether sufficient funds and resources can be secured helps to assess whether a study is feasible. 

    Questions to ask about your study: 

    • Has a study budget been generated/reviewed/finalized? 
    • Can the researcher(s) devote the necessary time to conduct and oversee the study?
    • Can the study coordinator(s) devote the necessary time to fulfill the study and sponsor/CRO requirements, including as required, accompanying participants to appointments?
    • Are other qualified professional and technical personnel available as required?

    COVENANT HEALTH RESEARCH CENTER (CHRC)

    Region:  Alberta

    Service: The CHRC offers a Research Grant for up to $5,000.00 per study. Research studies at Covenant Health requiring seed funding for start-up purposes, or approved studies underway that require assistance with operational dollars are eligible.

    Eligibility: Covenant Health Researchers

    Contact: 780-735-2274 or research@covenanthealth.ca

    More Information: Covenant Health Research Centre (CHRC) - Grant Information

     

    RESEARCH SERVICES OFFICE - UNIVERSITY OF ALBERTA

    Region:  Edmonton

    Service: Identification of potential funding sources, assistance with the application process and guidance with the financial management of awards.

    Eligibility: University of Alberta Researchers

    Contact: rsoinfo@ualberta.ca or 780-492-5787

    More Information: RSO Website

     

    RESEARCH SERVICES OFFICE - UNIVERSITY OF CALGARY

    Region: Calgary

    Service: Provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities.

    Eligibility: University of Calgary Researchers

    Contact: rsogrants@ucalgary.ca

    More Information: UCalgary RSO Webpage or Grants and Awards Division Webpage

    BUDGETING TEMPLATE

    Developing an accurate budget is vital to ensure there’s adequate funds to properly conduct a study. The ACRC Internal Costing Template is a simple planning tool to assist researchers in estimating the expenses for budget preparation and negotiation of industry-sponsored and grant funded trials. It can be customized to any discipline or research area and promotes constancy in budget development.

    ACRC Internal Costing Template

  2. 2

    Study Feasibility

    What resources will you need access to for your study?

    Reviewing the requirements of a study as relates to access to target study populations, data, equipment and clinic space can help to assess whether a study is feasible. 

    Questions to ask:

    • Are the target study patient populations available for recruitment in appropriate numbers on site or at multiple-sites?
    • Are there sufficient clinical resources at each proposed research site for the study?
    • Can recruitment of participants be achieved within the timeframe stated?
    • Does enrollment compete with other studies seeking the same patients?
    • Does the required data exist in an easily accessible format and are there restrictions to gaining access to the data?
    • Can I access appropriate purchased services I.E. Lab, x-ray etc. as needed?
    0

    ALBERTA HEALTH SERVICES (AHS) RESEARCH FACILITATION

    Region: Alberta

    Service: Assessment of administrative data suitability and availability

    Eligibility: All researchers using AHS data sources

    Contact: research.facilitation@ahs.ca

    More Information: Visit the AHS Research Facilitation page for more information.

     

    COVENANT HEALTH RESEARCH CENTER (CHRC)

    Region: Alberta

    Service: Supporting New Researchers

    Eligibility: Covenant Health Researchers

    Contact: 780-735-2274 or research@covenanthealth.ca

    More Inforamtion: CHRC Website

     

    THE METHODS HUB

    Region:  Calgary

    Service: The Methods Hub is a group of dedicated health researchers who have expertise and provide education in methodology.

    Eligibility: Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information:  Visit The Methods Hub website

     

     

     

  3. 3

    Study Review

    Has the study been reviewed by the qualified individuals and the applicable departments?

    Reviewing the scientific and operational requirements of a study can help to address whether a study is feasible.

    Questions to ask yourself and others about the feasibility of your project at a departmental and institutional level:

    1. Does the study question fit with the mandate of your institution?
    2. Does the study addresses an important question and have a high likelihood of improving clinical practice?
    3. Is the protocol well designed and have an appropriate risk-to-benefit ratio for the participant population?
    4. Do the researcher(s) have the appropriate training/qualifications and experience in this therapeutic area and type of trial?
    5. Are the inclusion/exclusion criteria overly restrictive?
    6. Are study approvals required and can study approvals be obtained?
      • Ethics approval?
      • Research Agreements?
      • Operational approval?
      • No Objection Letter from Health Canada?
      • Sponsor agreements (contact, master agreement with work orders)?
      • Sub-site agreements?
      • Privacy impact assessment?
    0

    ALBERTA HEALTH SERVICES (AHS) RESEARCH FACILITATION

    Region: Alberta

    Service: Assessment of administrative data suitability and availability

    Eligibility: All researchers using AHS data sources

    Contact: research.facilitation@ahs.ca

    More Information: Visit the AHS Research Facilitation page for more information.

     

    COVENANT HEALTH RESEARCH CENTER (CHRC)

    Region: Alberta

    Service: Supporting New Researchers

    Eligibility: Covenant Health Researchers

    Contact: 780-735-2274 or research@covenanthealth.ca

    More Inforamtion: CHRC Website

     

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service: Protocol review (NACTRC will fund a one-time consultation with EPICORE Centre for protocol assistance)

    Eligibility: University of Alberta Researchers

    Contact: (780) 492-8525 or 1-877-876-9888

    More Information: Visit the EPICORE Centre website

     

    THE METHODS HUB

    Region:  Calgary

    Service: The Methods Hub is a group of dedicated health researchers who have expertise and provide education in methodology.

    Eligibility: Alberta Researchers

    Contact: themethodshub@ucalgary.ca

    More Information:  Visit The Methods Hub website

     

    QUALITY MANAGEMENT IN CLINICAL RESEARCH (QMCR) - UNIVERSITY OF ALBERTA

    Region: Edmonton

    Service: Risk assessment, quality improvement, quality control, quality assurance, clinicaltrials.gov management

    Eligibility: University of Alberta Researchers

    Contact: scott.jamieson@ualberta.ca or 780-492-6223

    More Information:

  4. 4

    Training

    What training do I and my study staff need to conduct clinical research and this study? How do I track what study-specific training my staff have received and how do I best deliver that training?

    High quality research stems from training and a knowledgeable research team.

    “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). (ICH GCP E6 (2.8)”.

     

    Training for the conduct of Clinical Research

    Highly qualified staff are required to conduct high quality research.

    To foster ongoing education, the Alberta Clinical Research Consortium in collaboration with the partner organizations are identifying training opportunities to help researchers and their staff help develop these skills.

    It is with this principle in mind that on March 20, 2015 the ACRC, speaking as representatives of the partner organizations endorsed the following training recommendations for researchers and research staff. 

     

    Study-Specific Training

    Research staff are to be familiar with the study and all of his/her delegated tasks necessary to conduct the trial according to the approved protocol. A Study Training Log may be used to document study-related training for each research staff member on the protocol and protocol amendments.

    The ACRC has developed a Study Training Log template to assist in the development of training documentation.

    ALBERTA HEALTH SERVICES

    Region: Alberta

    Service: Provide access to CITI training

    Eligibility: Alberta Health Services researchers

    Contact: research.administration@ahs.ca

    More Information: Visit the CITI-Canada Training webpage

     

    ALBERTA INNOVATES

    Region: Alberta

    Service: Provide access to CITI training

    Eligibility: Alberta Innovates employees and community researchers

    Contact: acrc@albertainnovates.ca

    More Information: Visit the CITI-Canada Training webpage

     

    COVENANT HEALTH RESEARCH CENTER (CHRC)

    Region: Alberta

    Service: Identifying and offering opportunities for research education and provides CITI Training

    Eligibility: Covenant Health Researchers

    Contact: 780-735-2274 or research@covenanthealth.ca

    More Inforamtion: CHRC Website or the Tools and Resources webpage

     

    EPIDEMIOLOGY COORDINATING AND RESEARCH CENTRE (EPICORE)

    Region:  Edmonton

    Service: Post-doctoral fellowship training in health research

    Eligibility: University of Alberta Researchers

    Contact: (780) 492-8525 or 1-877-876-9888

    More Information: Visit the EPICORE Centre website

     

    QUALITY MANAGEMENT IN CLINICAL RESEARCH (QMCR) - UNIVERSITY OF ALBERTA

    Region: Edmonton

    Service: CITI Canada access

    Eligibility: University of Alberta staff

    Contact: scott.jamieson@ualberta.ca or 780-492-6223

    More Information: Visit the QMCR website

     

    NORTHERN ALBERTA CLINICAL TRIALS AND RESEARCH CENTER (NACTRC)

    Region: Edmonton

    Service:  Clinical Research Seminar Series, periodically offer the SOCRA exam in Alberta

    Eligibility:  University of Alberta Researchers

    Contact: Complete the NACTRC Contact Form

    More Information: NACTRC Research Support webpage

     

    UNIVERSITY OF CALGARY

    Region: Calgary

    Service: Provide access to CITI training

    Eligibility: University of Calgary researchers

    Contact: linda.longpre@ucalgary.ca

    More Information: Visit the CITI-Canada Training webpage

    STUDY TRAINING LOG

    Research staff are to be familiar with the study and all of his/her delegated tasks necessary to conduct the trial according to the approved protocol. The Study Training Log may be used to document study-related training for each research staff member on the protocol and protocol amendments.

    Study Training Log

  5. 5

    Privacy Considerations

    The clinical health research community has a responsibility to protect the privacy of participants where personal information and personal health information may be used for research purposes.

    Clinical health researchers should have an understanding of the privacy and security requirements laid out locally, provincially and federally for health research with humans including the appropriate collection, use, dissemination, retention and destruction of personal health information for the purposes of a clinical study.

    Privacy Training:

    Alberta Health Services

    University of Alberta

    University of Calgary

    ALBERTA HEALTH SERVICES PRIVACY OFFICE

    Region: Alberta

    Service: Ensuring research projects are compliant with HIA and FOIP and institutional policy

    Eligibility: AHS Researchers

    Contact: privacy@ahs.ca, or 1-877-476-9874, 1-877-573-5107

    More Information: AHS Privacy Office Webpage

     

    ALBERTA OFFICE OF THE INFORMATION & PRIVACY COMMISSIONER

    Region: Alberta

    Service: Information on how to complete a Privacy Impact Assessment

    Eligibility: Open

    Contact: Phone: 780.422.6860, Toll-free: 1.888.878.4044, generalinfo@oipc.ab.ca

    More Information: OPIC website

      

    COVENANT HEALTH

    Region: Alberta

    Service: Advice on privacy issues with regard to CH research projects

    Eligibility: Covenant Health Researchers

    Contact: privacy@CovenantHealth.ca or 1-866-254-8181

    More Information:  Covenant Health Information and Privacy Page

     

    UNIVERSITY OF ALBERTA INFORMATION AND PRIVACY OFFICE

    Region: Edmonton

    Service: Assist the university to operate in a manner consistent with the requirements of privacy legislation.

    Eligibility: University of Alberta Employees

    Contact: foipp@ualberta.ca, Ph. 780-492-9419, Fax 780-492-6571

    More Information: Visit the UofA IPO website

     

    UNIVERSITY OF CALGARY PRIVACY AND RECORDS - CUMMING  SCHOOL OF MEDICINE

    Region: Calgary

    Service: Assist the university to operate in a manner consistent with the requirements of privacy legislation.

    Eligibility: University of Alberta Employees

    Contact: gefiebel@ucalgary.ca or 403-210-7598

    More Information: Visit the UCalgary Legal Services website

     

     

PROJECT IN SET-UP

Once the protocol has been detailed and finalized, there are a number of approvals to help ensure participant protection, privacy and confidentiality, as well as, ethical and organizational oversight. Many of these steps proceed concurrently.
  1. 1

    Standard Operating Procedures (SOPs)

    What is an SOP?

    Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions on routine operations, processes and practices followed within an unit or organization. Following SOPs ensures that there are consistent and uniform practices.

    The SOPs should detail the specific steps, incorporate institutional policies and applicable regulations such as ICH E6 Good Clinical Practice. It is recommended that the SOPs are written that allow for variation while still ensuring the central tenets of the procedure are followed. For example, the SOP may outline that the 'study file is to be stored in a locked cabinet' but not necessarily 'in the third cabinet from the top'.

    The SOPs are to be signed by the group or department research administrator or physician with the date of approval. Research team members should be trained on the SOP and training documented including date of completion of training. The SOPs are to be reviewed and study staff refreshed on a regular basis.

    N2 STANDARD OPERATING PROCEDURES

    Looking for SOPs or want to ensure yours are Health Canada compliant? The ACRC partner organizations are pleased to provide you with a core set of N2 SOPs covering areas from roles and responsibilities to equipment calibration and maintenance. These SOPs are reviewed every second year to ensure compliance with changes in regulations. Also available are biospecimen SOPs. The SOP Table of Contents is available for your review. Should you require a full version of the documents, please email acrc@albertainnovates.ca.

  2. 2

    Contracts

    Does your study have documents and legal agreements that must be reviewed by the applicable legal department?

    Once the protocol has been detailed and finalized, there are a number of approvals to help ensure participant protection, privacy and confidentiality, as well as, ethical and organizational oversight. Many of these steps proceed concurrently.

    These documents may include;

    • Grants
    • Confidentiality Disclosure Agreements (CDA)
    • Clinical Trials Agreements (CTA)
    • Draft contracts
    • Data Transfer Agreements (DTA)
    • Material Transfer Agreements (MTA)
    • Study sub-site agreements/contracts
    • Legal document amendments

    COVENANT HEALTH RESEARCH CENTER (CHRC)

    Region:  Alberta

    Service: Covenant Health Legal Council will review all clinical trial research agreements and provide a written acknowledgement to the Principal Investigator or Research Coordinator once contract is confirmed.

    Eligibility: Covenant Health Researchers

    Contact: 780-735-2274 or research@covenanthealth.ca

    More Information: Covenant Health Research Centre (CHRC)

     

    CUMMING SCHOOL OF MEDICINE: LEGAL, RESEARCH SERVICES - UNIVERSITY OF CALGARY

    Region:  Calgary

    Service: The Cumming School of Medicine’s Legal, Research Services, team (CSM legal) provides legal review of contracts and agreements. The team can assist with drafting, negotiation and execution. Submit a new contract for review and signing by designated University of Calgary authorities, or learn more by checking out the tabs below.

    Eligibility: University of Calgary Researchers

    Contact: csmlegal@ucalgary.ca

    More Information: CSM Legal, Research Services

     

    NORTHERN ALBERTA CLINICAL TRIALS AND RESEARCH CENTER (NACTRC)

    Region:  Edmonton

    Service: NACTRC employs a team of legal experts including clinical research administrators, clinical trials administrators, contracts specialists, and lawyers that work closely with sponsors, researchers. and administrators to appropriately allocate the responsibilities for a study between the sponsor, investigator, AHS, and University, as well as to ensure turnaround times are met and to safeguard AHS’s and the University’s interests.

    Eligibility: University of Alberta Researchers

    Contact: Complete the NACTRC Contact Form

    More Information: NACTRC

     

    RESEARCH SERVICES OFFICE - UNIVERSITY OF ALBERTA

    Region:  Edmonton

    Service: Negotiation and approval of research agreements/contracts with foreign and domestic federal, provincial and industry sponsors, excluding institutional activities and major collaborative partnerships (see Partnership & Institutional Projects for a further listing of excluded programs).

    Eligibility: University of Alberta Researchers

    Contact: Email rsoinfo@ualberta.ca or see contact page for directory

    More Information: Understanding Contracts Video, RSO Webpage

     

     

  3. 3

    Ethics Approval

    Research involving human participants in Alberta follows the Tri-Council Policy Statement 2ICH GCP, Health Information Act, Health Canada Regulations and Guidelines.

    Any project/study which involves reviewing and/or Collecting of specimens, data or information on human participants for research purposes requires ethics approval from one of the three Alberta Health Information Act designated boards.

    Research involving human participants in Alberta follows the Tri-Council Policy Statement 2ICH GCP, Health Information Act, Health Canada Regulations and Guidelines. 

     

    What is involved?

    Generally the Research Ethics Boards may request you to submit:

    • Ethics application form (typically done online)
    • Protocol or study plan
    • Any material a participant may see (ie. advertisement, diary)
    • Questionnaires
    • Recruitment materials
    • Informed Consent Forms (ICF)
    • Health Canada approval (if applicable)

     

    Where do I apply?

    There are three HIA designated Boards in Alberta:

    1. HREBA:

    • For cancer studies
    • For community-based clinical trials
    • For community health studies

    For University affiliated faculty, staff or students:

    2. University of Alberta (HREB) - HREB administers the ethics review process for all faculty, staff and students of the University of Alberta (U of A) health sciences faculties, Alberta Health Services, and Covenant Health.

    3. University of Calgary (CHREB) - At the University of Calgary, there are two Research Ethics Boards responsible for reviewing research applications involving human participants:  The Conjoint Health Research Ethics Board (CHREB) and the Conjoint Faculties Research Ethics Board (CFREB).  The Conjoint Health Research Ethics Board (CHREB) reviews applications from Researchers affiliated with the Faculties of: Kinesiology, Medicine, Nursing

    More information on: Where to Apply - Human Health Research Ethics Approval in Alberta?

     

    Is ethics approval required for my project?

    Some projects (i.e. research involving public available information or research based on observation in a public place not involving interaction with an individual or a third party.) may not need ethics approval. Any study involving participants either directly or by chart review will require ethics approval. It is best to check with the respective Board to check if your study requires approval or is exempt.If the primary purpose of the project is to improve practice or service delivery with an organization or setting, is site or program-specific or targets a service or process improvement, it may be either a quality improvement or program evaluation study.

    The ARECCI Ethics Screening Tool and a set of guidelines have been developed to help researchers distinguish the ethics requirements of a quality improvement or program evaluation study. 

     

    What happens once I submit my study to a REB?

    Each research ethics board reviews the study protocol, patient materials (such as the consent forms or recruitment posters) and other documents to ensure that the rights, safety and well-being of research participants are protected.Alberta’s research ethics boards consist of people who have expertise in research, ethics and law.  There must also be individuals who have no affiliation with the institution, called community members. 

     

    How can I improve the quality of my application?

    A major part of any ethics application process involving human participants is developing a good protocol/study plan and good Informed Consent Forms (ICFs). Properly developed protocol study/plan and informed consent forms will help smooth out the process of Ethics Approval. Depending on the type of research you are conducting and the target population, different types of consent forms may need to be utilized.

    ARECCI ETHICS GUIDELINES AND SCREENING TOOL

    The ARECCI Ethics Screening Tool and a set of guidelines have been developed to help researchers distinguish the ethics requirements of a quality improvement or program evaluation study.

    INFORMED CONSENT TEMPLATES

    Each ethics board has templates in order to facilitate development of informed consent forms:

    Conjoint Health Research Ethics Board/University of Calgary (CHREB)

    Health Research Ethics Board/University of Alberta (HREB)

    Health Research Ethics Board of Alberta (HREBA): Cancer Committee (CC)

    Clinical Trials Committee (CTC)

  4. 4

    Regulatory Approvals

    What Regulatory Approvals will my study require?

    A research study may require one or more regulatory approvals.  

    The study may require submission of a Clinical Trial Application (CTA) with Health Canada if the study involves;

    • a new drug/device/natural health product;
    • a comparative bioavailability study; or
    • a marketed drug/device/natural health product outside of the approved use (i.e. a different indication, target population, route of administration or dosage regimen)

    If a CTA is successful and there have been no deficiencies, Health Canada will issue a No Objection Letter (NOL).

     

    Are the study Sponsor or Contract Research Organization located in the US?

    Other regulatory approvals that may be required include;

    • W-8 BEN: this form relates to tax exemption for research funds directed to the study site, and is a requirement of the Internal Revenue Service. This form must be signed by an authorized representative from the institution where the funds are deposited.
    • Form 1572, The Statement of Investigator: an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.
  5. 5

    s54 HIA and FOIP Research Agreements

    Does your study involve accessing health information?

    Several types of Research Agreements may be required for your study.

    Research Agreements help to ensure the security and utility of health information by laying out how health information may be used or disclosed for each specific research study.

     

    Why are HIA or FOIP Research Agreements needed?

    • HIA: Researchers requesting health information must meet the requirements of the Health Information Act (HIA) s.54 and, in the absence of a clinical trial agreement, a research agreement binds the researcher to these requirements.
    • FOIP: All research which involves employees or employee information must be in compliance with Alberta's Freedom of Information and Protection of Privacy Act (FOIP Act).
    • Research Agreements may also help to address the feasibility of a research study by ensuring requested health information can be appropriately obtained and matched from different data sources.

     

    How do I apply for a Research Agreement?

    • As a researcher, depending on your request, you may not need to initiate the process outside of your normal ethics application process. By notifying your ethics board that you will be needing access to healthcare resources as part of your ethics application, this will, in many instances, notify research administrators that your study will have to be assessed as potentially needing a research agreement. 
    • It is the responsibility of each custodian (offices listed below) to assess, initiate and ensure a research agreement has been signed when required for each health information-related study.
    • It is the responsibility of each researcher to provide requested information and documentation as requested by the custodian.
    • In respect to information requests from AHS and Covenant Health (custodians), research administrators are notified when a request for health-information has been approved by an HIA-designated research ethics board.

     

    What will the data custodian ask for?

    • AHS: Research Administration may ask you for documents to assess whether a AHS research agreement is required and support the filling out of;  
      • Schedule A: the full approved research proposal
      • Schedule B: the Research Ethics Board approval letter
      • Schedule C: the name of source systems and corresponding list of data elements from each source system or repository if applicable (to ensure the data is available!)
      • Schedule D: other information including details as to how AHS expects patients to be contacted for the research study

     

    What happens if I have a fully executed CTA with AHS?

    A Clinical Trial Agreement (CTA) in most cases meets the requirements of AHS and is undertaken between the sponsor and the institution. Should a Clinical Trial Agreement exist, an HIA s.54 agreement may not be required. 

     

    Who do I talk to about Research Agreements?

    • For more information on the HIA Research Agreement requirement for AHS, please contact AHS Provincial Research Administration at Research.Administration@ahs.ca.
    • For more information from the Covenant Health Research Centre please contact Research Administration through their website or research@covenanthealth.ca
  6. 6

    Operational Approval

    Will I need an Operational Approval(s)?

    If your clinical research utilizes Alberta Health Services (Property, Resources, Facilities, Patients or Staff), you must obtain an Operational Approval from each area that you are accessing. The individual responsible for approving your request will determine whether their area is able to support your research.

    Early dialogue is encouraged with the applicable department/facilities to determine whether they have the necessary equipment, staff, space, etc. available for the study. It is recommended to have a draft or finalized study protocol available for these discussions. For a protocol template click here.

    Operational approvals are provided in Alberta by:

     

    Streamlined AHS Provincial Research Administration Processes - Calgary Region

    Please note that research administrative processes in the Calgary region have recently changed. Processes for AHS Operational Approval, Requests for AHS Data and Requests for AHS IT System Access have all been streamlined as of February 1, 2016. Please click here for more details.

     

    NORTHERN ALBERTA CLINICAL TRIALS AND RESEARCH CENTER (NACTRC)

    Region: Edmonton

    Service:  Provide system to apply for Operational Approvals

    Eligibility:  University of Alberta Researchers

    Contact: Complete the NACTRC Contact Form

    More Information: For more information on this service you must have an account with NACTRC, login to your account and click on "PI Resources".

  7. 7

    Administrative Approval

    When will I receive my Administrative Approval?

    A fully executed administrative approval for a study will be issued when all other approvals are in place. This will include ethics approval, and as required; operational approval, a research agreements and a purchased services agreement.

    Administrative approvals are provided in Alberta by research administration centers such as;

  8. 8

    Account Set-up

    Who is responsible for setting up the accounts for your study?

    Resources for account set-up in Alberta; 

  9. 9

    Data Safety Management Board (DSMB)

    DATA SAFETY MONITORING BOARD

    A multi-disciplinary, expert advisory group established by a research sponsor, that is responsible for safeguarding the interests of participants by reviewing emerging data, assessing the safety and efficacy of clinical trial procedures, and monitoring the overall conduct of a trial. (CDISC)

    Roles and Responsibilities of a DSMB:  The DSMB should review each protocol for any major concern prior to implementation. During the trial, the DSMB should review cumulative study data to evaluate safety, study conduct, and scientific validity and integrity of the trial. As part of this responsibility, DSMB members must be satisfied that the timeliness, completeness, and accuracy of the data submitted to them for review are sufficient for evaluation of the safety and welfare of study participants. The DSMB should also assess the performance of overall study operations and any other relevant issues, as necessary.1

    Northern Alberta Clinical Trials Research Center (NACTRC) provides services to investigators for in setting up a DSMB documents (in collaboration with AHS and Iron Mountain). For more information on this service you must have an account with NACTRC, login to your account and click on "PI Resources" or for more information please contact Scott.Jamieson@ualberta.ca.

  10. 10

    Trial Registration

    Are you required to register your trial?

    Registering your trial helps to ensure information about clinical trials is available publicly. 

    As part of a policy enacted in 2005 by the International Committee of Medical Journal Editors (ICMJE), researchers are required to register their trial at an accepted registry website such as clinicaltrials.gov before patient enrollment if the intent is to publish the research in an ICMJE journal affiliate. 

    Support and guidance is available within Alberta universities to help researchers register their trial.

    • University of Calgary and CCCR: Researchers can initiate and maintain their clinicaltrials.gov registration using guidelines found here.
  11. 11

    Site Initiation Visit

    The Site Initiation Visit (SIV) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment. The principal investigator (PI) must attend this visit together with as many members of the research team as possible. The visit occurs after all the approvals are obtained. During the visit, there is confirmation of the necessary approvals are in place, study-related materials have been reviewed and approved as necessary, sufficient investigational product and laboratory supplies, and the staff have been trained on the protocol and SOPs. 

    SITE INITIATION MEETING PACKAGE

    Site initiation is the checkpoint to make sure all approvals, documentation and procedures are in place before a study starts and participants can be enrolled. A site initiation visit is held near the desired study start up time in order to train the study staff on the protocol and procedures. The Site Initiation Meeting Package includes:

    These templates may be fully customized for specific study needs and come with a Guidance Document for tips on usage and best practice.

ACTIVE STUDY

Once all of the necessary approvals have been obtained, the study or project can begin (i.e. open to recruiting participants, obtaining charts or data for review). Throughout the study, annual ethics approvals; protocol and/or contract amendments; monitoring, etc. may be required. Note: during this stage, the study may progress to the stage of closed to enrolling additional participants, but still be active for data analysis or queries.
  1. 1

    Recruitment

    Recruitment for clinical research studies can be one of the most challenging tasks. Many studies fail meet recruitment targets. Building a realistic recruitment plan at the study protocol phase is essential. The most common mistake in determining recruitment targets are investigators greatly over-estimating the pool of available patients who meet the inclusion criteria(1). 

    A detailed recruitment strategy should be developed and tailored specifically to the research question. Patients will decline to participate in studies if they are too complex, too time consuming or, in their perception, may hinder treatment. These details must be considered when designing a recruitment strategy. A poor recruitment strategy can greatly lengthen a studies timeline as well as increase budget, delay results and potentially hinder publication, reliability and validity.

    All recruitment strategies must be approved by the appropriate research ethics board.

    0

    HEALTHY INFANTS AND CHILDREN CLINICAL RESEARCH PROGRAM (HICCUP)

    Region: Alberta

    Service: A registry of pediatric healthy controls that may want to participate in clinical research. 

    Eligibility:  Principal investigators of an ethically approved, scientifically reviewed clinical research study in need of child or parent subjects to serve as population samples or healthy controls.

    Contact: 

    Edmonton: meghan.linsdell@ualberta.ca or 780-248-5605

    Calgary: hiccup@albertahealthservices.ca or 403-955-2472

    More Information: HICCUP Edmonton, HICCUP Calgary

     

    LOIS HOLE CLINICAL RESEARCH UNIT

    Region: Edmonton

    Service: Provides guidelines and approvals for research access to patients (in labour and delivery, antepartum, postpartum, gynecology, operating rooms and/or ambulatory care), their families and staff members at the Lois Hole Hospital for Women.

    Eligibility: Researchers who require access to Women's Health patients (labour and delivery, antepartum, postpartum, gynecology, operating rooms and/or ambulatory care), their families or staff members of the Lois Hole Hospital for Women (LHHW) at the Royal Alexandra Hospital.

    Contact:  (780) 735-4802 or janie.clink@albertahealthservices.ca

    More Information: Lois Hole Clinical Research Unit Webpage

     

    UNIVERSITY OF CALGARY - PARTICIPATE IN RESEARCH

    Region: Calgary

    Service: Support researchers to recruit human participants

    Eligibility: University of Calgary Researchers

    Contact: research@ucalgary.ca

    More Information: Participate in Research Webpage

    N2 Canada hosts many resources for research staff to provide to potential patients for information regarding clinical trials. Check out the N2 website It Starts with Me.

    As well, N2 provides resources such as a promotional brochure, pamphlet, video or a Powerpoint Presentation "Clinical Trials 101" which may be used to help inform patients on what is involved when participating in a clinical trial.

    N2 Brochure in EnglishN2 Brochure in FrenchClinical Trials 101

     

    1. Spilker B, Cramer J. Patient recruitment in clinical trials. New York (NY): Raven Press Ltd; 1992.

  2. 2

    Monitoring

    What monitoring is required for your study?

    During the course of the study it is important to monitor the progress regularly to ensure it is run in compliance with regulations, the protocol, the contracts and agreements, the budget and can be completed with the allotted resources and finances. 

    Diligent monitoring will help to identify problems as they arise before study completion and keep the study on track.

    During the course of the study it is important to monitor the progress regularly to ensure it is run in compliance with regulations, the protocol, the contracts and agreements and the budget. Also, that it can be completed with the allotted time, resources and finances. Monitoring considerations include;

    • Investigator and staff qualifications
    • Verification of resources and facilities
    • Receipt, use and disposal of investigational products
    • Informed consent obtained and documented
    • Source document and trial record documentation

    A regulatory binder helps organize the essential documents; provides easy access to essential documents required by the study monitors, auditors, REB and regulatory authorities for audit/review purposes; and enables the research team to reference information. 

  3. 3

    Reporting

    What reporting will be required for your study?

    Annual scientific progress reports are often requested as part of funded research grants or awards and may be required for each year the fund is awarded following by a final report after the end of the study.

    Care should be taken to review the individual requirements and deadlines for these annual reviews as failure to comply could result in funds being withheld, study delay or even termination.

    In anticipation of required annual reporting, researchers may keep an up-to-date record of;

    • Results obtained (milestones, major findings)
    • Publications
    • Conference presentations/abstracts
    • Scientific communications related to the study
    • List of additional grant funding obtained as a result of the study results or funding 

    Reports also must be made to the REB in the case of a Serious Adverse Event (SAE), Protocol deviation or violation, or safety report: 

     

  4. 4

    Amendments

    Do you need to make an amendment to your study protocol or contracts?

    Notifying the appropriate authority of any changes will ensure your study follows applicable rules and regulations while maintaining trust in your study and operations.

     

    Amendments to the Protocol

    During the course of the study, due to unforeseen circumstances, it may difficult to adhere to the study protocol as written and become necessary to make changes to the study protocol and/or the informed consent forms.

    Any changes to a research protocol should have a solid ethical and/or scientific rationale and should be documented accordingly.  All amendment applications should be submitted promptly to the relevant Research Ethics Board (REB).

    For multi-site studies, all participating sites should be notified of the changes, amend their ethics as required, and coordinate implementation of the necessary changes to protocol, documentation and data collection.

     

    Amendments to the Contract

    It may not always be possible to anticipate how the relationship between funder/sponsor and researcher will progress at the time of study start-up and contract negotiation. Common amendments include a change in the lead investigator or an extension to a project end date. Changes to an agreement may require sponsor approval and will be processed through the research services or contracts department who is administering the study. 

CLOSED

All study-related activity is completed. Applicable parties who have been involved in the study are informed. (i.e. research ethics board, research office, finance, purchased services, sponsor). At this point, research materials are gathered, and samples or data is shipped, saved, or destroyed.
  1. 1

    Prepare for Study Closure

    Have you identified all the requirements for closing out your study?

    Many things need to be considered when closing the study. A closeout visit should be held with either sponsor and/or study staff as appropriate. Notifications to  regulatory agencies must be sent out. All queries and auditor/monitor findings must be resolved. If there is an investigational product, it must be dealt with accordingly. Decisions must be made (if not already done) about where study files/materials will be stored. 

     

    STUDY CLOSURE

    To help with the process of study closure, the use of a study closure checklist is recommended.

  2. 2

    Inform Institution/Regulatory Agencies

    Have you notified your institution, department and/or Regulatory Agencies of your intent to close your study? 

    A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.  

    Your institution may have specific guidance and rules regarding the recommended approach to closing your study. 

    Health Canada may also need to be notified at study closure, this is typically the responsibility of the sponsor.

  3. 3

    Inform REB

    Have you notified the REB?

    REB require investigators to report when your study is complete. This is typically done through the electronic ethics system (REMO/IRISS). At this time study end date, final recruitment numbers and all documentation must be up-to-date.

    A study can be closed if:

    • All contact with human participants is complete – including follow up and sending out of study results;
    • Grant access is not required;
    • There is US funding or the study falls under FDA regulations;
    • Ongoing data analyses does NOT involve personally identifying information.

     Find more information on the study closure process for:

    University of Alberta (HREB/REMO)

    University of Calgary (CHREB/IRISS)

    Health Research Ethics Board of Alberta (IRISS)

  4. 4

    Archive Documents

    Do you have a plan for the long-term storage or archiving of your study-related documents?

    Certain study files and documents must be kept for an extended length of time. You may choose to store these yourself, or they may be stored offsite via an information management service.

     

    What am I required to archive?  

    Drug, device or natural health product studies that are regulated by Health Canada require 25-year study-related record retention. Studies not subject to Health Canada regulations must be retained for 7 years. However, sponsor, publishing journal or professional affiliation standards for record retention may apply. Check with your appropriate institution as to whether they have a contract with an information management company which aides in cost reduction.

    Record Retention Requirements 

    University of Alberta - Policy on Record Retention

    University of Calgary - Record Retention Rule

    Health Canada Requirements

    NORTHERN ALBERTA CLINICAL TRIALS AND RESEARCH CENTER (NACTRC)

    Region: Edmonton

    Service: Northern Alberta Clinical Trials Research Center (NACTRC) provides services to investigators for archiving documents (in collaboration with AHS and Iron Mountain). The new agreement with Iron Mountain enables investigators to pre-pay for storage and auto-destruction so that these costs can be included in the contract and budget for sponsor reimbursement. The storage and destruction of clinical research documentation is an ICH Good Clinical Practice obligation on the investigator.

    Eligibility:  University of Alberta Researchers

    Contact: Complete the NACTRC Contact Form

    More Information: For more information on this service you must have an account with NACTRC, login to your account and click on "PI Resources".

     

    CALGARY CENTRE FOR CLINICAL RESEARCH

    Region: Calgary

    Service: Please ensure that the University of Calgary's archiving policies and procedures are followed for all clinical trials that are completed.  General information on offsite storage and destruction of clinical trials records can be found on this website. 

    Eligibility: University of Calgary Researchers

    Contact: cccr@ucalgary.ca

    More Information: Specific archiving questions should be directed to Archives Office.

     

     

  5. 5

    Publishing your Study

    What will you publish? Where will you submit your publication? When is the best time to do this?

    A clinical trial is not considered complete until the study report is published. The final study report is the responsibility of the sponsor-investigator and follows a defined format.

    Study results may also be published in the form of peer-reviewed publications. Note that clinical trial registration in a public trials registry before enrolment of the first participant is a general requirement for publication of clinical trial results.

    Both of these types of reports can be planned in the development phase and finalized throughout the study and its close.

     

    1. Final Study Report

    One of the requirements of trial closure is that a summary of the final study report be sent to the responsible regulatory authorities as well as the Research Ethics Board.

    Structure and content:  The Health Canada Guidance Document specifies the structure and content of the final study report. Following this guidance enables you to compile a core study report that is applicable to regulatory authorities of the ICH regions.

    Alberta specific requirements:

    A final study report must be sent through the REB process (either via REMO or IRISS). In the case of a study that was conducted through, the Covenant Health Research Centre, a final study report must be submitted to their office.

     

    2. Peer Reviewed Publications

    What do you want to publish?

    Think through and define what you want to publish. What are your primary and secondary hypotheses?

    Depending on the size of the study and your study team, think about who will be involved in the publications. Talk through authorship early. [Example: Fraser Health Authorship Agreement] The International Committee of Medical Journal Editors (ICJME) defines what is required for authorship  although each journal may have its own criteria.

     

    Where do you want to publish?

    Think about journals you may want to submit to, such as the major journals in your field, and whether your publication would be appropriate. Consider the impact factor of the journal. Consider first and second choices for submitting your publication.

     

    How will you format the publications?

    There are several guidelines for reporting your study which apply to different study designs. For example, CONSORT for randomized trials, STROBE for observational studies and PRISMA for systematic reviews and meta-analyses. A resource such as the EQUATOR Network contains a large collection of reporting guidelines.

    ICJME has a set of comprehensive recommendations for preparing and submitting a manuscript. As well, each journal may have its own author instructions. You may consider writing a generic manuscript to be modified for specific publications. Most full journal articles are about 3000 words.

    Writing your manuscript

    One method of starting is to outline the general sections of a journal publication: Introduction, Methods, Results, and Discussion. Each section will start with a heading and topic sentence. A good place to start is by reviewing the protocol, as you can base the introduction and methods on the hypotheses, aims and methods described within.

    You will also keep the big picture in mind as you write the article: the gaps in knowledge, the questions you aimed to answer, the methods you used to answer them, the results, and what those results mean. Write for a non-expert, using consistent terminology. Once all co-authors have written and reviewed the manuscript, it may be useful to have an outside colleague review the manuscript before submission.

    Submitting manuscript

    Once the paper is ready to submit, follow the submission procedures of the journal. This will likely include a cover letter and/or a completed journal submission form. Some journals have a pre-submission checklist that you can follow.

    Peer review and response/revision

    Peer review is the process of review of the manuscript by outside experts who are not affiliated with the journal. Peer reviewers will recommend acceptance, revisions, or rejection of the manuscript. The journal editor is not bound by the reviewers’ recommendations. The editorial response may include an opportunity to revise and resubmit. In this case, along with the re-submission, you and your coauthors would respond item by item to the reviewers’ points in an accompanying letter.

    WOMEN AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)

    Region: Edmonton

    Service: WCHRI offers assistance with manuscript review (results and methodology sections) for your qualitative research project.

    Eligibility: WCHRI Members

    Contact: wchri@ualberta.ca or 780-248-5602

    More Information:  For more information and to access any of our services, complete the research support request form or go to our Qualitative Research webpage

    CLINICAL TRIALS REGISTRATION AND PUBLICATION

    ClinicalTrials.gov

    Elsevier

    OHSU Library - LibGuides

     

    REPORTING

    Consolidated Standards of Reporting Trials (CONSORT) for randomized controlled trials (RCTs)

    Catalogue of Reporting Guidelines for Health Research (EQUATOR)  for observational studies, diagnostic accuracy studies, biospecimen reporting, reliability and agreement studies, systematic reviews and meta-analyses, qualitative research, mixed methods studies, economic evaluations, quality improvement studies, and other reporting guidelines.

     

    "Recommendations for the Donduct, Reporting, Ediging, and Publication of Scholarly Work in Medical Journals". ICMJE December 2015. Retrieved June 2016.

    Bordeaux, Bryan C. et al. "Guidelines for Writing Manuscripts About Community-Based Participatory Research for Peer-Reviewed Journals". The Johns Hopkins University Press 2007, Retrieved June 2016.

    Crowson, Matthew C. "A crash course in medical writing for health profession students". Journal of Cancer Education, 2013. Retrieved June 2016.

    Azer, S.A. et al. "Writing for Publication in Medical Education in High Impact Journals". ERMPS 2014. Retrieved June 2016. 

    "The Equator Network". Retrieved June 2016. 

    "Writing Process for Manuscripts". AAFP NRN January 2006. Retrieved June 2016.

    Goodman, Andy. "Why Bad Presentations Happy to Good Causes". Canadian Foundation for Healthcare Improvement June 2008. Retrieved June 2016

    Purrington, Colin. "Designing Conference Posters".  March 2013. Retrieved June 2016.

    Rodriguez, Natalia. "Infographic:  Tips for designing better research posters".  Elsevier Connect May 2015. Retrieved June 2016

    Browner, Warren S. Publishing & Presenting Clinical Research. Chapter 14. Wolters Kluwer, 2013.

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