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.
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.
Alberta
Alberta Clinical Research Consortium - Glossary & Common Terminology
Canada
Canadian Institutes of Health Research (CIHR) Jargon Buster
"It Starts with Me" Glossary (N2 Canada) - Participant-friendly terminology for clinical research
International
National Institute for Health Research (NIHR, UK) INVOLVE - Jargon Buster
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.
The Purpose of Alberta Children's Hospital Research Institute (ACHRI) is to support and advance the research capacity of ACHRI members and their teams, through consultation and direction at all stages of research (Early consultation is OPTIMAL). To access support services, all ACHRI members have access to 6 hours of free research methods support per project, after which research services are available at the prorated cost of $50/hr.
Research is a clinical strategic priority within Alberta Health Services. AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
WARD OF THE 21ST CENTURY (W21C)
Ward of the 21st Century (based at the University of Calgary) is a research and innovation initiative that focuses on creative collaborations to develop new ideas to build new paradigms for healthcare delivery.
Physicians, industry experts and academics can bring ideas for prototyping in pre-clinical and clinical environments.
Please see our Research Question Development Guide.
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.
The Purpose of Alberta Children's Hospital Research Institute (ACHRI) is to support and advance the research capacity of ACHRI members and their teams, through consultation and direction at all stages of research (Early consultation is OPTIMAL). To access support services, all ACHRI members have access to 6 hours of free research methods support per project, after which research services are available at the prorated cost of $50/hr.
AHS: Research is a clinical strategic priority within Alberta Health Services. AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Alberta SPOR SUPPORT Unit is dedicated to the integration of research into care, so that the right patient receives the right care at the right time. We foster evidence-informed health care by bringing innovative diagnostic and therapeutic approaches to the point of care, to ensure greater quality, accountability, and accessibility of care. We support researchers conducting patient-centered research by providing access to experts and knowledge in seven core areas of expertise: Career Development Platform, Consultation & Research Services Platform, Data Platform, Knowledge Translation Platform, Methods and Support Development Platform, and Patient Engagement. The AbSPORU Patient Engagement Platform can provide information and resources on how to engage and connect you to patients or the public.
Ward of the 21st Century (based at the University of Calgary) is a research and innovation initiative that focuses on creative collaborations to develop new ideas to build new paradigms for healthcare delivery.
Physicians, industry experts and academics can bring ideas for prototyping in pre-clinical and clinical environments.
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.
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).
WOMEN'S AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)
The Women and Children’s Health Research Institute aims to improve the health outcomes for women and children’s health through supporting biomedical, clinical and translational research activities that create new knowledge and translate it into practice.
WCHRI provides a wide range of support including direct research support, competitive grant competitions, support services, physical infrastructure, professional development and training, networking opportunities, and financial support for summer and graduate students and clinical resident trainees.
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
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.
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
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.
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
Region: Alberta
Service: Proposal Development
Eligibility: AHS Researchers
Contact: research.facilitation@ahs.ca
More Information: AHS - Research Facilitation
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
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
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 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.
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."
WOMEN'S AND CHILDREN'S HEALTH RESEARCH INSTITUTE (WCHRI)
The Women and Children’s Health Research Institute aims to improve the health outcomes for women and children’s health through supporting biomedical, clinical and translational research activities that create new knowledge and translate it into practice.
WCHRI provides a wide range of support including direct research support, competitive grant competitions, support services, physical infrastructure, professional development and training, networking opportunities, and financial support for summer and graduate students and clinical resident trainees.
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.
These new templates may be fully customized for specific study needs and come with a Guidance Document for tips on usage and best practice.
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
TCPS2:
5.3 & 5.4 Safeguarding Information
5.5A, 5.5B, 5.6 Consent and Secondary Use of Identifiable Information for Research Purposes
21 CFR Part 11, Electronic Records; Electronic Signatures - Scope and Application
ICH GCP E6 8. Essential Documents for the Conduct of a Clinical Trial - Health Canada
The Purpose of Alberta Children's Hospital Research Institute (ACHRI) is to support and advance the research capacity of ACHRI members and their teams, through consultation and direction at all stages of research (Early consultation is OPTIMAL). To access support services, all ACHRI members have access to 6 hours of free research methods support per project, after which research services are available at the prorated cost of $50/hr.
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Alberta SPOR SUPPORT Unit is dedicated to the integration of research into care, so that the right patient receives the right care at the right time. We foster evidence-informed health care by bringing innovative diagnostic and therapeutic approaches to the point of care, to ensure greater quality, accountability, and accessibility of care. We support researchers conducting patient-centered research by providing access to experts and knowledge in seven core areas of expertise: Career Development Platform, Consultation & Research Services Platform, Data Platform, Knowledge Translation Platform, Methods and Support Development Platform, and Patient Engagement Platform.
Covenant Health also offers support in data access. To make a request contact their Data & Decision Support and complete a request form.
EPICORE: Epidemiology Coordinating and Research Centre, is focused on providing support for clinical trials and health services research.
They are involved in protocol design, case report forms design, database creation, study management, implementation, site coordination for multi-centre trials, data management, and analysis.
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
REDCap is an electronic database that can help you manage your data.
When Albertans interact with research, health, and social services programs, huge information sources are gathered and stored. Whether a patient participates in clinical trials or receive care from the health system, information is being generated and stored in provincial information systems. The data in these information systems is important to Albertans. It can be used for further research studies that help us understand how Albertans get healthy and stay healthy. It is also an important feature in genomics and patient-oriented research - helping us to move forward and create a new wave of personalized medicine services. Alberta Innovates - Health Solutions is leading a Secondary Use Data Project with the aim to bring these huge information sources together in a privacy-protected and secure manner. When this aim is achieved, researchers and quality improvement experts will use the data to gain insight and produce discoveries that lead to better health and quality of life for Albertans.
The Women and Children’s Health Research Institute aims to improve the health outcomes for women and children’s health through supporting biomedical, clinical and translational research activities that create new knowledge and translate it into practice.
WCHRI provides a wide range of support including direct research support, competitive grant competitions, support services, physical infrastructure, professional development and training, networking opportunities, and financial support for summer and graduate students and clinical resident trainees.
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).
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)
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.
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.
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:
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.
Key Features of REDCap:
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.
[2] CDISC
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.
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.
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?
EPICORE: Epidemiology Coordinating and Research Centre, is focused on providing support for clinical trials and health services research.
They are involved in protocol design, case report forms design, database creation, study management, implementation, site coordination for multi-centre trials, data management, and analysis.
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.
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 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.
TCPS2 Chapter 3 - The Consent Process
ICH GCP E6 Consolidated Document 4.8 - Informed Consent of Trials Subjects
The Purpose of Alberta Children's Hospital Research Institute (ACHRI) is to support and advance the research capacity of ACHRI members and their teams, through consultation and direction at all stages of research (Early consultation is OPTIMAL). To access support services, all ACHRI members have access to 6 hours of free research methods support per project, after which research services are available at the prorated cost of $50/hr.
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Alberta SPOR SUPPORT Unit is dedicated to the integration of research into care, so that the right patient receives the right care at the right time. We foster evidence-informed health care by bringing innovative diagnostic and therapeutic approaches to the point of care, to ensure greater quality, accountability, and accessibility of care. We support researchers conducting patient-centered research by providing access to experts and knowledge in seven core areas of expertise: Career Development Platform, Consultation & Research Services Platform, Data Platform, Knowledge Translation Platform, Methods and Support Development Platform, and atient Engagement Platform.
The Calgary Centre for Clinical Research (CCCR) promotes "Excellence in health for the 21st century: integration and collaboration of research, knowledge and health innovation".
EPICORE: Epidemiology Coordinating and Research Centre, is focused on providing support for clinical trials and health services research.
They are involved in protocol design, case report forms design, database creation, study management, implementation, site coordination for multi-centre trials, data management, and analysis.
Innovate Calgary is where startups, entrepreneurs, researchers, investors, industry and partners take innovation and ideas to business. It takes an ecosystem to drive the commercialization success of an innovation or discovery, and we are here to give you the help you need to take your startup, discovery or investment to the next stage of growth or market entry. How? It's simple, Just Ask.
Innovate Calgary is the technology-transfer and business-incubation centre for the University of Calgary. Working closely with Research Services and the Office of the Vice-President (Research), we work to help bridge the gap between discovery and innovation.
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
The Women and Children’s Health Research Institute aims to improve the health outcomes for women and children’s health through supporting biomedical, clinical and translational research activities that create new knowledge and translate it into practice.
WCHRI provides a wide range of support including direct research support, competitive grant competitions, support services, physical infrastructure, professional development and training, networking opportunities, and financial support for summer and graduate students and clinical resident trainees.
Each ethics board has templates in order to facilitate this process:
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 - (Additional Templates)
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.
The Purpose of Alberta Children's Hospital Research Institute (ACHRI) is to support and advance the research capacity of ACHRI members and their teams, through consultation and direction at all stages of research (Early consultation is OPTIMAL). To access support services, all ACHRI members have access to 6 hours of free research methods support per project, after which research services are available at the prorated cost of $50/hr.
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Alberta SPOR SUPPORT Unit is dedicated to the integration of research into care, so that the right patient receives the right care at the right time. We foster evidence-informed health care by bringing innovative diagnostic and therapeutic approaches to the point of care, to ensure greater quality, accountability, and accessibility of care. We support researchers conducting patient-centered research by providing access to experts and knowledge in seven core areas of expertise: Career Development Platform, Consultation & Research Services Platform, Data Platform, Knowledge Translation Platform, Methods and Support Development Platform, and atient Engagement Platform.
The Calgary Centre for Clinical Research (CCCR) promotes "Excellence in health for the 21st century: integration and collaboration of research, knowledge and health innovation".
EPICORE: Epidemiology Coordinating and Research Centre, is focused on providing support for clinical trials and health services research.
They are involved in protocol design, case report forms design, database creation, study management, implementation, site coordination for multi-centre trials, data management, and analysis.
Innovate Calgary is where startups, entrepreneurs, researchers, investors, industry and partners take innovation and ideas to business. It takes an ecosystem to drive the commercialization success of an innovation or discovery, and we are here to give you the help you need to take your startup, discovery or investment to the next stage of growth or market entry. How? It's simple, Just Ask.
Innovate Calgary is the technology-transfer and business-incubation centre for the University of Calgary. Working closely with Research Services and the Office of the Vice-President (Research), we work to help bridge the gap between discovery and innovation.
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
The Women and Children’s Health Research Institute aims to improve the health outcomes for women and children’s health through supporting biomedical, clinical and translational research activities that create new knowledge and translate it into practice.
WCHRI provides a wide range of support including direct research support, competitive grant competitions, support services, physical infrastructure, professional development and training, networking opportunities, and financial support for summer and graduate students and clinical resident trainees.
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.
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
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:
The Covenant Health Research Centre (CHRC) is dedicated to promoting innovation, facilitating inquiry, developing partnerships, and integrating research into practice in alignment with Covenant Health's Mission, Vision, Values and strategic directions. Since inaugural operations in 2003, the CHRC has review more than 870 research studies, has secured operational/administrative approval for 713 studies and approval for 84 research grants representing over $283,000.00 in funding.
The CHRC strategic focus in on:
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.
You can find grant information at: http://www.covenanthealth.ca/research-centre/research-administration/funding
And for any inquiries, folks can contact our main office number at 
780-735-2274
or email research@covenanthealth.ca
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
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.
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:
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Covenant Health Research Centre (CHRC) is dedicated to promoting innovation, facilitating inquiry, developing partnerships, and integrating research into practice in alignment with Covenant Health's Mission, Vision, Values and strategic directions. Since inaugural operations in 2003, the CHRC has review more than 870 research studies, has secured operational/administrative approval for 713 studies and approval for 84 research grants representing over $283,000.00 in funding.
The CHRC strategic focus in on:
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.
You can find grant information at: http://www.covenanthealth.ca/research-centre/research-administration/funding
And for any inquiries, folks can contact our main office number at 780-735-2274 or email research@covenanthealth.ca
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
Northern Alberta Clinical Trials Research Center (NACTRC) provides resources to investigators for Clinical Trial budgeting. For more information on this resource you must have an account with NACTRC, login to your account and click on "PI Resources".
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:
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Covenant Health Research Centre (CHRC) is dedicated to promoting innovation, facilitating inquiry, developing partnerships, and integrating research into practice in alignment with Covenant Health's Mission, Vision, Values and strategic directions. Since inaugural operations in 2003, the CHRC has review more than 870 research studies, has secured operational/administrative approval for 713 studies and approval for 84 research grants representing over $283,000.00 in funding.
The CHRC strategic focus in on:
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.
You can find grant information at: http://www.covenanthealth.ca/research-centre/research-administration/funding
And for any inquiries, folks can contact our main office number at 780-735-2274 or email research@covenanthealth.ca.
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta. In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services. While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.
For a complete list of services see the QMCR website.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
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.
AHS: Research is a clinical strategic priority within Alberta Health Services.
AHS Research Facilitation provides consultation and support for all research and innovation projects. Services offered include proposal development (assessment of AHS Administrative Data feasibility and suitability, limited methods support), as well as post ethics support (administrative data extraction and linkage, statistical support for select projects or on a cost-recover basis).
Click here for more information or contact research.facilitation@ahs.ca.
The Covenant Health Research Centre (CHRC) is dedicated to promoting innovation, facilitating inquiry, developing partnerships, and integrating research into practice in alignment with Covenant Health's Mission, Vision, Values and strategic directions. Since inaugural operations in 2003, the CHRC has review more than 870 research studies, has secured operational/administrative approval for 713 studies and approval for 84 research grants representing over $283,000.00 in funding.
The CHRC strategic focus in on:
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.
You can find grant information at: http://www.covenanthealth.ca/research-centre/research-administration/funding
And for any inquiries, folks can contact our main office number at 780-735-2274 or email research@covenanthealth.ca.
The Methods Hub is a group of dedicated health researchers who have expertise in methodology.
The Methods Hub focuses on consolidating individual and collective expertise across the spectrum of both quantitative and qualitative research methods.
You may be eligible for support from the Methods Hub as part of the Methods Support & Development Platform within SPOR.
The QMCR Department was created as an oversight mechanism for human research activities conducted at the University of Alberta. In order to ensure QMCR has an arms’ length relationship with both ethics and research administration, it was decided, with the approval of the Board Audit Committee, that the unit be housed with Internal Audit Services. While the endorsed mandate is broad, QMCR will initially direct its services towards clinical trials where the University of Alberta is considered the sponsor organization (i.e. Principal Investigator-Initiated trials). This initial focus is based on elements of risk associated with specific trials as well as resource constraints.
For a complete list of services see the QMCR website.
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
CITI Canada Training Opportunities
Society of Clinical Research Associates (SOCRA) - Professional Certification
Association of Clinical Research Professionals (ACRP) - Professional Certification
The Office of Research Integrity Interactive Video The Research Clinic
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.
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.
Alberta Health Services Privacy Office:
Email: privacy@albertahealthservices.ca
Phone: 1-877-476-9874
Covenant Health
Chief Privacy Officer: privacy@CovenantHealth.ca
Phone: 1-866-254-8181
University of Alberta Information & Privacy Office:
University of Calgary
Privacy and Records Officer: Will Fiebelkorn, E-mail: gefiebel@ucalgary.ca
CIHR Best Practices for Protecting Privacy in Health Research (September 2005)
Recognizing that one of the key ethical challenges for the health research community is to appropriately protect the privacy of those individuals whose information is used for research purposes, CIHR has promoted and initiated dialogue with the broad health research community on a range of privacy-related matters for many years. In particular, a multi-stakeholder workshop in November 2002 entitled Privacy in Health Research: Sharing Perspectives and Paving the Way Forward resulted in a number of recommendations, including that CIHR initiate the development of privacy best practices and promote the harmonization of privacy laws and policies that impact on health research.
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.
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.
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;
Contact the following organizations to obtain a fully executed legal document for your study:
The Covenant Health Research Centre (CHRC) is dedicated to promoting innovation, facilitating inquiry, developing partnerships, and integrating research into practice in alignment with Covenant Health's Mission, Vision, Values and strategic directions. Since inaugural operations in 2003, the CHRC has review more than 870 research studies, has secured operational/administrative approval for 713 studies and approval for 84 research grants representing over $283,000.00 in funding.
The CHRC strategic focus in on:
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.
You can find grant information at: http://www.covenanthealth.ca/research-centre/research-administration/funding
And for any inquiries, folks can contact our main office number at 780-735-2274 or email research@covenanthealth.ca.
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
Click here for information on how to get help with legal document submission at the University of Alberta.
The Research Services Office (RSO) supports researchers and administrators by providing services focused on the identification of potential funding sources, assistance with the application process and guidance with the financial management of awards. The RSO serves the Faculties of the University of Alberta and its affiliated institutes, centres and hospitals. In addition, the RSO works with partners in the external community, industry and government agencies to advance the University’s goal to be a major catalyst for social and economic development.
Research Services provides advice and assistance with sponsored research, grants and contracts for research and scholarly activities, and help on University policy, procedures and requirements. Research Services also provides information regarding the interpretation and application of the University's Intellectual Property policy.
The Research Services Office works with the University of Calgary's research community to advance the research enterprise. As a team of professional service partners, the Research Services team aims to increase sponsored research revenue, reduce financial, reputational and market risk and manage compliance for the University.
Research involving human participants in Alberta follows the Tri-Council Policy Statement 2, ICH 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 2, ICH GCP, Health Information Act, Health Canada Regulations and Guidelines.
What is involved?
Generally the Research Ethics Boards may request you to submit:
Where do I apply?
There are three HIA designated Boards in Alberta:
1. HREBA:
For University affiliated faculty, staff or students:
2. University of Alberta (HREB) - All research involving human participants conducted by staff or students affiliated with the University of Alberta, or involving University resources, must be reviewed and approved by one of the University’s Research Ethics Boards (REB) before the research starts.
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.
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.
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 - (Additional Templates)
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;
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;
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?
How do I apply for a Research Agreement?
What will the data custodian ask for?
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?
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)
NACTRC is a premier research and clinical trials network that was established in 1999 to provide pharmaceutical and research-intensive companies with a higher standard in quality, cost-efficient clinical trial research. We are a joint venture between Alberta Health Services, one of Canada's largest integrated academic health regions, and the University of Alberta, one of Canada's leading research-intensive universities.
To arrange for an Operational Approval you will need to create an account with NACTRC and apply. Click here to get started.
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;
Who is responsible for setting up the accounts for your study?
Resources for account set-up in Alberta;
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.
1 Data Safety Monitoring Board (DSMB) Guidelines: https://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm
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.
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.
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.
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.
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 English, N2 Brochure in French, Clinical Trials 101
Healthy Infants and Children Clinical Research Program (HICCUP) is available in both Edmonton and Calgary. HICCUP is developing a registry of pediatric healthy controls that may want to participate in clinical research. In order to request access to a participant list from the HICCUP database, you must be the principal investigator of an ethically approved, scientifically reviewed clinical research study in need of child or parent subjects to serve as population samples or healthy controls.
1. Spilker B, Cramer J. Patient recruitment in clinical trials. New York (NY): Raven Press Ltd; 1992.
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;
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.
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;
Reports also must be made to the REB in the case of a Serious Adverse Event (SAE), Protocol deviation or violation, or safety report:
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.
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.
To help with the process of study closure, the use of a study closure checklist is recommended.
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.
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:
Find more information on the study closure process for:
University of Alberta (HREB/REMO)
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
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.
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.