Frequently Asked Questions

Below you will find frequently asked questions (FAQs) for the Alberta Clinical Research Roadmap. Use the search function to find any topic. Below each FAQ you will find the links to related Stage(s) and more detailed information in the Roadmap as well as tools, services and resources. Please contact us if you have a suggestion for an FAQ, resource or service available in Alberta.

Also see our Glossary and Common Terminology definitions of clinical research terms and acronyms.

What is ethics approval and how can I apply?

Ethics approval is granted when you have applied to the appropriate ethics board for your institution and you have met all the requirements to go ahead with your study. Ethics approval is necessary for any research project touching a human subject (this includes data).

In Alberta there are 3 ethics boards. At University of Alberta there is the Health Research Ethics Board, at University of Calgary there is the Conjoint Health Research Ethics Board which are responsible for reviewing all health related research applications involving human participants. The Health Research Ethics Board of Alberta review applications for all cancer and community based research projects and clinical trials. To see which one is appropriate for your project click here.

All 3 ethics board in Alberta have an online submission process.

Development: Find more in ethics requirements
Project in Set-up: Find more information on how to get an ethics approval

 

 

What is informed consent?

Informed consent is a process by which a participant voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate. (N2)

According to TCPS2 Chapter 3 the general principles of consent are that it should be voluntary, informed and ongoing.

 

Development: Find more information on informed consent process

Project in set-up: Find information on informed consent form templates

What elements should be included in a protocol?

A good protocol is essential in implementing a solid study plan. Key elements (I.E. methodology, inclusion/exclusion criteria) should be included. A protocol should provide a clear idea of how your study will be carried out.

Development: Find information on how to develop a protocol template

How do I calculate sample size?

Appropriate sample size is necessary in order to have sufficient statistical power. Several resources are available to help you calculate sample size.

Development: Find resources on how to calculate sample size

Where can I access the data I need?

Make sure data required to answer the research question is available via collection, or secondary use. There are several services in Alberta available to help you collect and manage data to the many databases are accessible in the province.

Secondary use data refers to the use of data that has already been capture outside of research. In Alberta, secondary use data may be accessed by applying the Alberta SPOR Support Unit - Portal. For more information see the Secondary Use Data Project (SUDP) webpage.

Find more information on:

Development: Data Collection

Development: Services available to help you with data collection

Development: Tools and templates:  Data Collection Package 

What tools are available to help me manage my data?

Developing a good plan for data collection and management is essential. Prior to ethics submission you will need to know how your data will be managed. Will you use a paper format? Will you be utilizing an electronic data capture system (EDC)? Are you utilizing secondary use data? There are services are available for help with data management. Both University of Alberta and University of Calgary offer access to REDCap, an electronic data capture system for researchers.

Development: Find more information on how to manage your data.

Development: Find information on how to access REDCap

What is a case report form (CRF)?

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial participant. (N2);

Paper - Case report form in which the data items are linked by the physical properties of paper to particular pages;

Data - Subset of clinical trial data that are entered into fields on a CRF. (CDISC)

Development: Find more information on data collection and CRFs.

Development: Find CRF templates here.

Who will my study engage/impact?

Considerations on who the study will impact prior to setting up the study should be taken. Studies may impact patients/public, healthcare professionals, or staff where the study will take place.

The Alberta SPORT Support Unit, Patient Engagement Platform offers a range of services and resources to help you ensure you have considered the patient perspective of your research project. Also, where applicable, how patients and the public can get involved in the planning of your project.

concept: Find more information on Engagement here

Find more information on the AbSPORU Patient Engagement Platform

Do I have the appropriate staff to complete my study?

Appropriate, well trained staff are necessary to complete your study and reach recruitment and budgeting targets. A research team may consist of a coordinator, nurse, lab or technical staff as well as the PI.

Training requirements for staff may be required by the sponsor, institution, or by regulation.

concept: Find more information on Research Teams here

Feasibility: Find more information on study Training here

 

What type of training do I need to work on a research study?

In Alberta several types of training are offered free, and for a fee:

The Weiser course is for Clinical Research Coordinators beginning in the research profession. It is offered by Northern Alberta Clinical Trials and Research Centre (NACTRC) which is located in Edmonton and is a 2 day course. TCPS2 is free online training through Health Canada.

CITI-Canada is an online clinical research training program that incorporates International Conference on Harmonization - Good Clinical Practice, Tri-Council Policy Statement Edition 2, and Health Canada guidelines. CITI-Canada is developed by CITI (Collaborative Institutional Training Initiative) and N2 (Network of Networks).  In order to take CITI training for free, you need to be affiliated with an institution (I.E. U of A, U of C, AHS or Alberta Innovates). Otherwise, there is a cost for independent learners.

SOCRA/ACRP are both professional designations which you need 2 years experience to apply for.

Training Recommendations for the province of Alberta are also available on the Roadmap

Feasibility: Find out more on training opportunities/recommendations in alberta

Do I have access to my target population to hit recruitment targets?

The most common error made in designing a clinical research study is overestimating the potential study participants. Do a review with your department and see how many potential participants may exist. Involve others in your department (co-investigators) and define your target population clearly. The more complex the trial, the less participants may considering participating in the study. Potential recruitment targets should be considered at the feasibility stage of the study.

Active: find more information on study recruitment

Active: find resources available for helping to recruit potential patients in Alberta

What is a study initiation visit?

The visit at which the sponsor’s monitor/CRA delivers all the clinical trial materials to the clinical trial site. A meeting will be held with the investigator and his/her team. The sponsor CRA will ensure that everyone is familiar with the protocol, the CRFs and the study procedures. Any outstanding pre-study paperwork is collected and often at the end of the visit the investigator can begin recruitment. (Weiser)

Project in set-up: Find our more information on Site Initiation Visits

What happens once I submit my study to an REB?

Once your study is submitted, your application with be reviewed by an appropriate ethics review committee. Upon review, you will either receive approval, or a request for changes. Once all changes have been re-submitted and accepted you will receive your ethics approval letter via the electronic system. Please note, ethics approval does not mean you can begin your study, necessary research agreements, operational and administrative approvals must be received prior to commencing.

Project in set-up:  Find our more about ethics

 

What regulatory approvals will my study require?

Several regulatory approvals/forms may be required depending on the type of study you are doing. You may need to submit a Clinical Trial Application (Health Canada) in order to receive a No Objection Letter. A W-8 BEN (IRS) or a Form 1572 (FDA) may also be required if the sponsor is American and needs to adhere to American regulations.

Find our more on:

Project in set-up:  Clinical Trial Application (CTA) - No Objection Letter

Project in set-up:  W-8 BEN

Project in set-up:  Forms 1572, The Statement of Investigator

What is an operational approval?

An Operational Approval assesses the impact of the clinical study/trial on departments within an institution/organization (e.g. pharmacy, nursing, medical imaging, laboratory, etc.). (ACRC) Anytime you are accessing a clinic area, medical records, hospital ward or any other area where it will impact Alberta Health Services staff, you must get an operational approval for each area you will impact.

Project in set-up:  Find out how to get an operational approval

What contracts/legal agreements will be required?

Several contracts or legal agreements may be required depending on the type of study you are doing. I.E. Confidentiality Disclosure Agreement (CDA), Data Transfer Agreements (DTA), Material Transfer Agreements (MTA), Sub-site agreements, institutional financial contracts etc. Some documents must be reviewed by the applicable department. 

Project in set-up:  Find information on who you can contact for information regarding contracts/legal agreements for your institution

What is a research agreement?

Research agreements are between the data repository owner (typically AHS or Covenant Health) and the PI. These are necessary in order to be complaint with the Health Information Act in Alberta. Research Agreements must be completed prior to any health information being disclosed and require an REB approval.

Project in set-up:  Find out more information on S54 HIA and FOIP Research Agreements

How do I set up an account for my study?

Depending upon how your study is funded, an account must be set up to handle your study funds. There are several services in place to help you do this.

Project in set-up:  Find Services to advise you on account set-up for your institution

What is an Administrative Approval (AA)?

Some institutions have an administrative approval process. An administrative approval is granted when all other approvals, agreements and contracts have been finalized. This is your final “okay” to begin your study.

Project in set-up:  Find more information on Administrative Approvals

Am I required to register my trial?

In 2005, the International Committee of Medical Journal Editors (ICMJE) made requirements for researchers to register their trial should they want to be published. This must be done prior to enrollment.

Project in set-up: Find more information on Trial Registration

Closure: Find more information on Publishing your study

What happens if I need to make amendments to my study?

From time to time, amendments will be need to be made to protocol, study materials, informed consent forms or contracts. Most amendments will need to be submitted to the REB for approval prior to implementation (protocol, ICF, study materials etc.). Amendments to contracts will need to be dealt with by the funder/sponsor and researcher along with necessary notification to the relevant institution.

Active: Find more information on Study Amendments

How do I archive my study documents once the study is closed?

It is good to have a plan to archive your study documents when a study closes. According to Health Canada, documents must be kept for 10 years. Each institution will have its own record retention requirements.

Closure: find Information on Records Retention

Closure: Find Services to help with archiving documents

How do I publish my study?

Several options are available for you to publish your study. Trial registration prior to starting your study is required in order to publish your study in a peer reviewed publication. Format of your manuscript will depend on the publication’s requirements, however, most journal articles are around 3,000 words. A final study report may also be required by responsible regulatory authorities as well as the REB.

Closure: Find information on how to publish your study results

Project in set-up: Find information on how to register your trial