Research Portal

CTN Research Toolbox

You have a great idea for a research project … now what?

It is important to understand and plan all activities required for a research study as early as possible,  prior to initiating the project, to prevent challenges and delays related to data collection, statistical analysis, human resources, budgets, regulatory requirements, recruitment, and additional activities specific to your project. Dedicate significant time to designing and project managing your study: clearly articulate your objectives, hypothesis, and how you will meet these objectives. Seeking expert advice on the activities listed will prevent your project from facing costly delays.

Become a CTN Investigator or Postdoctoral Fellow

Only CTN Investigators, Postdoctoral fellows, and their research staff can access the CTN’s Scientific Core and National Centre research services. For information about the requirements to become a Postdoctoral Fellow, please see the Postdoctoral Fellowship Program page.

CTN Investigator Membership Criteria
  • A new investigator must be recommended and approved by the Scientific Core Leads;
  • Full investigator membership is limited to Canadians (affiliate membership may be offered to non-Canadians and other applicants who do not meet the criteria for full investigator membership);
  • The membership terms align with the CTN’s CIHR grant, the Cores will review and renew membership when the CTN’s CIHR grant is renewed (for example the next renewal cycle is 2019); and
  • CTN postdoctoral fellows cannot be considered for membership; once their fellowship is completed they may be invited.
Application Process

The CTN investigator application process includes:

  • Submission of a full CV
  • Completion of a short application form that asks the applicant the following questions:
    • How do your research interests align with the scientific priorities of the CTN?
    • What expertise and experience do you possess that you feel can contribute to the network?
    • Are you willing to serve on CTN Committees, such as the Scientific Review Committee, the Data Safety and Monitoring Committee, or the Postdoctoral Fellowship Awards committee?
CTN Investigator Benefits

The following opportunities are open to full CTN Investigators:

  • An ability to serve as principal or site investigator in CTN trials;
  • An option to join one or more of the CTN’s four (4) Core Scientific teams;
  • Access to Core support for trial and/or concept development;
  • Access to CTN National Centre research support services for approved studies and initiatives;
  • The opportunity to supervise CTN postdoctoral fellows;
  • Access to information about trials in development with the following proviso:

Information of this nature should be treated as confidential and you must not permit its disclosure or use without the CTN’s prior written consent except as required by applicable law, including the Freedom of Information and Protection of Privacy Act.

  • Invitation to relevant clinical trial meetings, workshops, etc;
  • An opportunity to request funds for protocol development meetings or related activities; and
  • Voting rights (when applicable).
CTN Investigator Obligations

A CTN Investigator must agree to:

  • be actively engaged in one or more CTN committees as membership opportunities arise and participate in Core meetings;
  • recognize the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS 2);
  • adhere to the CTN Publication Policy:
    • CTN Investigators must list the CIHR Canadian HIV Trials Network (CTN) as an affiliate organization for all of your CTN-related publications including ALL documents derived from CTN-approved studies created with direct financial support or in-kind contributions from the CTN
  • provide realistic enrolment and retention estimates for CTN studies in which they participate;
  • submit timely and accurate data for CTN studies in which they participate;
  • submit periodic (no more than annually) activity reports to Core groups and the CTN when requested; and
  • periodic review of their CTN membership.
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Click here to download a PDF version of the toolbox process map.

Project Development

These next four sections are generic and apply to anyone developing a research project. The CTN can be consulted for advice and can provide services to our investigators in the areas of study planning, study implementation, collaboration, and communications. Please see Project Set Up / CTN Services and Other Considerations for a full list of available in-kind services.

Literature Search

A proper literature search is integral to defining your research question and designing your study. Here are a few examples of available resources that can help in conducting an in-depth review. Check with your own institution for specific services offered.

Refine Your Idea

If your research question is too broad, you will have difficulty designing a focused study to collect data to answer your hypothesis. If it’s too narrow, you will have difficulty finding the appropriate participants.

Do not forget that engaging your research population during grant or project development is now required by most funders and has become the norm in health research. Refining your idea with the community will quickly provide you with a pragmatic view on the applicability and feasibility of your research. A working group of the Prevention and Vulnerable Populations Core has created Community Engaged Research Practice to help guide researchers towards successful and meaningful engagement of community members.

Create a Proposal/Draft Protocol

Seek experts who will provide you with advice and who will review your proposal. Determine if your institution will provide assistance with project/grant development.

With advance planning, an investigator can receive formal CTN feedback prior to submission to a granting agency or a Research Ethics Board (REB). Please refer to the CTN Submission and Review Process Guidance information, either as a PDF download or in the CTN Review Phase section. This is referred to as a Pre-Final Proposal — the CTN provides Community Advisory Committee (CAC) and Scientific Review Committee (SRC) recommendations/input for Pre-Final applications to improve the likelihood of receiving funding from CIHR and other granting agencies.

A Pre-Final Proposal must contain (electronic copy):

  • A completed Letter of Intent Submission Form
  • A draft protocol, in a form suitable for submission to a granting agency or an REB
  • A draft informed consent form

In addition, if you simply need advice on where to find experts for this stage of development, the CTN National Centre or Core Leads can be consulted to help link you to relevant experts. Call 1-800-661-4664 and ask for Erin Cherban, Chief Clinical Research Officer, or email echerban@hivnet.ubc.ca.

Planning Methodology

  • Need help understanding the basics of statistics? Visit Graphpad.
  • The Patient-Centered Outcomes Research Institute (PCORI) recently released a detailed report on methodology standards, beginning with formulating research questions through to data analyses; download it here.

Preparing a Budget:

  • Download a detailed list of potential expenses.
  • Download a site-level study budget template.
Secure Funding

CIHR is the primary source of federal funds for health research in Canada.

Other suggestions for funding are:

  • Provincial and institutional funding competitions.
  • Disease-related foundations (e.g. CANFAR, Heart and Stroke Foundation).
  • Approach Industry partners and discuss your project with them. A pharmaceutical or medical device company may or may not provide direct funding for a project via their established investigator-initiated study funding mechanism, but they may consider donating the study intervention (e.g. drug or device).
  • Hospital Foundations.

CTN Review Phase

The CTN holds in-person meeting two times per year. Applicants who are invited to submit to the CTN via the regular study or pilot funding programs will be invited to attend the CTN meeting before their application is due. At this meeting, applicants will be required to present an overview of their study and will have the opportunity to seek advice from the Core leads, Community Advisory Committee, and Scientific Review Committee members in attendance and National Centre personnel (for advice on project management, data management, statistics and methodology, and regulatory affairs, if applicable) PRIOR to finalization of the protocol and full application to the CTN.

If an application is successful and a study receives in-kind services from the CTN, investigators will be required to make the changes requested by the review committees and will then have further opportuntity to refine the protocol with feedback from personnel at the National Centre.

The CTN conducts two types of review:

  • Regular Study Submission: Applicants who meet the criteria for submission to the CTN have the opportunity to apply to the CTN two times each calendar year.
  • Pilot Study Funding Program: Applicants who meet the criteria for this funding program have the opportunity to apply to the CTN one time per calendar year.

The CTN Submission Schedule may be downloaded here.

Regular Study Submissions:

CTN Study Review and Approval Process

  • Any questions may be directed to the CTN at 1-800-661-4664 / 604-806-8340 or by email to submissions@hivnet.ubc.ca
  • The Study Submission and Review Process Guidance is available here. Please review this document prior to submission.
  • Links for all submission forms are included below.
Stage 1: Registration — Letter of Intent Application
  • Letter of Intent (LOI) Registration Form is available here.

The CTN only accepts proposals for studies that have received primary funding and that align with the CTN’s scientific priorities. These are outlined in Study Submission and Review Process Guidance Appendix A – Glossary of Terms. The following type of study proposals are encouraged:

  • Multi-centred clinical trials;
  • Multi-centred clinical research studies;
  • Cohort studies, but only national multi-centred observational studies that have been peer-reviewed, approved, and fully funded by another funding agency;
  • Pilot studies that do not fit the criteria for the CTN Pilot Study Funding Program may be funded if justification can be provided;
  • Implementation science projects, preferably multi-centred and with a focus on health care innovation; and
  • Community-based research that aligns with the scientific priorities.

The CTN may also accept innovative proposals that will advance research and health care. The Core Co-leads will provide guidance for these applicants and may be required to advocate on their behalf to provide a rationale to the CTN and the review committees for supporting this type of innovation.

Eligibility and Process:

  • Only CTN Investigators may apply.
  • CTN Investigators must contact the Core Co-leads a minimum of 30 days prior to the LOI deadline as the Core Co-leads can guide the applicant, ensure the submission aligns with the CTN’s scientific priorities, and provide Core approval of the registration by signing the LOI registration submission Form.
  • A sample of the LOI Checklist and Registration Form are included in Study Submission and Review Process Guidance Appendix B.
  • Studies/projects must have primary funding prior to the Full Submission deadline; cohort studies must be fully funded prior to submission. When making requests for CTN services or supplemental funds, be realistic with your estimates as limited funds are available. The CTN asks applicants to indicate which CTN services they will be requesting, if invited to submit a full proposal. This assists the CTN with pre-planning for allocating resources to new studies. If applicants are requesting supplemental funds, they must be explicit and provide justification for their request.
  • The CTN will not provide:
  • full study funding;
  • “top-up” funding without proper justification;
  • study drugs or devices;
  • on-site personnel for studies; or
  • funds for archiving or archiving services.

Note for applicants requesting CTN services or supplemental funds:

All approved projects are reviewed by the CTN’s Funding Committee. There is no guarantee that the Funding Committee will approve the CTN services or supplemental funds requested by the applicant. It is possible for CTN-approved projects to receive no additional resource support.

  • When completed, the LOI Registration Form must be emailed as an attachment to submissions@hivnet.ubc.ca.
  • Once submitted, the CTN will contact the Core Co-leads to document that the Core, in principle, agrees with the submission and supports the CTN in inviting the applicant to submit a Full Application.
  • Finally, the CTN will invite applicants to submit a Full Application.

Stage 2: Full Submission

The CTN will invite successful LOI applicants to submit a full submission to the CTN. The applicant’s email invitation from the CTN will also include the information about the applicant’s invitation to attend the CTN meeting to receive assistance with developing their application, the due date, and contact details for applicants who have questions.

A Final Proposal Submission must include (electronic copy):

  • A completed cover letter
  • A completed, signed Full Submission Application Form
  • The documents listed on the first page (Full Submission Form Checklist) that are applicable to the project. The following documents are required:
    • a copy of the primary funding award letter and a full budget for the project;
    • if grant funded, a copy of the grant (including the budget, budget justification, and all appendices), and a copy of the approval letter and all reviewer comments;
    • a copy of the protocol (or project plan/grant if a full protocol is not available);
    • the Participant Information Sheet and/or Informed Consent Form (ICF), and
    • if a clinical trial, the Health Canada “No Objection Letter” (if completed) and information about drug/device procurement.
  • Additional documents such as case report forms, Investigator’s Brochures (or product monographs), letters of endorsement/participation from community groups, and all other types of information that supports the submission, should be included.

When completed, the application and all attachments should be emailed to submissions@hivnet.ubc.ca.

Any questions may be directed to the CTN at 1-800-661-4664 / 604-806-8340 or by email at submissions@hivnet.ubc.ca.

Full Submission Review Process

Please refer to the above schematic. The documents submitted to the CTN undergo peer review by the Scientific Review Committee (SRC), if required, and the Community Advisory Committee (CAC). All committee members are bound by confidentiality agreements. Information about the review committees may be found in our Committees section.

  • The CAC reviews all Full Submissions and may ask for required/recommended changes to the informed consent form and pose questions to the investigator regarding the protocol. A response from the investigator is required before CAC can approve the study.
  • The CTN will accept the review of other nationally recognized peer-review panels of clinical trials/research, such as CIHR’s randomized controlled trial (RCT) review panels, or the NIH RCT review panels. In such cases, a review by the SRC would not be necessary, however, all external reviews must be included in the submission.
  • Submissions receiving an SRC score of 3.5 or higher and CAC’s recommended and required changes, are presented to the Steering Committee for approval consideration (“Approvable”).
  • Submissions with an SRC score of less than 3.5 are provided with the reviewer’s comments and CAC’s recommended and required changes. These projects may be re-submitted for the next review cycle, but must include the changes suggested by the review panels and any new information.
  • The Steering Committee then reviews the submissions that the review committees have deemed Approvable and ultimately makes the decision to approve the submission. Once approved, a final CTN number is assigned to the study.
  • All approved submissions are reviewed by the Funding Committee for resource allocation. The Funding Committee may or may not assign both in-kind and monetary funds. It is important that the applicant provide all relevant financial details to enable a full and impartial review.
  • Within eight weeks of the reviews, the applicant will receive correspondence from the National Director that outlines the results of the reviews and describes the resource allocation (if any).
  • Successful applicants are required to provide the CTN with the enrolment updates, notification of conference presentations, and publications as outlined in the correspondence they receive from the CTN. Applicants who suspend CTN-approved projects for any reason are required to report this suspension to the CTN immediately.
  • Successful applicants are required to acknowledge CTN support when issuing publications, scientific presentations, press releases, and other documents describing projects or programs supported by the CTN in whole or in part. CTN Publication Guidelines are available online and are provided to successful applicants.

The CTN cannot grant final approval to a submission until all of the required information has been received. In the case of a re-submission all required changes and/or revisions must be included with the resubmitted documents.

Successful applicants are required to complete all the necessary requirements for their home institution, which include:

  • Fulfilling their institutional Research Ethics Board requirements.
  • Observing the progress of contract negotiation between their home institution and the CTN National Centre and promptly responding to their home institution to ensure that contract negotiations occur in a timely fashion.
  • Establishing a grant account per the requirements of their home institution, oversee (if applicable) spending for the study, and provide the CTN National Centre with financial statements as required.

Pilot Study Submissions:

Pilot Study Funding Program

  • Pilot Study Funding Program Guidance Document is available here. Please review this document prior to submission.
  • Links for all submission forms are included below.

The CTN Pilot Study Funding Program was implemented at the request of Network Investigators, to provide funding for pilot or proof-of-concept studies. Funding for these types of studies is difficult to obtain and these studies are required to determine the feasibility, acceptability, sample size, and/or otherwise inform the development of an adequately statistically powered, larger study.

Studies are supported with a cash contribution of up to $50,000 and are eligible for a maximum of $50,000 of in-kind services from the CTN National Centre. The award is intended to pay for all of the direct costs associated with the study. This program is targeted to support new projects, thus applications from existing projects seeking top-up funding are not accepted.

An additional purpose of the Program is to provide training and mentorship opportunities for junior investigators in order to gain experience by working with senior investigators across the Network, and with National Centre staff for support services, on how to run an intervention/clinical trial or how to implement a research project. The Program is only open to CTN Investigators who are within ten years of their first university appointment or professional position or fellows/trainees who are supervised by a CTN Investigator—the supervising CTN Investigator must meet the criteria to hold funds at their home institution. Current CTN Postdoctoral Fellows are eligible to apply, however, their funds must be held by the CTN Investigator who is their supervisor.

In summary, the Program is intended to provide the following:

  • Sole funding for all direct costs for new pilot or proof of concept studies with high scientific/ medical merit;
  • Data and feasibility information to support the development of a randomized controlled trial (RCT) or larger study;
  • Mentorship opportunity for junior investigators (including CTN Postdoctoral Fellows) to work with senior CTN Investigators; and
  • An opportunity for the CTN National Centre personnel to mentor junior investigators in study design, regulatory, and operational requirements.

This Program will not:

  • Provide funds/services to existing studies;
  • Provide funds/services to studies that have other sources of funding for the direct study costs/services;
  • Fund studies led by researchers who are not CTN Investigators;
  • Provide funds for CTN Investigators who were in their first position ten or more years ago (unless able to provide documented proof of leave), except where acting as supervisor to CTN Postdoctoral Fellows.
  • Provide in-kind services in excess of $50,000. The level of service required will be determined during the evaluation of the study, and studies that exceed this level of service will be rejected unless the candidate’s home institution agrees to provide additional, in-kind services to support the study.  The CTN National Centre will work with personnel to ensure that service provision is capped accordingly.
  • Pilot Study Funding Program Concept Submission Form is available here.

Pilot Study Funding Process

  • Candidates who are interested in applying for this funding opportunity, and who fulfill the Program Requirements, must contact at least one of the Core Co-leads at least 30 days prior to Concept Form Submission deadline. The Core Co-lead will provide the candidate with guidance, ensure the concept aligns with the CTN’s areas of scientific focus outlined on the Concept Submission Form, and sign off on the concept submission form. For assistance contacting the appropriate Core Co-lead, please email submissions@hivnet.ubc.ca.
  • Pilot Study Funding Program Concept Submission Form is available here.
  • After the concepts are submitted, the Core Co-leads will meet to vet the Concept Submission Forms and recommend a short-list of concepts for full submission.
  • The CTN invites the candidates with the short-listed concepts to submit a full proposal.
  • Pilot Study Funding Program Full Proposal Form is available here.
  • Candidates who are invited to submit full proposals will be invited to attend the CTN semi-annual meeting to meet with Core Leads, Core Members, CAC Members, and CTN National Centre Staff to receive informal assistance and guidance with developing their final proposal.
  • The candidates must complete the full application and should liaise with the applicable Core Co-lead and the CTN National Centre while completing the application. The application must be submitted by the deadline.
  • Submissions are then reviewed by the Pilot Study Adjudication Committee.

All applicants will be notified of the decision, and successful applicants will be notified about the amount of financial and in-kind support they will receive. Successful applicants will then work with the applicable Core and CTN National Centre to begin their pilot study.

Post-Review Process:

  • All applicants will be notified by the CTN National Centre regarding the success of their application. Successful applicants will receive confirmation of the award amount and the in-kind services to be provided along with the study lead’s responsibilities and reporting requirements.
  • The financial award will be provided in two separate payments. The initial payment will be released when the CTN is notified of Research Ethics Board and Institutional (if applicable) approval and when the contract between the CTN National Centre and the applicant’s home institution is complete. The second payment will be provided once half the recruitment is complete and only with the submission of a progress report at the request of the CTN.
  • Studies must be initiated within 12 months. If merited, only one extension will be granted; if the study is not initiated within 18 months, the award must be returned to the CTN.
  • Awardees must develop the pilot study in consultation with an appropriate CTN Core and their supervisor (if applicable).
  • The awardee must provide updates about the progress of the Pilot Study when requested, for example, for the Core meetings during the CTN’s annual meetings or when requested by the CTN National Centre.
  • During the pilot study and upon completion, awardees are encouraged to publish or present their findings and adhere to the CTN Publication Guidelines.

Project Set-Up

Depending on the complexity of your study and assuming reasonable turnaround times, an estimated timeline for project set-up is from 6 to 12 months.

Health Canada applications (if applicable), ethics submission, contract review, and administrative approvals can often be undertaken simultaneously. Check with your local institution’s research administration.

Finalize/Update Protocol

While you can use your proposal as a template for your protocol, a proposal is only written to obtain funding for your study. A study protocol contains detailed instructions on how the study will be conducted, and includes information to meet regulatory requirements (if applicable). CTN provides protocol templates for use in interventional and non-interventional clinical studies.

CTN Research Services

In-Kind Services – The CTN National Centre in-kind services available for request:

Protocol Development: incorporates many of the services listed below.

Data Management services may include: data collection worksheet generation, database design and edit check programming, database training, user management, data cleaning and query management, medical coding, reporting, data linkage and extraction, and data entry.

Statistical and Methodological consultation may include: developing study methodology (e.g., quantifying research objectives, sample size calculation, statistical analysis plan), data analysis, interpretation of results, drafting of manuscripts, and responding to reviewer comments. In addition, this group can provide consultation on automated randomization systems for studies.

Health Economics analysis may include: design of health economics studies; conducting economic evaluations of various health interventions; performing systematic reviews and meta-analysis commonly required in cost-effectiveness decision analytic modeling; and evaluating health policies, such as drug pricing regulations.

Regulatory Affairs services may include: assistance completing protocol and informed consent forms; recruitment plan; budget development; study operations manuals; study management of multi-centre studies; training study staff on protocol and study procedures; liaising with third party vendors (Investigational product, Laboratory services, and etc.); and ensuring quality and accountability procedures, as required by regulatory agencies, are provided for each study.

Monitoring services may include: trained and certified monitoring staff who develop monitoring plans and who conduct onsite and remote monitoring to assess data quality, regulatory, and protocol compliance. In addition, we can provide support for regulatory inspections and sponsor audits.

Project Management services may include: assistance completing protocol and informed consents; recruitment plan; budget development; study operations manuals; study management of multi-centre studies; training study staff on protocol requirements (site procedures and investigator’s meetings); liaising with vendors on investigational product and laboratory requirements; and ensuring quality and accountability procedures, as required by regulatory agencies, are provided for each study.

Data Safety and Monitoring Committee (DSMC): interventional studies require unbiased review of safety and efficacy of new trial interventions or trials in progress to ensure that the safety of participants is protected. The CTN’s DSMC meets two times per year and will provide information about a study’s safety and efficacy status to the lead study investigator.

Communications and Knowledge Translation: All CTN studies receive bilingual plain language study descriptions to promote their studies on the CTN website and on CATIE’s website, listing in Connections newsletter, promotion through social media channels, and community outreach through articles and presentations. Additional services, on request, may include: creation of websites and social media campaigns for studies, production of study documents and materials; assistance with press releases and interactions with the media; integrated and end-of-grant knowledge translation plans; and support for the development of policy documents.

Other services may include: assistance liaising with other external parties to gain extra resources for studies, program evaluation, and medical writing.

For more information about CTN in-kind services contact echerban@hivnet.ubc.ca.

Submit a Clinical Trial Application

If your study is testing a new drug, or an approved drug outside of its approved use, then you will have to submit a Clinical Trial Application (CTA) with Health Canada; click here to see when a CTA is needed. CTN has a regulatory affairs department that can submit a CTA, manage the lifecycle of your regulatory application, and liaise with Health Canada on your behalf.

  • It is recommended that you contact Dana Nohynek (Director, Regulatory Affairs and Quality Assurance, CTN)
  • Health Canada Clinical Trial Application can be found here.
  • Further information can be found on the Centre for Health Evaluation and Outcomes Sciences website.

If your study involves an investigational medical device, you may need to obtain an Investigational Testing Authorization (ITA) from Health Canada. Contact Dana Nohynek for further advice.

  • Health Canada Application for Investigational Testing can be found here.

Are you testing a Natural Health Product? Contact Dana Nohynek for further advice.

  • Health Canada Natural and Non-prescription Health Product Directorate

Obtain Ethics, Contracts, and Organization Approval

The exact procedures and timing will vary among institutions, but before starting any type of research study, you must submit your study for review by your local ethics committee and obtain approval, obtain organizational/institutional approval, and fully execute any required contracts or agreements. This includes finalizing the CTN Affiliation Agreement and the Agreement between PHC/UBC and local site institution.

Successful applicants are required to complete all the necessary requirements for their home institution. These include:

  • Fulfilling their institutional Research Ethics Board requirements.
  • Observing the progress of contract negotiation between their home institution and the CTN National Centre and responding to their home institution in a prompt manner to ensure that contract negotiations occur in a timely fashion.
  • Establishing a grant account per the requirements of their home institution, oversee (if applicable) spending for the study, and provide the CTN National Centre with financial statements as required.

Looking for sites to help you with your research? Use our study feasibility checklist to determine if a potential site can meet your needs.

Study Documentation and Training

Essential documents for Clinical Trials:

Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, recording, analyzing, and reporting of research that involves human participants. Ultimately, GCP are in place to protect the rights, safety, and welfare of humans participating in research, and to assure the quality, reliability, and integrity of data collected. All members of the research team (investigators, sponsors, and research ethics boards) are required to follow GCP.

All Health Canada regulated clinical trials require maintenance of essential documents, see here. It is strongly recommended that all non-regulated research studies maintain these documents to comply with GCP guidelines. These documents are generally filed in the Trial Master File (sponsor), or the site regulatory file (site level). To assist you, included in the following list of required documents are templates that can be used/modified for investigator-initiated studies as well as sponsored studies.

Download a listing of Essential Documents and their purposes here.

Suggested logs for clinical trials:

Current CVs and practice licenses (as appropriate) should be maintained to show the qualifications of the study team.

Training and Standard Operating Procedures (SOPs) for Clinical Research Studies:

  • Most Research Ethics Boards (REBs) require that the course on research ethics be completed by all study team members, prior to receiving REB approval.
  • Through CTN’s membership in the Network of Networks (N2), or your local institution, you have access to all other required training courses on CITI Program.
    • You must complete, at a minimum:
      • GCP training. Note: Health Canada does not define how frequently GCP training should be completed, but in general, sponsors require re-training every two years (N2 offers a refresher course). Check with the institution you signed up with for their specific retraining requirements.
      • If shipping specimens is included in your protocol, all personnel conducting the shipping must complete the Transportation of Dangerous Goods certification.
    • Recommended
      • Division 5 training (required for regulated studies)
      • Responsible Conduct of Research (RCR)
    • Membership in N2 also provides access to a set of clinical research Standard Operating Procedures (SOPs) if your institution or research group do not have their own. Contact Erin Cherban or Leslie Love if you need access to these. At a minimum, you should have the following SOPs for a Health Canada regulated clinical trial:
      • Informed Consent Process
      • Serious Adverse Drug Reaction Reporting
      • Research Team Training
      • Equipment Calibration and Maintenance
      • Long Term Storage of Study Documents
      • Management of Investigational Product (if applicable)

Trial registration requirements:

Any clinical study involving human participants must be registered on a public clinical trial registration website. The most commonly used is clinicaltrials.gov. Check with your local institution for information on registering your study. CTN can provide assistance with this service.

Defining Roles & Responsibilities:

If you are acting as sponsor-investigator for a multi-centre study, or you are receiving some support from an industry partner, it is a good idea to document who is responsible for each study activity. This is often required when negotiating a contract with another institution. CTN requires a fully executed Roles and Responsibilities document be added as an addendum to the study contract.

Human Resources:

You may wish to conduct a needs assessment in advance to determine your human resource requirements to perform the study. For example, how much work will this study entail and what sort of training is required? For Health Canada regulated clinical trials, you are required to conduct this needs assessment prior to hiring staff.

You are legally obligated to ensure that both you and your staff have sufficient time to conduct the trial and that all personnel affiliated with the trial are sufficiently trained for their position and their duties during their trial.

Data Management:

We encourage investigators to contact the CTN’s Data Management group during protocol development. What type of database do you need to collect your data? Evaluate the scope of data to be collected as that will drive the decision. One of our team can review the protocol and schedule of events, assist in building data collection instruments, identify critical data, review investigator responsibilities, discuss database design, and determine timelines from protocol approval to end user training and database release. Our team can also assist you to select a most appropriate database platform based on the nature of your data.

It is important for investigators to be aware that any delay in meeting milestones/timelines affects downstream activities. Investigator input or approval is required at various stages of database development:

  • Protocol Approval
  • Data Collection Worksheets (DCWS) Approval
  • Data Management Plan (DMP) Approval
  • Online Review
  • Database Release and User Request Approval

For details of Data Management Milestones, timelines, and team members involved, please download the document here.

A note about changes after the database has been released: The CTN has a robust Change Control procedure to ensure the integrity of our systems and data. Changes to a database following its release to production require a thorough justification, an impact assessment, and validation. Depending on the database, there may also be system limitations to consider. We endeavor to get things right the first time, with extensive review and approval of the database design before release.

Monitoring Plan and Statistical Analysis Plan (for multicentre studies):

For Health Canada regulated clinical trials, you are required to provide oversight on the study to ensure it is conducted in accordance with the protocol, SOPs, GCP, and local requirements. Generally, this is completed by either onsite monitoring of study sites, or remote monitoring through the data collected. The purpose of monitoring is to ensure the rights and wellbeing of participants are maintained, and that the data collected are accurate, complete, and verifiable from source documents (GCP 5.18.1). The extent and nature of monitoring will depend on the study — CTN provides a monitoring plan template. Contact Erin Cherban or Leslie Love if you need access to a monitoring plan template.

A Statistical Analysis Plan (SAP) is created to define the details of the planned statistical analysis for your research study. It should be created before the research starts. It usually includes sample tables and listings of data, and the manner in which the datasets will be analyzed. It usually lists methods for protocol deviations, unblinding, and how to deal with missing data. The SAP needs to be created by a statistician with experience in clinical trials.

Think you are ready to start? Check out our Study Startup Checklist to ensure you have everything in place.

Project Execution

Conduct the Study

CTN provides support in the following areas:

Clinical trial and Project Management and Monitoring (CTN can also provide templates for use by external study project management)

  • Site Initiation and Training – Site initiation is performed on site or remotely. CTN Project Managers can ensure that all the site personnel complete required training (regulatory and study related) and ensure that essential documents are in place. Download SIV Training Report here.
  • Serious Adverse Event (SAE) management and reporting in Canada – review and report SAEs to Health Canada for the participating sites. SAE Report Cover Sheet and SAE Log.
  • Research Ethics Board (REB) communication and submissions – provide assistance to the participating sites in REB submissions and follow-ups.
  • Protocol deviation management – provide assistance in the process of requesting, identifying, reporting, approving, and tracking protocol deviations. Protocol Deviation Form and Protocol Deviation Log.
  • Essential documents management – Assist participating sites in creating and maintaining the Investigator Site File (ISF), and assist the Sponsor Investigator in creating and maintaining the Trial Master File (TMF). TMF TOC and ISF TOC.
  • Audits and Inspections by external parties – Assist participating sites in preparing for audits and inspections by external parties such as regulatory authorities (e.g. Health Canada or the US Food and Drug Administration), institutional auditor, or industry partner.
  • Management of Investigational Products at site – Assist participating sites in receipt, accountability, labelling, storage, dispensing, return, and authorized destruction of the Investigational Product(s). Site Drug Accountability LogTemperature Log #1Temperature Log #2Participant Drug Accountability Log, and Drug Destruction Form.
  • Management of Biological Specimen – Assist participating sites in collection, labelling, processing, storage, and destruction of biological specimens. Specimen Storage Shipment LogLaboratory Requisitionand Equipment Maintenance Log.
  • Creation of monitoring plan – Monitoring Plan, Monitoring Confirmation Letter, Monitoring Visit Log, Monitoring Visit Report, Monitoring Follow-up Letter, and Telephone Log.

Study data management

  • Data Collection Worksheets design
  • Database design and edit checks programming
  • Data cleaning and query management
  • Reports generation
  • Users management
  • Adverse event coding (upon team’s request)

Data Safety Monitoring Committee (DSMC)

The DSMC’s mandate is the following:

  • To monitor the conduct and progress of clinical trials to determine if any trial should be modified or stopped and make recommendations;
  • To evaluate accumulating study data for treatment benefit or harm;
  • To recommend protocol changes;
  • To review and approve clinical trial design and methods insofar as these impinge upon the DSMC’s functions;
  • To alert clinical trial leaders regarding emerging procedural or ethical issues; and
  • To monitor enrolment to assure that clinical trials proceed in a timely fashion.
Statistical Support/Analyze Data
  • Finalize the Statistical Analysis Plan
  • Program the data summaries and analyses
  • Analyze data
  • Prepare data summaries, tables, and plots for abstracts/presentations/manuscripts
  • Assist with drafting text for methods section of abstracts/presentations/manuscripts

Health Economics

  • Design of health economics studies;
  • Conducting economic evaluations of various health interventions;
  • Performing systematic reviews and meta-analysis commonly required in cost-effectiveness decision analytic modeling; and
  • Evaluating health policies.
Disseminate Results/Publish the Data
  • Write a plain language description of study results in both official languages
  • Disseminate plain language results via website, social media, Connections newsletter, and community outreach
  • Provide a press release of study results (on request)
  • Assist in implementing Knowledge Translation strategies based on protocol and raise awareness of study results among knowledge users
  • Develop and design Knowledge Translation documents such as thank you cards/result cards for participants (on request)
  • Provide publication guidelines to acknowledge CTN support on papers, posters, and presentations
  • Track publications and presentations to post in Connections newsletter, website and for reporting to CIHR
Study Closure and Archiving

For clinical trials regulated by Health Canada, you are required by Health Canada to retain study documents for 25 years after trial completion. If your study is not a regulated clinical trial, you should retain your records per institutional requirements. Don’t forget to close the study with your local Ethics Board, and with any funding agencies as well. Download a Close-out Visit Report and a Close-out Letter.

Further Information:

Network of Networks

Health Canada Clinical Trials

Common clinical research terminology

 

If you have any questions, comments, or concerns please contact info@hivnet.ubc.ca.

 

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