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 (see specific guidelines);
  • 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

The next four sections apply to anyone developing a research project. The CTN can be consulted for advice and provide services to our investigators (see Project Set Up).

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. 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 answer your hypothesis. If it’s too narrow, you will have difficulty finding appropriate participants.

Remember, 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 give you a pragmatic view on the applicability and feasibility of your research. The Community Engaged Research Practice can help researchers successfully engage with community members.

Create a Proposal/Draft Proposal

Seek experts who will provide you with advice and review your proposal. Find out if your institution will assist with project/grant development.

With advance planning, an investigator can receive formal CTN feedback before submission to a granting agency or a Research Ethics Board (REB). This Pre-Final Proposal stage involves the CTN providing Community Advisory Committee (CAC) and Scientific Review Committee (SRC) feedback on Pre-Final applications to improve the likelihood of receiving funding from granting agencies. Please refer to the CTN Submission and Review Process Guidance information, available as a PDF download or in the CTN Review Phase section.

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

If you simply need advice on where to find experts for this stage of development, the CTN National Centre or Core Leads could put you in touch with relevant experts. Contact Erin Cherban, Chief Clinical Research Officer (1-800-661-4664; 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 report on methodology standards. 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).
  • Industry partners. A pharmaceutical or medical device company may provide direct funding for a project via their established investigator-initiated study funding mechanism, or they may consider donating the study intervention (e.g. drug or device).
  • Hospital Foundations.

CTN Review Phase

The CTN holds in-person meetings twice a 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 present an overview of their study and 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).

If an application is successful and a study receives in-kind services from the CTN, investigators must make the changes requested by the review committees. They then have further opportunity to refine the protocol with feedback from the National Centre.

The CTN conducts two types of review:

  • Regular Study Submission: Applicants who meet the criteria for submission can apply to the CTN twice per calendar year.
  • Pilot Study Funding Program: Applicants who meet the criteria have the opportunity to apply once per calendar year.

The CTN Submission Schedule may be downloaded here.

Regular Study Submissions:

CTN Study Review and Approval Process

  • If you have any questions, call 1-800-661-4664 / 604-806-8340 or email 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 align with their scientific priorities. The following type of 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, if justification can be provided
  • Implementation science projects, preferably multi-centred and with a focus on health care innovation
  • 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 at least 30 days before 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 form plus an LOI checklist is available here)
  • 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. 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.

  • 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.

Stage 2: Full Submission

The CTN will invite successful LOI applicants to provide a full submission. The email invitation will include the information about the CTN meeting they should attend to receive application assistance, 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 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);
    • 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, questionnaires, 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 changes to the informed consent form and ask the investigator questions 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 or NIH’s randomized controlled trial (RCT) review panels. In such cases, a review by the SRC would not be necessary. All external reviews must be included in the submission.
  • Submissions receiving an SRC score of 3.5 or higher and CAC’s feedback 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 feedback. 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 reviews the ‘Approvable’ submissions 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. 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 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 must 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 avoid delays.
  • 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 will be available soon. Please review this document prior to submission.
  • Links for all submission forms are included below. **updated documents coming soon**

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

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. Applications from existing projects seeking top-up funding are not accepted.

This Program also provides training and mentorship opportunities for junior investigators in order to gain experience on how to run an intervention/clinical trial or implement a research project, by working with senior investigators and National Centre staff. 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. Current CTN Postdoctoral Fellows are eligible to apply, however, their funds must be held by their supervising CTN Investigator.

Pilot Study Funding Program Concept Submission Form will be available soon.

Pilot Study Funding Process

  • Candidates who are interested in applying, and who fulfill the Program Requirements, must contact at least one of the Core Co-leads at least 30 days before the 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
  • 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 will be available soon.
  • 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 doing so.
  • 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 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, 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.
  • During the pilot study and upon completion, awardees are encouraged to publish or present their findings, adhering to the CTN Publication Guidelines.

Documents

Submission Calendar

Letter of Intent Registration Form

Study Submission and Review Process Guidance

Full Submission Application Form *undergoing revision*

Full Submission Cover Letter Template

Recruitment Plan

Project Budget Template

Site Investigator Confirmation of Participation Form

Pilot Study Funding Program Guidance Document *undergoing revision*

Pilot Study Funding Program Concept Submission Form *undergoing revision*

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 a protocol template for use in interventional clinical studies.

CTN Research Services

The CTN National Centre in-kind services available for request:

  • Protocol Development: incorporates many of the services listed below.
  • Data Management services
  • Statistical and Methodological consultation
  • Health Economics analysis
  • Regulatory Affairs services
  • Monitoring services
  • Project Management services
  • Data Safety and Monitoring Committee (DSMC): interventional studies require unbiased review of safety and efficacy of new trial interventions or trials in progress.

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 may be requested.

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) to 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 (click here for more information).

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

Are you testing a Natural Health Product? Health Canada Natural and Non-prescription Health Product Directorate

In August 2019, Health Canada, Regulatory Operations and Enforcement Branch (ROEB), released Guidance Document (GUI-0100), providing guidance on interpreting the regulations around conducting a regulated clinical trial in Canada.

“This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2)in the Canadian context.”

Contact Dana Nohynek for further advice.

Obtain Ethics, Contracts, and Organization Approval

Before starting any type of research study, you must obtain approval from your local ethics committee, 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 including:

  • 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 promptly
  • 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. It is 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. 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, the following list of required documents includes templates that can be used/modified for investigator-initiated and 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 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: 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 re-training 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. 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, 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 (e.g. 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 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.

Data Management:

We encourage investigators to contact the CTN’s Data Management group during protocol development, who can review the protocol and schedule of events, assist in building data collection instruments, identify critical data, review investigator responsibilities, discuss database design and platform, and determine timelines from protocol approval to end user training and database release.

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 must 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. Contact Erin Cherban or Leslie Love if you need a monitoring plan template.

A Statistical Analysis Plan (SAP) is created before the research starts and defines the details of the planned statistical analysis. It usually includes sample tables, 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.

Risk Management Plan:

The 2016 ICH E6 (R2) Addendum to Good Clinical Practice guideline requires clinical trial sponsors to incorporate a risk management plan. Risk Management allows the study team to identify areas where issues may occur, and incorporate strategies to prevent issues from impacting the study’s successful completion. For further information see Risk Management 101.

Think you are ready to start? Doublecheck using our Study Startup Checklist.

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)

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 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. Download 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 ctninfo@hivnet.ubc.ca.

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