When it’s time to execute your project there are a number of documents that will help you record and track information. CTN provides support in the following areas:
Clinical trial and Project Management and Monitoring*
- Conduct site initiation (onsite or remotely) and training of site personnel. Download SIV Training Report here.
- Review and report serious adverse events to Health Canada using SAE Report Cover Sheet, SAE Log, and SAE Assessment Form.
- Communicate and manage submissions to Research Ethics Boards (REBs).
- Manage protocol deviations. Protocol Deviation Form and Protocol Deviation Log.
- Help participating sites create and maintain the Investigator Site File (ISF), and assist the Sponsor Investigator in creating and maintaining the Trial Master File (TMF). TMF TOC and ISF TOC.
- Help participating sites prepare for audits and inspections by external parties such as regulatory authorities, institutional auditor, or industry partner.
- Manage Investigational Products onsite (receipt, accountability, labelling, storage, dispensing, return, and authorized destruction). Site IP Accountability Log, Temperature Log #1, Temperature Log #2, Participant IP Accountability Log, and Drug Destruction Form.
- Manage Biological Specimens onsite (collection, labelling, processing, storage, and destruction). Specimen Storage Shipment Log, Laboratory Requisition, and Equipment Maintenance Log.
- Create Monitoring Plan –Monitoring Plan, Monitoring Confirmation Letter, Monitoring Visit Log, Monitoring Visit Report, Monitoring Follow-up Letter, and Telephone Log.
*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 CTN 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.