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 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.