Recruitment and participant retention can be the most challenging aspect of any clinical research study. A potential study participant may meet all the inclusion/exclusion criteria, but find the time commitment too onerous, the study too complicated, or be worried about how participation may affect their disease. You should have a realistic recruitment plan in place: site databases, social media, and print advertising are just some suggested recruitment strategies. Note that any recruitment materials must be approved by the REB.
Monitoring, Audits, and Inspection
Monitoring is considered the oversight, or quality review, of the study as it progresses to ensure it is being run in compliance with the study protocol, GCP, and local regulations. Generally, monitoring is ongoing throughout the study. Similar to monitoring, the purpose of an independent audit is to ensure the investigator is in compliance. All clinical studies can be audited by the local REB or by the study sponsor. In addition, all Health Canada regulated studies are potentially subject to inspections and/or audits by Health Canada. If you are notified that your study is subject to an audit or inspection, contact Erin Cherban, Chief Clinical Research Officer, Advancing Health/CTN.