You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
You may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances.
Topics: Outsourcing, Safety Monitoring Oversight
A safety monitoring group may be called many different things— a data monitoring committee, a data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study risks.
Topics: FDA, Safety Monitoring Oversight
Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) and/or a Clinical Events Committee (CEC).
Topics: CEC, DSMB, Safety Monitoring Oversight