Rachel Silver-Kessler, Director of Clinical Support Services, IMARC
Research sponsors and sites know the importance of implementing quality assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into data safety monitoring boards, clinical events committees and medical monitoring? Take a look at these four tips:
1. Follow thoughtful procedures
The FDA guidance, The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors recommends that data monitoring committees (DMCs) follow written procedures to guide its activities, including for composing safety groups and assessing potential conflicts of interest, holding meetings, and for the format of reports to the group.
2. Gain consensus and implement a charter
The FDA Guidance also encourages DMCs to operate under a written charter that identifies the procedures to be followed (see Step 1). The charter will also outline roles and responsibilities of those in or interacting with the safety group, so collaboration and consensus from various stakeholders are important. The charter should also specify details for the study including scheduling of meetings, how a quorum will be defined, and how meeting minutes will be recorded and stored.
3. Maintain well-organized documentation
Speaking of meeting minutes, a safety oversight group should record the details of its activities and decisions. The charter will outline who is responsible for this, how issues should be communicated and how records will be retained during the study and archived after the study concludes. If an outsourced administrator is used to support safety oversight, maintaining this documentation should be a breeze, allowing the safety experts to focus on their study reviews.
4. Build quality control steps into processes
What better way to complement a focus on quality assurance than to add quality control into the picture? A DSMB, CEC or medical monitor has the ability to greatly impact a study through recommendations (such as to alter the protocol), adjudicated events or by providing other expert advice. Adding a QC step, such as a peer review, can ensure the accuracy of meeting minutes, consensus for adjudication decisions and consistent application of safety review criteria.
Following these four steps will bring quality assurance methods to your safety oversight groups for robust DSMBs, CECs and medical monitoring processes. For other best practices and qualities to look for from your safety administrator, download our guide.
What recommendations do you have for bringing quality into safety management for clinical studies?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.