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.
On July 31, 2019 the Association of Clinical Research Professionals (ACRP) will be hosting a webinar titled, “Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance”. Michael Marotta and Bradley Lieberman from IMARC Research, Inc. will be the speakers.
Topics: IMARC Research, ACRP, Webinar, AE Reporting
This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees, and help attendees understand the differences between Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and Medical Monitors. Professionals at research sponsors, CROs, sites, and IRBs will learn when each type of safety oversight is recommended and how to provide effective, efficient safety monitoring. Participants will also hear from a DSMB Chair about their experiences and the important impact of safety groups to research studies.
Topics: IMARC Research, Safety Oversight, Webinar