2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC18
Submitter : Ms. Catherine Adair Date & Time: 04/13/2005 06:04:52
Organization : Univ Of Mississsippi MedCent.Clinical ResearchProg
Category : Health Professional
Issue Areas/Comments
Having worked in clinical research for the past 25 years in multi-center trials , the burden imposed on myself and our local IRB relating to under- reporting from other sites is overwhelming, and non- productive in protecting our research subjects. My recommendation would be that the sponsor be responsible for preparation of summary adverse event reports to lessen this work load. All adverse events determined to involve risk by either investigators or the sponsor, need to be rapidly communicated to us for forwarding to our IRB. Those deemed unrelated should be provided in summary form, allowing the local investigator the opportunity to review and make a different determination of risk. The unrelated events could then be forwarded in summary form at the time of continuing review to our local IRB.