Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Adverse Events Definition Should Be Narrower, IRB Groups Tell FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The Consortium of Independent Review Boards favors reporting only adverse events that "probably or definitely" related to the study drug. Current regulation requires adverse events to be reported to IRBs if they are "at least possibly" related to the drug.

You may also be interested in...



Phase III Trial Oversight Should Rely On Adverse Event "Summaries," CRO Association Says

The Association of Clinical Research Organizations supports using partially blinded data summaries to help institutional review boards overseeing multi-center trials

Phase III Trial Oversight Should Rely On Adverse Event "Summaries," CRO Association Says

The Association of Clinical Research Organizations supports using partially blinded data summaries to help institutional review boards overseeing multi-center trials

Clinical Trial Adverse Event Reporting To Be Discussed At FDA Public Hearing

Agency announces March 21 hearing to consider the types of adverse event reports that should be submitted to institutional review boards. The proliferation of multi-center studies is one reason behind FDA’s decision to revisit the process by which IRBs assess such information.

Related Content

Topics

UsernamePublicRestriction

Register

PS061801

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel