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Posted by Michael Marotta on Mon, Nov 06, 2017

Hear Ye, Hear Ye, This Meeting is Called to Order

This is the second of a two blog series on the Draft Guidance for Institutions and IRBs.  The first blog was published on January 7, 2016.

In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.

Topics: Draft Guidance, IRBs, FDA, Institutions

Posted by Emily Haglund on Thu, Jan 07, 2016

Minutes of Institutional Review Board (IRB) Meetings: Draft Guidance for Institutions and IRBs

The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.

Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings

Posted by Lauren Easley on Wed, Jan 03, 2018

2013 Top FDA Warning Letter Findings

For the fifth year, IMARC has searched through the warning letters posted on the FDA’s website to compile a list of the top findings for clinical investigators. This year, we noted twelve warning letters that were issued in 2013. In the past years, the most common citings tend to revolve around failure to follow the clinical investigational plan, insufficient recordkeeping, and inadequate subject protection. Interested to see if the trends continued for 2013?

Topics: Sponsors, FDA Warning Letters, IRBs, IMARC Research

Posted by Stephani Hulec on Wed, Mar 04, 2015

Record Retention: Just How Long Do We Have to Keep All This Stuff?

You did it!

Topics: IRBs, Record Retention, Clinical Research

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