Fwd: Open Data, registered trials S&E FDA

[Ben Goldacre]

I'm sure many on this list are also on EBH, but in case not, this below is interesting, consultation on FDA guidelines on managing trial data, potential avenue for advocating for transparency. 

---------- Forwarded message ----------
From: Amy Price <heali...@msn.com>
Date: Thu, Jan 10, 2013 at 2:18 AM
Subject: Open Data, registered trials S&E FDA
To: EVIDENCE-B...@jiscmail.ac.uk

Dear All,

Maybe adding comments to these drafts could be another way to make a difference and shift the culture towards ethical transparency and open data. I just got this or would have contributed earlier. If you are not use based and would like me to share your points, please let me know I would be happy to progress this: 

Request for Comments: Draft Guidance for Industry - Electronic Source Data in Clinical Investigations

FDA is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, CROs, data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. Comments are due by January 22, 2013. More information

Request for Comments: Draft Guidance for IRBs, Clinical Investigators, and Sponsors - IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed
This draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. Comments are due by January 22, 2013. 
More information

Best,

Amy Price