GCP-RMA

Good Clinical Practice Records Managers Association
Home
Contact Us
Meetings
Membership
News
Publications
Who are GCP-RMA?
Email Mngt
Title: First association meeting to be held in Germany  
:
Germany was a new location for the Association when it held its meeting in April 2009. Kindly hosted by Bayer-Schering Pharma, this meeting included a range of discussion topics including
  • use of Microsoft Sharepoint as a replacement for shared network drives;
  • records management issues during company acquisitions;
  • case study of OmniRIM implementation for document management;
  • demonstration and discussion of an example archive tracking system;
  • implementation of OpenText LiveLink as a corporate records management tool;
  • update from the DIA eTMF Reference Model; and
  • activities relating to current Association work projects.

If these are topics you are involved in and you meet the criteria for membership, please join and contribute to our discussions.

 
Created: 05/05/2009  

Title: Relevant Communications Guidance Document Issued  
:
This document which has been developed by the  GCP-RMA is intended to supplement the ICH Guideline for Good Clinical Practice section 8.3.11 “Relevant Communications Other Than Site Visits”. 2. In particular, it provides guidance on how to decide whether a communication is ‘relevant’ or not.
Click HERE to download.
 
Created: 07/07/2009  

Title: Successful meeting in UK  
:
The GCP-RMA held a very successful meeting recently in Marlow, UK 23-24 September. The varied agenda included discussions on:
  • Digital pen technology and its use in clinical trials
  • Use of document management technology at sponsor sites
  • Update on data privacy
  • Update on GCP inspection experiences

As usual, there was much discussion both during meeting sessions and outside of the main meeting during breaks and evening social events.

 
Created: 29/09/2008