GCP-RMA

Good Clinical Practice Records Managers Association

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Members of the GCP-RMA keep in touch with each other using a variety of means.

All members require a Yahoo! Groups account in order to access electronic discussions that take place using the Yahoo! Groups service. This service also grants access to Association documents, our online calendar, a complete set of email postings, an online photo album from our meetings and online polls. Access to this area is restricted to GCP-RMA members only.

The group holds telephone conference calls once a month to discuss relevant topics e.g. recently issued guidelines or legislation; upcoming conferences, training courses and meetings; issues of specific interest to individual members.

In addition, the Association holds face-to-face meetings on an occasional basis. These are usually workshop-style where it is expected that attendees will come to participate and contribute to a discussion. Occasionally a keynote speaker will be invited to stimulate discussion.
 
The Association is thus a network or community of records managers committed to sharing issues, practices etc for the common good. The constitution includes a non-disclosure clause which facilitates more open discussion and sharing of ideas between members, either on a one-to-one basis, during conference calls or during workshops. The Association reserves the right to terminate the membership of individuals who are “spectators”.


Most recent meeting:
March 2010, Basel, Switzerland
The focus of this meeting was on electronic document management, including discussion topics on e-TMFs; retention schedules in an electronic environment; electronic archiving; legal admissibility; medical device regulations; observational studies; strategic records management.
 

Other Meetings:

September 2009
Where: Strasbourg, France.
Subject: SOP development; off-site storage; data protection; cloud computing; fileplans; DIA TMF reference model initiative; and other hot topics.
 
April 2009
Where: Wuppertal, Germany
Subject: This meeting included a range of discussion topics including Microsoft Sharepoint; records management issues during company acquisitions; OmniRIM; archive tracking systems; OpenText LiveLink; the DIA eTMF Reference Model; and activities relating to current Association work projects.
 
September 2008
Where: Marlow, UK.
Subject: This meeting included a range of discussion topics including digital pen technology, eTMF solutions, and feedback from regulatory inspections.
 
March 2008
Where: Basel, Switzerland
Subject: The focus of this meeting was aspects of electronic records management, including presentations and discussions on the PhlexEview and FirstDoc / FirstPoint solutions.
 
 
 
 
 
 
September 2007
Where: Amsterdam, Netherlands
Subject: The focus of this meeting was the design and development of a generic filing hierarchy for trial records with an associated glossary/thesaurus. It is hoped that this will become the default file plan across industry for trial-related records.
 
September 2006
Where:
Copenhagen, Denmark
Subject: Workshop on email management. Trial master file hierarchies and nomenclature. Management of eCRFs. Review of current records management guidance.
 
June 2005
Where:
Heathrow, UK
Subject: Various GCP topics, including email management, electronic trial master file, organizational models for records management, GCP inspections

 

 

September 2002
Where: Basel, Switzerland
Subject: GCP Directive: Guidelines on the trial master file and archiving
 
 
February 2002
Where: Paris, France
Subject: Electronic records