GxP Perspectives is Thankful


GxP Perspectives is Thankful

GxP Perspectives
is Thankful

Today is Thanksgiving in the U.S., a day to be thankful for what we have. It is my favorite holiday. I enjoy eating and I think that saying “thank you” is pretty important. I’m thankful for the readers of GxP Perspectives on the Blog’s third Thanksgiving. I am in particular very thankful for the Guest Commentaries that have been submitted to the Blog. This year they have been great. I am also thankful for the ability to take a break once in a while (which I have been doing). And finally I’m thankful to my family and friends who seem to put up with me. OK- this is a short post but it does have two important announcements, one on the TMF Reference Model from Co-Chairs Lisa Mulcahy and Karren Redding and the other about the GCP CAPA Conference that GxP Perspectives is a media sponsor.

Carl Anderson – GxP Perspectives –
24 November 2011

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TMF Update:

Eighteen months ago, the only guide to the contents of the trial master file (TMF) was ICH-GCP, specifically section 6. Today we have the TMF Reference model, created by a wide variety of experts across pharmaceutical companies, CROs and technical vendors. Version 1.1 was released in February 2011, and has been adopted by many companies – pharmaceutical and CRO alike. The TMF Reference Model has also received positive feedback from the Regulators, with recent comments about what a great reference it is and how much hard work must have gone into it!

Version 1.2 will be released in December – The exciting addition is the adaptation for the contents of Investigator Site Files, facilitating alignment between trial master file contents at the Sponsor or CRO, and Investigator site file contents at the Investigator site. If this part of the model has the same uptake as the main TMF Reference Model, imagine how much easier it will be for the Investigators in terms of standardisation.

Watch this space closely – version 2 will be released early in 2012, to include device studies, process-based metadata and Investigator initiated studies. This is not the limit of the group developments – we are also looking at intra-operability from an electronic perspective, document destruction (a huge area of interest which extends way beyond the TMF) and even quality aspects of the TMF (a new idea put to us just yesterday!)

Karen Redding
Lisa Mulcahy
Co-Chairs of the TMF Reference Model

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2nd Annual Developing CAPAs in the GCP Environment 19-20 January 2012 in Arlington, VA. The keynote speaker is Dr. Leslie Ball, FDA, with a regulatory update on FDA’s Expectations for Clinical CAPAs and Reponses to FDA Warnings. For more information:

GCP CAPA Conference

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