tmfrefmodel.blogspot.com
TMF Reference Model: September 2012
http://tmfrefmodel.blogspot.com/2012_09_01_archive.html
About the TMF Reference Model. Wednesday, 26 September 2012. What is the TMF reference model team working on now? The focus of Version 2.0 was on the expansion of the applicability of the Model, encompassing a variety of different aspects of Trial Master File management:. The Investigator Site File. IIS), those where the investigator also takes on the responsibility of the trial sponsor, have increased record keeping challenges. TMF content for IIS studies has been included in the model. Due to t...So to...
tmfrefmodel.blogspot.com
TMF Reference Model: September 2010
http://tmfrefmodel.blogspot.com/2010_09_01_archive.html
About the TMF Reference Model. Thursday, 23 September 2010. Is it permissible to destroy original paper TMF documents? This, and related questions, will be answered by a new sub-team that has just been initiated by the TMF Reference Model SIAC. We as an industry are grappling with the topic of the destruction of paper original documentation that has been scanned into an EDMS, or for us particularly, an eTMF. For example:. What are the technology requirements for acceptable scanning? The word gets around.
tmfrefmodel.blogspot.com
TMF Reference Model: July 2010
http://tmfrefmodel.blogspot.com/2010_07_01_archive.html
About the TMF Reference Model. Thursday, 1 July 2010. Rationale for the model. ICH Guidelines define the TMF as containing those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. (ICH Guideline for Good Clinical Practice, E 6, Section 8). Simple tem...
tmfrefmodel.blogspot.com
TMF Reference Model: TMF Reference Model Group Meeting - 14-JAN-2013
http://tmfrefmodel.blogspot.com/2013/01/tmf-reference-model-group-meeting-14.html
About the TMF Reference Model. Monday, 28 January 2013. TMF Reference Model Group Meeting - 14-JAN-2013. There wer 65 people on today's call! There are currently 320 members from around 200 companies. Notes from meeting:. New leadership committee – Chairman and core team. Goals to expand SIAC enrollment to other regions (Asia Pac critical). Other goals to be defined across the groups (EDM RM, TMF RM, Content reuse, Framework for destruction and Cloud computing (possible). Future TMF relevant Conferences (.
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About Us | Heath Barrowcliff Consulting Ltd
https://heath-barrowcliff-consulting.co.uk/consultants
Heath Barrowcliff Consulting Ltd. Electronic Document and Records Systems. Commercial Records Storage Contracts. Commercial Records Storage Advice. Process and Policy Authoring. Director and Principal Consultant. Russell has over 20 years experience in document, records, archive, and information management across a wide variety of sectors including pharmaceuticals, the legal sector, banking, professional services, and central and local government. Poacher-turned-game-keeper , Stephen has been employed in...
tmfrefmodel.blogspot.com
TMF Reference Model: May 2013
http://tmfrefmodel.blogspot.com/2013_05_01_archive.html
About the TMF Reference Model. Monday, 20 May 2013. TMF Reference Model blog moved to http:/ tmfrefmodel.com. The TMF Reference Model blog has now moved to http:/ tmfrefmodel.com. Wednesday, 8 May 2013. How does your TMF / ISF compare? Take the 2013 survey! So this is a last call to action! The survey closes May 16th so you only have a few days left to complete it. Please TAKE THE SURVEY NOW. Subscribe to: Posts (Atom). EuroMeeting, DIA, Mar 4-6, Amsterdam, Netherlands. Take the 2013 survey now! TMF Refe...