This category is used for documents that are not displayed in the library but are placed on pages using the shortcode link.
Managing Electronic Records – Online Training Day 1 (December 2022)
Recording of the "Managing Electronic Records" training session given online on 6th December 2022. Running time 2 hours 25 minutes.
A Guide to the Use Management and Archiving of Electronic Signatures published June 2019
A Guide to the Use Management and Archiving of Electronic Signatures
eTMF Vendor Selection Template, published March 2017
Template from the HSRAA GCP special interest group for the RFP for selection of an eTMF vendor
Guidance Document on TMF Relevant Communications, published June 2009
GCP-RMA guidance on relevant communications for the trial master file
Selecting a Commercial Records Storage Provider, published March 2012
GCP-RMA guidance for Selecting a Commercial Records Storage Provider.
Reconciliation of issued, used and un-used CRF books/modules/pages
GCP-RMA guideline on Reconciliation of issued, used and un-used CRF books/modules/pages
EFGCP Guidelines for retention of records at investigator sites, 2002 edition
EFGCP Guidelines for retention of records at investigator sites, originally published March 1995, this version updated to include the 2001 EU clinical trials directive
The Role and Use of PDF in Records Retention, published November 2016
White paper from the HSRAA Electronic Records Special Interest Group on the role and use of PDF and PDF/A in records retention and archiving.