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Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The eClinical Forum Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE  PAPERS: These white papers provide details of the positions described in a position paper titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials” released on 26/Feb/2021. 

Nature of a Distributed Trial Master File ‐ Practical Aspects: The Essential records consist of trial-specific, non‐trial-specific documentation, and data. The non‐trial specific essential records may be retained separately and signposted in the sponsor (e)TMF. The location of these records will vary depending on the type and source of the records in question. Consequently, the whole (e)TMF will span across multiple locations and be distributed among multiple parties. The aggregation of trial and non‐trial specific essential records must allow for the seamless reconstruction of clinical development activities, must be open to audits and inspections, and must fulfill all regulatory and legal purposes for the applicable full retention periods. This white paper is intended to provide hands‐on practical guidance on (e)TMF implementation by describing examples of risks in practice with proposed recommendation(s).

The Decommissioning of Computerised Systems Used in Clinical Trials: Clinical trials typically involve the use of multiple computerised systems and many of these systems are rarely developed for use in one trial alone. Instead, specific trial configurations are built on common platforms across multiple sponsors and contract research organisations (CROs). This white paper addresses the decommissioning of computerised systems such as EDC/eCOA systems used in clinical trials

Data Formats Used in Clinical Trials: There are disparate views in our current climate on how data should be archived and handled. This follows regulatory guidance that expects information to be available in a way that allows queries whilst understanding that such formats are not necessarily practical over the full retention lifetime. This white paper explains the options, risks, and benefits of using a flexible multiformat approach to ensure recall can be conducted in the future.

 

 

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