Signature Requirements for the eTMF
A Regulatory and Technological Assessment
White paper
Jul 25, 2019

Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (TMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit.

While working with our clients, we at IQVIA often participate in discussions around which documents in an electronic Trial Master File (eTMF) really require signatures. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures.

Research shows that relatively few documents have signature requirements based on regulations. Often, signatures are obtained because of an organizational policy, written or unwritten, not based on regulations. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) reinforces this distinction in its 2012 Good Clinical Practices Guide

Often, obtaining signatures is a holdover from the paper world where signatures were the only way to prove that an individual had an opportunity to review a document before it was finalized. Since modern electronic document management systems provide this information in logs and audit trails, the record exists without the need for signatures.

Knowing the actual regulatory requirements will assist organizations in making sound decisions about which signatures add value, and eliminating signatures they deem unnecessary.

 

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