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US FDA insists on use of electronic records, signatures for clinical investigations in its latest draft norms

Nandita Vijay, Bengaluru
Monday, July 17, 2017, 08:00 Hrs  [IST]

USFDA now mandates use of electronic records, signatures in clinical investigations in its latest draft norms. It expects the clinical research sector to comment on the guidelines before August end.

The draft document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs) and contract research organizations (CROs) on the use of electronic records and electronic signatures in clinical investigations of medical products under 21 CFR part 11, Electronic Records and Electronic Signatures.

Procedures need to be followed to help ensure that electronic records and electronic signatures meet FDA requirements which are reliable and generally equivalent to paper records and handwritten signatures executed on paper.

The objective is to update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations. The aim is to encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations.

In March 1997, FDA published a final rule to establish criteria that needs to be met when a record is required in electronic format replacing a paper record and when electronic signatures are opted in place of traditional handwritten signatures.

The part 11 regulations, which apply to all FDA programme areas, were intended to permit the widest possible use of electronic technology. These regulations are compatible with the regulatory authority’s responsibility in public health, while also ensuring the authenticity, reliability and confidentiality of electronic records. It is to ensure that the endorser cannot readily repudiate the signed record as not being genuine.

The guidance applies to electronic records and electronic signatures for clinical investigations of medical products that are maintained in electronic format in place of paper format. Electronic signatures required for clinical investigations intended to be the equivalent of handwritten signatures, initials, and other general signings.

Electronic systems, include commercial off-the-shelf (COTS) and customized, owned or managed by sponsors and other regulated entities. It also covers those used in medical care, mobile technology and telecommunication systems.

The regulator does not mandate or specify any particular methods for electronic signatures, including any particular biometric method upon which an electronic signature may be based.

“This guidance is current and most apt in the current context of online and offline submission. It elucidates the use of electronic records and electronic signatures in clinical investigations of medical products which include human drugs and biological products, medical devices, and combination products,” Prema Desai, pharma consultant told Pharmabiz.

The procedures defined need to be followed in order to ensure that the records and signatures are considered trustworthy, reliable, and equivalent to hand written signatures executed on paper, she added.


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