FDA Guidance On Electronic Clinical Trial Data Slated For Late August

FDA plans to publish a draft guidance on the use of computerized systems in clinical trials by the end of August.

The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999.

The revisions will bring FDA's thinking on the topic in line with policy articulated in its broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application."

The draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements.

Many of the guidance's general principles are expected to address clinical trial electronic record security. The document will likely recommend that security measures be established to prevent unauthorized access to the computerized system and the data in the electronic record.

The guidance is also understood to suggest that changes made to data stored on electronic media may require an electronic "audit trail."

Such audit trails or other security measures should document who made the changes to the electronic records, when the revisions were made and the reasons for their implementation.

With regard to specifics of how protocols incorporating the use of computerized systems should be designed, FDA is expected to recommend that each study protocol identify and document when the system will be used and with what types of software and hardware.

The guidance is also expected to suggest that electronic clinical trial data be stored at the site where the investigation is conducted.

In comments on FDA's 2003 Part 11 guidance, the Pharmaceutical Research & Manufacturers of America urged the agency to permit electronic storage of clinical data by third parties to ease the burden on clinical investigators and investigation sites (¹ (Also see "FDA Should Allow Third-Party Electronic Storage Of Clinical Data – PhRMA" - Pink Sheet, 2 Jun, 2003.), p. 30).