FDA Establishes Electronic Privacy, Security, And Reliability Criteria For Clinical Trial Records

In Short

The Situation: Technological advances and the growing use of electronic records and tools potentially raise privacy and security concerns in connection with certain FDA-related activities.

The Action: FDA has released a draft guidance to ensure that entities regulated by the Agency follow certain procedures and processes that must be in place to safeguard the electronic records used in clinical research activities and electronic submissions.

Looking Ahead: Stakeholders have until August 21, 2017, to direct comments on the draft guidance to FDA.

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic signatures used for certain FDA-related activities. FDA subsequently issued several draft guidance documents and a policy statement to clarify Part 11 but withdrew these documents in early