How to prepare mHealth computerized systems for FDA Regulated Clinical Trials

Technology can offer new and exciting options, but it may also be overwhelming.  Below is a navigation tool the mHealth Research Core (mHRC) put together to help you balance regulatory considerations while moving your Part 11 regulated research project forward.

Compliance to Part 11

Compliance to Part 11 is applied using a risk-based approach considering (1) the level of risk of the study [e.g., the risk associated with the use of the study drug or device and the vulnerability of the patient population], (2) the intended use of the technology, and (3) whether the study is conducted with commercial intent.

When establishing Part 11 compliance there are three levels of consideration:

  • The system level
  • The configuration level
  • The use case level (which is often the study level)

At the use case (study) level Part 11 compliance often takes the shape of establishing policies and/or procedures to govern your testing and use of the technology. To find out more information please check out the Trial-CARE’s Introduction to Part 11 (a PDF presentation). In addition, Trial-CARE has created guidance documents for Investigator Responsibilities in Part 11 Regulated Research and eSignature Requirements in Part 11 Regulated Research.

If your study is regulated by Part 11 or if you would like help determining if your study is regulated by Part 11, please contact the Trial-CARE Division of The Center for Clinical Studies at to set-up a consultation.


  • Central elements for computerized systems in FDA 21 CFR Part 11 and ICH E6 R2 regulated research:
    • Risk MitigationUser Access ControlsE-SignatureData integrity (ALCOA Plus)
    • Secure and encrypted data collection, transfer, storage, and analysis
    • Audit trails

Relevant Resources: