How to prepare mHealth computerized systems for FDA Regulated Clinical Trials

Technology is often new, exciting and 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.

Establish system controls and procedural controls for both the study and the technology:

  • Policies and Standard Operating Procedures (SOP)
    • Contact the Center for Clinical Studies Trial-CARE Unit at to learn more about investigator responsibilities and the required SOPs in Part 11 regulated research.
    • For FDA regulated technology the entity creating the technology and/or managing the data will need standard operating procedures for the following:
      • Software Development Life Cycle (SDLC)
      •  Validation of Computerized System
      • Back-Up, Security, and Disaster Recovery

Validation of Computerized Systems:

  • System Validation Plan
  • System Requirement Specifications
  • System Test Plan
  • Validation Summary Report


  • Central elements for computerized systems in FDA 21 CFR Part 11 and ICH E6 R2 regulated research:
    • Risk Mitigation
    • User Access Controls
    • E-Signature
    • Data integrity (ALCOA Plus)
    • Secure and encrypted data collection, transfer, and storage
    • Audit trails
Relevant Resources: