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 issues while moving your project forward.

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

  • Policies and Standard Operating Procedures (SOP)
  • 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
    • Back-Up and Security
    • Disaster Recovery

Validation of Computerized Systems:

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


Relevant Regulations:
  • FDA-21 Part 11 and ICH E6 R2
    • Risk Mitigation
    • User Access Controls
    • E-Signature
    • Secure and encrypted data collection, transfer, and storage
Relevant Resources: