The main issue with this approach is thatno time has been allocated for ongoing maintenance and updates of the Data Management Plan (DMP)throughout the study lifecycle.
According to theGCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is aliving document— it must be continuously maintained and updated as study procedures evolve, particularly afterprotocol amendments, database modifications, or changes in data validation or reconciliation procedures.
Budgeting only for initial creation (forty hours) over three months ignores the substantial effort required forDMP version control, stakeholder communication, and mid-study updates. These updates are mandatory to maintain compliance withICH E6 (R2) GCP Section 5.5.3, which requires that all procedural documentation accurately reflect current practices.
Thus, the problem is not the time allocated for creation but thelack of planning for ongoing maintenance.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Plan (DMP), Section 5.3 – DMP Maintenance and Version Control
ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Documentation of Data Handling Procedures
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Section on Documentation Updates
