The main issue with this approach is that no time has been allocated for ongoing maintenance and updates of the Data Management Plan (DMP) throughout the study lifecycle.
According to the GCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is a living document - it must be continuously maintained and updated as study procedures evolve, particularly after protocol 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 for DMP version control, stakeholder communication, and mid-study updates. These updates are mandatory to maintain compliance with ICH 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 the lack 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