According toICH E6(R2) Good Clinical Practice (GCP), Section 5.18.1, theSponsoris ultimatelyresponsible for developing and implementing the Monitoring Plan.
The Monitoring Plan defines:
Theextent and nature of monitoring(e.g., on-site, remote, risk-based).
Theresponsibilities of monitors.
Thecommunication and escalation proceduresfor data quality and protocol compliance.
While theCRO (B)orMonitor (D)may perform monitoring activities under delegation, theSponsorretains legal accountability for ensuring a compliant and effective plan is developed and maintained. TheData Manager (C)may contribute by outlining data review workflows, but is not responsible for authoring or owning the plan.
Therefore,option A (Sponsor)is the correct answer.
Reference (CCDM-Verified Sources):
ICH E6(R2) GCP, Section 5.18.1 – Purpose and Responsibilities for Monitoring
SCDM GCDMP, Chapter: Regulatory Compliance and Oversight, Section 5.3 – Sponsor Responsibilities in Monitoring and Quality Assurance
FDA Guidance for Industry: Oversight of Clinical Investigations – Sponsor Responsibilities (2013)
