Exam CCDM Topic 4 Question 105 Discussion

According to ICH E6(R2) Good Clinical Practice (GCP), Section 5.18.1, the Sponsor is ultimately responsible for developing and implementing the Monitoring Plan.
The Monitoring Plan defines:
The extent and nature of monitoring (e.g., on-site, remote, risk-based).
The responsibilities of monitors.
The communication and escalation procedures for data quality and protocol compliance.
While the CRO (B) or Monitor (D) may perform monitoring activities under delegation, the Sponsor retains legal accountability for ensuring a compliant and effective plan is developed and maintained. The Data 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)