The Scope of Work (SOW) is a contractual document that outlines the specific deliverables, responsibilities, timelines, and budgetary details for a given project between the sponsor and the contract research organization (CRO).
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Communication), the SOW defines what work will be performed, how many resources are allocated, and the expected deliverables. This includes detailed information such as:
The number of database builds or migrations,
Timelines for deliverables (e.g., database lock),
Responsibility distribution between sponsor and CRO, and
Budget parameters for defined activities.
Therefore, if a Data Manager needs to determine how many database migrations are budgeted for a project, the SOW is the correct document to reference.
Information such as PK sample scheduling (option A), site monitoring dates (option B), or staff contact details (option D) would be found in operational plans or contact lists, not in the SOW.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 6.2 - Scope of Work Definition and Deliverables ICH E6 (R2) GCP, Section 5.5.3 - Documentation and Responsibilities for Data Management Tasks FDA Guidance for Industry: Oversight of Clinical Investigations - Sponsor and CRO Agreements