Which protocol section most concisely conveys timing of data collection throughout a study?

TheStudy Schedule of Events(SoE) section in the protocol is the most concise and comprehensive representation of thetiming of data collectionthroughout a study.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Management Planning and Study Start-up)andICH E6 (R2) GCP, the SoE outlines what assessments, procedures, and data collections occur at each study visit (e.g., screening, baseline, treatment visits, follow-up). This table is a foundational tool forCRF design,database structure, andedit-check development, ensuring alignment between the protocol and data management systems.

While thestudy endpoints section (A)defineswhatis measured, and theprotocol synopsis (C)summarizes the design, only theschedule of events (B)specifieswhendata collection occurs for each parameter. TheICH essential documents (D)pertain to regulatory documentation, not study visit timing.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Study Start-up, Section 4.1 – Using the Schedule of Events for Database Design

ICH E6 (R2) GCP, Section 6.3 – Trial Design and Schedule of Assessments

FDA Guidance for Industry: Protocol Design and Data Collection Standards