SCDM CCDM Exam With Confidence Using Practice Dumps

TheScope of Work (SOW)is a project management document that defineswhat services are includedin the work agreement between the sponsor and the CRO or vendor. It outlines deliverables, responsibilities, timelines, and budget allocations.

According to theGCDMP (Chapter: Project Management in Data Management), the SOW includes specifications such as:

The number and frequency ofdata transfers,

Database build and lockmilestones,

Quality control deliverables, and

Resource allocationfor data management tasks.

The SOW does not cover operational site-level details such as monitoring schedules (B), protocol sampling details (C), or personnel contact lists (D).

Therefore,option A (number of data transfers budgeted for a project)correctly identifies a use case directly addressed in the SOW.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management, Section 4.1 – Scope of Work and Resource Planning

ICH E6(R2) GCP, Section 5.5 – Sponsor Oversight and Data Management Responsibilities

PMI Project Management Framework – Scope Definition and Deliverable Specifications

RACIis aproject management and governance frameworkused to defineroles and responsibilitieswithin a project. Each letter represents a distinct role type:

Responsible (R):The person(s) who perform the work or execute the task.

Accountable (A):The individual ultimately answerable for the task’s completion and success (only one per activity).

Consulted (C):Subject matter experts who provide input or guidance before decisions are made.

Informed (I):Individuals kept up to date on progress or outcomes but not directly involved in execution.

The RACI model ensuresclarity in ownership and accountability, preventing duplication of effort or responsibility confusion. It is a key component of theGCDMP (Chapter: Project Management in Data Management)for ensuring clear delegation and communication within clinical data management teams.

Hence,option Dis correct.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management in Data Management, Section 5.1 – Roles, Responsibilities, and RACI Matrices

Project Management Institute (PMI) Framework – Responsibility Assignment Matrices (RACI)

ICH E6(R2) GCP, Section 5.1.1 – Defined Roles and Quality Oversight Responsibilities

The most significant difference in theData Manager’s rolewhen using anElectronic Data Capture (EDC)system is thatdata updates are implemented directly by site personnel(Option A).

According to theGCDMP (Chapter: Electronic Data Capture Systems), EDC technology shifts responsibility for data entry and correction from the sponsor or CRO to the investigator site, enabling real-time data entry and validation. This eliminates the need for double entry or remote data transcription, allowing Data Managers to focus onsystem validation, query management, and data quality oversightrather than physical data handling.

However, the EDC system still requires full validation (contrary to Option B). Metrics generation (Option C) and CRF tracking (Option D) are important but not unique to EDC-based workflows.

Thus, the correct answer isOption A – Data updates are implemented by the sites, reflecting the most fundamental operational shift introduced by EDC systems.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 4.1 – Role of the Data Manager in EDC

ICH E6 (R2) GCP, Section 5.5.3 – Electronic Data Entry and Responsibilities

FDA 21 CFR Part 11 – Electronic Records and Signatures: Data Entry Responsibilities