Clinical Data Management CCDM Exam Dumps

The best choice for managingStandard Operating Procedures (SOPs)in a compliant and auditable manner is aDocument Management System (DMS).

According to theGCDMP (Chapter: Regulatory Requirements and Compliance)andICH E6 (R2), SOPs must beversion-controlled, securely stored, retrievable, and auditable. Avalidated DMSsupports controlled access, document lifecycle management (draft, review, approval, and archival), and electronic audit trails, ensuring full compliance withFDA 21 CFR Part 11andGood Documentation Practices (GDP).

WhileLearning Management Systems (C)track training, they are not intended for document control.Spreadsheets (B)andpaper systems (D)cannot provide adequate version tracking, access security, or audit capability required for regulatory inspection readiness.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Requirements and Compliance, Section 5.2 – SOP Management and Document Control

ICH E6 (R2) GCP, Section 5.5.3 – Document and Record Management

FDA 21 CFR Part 11 – Electronic Records and Signatures, Section 11.10 – System Validation and Document Controls

AData Transfer Agreement (DTA)defines the operational and technical details for transferring data between a sponsor and an external vendor (e.g., central lab, ECG vendor). It is a formalized, controlled document specifyingwhat data will be sent, when transfers will occur, the transfer method, file structure, encryption or security protocols, and the recipients of the data.

The DTA is developed jointly by the sponsor and vendor before production data transfers begin. According to theGCDMP, Chapter on External Data Transfers, this agreement ensures both parties share a clear understanding of timing, responsibility, and data content to minimize errors and ensure regulatory compliance.

TheData Management Plan (DMP)outlines general data handling processes but does not capture the technical specifics of vendor data transfer logistics. TheProject Plan (A)andCommunication Plan (B)are broader operational tools and not specific to data transfer protocols.

Hence,option C (Data Transfer Agreement)is the correct answer, as it precisely governs the procedural and technical framework of vendor data exchange.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: External Data Transfers, Section 4.1 – Data Transfer Agreements and Specifications

ICH E6(R2) Good Clinical Practice, Section 5.5 – Trial Management, Data Handling, and Record Keeping

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)

In a relational clinical database, themost efficient and normalized structurefor data collected repeatedly over time—such asvital signs—isone record per patient per visit.

Each patient will have multiple records, one for each visit when vital signs are assessed. This structure supports:

Time-based analysis (e.g., trends across visits),

Accurate data linkage with visit-level metadata, and

Efficient querying for longitudinal data.

According to theGCDMP (Chapter: Database Design and Build), the relational design principle dictates that data should be stored at thelowest unique level of observation. Since vital signs vary by both patient and visit, the combination ofpatient ID + visit IDforms a unique key for each record.

Option A (per visit) lacks patient identification, while options B and D aggregate data too broadly, losing temporal detail.

Thus,option C (One record per patient per visit)correctly represents the normalized design structure.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Design and Build, Section 4.2 – Normalization and Table Structure

CDISC SDTM Implementation Guide, Section 5.3 – Visit-Level and Observation-Level Data Structures

ICH E6(R2) GCP, Section 5.5.3 – Data Handling Principles