SCDM CCDM Exam With Confidence Using Practice Dumps

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

To synchronize data fromelectronic patient-reported outcomes (ePRO)andwearable activity-monitoring deviceswith site-entered visit data, both thestudy subject identifieranddate/timeare essential.

According to theGCDMP (Chapter: Data Management Planning and Study Start-up), each dataset must containkey identifiersthat allow for accuratedata integration and temporal alignment. In studies involving multiple digital data sources, time-stamped subject identifiers are necessary to ensure that the device-generated data correspond to the correct subject and study visit.

Thesubject identifierensuresdata traceability and linkageto the appropriate participant, whiledate/timeallows synchronization of device data (e.g., activity or physiological measurements) with the corresponding site-reported visit or event. Geo-spatial data (options C and D) are typically not relevant to study endpoints and pose unnecessary privacy risks underHIPAAandGDPRguidelines.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Integration and eSource Data, Section 5.2 – Data Alignment and Synchronization Principles

FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Section 4.2 – Data Linking and Synchronization

ICH E6 (R2) GCP, Section 5.5.3 – Data Traceability and Integrity

Regulatory agencies such as theFDAandICHrequire thatelectronic data be retained in a format that preserves audit trails and traceability.

While PDF images (option C) provide a static representation of data, they do not preserve theunderlying audit trail(i.e., who changed what, when, and why). TheASCII data files with corresponding audit trails(option D) provide complete transparency and comply with21 CFR Part 11andGCDMParchival standards.

Option A(storing computers) is unnecessary and impractical, andOption B(paper source documents) are site records, not system archives.

Hence,option Dis correct —ASCII data files with audit trailsmeet traceability and compliance standards.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 – Archival Formats and Audit Trail Retention

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity, Audit Trails, and Record Retention

FDA 21 CFR Part 11 – Electronic Records; Audit Trail and Retention Requirements