SCDM CCDM Exam With Confidence Using Practice Dumps

Thebest practicewhen implementing aprotocol amendmentthat affects CRF content or data collection timing is toupdate the eCRF completion guidelines and notify sites before implementing the change.

According to theGCDMP (Chapter: CRF Design and Data Collection), theeCRF Completion Guidelines (eCRF CG)are an essential study tool that instructs site personnel on accurate and consistent data entry. When new data elements or collection time points are added, the guidelines must berevised, version-controlled, and communicatedto all users prior to implementation to ensure sites collect and enter data correctly.

Simply relying on the revised CRF (option C) or updating the document without notification (option B) violates communication and training standards. Likewise, notifying sites without updating the documentation (option D) leaves insufficient reference material for data entry compliance.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.5 – Managing CRF Revisions and Site Communication

ICH E6 (R2) GCP, Section 5.18.4 – Communication of Protocol Amendments and Documentation Updates

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Site Communication and Documentation Management

Duringdata reconciliationbetween a central laboratory and CRF data, the source of truth is typically thecentral lab database, as it provides directly measured, vendor-generated results.

When thecentral lab has data but the CRF does not (option C), the Data Manager must first query thecentral labto confirm that the result was transmitted correctly, since discrepancies may stem from data processing or timing issues. Once confirmed, a secondary query may be issued to the site to ensure CRF completion and alignment.

Conversely, if the CRF contains data but the central lab is missing results (option B), the issue is site-level, not vendor-level.

According to theGCDMP (Chapter: External Data Transfers and Reconciliation),priority for querying depends on the authoritative source— for lab data, thecentral labis considered the source of record.

Therefore,option Cis correct.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: External Data Transfers and Reconciliation, Section 6.1 – Reconciliation of Central Lab and CRF Data

ICH E6(R2) GCP, Section 5.5.3 – Source Data Verification and Vendor Reconciliation

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 – Data Reconciliation and Traceability

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