SCDM CCDM Practice Test Questions Answers

In arandomized, double-blind, placebo-controlled study, if statistical analysis shows that theplacebo appears to outperform the investigational product, a likely cause is adata management or coding error, particularly intreatment code entry or mapping.

According to theGCDMP (Chapter: Database Design and Build), treatment assignment data — typically stored in randomization or code-break files — must beaccurately integratedinto the clinical database. Any mismatch between randomization codes, subject identifiers, or treatment arms can lead to incorrect grouping during analysis, producing false conclusions such as placebo superiority.

The Data Manager should initiate aroot cause reviewof randomization data integration and treatment mapping. The placebo is never designed to have active medicinal effects (option A). Option D is incorrect because the described scenario implies a data inconsistency, not true efficacy differences. Proper verification of randomization coding and reconciliation between data management and statistical programming systems are essential.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Build, Section 6.1 – Randomization and Treatment Code Management

ICH E6 (R2) GCP, Section 5.5.3 – Data Verification and Coding Accuracy

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Mapping and Validation Requirements

Database auditsare conducted to ensureongoing data accuracy, completeness, and compliancethroughout the lifecycle of a clinical trial. According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Quality Assurance and Control), quality audits are most effective when performedperiodically during study conduct, rather than waiting until study completion.

Performing audits periodically allows early detection of data entry errors, protocol deviations, and system inconsistencies, thereby reducing the risk of large-scale data issues before database lock. This proactive approach aligns withrisk-based quality management principlesoutlined inICH E6(R2)and ensures corrective actions are implemented in real time.

Options A and B represent reactive quality control, which occurs too late to prevent data issues. Option C (after first few cases) provides initial validation but does not ensure continuous oversight.

Therefore,option D — “Periodically throughout the study”— represents the optimal and compliant timing for quality audits of the database.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 5.3 – Ongoing Quality Control and Auditing

ICH E6(R2) GCP, Section 5.1.1 – Quality Management System and Risk-Based Monitoring

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 – Data Review and Auditing Practices

When efficacy data arenot covered by existing CDISC SDTM domains, thefirst resourcethe Data Manager should consult is theCDISC Therapeutic Area Implementation Guide (TAIG)for that therapeutic field.

According to theGCDMP (Chapter: Standards and Data Mapping), CDISC’s Therapeutic Area User Guides (TAUGs) and Implementation Guides providestandardized data structures, variable definitions, controlled terminology, and implementation examplesfor specific diseases or therapeutic areas. These guides ensure consistency across studies, promote interoperability, and align data collection with regulatory submission expectations.

Consulting other sponsors’ forms or external registries (options A and C) can be informative but do not provide authoritative CDISC-compliant standards. SNOMED terms (option B) address medical terminology, not structural data domain definitions.

Therefore,Option Dis correct—CDISC TA Implementation Guidesare the recognized primary reference when extending or designing SDTM-compliant CRFs.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Standards and Data Mapping, Section 4.2 – Use of CDISC Standards

CDISC Therapeutic Area User Guides (TAUGs) – Implementation Guidance for Domain Extension

FDA Data Standards Catalog – CDISC Therapeutic Area Standards

TheInformed Consent Form (ICF)is the document that explicitly describes what study subjects can expect regardingdata disclosure, privacy, and confidentialityduring and after participation in a clinical trial. According toICH E6 (R2) Good Clinical PracticeandFDA Human Subject Protection Regulations (21 CFR Parts 50 and 56), participants must be fully informed about how their personal and clinical data will be collected, used, stored, and shared — both during the study and in any subsequent data-sharing or publication activities.

TheGCDMPreiterates that clinical data managers must ensure that all data handling practices align with the privacy commitments made in the ICF. This includes compliance withdata protection regulationssuch as HIPAA (in the U.S.) and GDPR (in the EU). The ICF defines the permissible scope of data use, ensuring ethical management and subject protection.

Documents like theprotocolordata sharing planmay outline procedures and responsibilities but do not directly inform participants of their rights and data use expectations. Only theICFis designed for that ethical communication purpose.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Ethics, Privacy, and Data Security

ICH E6 (R2) Good Clinical Practice, Sections 4.8.10 & 4.8.12

FDA 21 CFR Part 50 – Protection of Human Subjects, Informed Consent Requirements

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