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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

The correct and compliant sequence forEDC system setup and implementationbegins onlyafter the study protocol is finalized, as all case report form (CRF) designs, database structures, and validation rules derive directly from the finalized protocol.

According toGCDMP (Chapter: EDC Systems Implementation), the proper order is:

Protocol finalized– defines endpoints and data requirements.

Database created– built according to the protocol and CRFs.

Edit checks created– programmed to validate data entry accuracy.

Database tested (UAT)– ensures functionality, integrity, and compliance.

Sites trained and system released– only then can data entry begin.

Option B follows this logical and regulatory-compliant sequence. Other options (A, C, D) are eitherpaper-based workflowsor violateGCP-compliant timelines(e.g., enrolling subjects before database validation).

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 – System Setup and Implementation Flow

ICH E6(R2) GCP, Section 5.5.3 – Computerized Systems Validation and User Training Before Use

FDA 21 CFR Part 11 – Validation and System Release Requirements

When electronic patient-reported outcomes (ePRO) devices are used, data are captured directly by subjects through validated devices and transmitted electronically to the study database. To ensurereal-time data quality control,programmed edit checksshould be implementedat the point of data entry— that is, as subjects input data into the device.

According toGood Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning),front-end programmed edit checksare the optimal method to prevent entry of invalid or out-of-range values in ePRO systems. This helps maintain data accuracy at the source, minimizing downstream queries and data cleaning workload.

OptionsAandBinvolve post-submission or manual review, which is less efficient and not compliant with the principle offirst-pass data validation.Option C(visualization) is a valuable secondary QC method for trends, but not for immediate data validation.

Therefore,option Dis correct —programmed edit checks upon data entryensure immediate validation and higher data integrity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.3 – Automated Edit Checks and Front-End Validation

ICH E6(R2) GCP, Section 5.5.3 – Computerized System Controls and Validation

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations (2013), Section 6 – Real-Time Data Quality Control

Inpaper-based trials, site staff (e.g., study coordinators) record data manually on paper Case Report Forms (CRFs), which are later transcribed by data entry personnel into an electronic database.

However, inEDC-based studies, thesite coordinatoris directly responsible forentering data into the EDC system. This eliminates the need for centralized double data entry and shortens data cleaning timelines.

TheGCDMP (Chapter: Electronic Data Capture Systems)states that EDC systems shift certain tasks, includingdata entry, initial query response, and source verification preparation, to the site level. Yet,data entryremains the most significant additional responsibility compared to paper-based studies.

Option A (Query resolution)is performed in both EDC and paper-based systems.

Option C (Data curation)is typically a Data Management function.

Option D (Medical record abstraction)is part of source documentation, not specific to EDC.

Thus,option B (Data entry)is correct — it is the additional site coordinator duty unique to EDC environments.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.3 – Site Responsibilities and Workflow Changes

ICH E6(R2) GCP, Section 5.5.3 – Data Entry and Role Delegation in Computerized Systems

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 – Site-Level Data Entry Controls