SCDM CCDM Dumps Questions Answers

In an EDC system,Site Study Coordinatorsare typically responsible fordata entry and updates, as they are the site-level personnel who record subject data from source documents into the electronic CRFs (eCRFs).

TheGood Clinical Data Management Practices (GCDMP, Chapter: EDC Systems)outlines that data entry and modification privileges should only be granted toqualified site personnelwho have completed EDC system training and are listed on the study delegation log. These users directly handle patient-level data entry and correction.

In contrast:

Clinical Study Monitors (B)review and verify data but do not enter or modify it.

EDC System Administrators (C)manage user access and configuration settings, not study data.

Study Statisticians (D)work with extracted, cleaned datasets but never have data modification privileges.

Thus,option A (Site Study Coordinator)correctly identifies the role with authorized data entry and update privileges.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 – User Roles and Access Permissions

ICH E6(R2) GCP, Section 4.1 – Investigator Responsibilities for Data Accuracy

FDA 21 CFR Part 11 – User Access and Accountability in Electronic Systems

When using acopyrighted or validated rating scale(e.g., Hamilton Depression Scale, Visual Analog Pain Scale), anymodification to the original instrument, including preprinting database codes on the CRF, must beapproved by the instrument’s owner or licensing authorityto ensure thevalidity and reliabilityof the instrument are not compromised.

According to theGCDMP (Chapter: CRF Design and Data Collection), validated rating scales are psychometrically tested tools. Any visual or structural modification (such as adding codes, changing layout, or rewording questions) can invalidate prior validation results. Therefore, the CRF designer mustconsult the independent source (copyright holder)for approval anddocument that the validity of the tool remains intact.

Merely consulting statisticians (option B) or verifying database alignment (option D) does not ensure compliance. Thus,Option Censures scientific and regulatory integrity.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 6.1 – Use of Validated Instruments and Rating Scales

ICH E6 (R2) GCP, Section 5.5.3 – Validation of Instruments and Data Capture Tools

FDA Guidance for Industry: Patient-Reported Outcome Measures – Use in Medical Product Development to Support Labeling Claims, Section 4 – Instrument Modification and Validation

In Structured Query Language (SQL), theWHEREclause is used to filter records based on specified criteria. The query retrievesall columnsfrom thepatienttable (SELECT *) but onlythose rowswhere themedical_record_numbervalue is greater than 9000.

This means:

Thenumber of columns (fields)remains the same as the original table.

Thenumber of rows (records)will beequal to or less thanthe number of rows in thepatienttable, depending on how many patients meet the filter condition.

Hence, the result set can only beshorter or equal in lengthcompared to the original table. It cannot be longer, wider, or narrower, since no new rows or columns are created.

Therefore,option B—“Shorter or of equal length than the patient table”— is correct.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Design and Build, Section 5.2 – Relational Database Queries and Filtering Logic

ICH E6(R2) GCP, Section 5.5.3 – Data Retrieval, Filtering, and Storage Principles

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 – Query Logic and Record Subsetting