SCDM Updated CCDM Exam Questions and Answers by chaya

Once a clinical database islocked, it becomesread-only— no further data modifications can be made by any users, including site personnel. This ensures that the data arefinalized, consistent, and auditablefor statistical analysis and regulatory submission.

According to theGCDMP (Chapter: Database Lock and Archiving), the lock process involves freezing the database to prevent accidental or unauthorized changes. After lock, access permissions are restricted, and all edit and update functions are disabled. If any corrections are required post-lock, the database must beunlocked under controlled procedures(with full audit trail documentation).

Thus,option C—The site study coordinator is not able to make the change— correctly reflects standard EDC functionality and regulatory compliance.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.2 – Database Lock Procedures and Controls

ICH E6(R2) GCP, Section 5.5.3 – Data Integrity and Audit Trail Requirements

FDA 21 CFR Part 11 – Controls for Electronic Records and System Lock Functions

When aprotocol is amended mid-study, resulting in additional data collection requirements, theData Management Plan (DMP)must beupdated accordinglyand all relevant stakeholders must benotified.

According to theGCDMP (Chapter: Data Management Planning and Study Start-up), the DMP is aliving documentthat defines all data management processes for a clinical study. It must accurately reflect thecurrent data flow, CRF design, validation procedures, and reporting structure. Any protocol amendments affecting data capture, structure, or analysis require immediate DMP revision and distribution to ensure alignment across data management, clinical, and biostatistics teams.

Failure to update and communicate DMP changes can lead to misalignment in data handling and introduce compliance risks during audits or inspections. Therefore,Option Bis correct: the DMP must be updated and the change communicated to all stakeholders (e.g., sponsor, CRO, clinical operations, biostatistics).

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Plan (DMP), Section 5.3 – Maintaining and Updating the DMP

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Documentation of Protocol Changes and Data Handling Procedures

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Section on Data Management Documentation

When designing or configuringdata entry screenswithin an Electronic Data Capture (EDC) system, three critical components are required for each field:

Data Type– Defines the nature of the data (e.g., text, numeric, date).

Prompt– The label or question displayed to the user.

Response Format– Specifies how the user enters or selects data (e.g., free text, drop-down, checkbox).

According to theGCDMP (Chapter: EDC Systems and Database Design), these three attributes form thelogical data structurerequired to build and validate data entry interfaces. They ensure consistency in how information is captured, displayed, and validated during data entry.

Whileuser roles (A)andhelp text (D)are system-level configurations, not field-level specifications,page numbers (C)relate to printed CRFs rather than digital data screens.

Therefore,option B (Data type, prompt, and response format)correctly identifies the essential information needed to define data entry screens.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: EDC Systems and Database Design, Section 4.3 – Screen Design Specifications

CDISC CDASH Implementation Guide, Section 3.2 – Data Field Attributes

ICH E6(R2) GCP, Section 5.5.3 – Data Capture and Input Standards

InElectronic Data Capture (EDC)studies, proper user training and access management are essential for maintainingdata integrity, security, and regulatory compliance. According to theGood Clinical Data Management Practices (GCDMP)andFDA 21 CFR Part 11, EDC systems must ensure that only qualified and trained personnel can access study data, and that all access rights reflect current study responsibilities.

User training and access must therefore be reviewed and updated whenever:

Site staff leave the study(access revocation is required),

New site staff are added(training and credentialing are required), and

Study team members change roles(access levels must be modified accordingly).

However, if asoftware upgradeoccurs thatdoes not impact the functional roles, user permissions, or data handling processes, retraining or reauthorization isnot required. This is because such updates do not alter compliance-critical workflows or user interactions.

Therefore, the exception isC – when a software upgrade does not affect users.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 7.1 – User Access and Training Controls

FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures, Section 11.10(i) & (k)

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – System Security and User Training