SCDM CCDM Exam Dumps

Manual or visual data review is used to identify complex clinical relationships and contextual inconsistencies that cannot be detected by automated edit checks.

According to the GCDMP (Chapter: Data Validation and Cleaning), automated edit checks are ideal for structured validations, such as missing fields (option C), reference ranges (option D), or predefined value lists (option A). However, certain clinical cross-checks---such as verifying adverse event treatments against concomitant medication records---require clinical judgment and contextual understanding.

For example, if an adverse event of 'severe headache' was reported but no analgesic appears in the concomitant medication log, the data may warrant manual review and query generation. These context-based checks are best performed by trained data reviewers or medical data managers during manual data review cycles.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.3 -- Manual Review and Clinical Data Consistency Checks

ICH E6 (R2) Good Clinical Practice, Section 5.18.4 -- Clinical Data Review Responsibilities

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations -- Data Verification Principles

In a discrepancy management workflow, ''Received from site and not yet reviewed'' is not a resolution type --- it represents a status, not a final resolution outcome.

According to the GCDMP (Chapter: Data Validation and Cleaning), resolution types describe how a data discrepancy was finalized or addressed, such as:

Resolved with data correction,

Confirmed as correct (no change required),

Self-evident correction applied by data management, or

Unresolvable discrepancies documented.

In contrast, statuses describe the stage of the query (e.g., open, sent, answered, pending review, closed). ''Received from site and not yet reviewed'' indicates an intermediate workflow state where the response awaits validation by data management.

Proper classification of resolution types is essential for performance reporting, audit readiness, and ensuring the traceability of query management actions under ICH E6 (R2) and FDA 21 CFR Part 11.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.3 -- Discrepancy Resolution Lifecycle

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 -- Data Handling and Record Management

FDA 21 CFR Part 11 -- Electronic Records; Audit Trails and Discrepancy Tracking Requirements

When a new version of MedDRA (Medical Dictionary for Regulatory Activities) is released, the correct action is to evaluate the extent and impact of the changes before implementation.

According to the GCDMP (Chapter: Medical Coding and Dictionaries), MedDRA updates are published twice yearly (March and September). Each release may introduce new terms, modify hierarchies, or retire old ones. Prior to adopting a new version, the Data Manager and Medical Coder must:

Assess the number and type of term changes,

Determine the potential effect on ongoing coding consistency, and

Decide whether migration to the new version is warranted mid-study or deferred until database lock.

Immediate recoding (option C) without evaluation may cause inconsistencies and require additional validation. Continuing with the existing version (option B) may be acceptable short-term but must be justified. Using an alternative dictionary (option D) is noncompliant, as MedDRA is the regulatory standard for safety reporting.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Medical Coding and Dictionaries, Section 6.3 -- Version Control and Impact Assessment

MedDRA Term Selection: Points to Consider (MSSO, Latest Version), Section 3 -- Versioning and Maintenance

ICH E2B(R3) -- Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

Before implementing an EDC system upgrade, the first task of the Data Manager is to assess the impact on the data.

According to the GCDMP (Chapter: Electronic Data Capture Systems) and FDA 21 CFR Part 11, any system upgrade must undergo impact assessment to determine how the change might affect data integrity, functionality, validation, and ongoing study operations. This assessment ensures that no data are lost, corrupted, or rendered inconsistent during or after the upgrade.

The Data Manager should evaluate:

Potential effects on existing data, edit checks, and reports,

System functionality impacting current workflows, and

Any revalidation requirements.

Only after the impact is understood should the Data Manager proceed to communicate with sites (option A), update documentation (option B), or modify CRFs if required (option D).

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 7.3 -- System Upgrades and Change Control

FDA 21 CFR Part 11 -- Change Control and Validation Requirements

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 -- Change Impact on Data Integrity and System Validation

When an investigator retires mid-study and the replacement refuses to use the Electronic Data Capture (EDC) system, the data manager must not take unilateral action but rather collaborate with the study team to explore acceptable solutions.

Per the GCDMP (Chapter: Project Management in Data Management), any deviation from the established data capture method --- particularly a change that affects regulatory compliance, data consistency, or site operations --- requires a cross-functional assessment. The study team, which includes clinical operations, project management, regulatory affairs, and data management, should evaluate feasible alternatives such as:

Allowing paper CRF entry followed by centralized data transcription,

Retraining site staff on EDC use, or

Temporarily suspending data entry until compliance can be restored.

Immediate site closure (option A) or unilateral decisions by data management (options C and D) violate escalation and communication protocols. Collaborative decision-making ensures continuity, compliance, and data integrity, in line with ICH E6 (R2) GCP and FDA 21 CFR Part 11.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 5.2 -- Handling Site and Investigator Changes

ICH E6 (R2) Good Clinical Practice, Section 4.1 -- Investigator Responsibilities

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations -- Section on EDC Operations and Site Management