SCDM CCDM Exam Dumps

In an Electronic Data Capture (EDC) system, even after a data manager completes all manual queries and marks data as 'clean,' the data may later appear unclean if the site (study coordinator) makes subsequent updates in the system after re-reviewing the source documents.

According to the Good Clinical Data Management Practices (GCDMP, Chapter: Electronic Data Capture Systems), site users maintain the authority to modify data entries as long as the system remains open for data entry. The EDC system audit trail captures such changes, which can automatically invalidate prior data reviews, triggering new discrepancies or changing system edit-check statuses.

This situation commonly occurs when the site identifies corrections in the source (e.g., wrong date or lab result) and updates the EDC form accordingly. These post-cleaning changes require additional review cycles to ensure the database reflects accurate and verified information before final lock.

Options B, C, and D are incorrect --- CRAs and medical monitors cannot directly change EDC data; they can only raise queries or request updates.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 6.3 -- Post-Cleaning Data Changes and Audit Trails

ICH E6 (R2) GCP, Section 5.5.3 -- Data Integrity and Change Control

FDA 21 CFR Part 11 -- Electronic Records: Change Documentation Requirements

The best practice when implementing a protocol amendment that affects CRF content or data collection timing is to update the eCRF completion guidelines and notify sites before implementing the change.

According to the GCDMP (Chapter: CRF Design and Data Collection), the eCRF Completion Guidelines (eCRF CG) are an essential study tool that instructs site personnel on accurate and consistent data entry. When new data elements or collection time points are added, the guidelines must be revised, version-controlled, and communicated to all users prior to implementation to ensure sites collect and enter data correctly.

Simply relying on the revised CRF (option C) or updating the document without notification (option B) violates communication and training standards. Likewise, notifying sites without updating the documentation (option D) leaves insufficient reference material for data entry compliance.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.5 -- Managing CRF Revisions and Site Communication

ICH E6 (R2) GCP, Section 5.18.4 -- Communication of Protocol Amendments and Documentation Updates

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 -- Site Communication and Documentation Management

In an ophthalmology clinical study, data criticality is determined by how directly a data element affects safety evaluation, efficacy assessment, and regulatory decision-making. According to the Good Clinical Data Management Practices (GCDMP, Chapter on Data Validation and Cleaning), critical data fields are those that:

Have a direct impact on the primary and secondary endpoints, or

Are essential for safety interpretation and adverse event causality assessment.

Among the listed options, Concomitant Medications (Option B) are considered critical data for ophthalmology studies. This is because many ocular treatments and investigational products can interact with systemic or topical medications, potentially affecting ocular response, intraocular pressure, corneal healing, or visual function outcomes. Any inconsistency in concomitant medication data could directly influence safety conclusions or efficacy interpretations.

Other options, while important, are less critical for this study type:

Subject Identifier (A) is essential for data traceability and audit purposes but is not directly related to safety or efficacy outcomes.

Weight (C) may be relevant in dose-dependent drug trials but is rarely a pivotal variable in ophthalmology, where local administration (eye drops, intraocular injections) is common.

Medical History (D) provides contextual background but does not have the same immediate impact on endpoint analysis as current concomitant treatments that can confound the therapeutic effect or cause ocular adverse events.

Per GCDMP and ICH E6 (R2) GCP guidelines, data validation plans must define critical data fields during study setup, reflecting therapeutic area--specific priorities. For ophthalmology, concomitant medications, ocular assessments (visual acuity, intraocular pressure, retinal thickness, etc.), and adverse events are typically designated as critical fields requiring heightened validation, source verification, and reconciliation accuracy before database lock.

Thus, when QA identifies discrepancies between the CRF and source, the Concomitant Medications field (Option B) is the most critical to address immediately to ensure clinical and regulatory data integrity.

Reference (CCDM-Verified Sources):

Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.4 -- Critical Data Fields and Data Validation Prioritization

ICH E6 (R2) Good Clinical Practice, Section 5.18 -- Monitoring and Source Data Verification

FDA Guidance for Industry: Oversight of Clinical Investigations --- A Risk-Based Approach to Monitoring, Section 5.3 -- Identification of Critical Data and Processes

SCDM GCDMP Chapter: Data Quality Assurance and Control -- Therapeutic Area--Specific Data Criticality Examples (Ophthalmology Studies)

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

When adverse events (AEs) are discovered after a database lock, the appropriate first step is to evaluate the impact of the missing data on the integrity, safety analysis, and regulatory validity of the study results.

According to GCDMP (Chapter: Data Quality Assurance and Control), any post-lock data discovery requires a root cause assessment and impact analysis before deciding whether to unlock the database. The key question is whether the missing AEs:

Affect primary safety endpoints,

Introduce bias in safety reporting, or

Alter efficacy conclusions.

Based on the assessment, the Data Management and Biostatistics teams determine if unlocking and correction are justified. Simply entering data immediately (A) or repeating checks (D) without analysis may violate data control procedures.

Hence, option B is correct --- the first step is to assess the impact on data validity and analysis.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 5.5 -- Post-Lock Findings and Impact Assessment

ICH E6(R2) GCP, Section 5.1.1 -- Quality Management and Risk Assessment

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 -- Post-Lock Data Management