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SCDM CCDM Exam
Certified Clinical Data Manager (Page 9 )

Updated On: 7-Feb-2026
Page 6 of 31
PDF with 150 Questions

Which list should be provided to support communication with sites regarding late data and queries?

  1. List of entered and clean data by site
  2. List of subjects screened and enrolled by site
  3. List of user account activity by site
  4. List of outstanding data and queries by site

Answer(s): D

Explanation:

Effective site communication in data management relies on transparent reporting of pending issues such as open queries, missing data, and overdue updates. According to the Good Clinical Data Management Practices (GCDMP, Chapter: Communication and Metrics), the list of outstanding data and queries by site provides a direct, actionable overview of what each site needs to address, supporting accountability and timely resolution.
This list typically includes subject identifiers, query types, dates generated, and status of resolution, allowing data managers to prioritize site follow-ups. Regular distribution of this report fosters efficient collaboration between the data management team, monitors, and site staff, ultimately improving database cleanliness and timeline adherence.
Options A and B reflect general study status but do not target data issue resolution. Option C pertains to user access oversight, not data progress. Hence, option D is the correct and most operationally relevant answer.


Reference:

(CCDM-Verified Sources)
SCDM GCDMP, Chapter: Communication and Metrics, Section 5.2 ­ Site Reporting and Query Management Metrics
ICH E6(R2) GCP, Section 5.18 ­ Site Oversight and Communication Requirements



In development of CRF Completion Guidelines (CCGs), which is a minimum requirement?

  1. CCGs are designed from the perspective of the Study Biostatistician to ensure that the data collected can be analyzed
  2. CCGs must be signed before database closure to include all possible protocol changes affecting CRF completion
  3. CCGs must include a version control on the updated document
  4. CCGs are developed with representatives of Data Management, Biostatistics, and Marketing departments

Answer(s): C

Explanation:

Case Report Form Completion Guidelines (CCGs) are essential study documents that instruct site staff on how to complete each field of the CRF correctly. A minimum requirement for CCGs, according to Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), is that they must include version control.
Version control ensures that all updates or revisions to the CCG--arising from protocol amendments or clarification of data entry rules--are documented, dated, and traceable. This guarantees that site personnel are always using the most current version and supports audit readiness. Option A describes an important design consideration but not a minimum compliance requirement. Option B is inaccurate, as CCGs must be approved and implemented before data collection begins, not after. Option D includes an irrelevant stakeholder (Marketing). Therefore, option C--"CCGs must include a version control on the updated document"--is correct and compliant with CCDM and GCP standards.


Reference:

(CCDM-Verified Sources)
SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 4.3 ­ Development and Maintenance of CRF Completion Guidelines
ICH E6(R2) GCP, Section 8.2.1 ­ Essential Documents and Version Control Requirements



In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

  1. Against a valid list of values.
  2. Across visits for consistency.
  3. Against a valid numeric range.
  4. On the format of a date.

Answer(s): B

Explanation:

In Electronic Data Capture (EDC) systems, edit checks are categorized based on when and how they are executed -- typically immediate (at data entry) or batch (post-entry). Checks that require data from multiple visits or forms are generally inefficient to run at data entry because they depend on information that may not yet exist in the system.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), cross-visit consistency checks -- such as comparing baseline and follow-up blood pressure or verifying date order between screening and dosing -- should be executed as batch or scheduled validations, not at the point of data entry. Running these complex checks in real time can slow system performance, increase query load unnecessarily, and confuse site users if related data are not yet entered.
Conversely, edit checks against valid ranges, formats, or predefined value lists (options A, C, and D) are simple, local validations ideally performed immediately at data entry to prevent basic errors. Therefore, cross-visit consistency checks (Option B) are best executed later, making them inefficient for real-time data entry validation.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.4 ­ Real-Time vs. Batch Edit Checks
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations ­ Section on Edit Checks and Data Validation Logic
CDISC SDTM Implementation Guide ­ Section on Temporal Data Consistency Validation



What action should a data manager take if an investigator retires in the middle of an EDC trial and the replacement does not agree to use EDC for the remainder of the trial?

  1. Notify the project manager and request that the site be closed.
  2. Explore other options for the site with the study team.
  3. Talk with the clinical research associate to identify alternative sites.
  4. Discuss the use of the site's data with the project statistician.

Answer(s): B

Explanation:

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



Query rules were tested with test data for each logic condition within each rule.
Which of the following types of testing was conducted?

  1. User box testing
  2. White box testing
  3. Black box testing
  4. T box testing

Answer(s): C

Explanation:

Testing query rules with test data inputs to confirm expected outputs without examining the underlying program logic is an example of black box testing. According to the GCDMP (Chapter: Data Validation and System Testing), black box testing is a functional testing approach used to verify that the system performs correctly from the end-user's perspective. In this method, testers input various conditions and observe outputs to ensure the system behaves as intended -- for instance, that edit checks trigger correctly when data fall outside predefined limits.
In contrast, white box testing involves examining internal logic, code, and algorithm structures. Because data managers typically validate edit checks through data-driven test cases rather than code inspection, black box testing is the appropriate and industry-standard method. This ensures compliance with validation documentation standards as outlined in FDA 21 CFR Part 11, Section 11.10(a) and ICH E6 (R2) system validation expectations.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.1 ­ Testing Approaches (Black Box and White Box) FDA 21 CFR Part 11 ­ System Validation Requirements
ICH E6 (R2) GCP, Section 5.5.3 ­ Computerized Systems Validation



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