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SCDM CCDM Exam
Certified Clinical Data Manager (Page 3 )

Updated On: 7-Feb-2026
Page 3 of 31
PDF with 150 Questions

Which metric reveals the timeliness of the site-work dimension of site performance?

  1. Time from Last Patient Last Visit to database lock
  2. Time from final protocol to first patient enrolled
  3. Time from site contract execution to first patient enrolled
  4. Median and range of time from query generation to resolution

Answer(s): D

Explanation:

The site-work dimension of site performance evaluates how efficiently sites manage and resolve data-related tasks -- particularly query resolution, data entry, and correction timelines. Among the given metrics, the median and range of time from query generation to resolution (D) directly measures the site's responsiveness and data management efficiency. According to the GCDMP (Chapter on Metrics and Performance Measurement), this indicator helps identify sites that delay query resolution, which can impact overall study timelines and data quality. Tracking this metric allows the data management team to proactively provide additional training or communication to underperforming sites.
Other options measure different aspects of project progress:

A reflects overall database closure speed.
B and C relate to study startup and enrollment readiness, not ongoing data work. Thus, option D accurately represents a site performance timeliness metric, aligning with CCDM principles for operational performance measurement.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Metrics and Performance Management, Section 5.4 ­ Site Query Resolution Metrics ICH E6(R2) Good Clinical Practice, Section 5.18 ­ Monitoring and Site Performance Oversight



What is the main reason 21 CFR Part 11 requires that EDC systems maintain an audit trail?

  1. To preserve data integrity
  2. To preserve the ability for modifications
  3. To preserve source document verifications
  4. To preserve data availability

Answer(s): A

Explanation:

The primary purpose of maintaining an audit trail as required under 21 CFR Part 11 is to preserve data integrity. According to the U.S. FDA's regulation on electronic records and signatures, every change to electronic data must be traceable, including information about who made the change, when it was made, and what the change entailed.
The Good Clinical Data Management Practices (GCDMP) outlines that an audit trail provides a permanent, chronological record of all modifications to clinical data. This ensures transparency and allows the reconstruction of the course of data entry and modification. The regulation aims to prevent unauthorized or undocumented data manipulation, thereby maintaining the accuracy, reliability, and validity of electronic records.
The FDA 21 CFR Part 11, Section 11.10(e) explicitly mandates that systems must use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. This ensures the data remains trustworthy and defensible in regulatory reviews or inspections. Therefore, the main reason for requiring an audit trail is to preserve data integrity -- ensuring that all data captured, modified, or transmitted is authentic, accurate, and complete throughout the study lifecycle.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Compliance and Data Integrity
FDA 21 CFR Part 11 ­ Electronic Records; Electronic Signatures, Section 11.10(e) ICH E6 (R2) Good Clinical Practice, Section 5.5.3 ­ Data Integrity and System Validation



Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:

  1. Portable Document Format (.pdf)
  2. Rich Text Format (.rtf)
  3. Microsoft Word (.docx)
  4. Statistical Analysis System (.sas)

Answer(s): A

Explanation:

Electronic submission standards, as established by FDA, CDISC, and ICH, require that an individual subject's complete Case Report Form (CRF) be submitted as a Portable Document Format (.pdf) file. The PDF format is universally recognized and accepted because it ensures that the structure, format, and visual fidelity of the CRF are preserved exactly as originally designed, regardless of software or hardware environment.
According to the FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format (2006) and CDISC SDTM standards, sponsors must include a subject-level CRF in PDF form for each participant in the submission dataset. This requirement ensures that reviewers can trace data points from analysis datasets back to their source entries in the CRF, fulfilling the principles of data traceability and transparency.
The Good Clinical Data Management Practices (GCDMP) also support this requirement, emphasizing that CRF archiving should maintain readability and regulatory accessibility. Formats like RTF, DOCX, or SAS datasets are not acceptable substitutes for regulatory CRF submission because they may alter formatting, structure, or introduce modifiable content, violating FDA data integrity principles.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Archiving and Submission FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format, April 2006 CDISC SDTM Implementation Guide, Section 5.3 ­ CRF Representation and Traceability



Which document describes what study subjects expect with respect to data disclosure during and after a study?

  1. Study data sharing plan
  2. ICH essential documents
  3. Informed consent form
  4. Study protocol

Answer(s): C

Explanation:

The Informed Consent Form (ICF) is the document that explicitly describes what study subjects can expect regarding data disclosure, privacy, and confidentiality during and after participation in a clinical trial. According to ICH E6 (R2) Good Clinical Practice and FDA Human Subject Protection Regulations (21 CFR Parts 50 and 56), participants must be fully informed about how their personal and clinical data will be collected, used, stored, and shared -- both during the study and in any subsequent data-sharing or publication activities.
The GCDMP reiterates that clinical data managers must ensure that all data handling practices align with the privacy commitments made in the ICF. This includes compliance with data protection regulations such as HIPAA (in the U.S.) and GDPR (in the EU). The ICF defines the permissible scope of data use, ensuring ethical management and subject protection.

Documents like the protocol or data sharing plan may outline procedures and responsibilities but do not directly inform participants of their rights and data use expectations. Only the ICF is designed for that ethical communication purpose.


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Ethics, Privacy, and Data Security
ICH E6 (R2) Good Clinical Practice, Sections 4.8.10 & 4.8.12 FDA 21 CFR Part 50 ­ Protection of Human Subjects, Informed Consent Requirements



Every database lock should follow documented approval of which stakeholders?

  1. Clinical/Scientific Representative, Data Manager, Biostatistician
  2. Clinical/Scientific Representative, Biostatistician, Programmer
  3. Clinical/Scientific Representative, Data Manager
  4. Clinical/Scientific Representative, Biostatistician

Answer(s): A

Explanation:

According to the Good Clinical Data Management Practices (GCDMP), the database lock (DBL) process signifies the formal closure of the clinical trial database, ensuring that no further changes can be made to the data before statistical analysis. This process must be documented, controlled, and approved by key study stakeholders to ensure data accuracy, completeness, and readiness for analysis.
The GCDMP specifies that database lock should occur only after all data cleaning, discrepancy resolution, and reconciliation activities are complete. The lock authorization typically requires the approval of the Clinical/Scientific Representative (to confirm clinical completeness), the Data Manager (to confirm data integrity and query closure), and the Biostatistician (to confirm readiness for statistical analysis).
This tri-party approval ensures that the database reflects final, verified data consistent with the clinical protocol, and that the statistical analysis dataset derived from the database is accurate and auditable. The approval process is documented via a Database Lock Authorization Form or Sign-off Log, which becomes part of the permanent trial master file (TMF).


Reference:

(CCDM-Verified Sources)
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 7.1 ­ Lock Procedures and Approvals
ICH E6 (R2) GCP, Section 5.5.3 ­ Data Handling and Record Keeping FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations ­ Section on Database Closure



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