Exactprep CCDM Questions

The primary purpose of maintaining anaudit trailas required under21 CFR Part 11isto 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.

TheGood 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 maintainingthe accuracy, reliability, and validityof electronic records.

TheFDA 21 CFR Part 11, Section 11.10(e)explicitly mandates that systems must usesecure, computer-generated, time-stamped audit trailsto 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 isto 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

Let’s calculate the workload:

200 patients × 30 minutes = 6,000 minutes/week

6,000 minutes ÷ 60 =100 hours/week

Over 6 months (~26 weeks): 100 × 26 =2,600 hours total

Assuming a full-time Data Manager works approximately160 hours/month, over6 months (960 hours)per full-time equivalent (FTE):

2,600 ÷ 960 ≈2.7 FTEs total for the entire study period

To find theaverage per month, we divide evenly over 6 months:

2.7 ÷ 6 ≈0.45 FTE per month, or approximately50% of a Data Manager per month.

Thus, the correct answer isB. Fifty percent of a Data Manager per month.

This estimate follows GCDMP best practices inresource planning, ensuring adequate data management capacity for ongoing external data handling activities.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management, Section 5.3 – Resource Estimation and Workload Planning

ICH E6(R2) GCP, Section 5.1.1 – Quality Systems and Adequate Staffing

According to theGood Clinical Data Management Practices (GCDMP), thedatabase 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 ensuredata 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 theClinical/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 aDatabase 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

Thebest practicewhen implementing aprotocol amendmentthat affects CRF content or data collection timing is toupdate the eCRF completion guidelines and notify sites before implementing the change.

According to theGCDMP (Chapter: CRF Design and Data Collection), theeCRF 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 berevised, version-controlled, and communicatedto 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