CCDM Exam Dumps : Certified Clinical Data Manager

The correct and compliant sequence forEDC system setup and implementationbegins onlyafter the study protocol is finalized, as all case report form (CRF) designs, database structures, and validation rules derive directly from the finalized protocol.

According toGCDMP (Chapter: EDC Systems Implementation), the proper order is:

Protocol finalized– defines endpoints and data requirements.

Database created– built according to the protocol and CRFs.

Edit checks created– programmed to validate data entry accuracy.

Database tested (UAT)– ensures functionality, integrity, and compliance.

Sites trained and system released– only then can data entry begin.

Option B follows this logical and regulatory-compliant sequence. Other options (A, C, D) are eitherpaper-based workflowsor violateGCP-compliant timelines(e.g., enrolling subjects before database validation).

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 – System Setup and Implementation Flow

ICH E6(R2) GCP, Section 5.5.3 – Computerized Systems Validation and User Training Before Use

FDA 21 CFR Part 11 – Validation and System Release Requirements

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

For a well-maintained 100-subject study withongoing data cleaningandcompleted reconciliations, thedatabase lockprocess typically takesa few daysafter theLast Patient Last Visit (LPLV).

According to theGCDMP (Chapter: Database Lock and Archiving), the duration of the lock process depends on the level of data cleanliness at LPLV. If the study team has conducted continuous data cleaning, query resolution, and external data reconciliation throughout the trial, then the final lock steps (e.g., final data review, documentation, and approvals) can be completed in2–5 days.

However, if significant cleaning or reconciliation remains outstanding, lock may take several weeks. Since the question states that data are “maintained almost all clean,”Option B – a few days– is the appropriate estimate.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 6.2 – Database Lock Preparation and Timelines

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Quality and Lock Procedures

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Lock and Archiving Procedures