This question tests workload estimation and resource planning, which are fundamental competencies outlined in the Good Clinical Data Management Practices (GCDMP, Chapter on Project Management in Data Management). The task is to determine the Data Manager effort required based on the frequency and duration of data collection and processing activities.

Let’s calculate step by step:

Number of patients: 100

Frequency: Weekly (once per week)

Duration: 6 months ≈ 26 weeks

Time per file: 20 minutes

Total time per week:

100 patients × 20 minutes = 2,000 minutes per week

= 2,000 ÷ 60 = 33.3 hours per week

Total hours over 6 months:

33.3 hours/week × 26 weeks = 866 hours total

A full-time Data Manager typically works ~160 hours per month, so over six months:

160 × 6 = 960 hours total full-time capacity.

Therefore, the workload of 866 hours is approximately equivalent to one full-time Data Manager working across the six-month period:

866 ÷ 960 ≈ 0.9 FTE (Full-Time Equivalent).

This aligns most closely with Option D: One Data Manager per month (i.e., a full-time resource is required throughout the duration of the trial).

According to the GCDMP Project Management chapter, accurate resource estimation is critical in ensuring data management timelines are met without overloading staff or compromising data quality. The estimation process must consider not just the raw data download time but also associated data processing, verification, and upload into the clinical database.

Other options underestimate the effort significantly:

A (10%) and B (50%) do not account for cumulative weekly workload across multiple patients.

C (Two Data Managers) overestimates, as one Data Manager working full-time can manage the load efficiently.

Therefore, Option D is correct — approximately one full-time Data Manager (1.0 FTE) is required for the activity data alone during the six-month trial.

Reference (CCDM-Verified Sources):

Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Project Management in Data Management, Section 5.3 – Workload Estimation and Resource Allocation

SCDM GCDMP, Chapter: Data Handling and Processing – Effort Estimation for Repetitive Data Tasks

ICH E6 (R2) Good Clinical Practice, Section 5.1 – Quality Management and Resource Planning

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Operational Considerations for Data Management Activities