MCC Industry Practices Insight Reports

Clinical Trial Site Data Entry Study:

An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies

With the adoption of the ICH E6 (R2) Addendum and the increasing focus on risk management in clinical trials, the timely data entry by sites following subject visits is becoming more important. Delayed data entry can lead to increased risk both to subjects and the trial. The Metrics Champion Consortium (MCC) conducted an online survey to elicit industry’s perspective on the critical process of data entry by investigative sites after a subject visit.

Data Entry Topics Explored In This Study

The survey gathered detailed data about the following data entry topics:

  • Importance of Rapid Data Entry
  • Data Entry Cycle Time Calculation
  • Data Entry Cycle Time Expectations
  • Data Entry Cycle Time Experience
  • Reasons for Data Entry Delays
  • Data Entry Cycle Time Management Strategies
  • Utilization of eSource Systems
  • Relationship Between Data Entry Cycle Times and Data Quality
  • Relationship Between Data Entry Cycle Times and Overall Site Performance
  • Relationship Between Data Entry Cycle Times and LPLV to DBL Cycle Times

The survey contained 28 questions and represents the experiences of 35 respondents at large and small organizations from across the industry. Results should be taken as indicative if not fully representative of practices across the industry. The rich data gathered in the survey are presented in 20 tables, charts, and graphs.

Table of Contents

  • List of Figures
  • Executive Summary
  • Survey Methodology and Respondent Demographics
  • Key Findings
  • Discussion
  • Recommendations
  • References
  • About the Metrics Champion Consortium


List of Figures

  • Table 1: Summary of survey questions and findings
  • Figure 1: Profile of respondents by organization type and size
  • Figure 2: Profile of respondents by role
  • Figure 3: Importance of sites entering subject data in EDC as soon as possible following a subject visit
  • Figure 4: Reasons organizations encourage sites to enter subject data into EDC in a timely manner
  • Figure 5: Data entry cycle time calculation methodologies
  • Figure 6: Data entry cycle time expectations of organizations
  • Figure 7: Data entry cycle time expectations varying by therapeutic area, country or region
  • Figure 8: Comparison of actual versus expected cycle times
  • Figure 9: Actual cycle time experience by region
  • Figure 10: Site contracting includes data entry cycle time expectations
  • Figure 11: Data sources delaying data entry process
  • Figure 12: eSource usage and reasons for not using eSource
  • Figure 13: Consequences for sites that do not comply with expected cycle time
  • Figure 14: Consequences for sites that do not comply with expected cycle time against actual cycle time
  • Figure 15: Role organization holds “accountable” to oversee that sites enter data within the established cycle time
  • Figure 16: Methods to help sites comply with cycle time expectation
  • Figure 17: Relationship between data entry cycle time and data quality
  • Figure 18: Relationship between data entry cycle times and site performance
  • Figure 19: Relationship between data entry cycle times and LPLV to database lock cycle times

Report cover

Pricing: $375

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MCC members are eligible to receive a 20% discount rate on this report. Please use the discount code available on the MCC Member Homepage or contact MCC to obtain the code.

To be invoiced for the report, please contact Lara Knitter for assistance.