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Table 5 “What are the key features of an optimal data collection method in a clinical study?”

From: Comparison of two data collection processes in clinical studies: electronic and paper case report forms

  Main features answered Details
Investigators Quality interface (x23) Fast, simple, without bugs and blocking, with flexible data entry
Reliable data collection, with few queries (x8) Alarms and mandatory fields
Electronic format (x3) Allowing data sharing without data recapture and duplication
CRAs Quality interface (x24) Fast, simple, without bugs and blocking, with flexible data entry
Accessible form (x7)  
Efficient monitoring (x5) Real-time queries and remote consultations
Quality of form (x5) No free answers, short and clear questions and few variables
Immediate controls during data entry (x3)  
Motivation and availability of investigators (x3)  
DMs Reliable data collection, few queries (x17) Controls and constraints during data entry and queries emailed automatically
Quality of database, easy to operate (x5)  
Quality of form (x5) Real-time queries and remote consultations
Quality of form (x5) No free answers, short and clear questions and few variables
Quality interface (x3) Ergonomic
Maximum access fees and free action for data managers (x2)  
  1. Responses from investigators, clinical research associates and data managers.
  2. CRA: clinical research associate, DM: data manager.