Reducing Data Queries Through Optimized eCRF Design

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

10 February, 2019

data-queries

Cleaning data in clinical trials can be a tedious task when the electronic case report form (eCRF) has not been properly designed.

Identifying and resolving discrepancies in data is a resource-consuming activity, particularly when multiple queries are to be issued to many sites y large studies.

Therefore, designing an eCRF that minimizes the risks of inconsistencies and reduces the need for queries on data fields provides a lot of value and benefits to clinical data management.

A first aspect to be ensured in eCRF design is to define relevant forms and data fields collecting truly useful information for the goals of the research.

A tendency is to request many data items, and then leave an important part of them out of the analysis.

As second key for optimal data collection is to avoid ambiguous or nonspecific responses. Open text fields generate variability in the answers, increasing the efforts required to make data sets uniform. The use of predefined dropdown lists is a useful method to reduce this type of variability and guarantee specific information.

Another good practice is to avoid repeated fields in different locations of the eCRF. Having to enter the same values more than once puts unnecessary burden on data entry staff, while generating low-value queries.

Finally, another wise advice is to include “not done” and/or “unknown” options for data fields. This increases clarity on the information that is not available at the local site, which saves clarification queries.

A clinical trial involves many tasks and efforts, and data management is one of the most critical and time-consuming parts of clinical studies. eCRFs should have strategic designs, seeking to increase clarity, minimize potential errors, and reduce the need for manual queries as much as possible.

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com