What is an eCRF?

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

10 February, 2019

An eCRF (electronic case report form) is a software system used to collect data in a clinical study. Commonly, eCRFs are web-based applications containing various data forms and fields designed to receive data in clinical trials or observational studies.

eCRFs are fundamental elements in clinical research since they are the instruments utilized by study coordinators and investigators to enter data from source documents, which are then cleaned and exported into the database for statistical analysis.

Electronic CRFs have progressively replaced paper-based CRFs, providing several benefits for sponsors, such as faster data collection, more efficient data cleaning and, overall, a decrease in the efforts and costs involved in the data management process as a whole.

Some of the key features that eCRFs should have include simplicity (clear design, ease of use), security (access control, data encryption), reliability (data backups, seamless service), and compliance (alignment with 21 CFR Part 11 requirements).

Sponsors should select the most adequate eCRF system considering the size and complexity of their clinical studies.

There is a wide range of eCRF solutions in the market, with different prices and features, so that study sponsors may carefully assess the technical needs of their projects before selecting a vendor.

eCRF technology has greatly evolved in recent years, and many solutions in the market offer advanced features of high value, such as built-in monitoring (integrated SDV mechanisms), data management and reporting tools.

IBM and Oracle are examples of leading eCRF vendors in the clinical research industry.

At the end of the day, high quality data is at the heart of the research success. Then, choosing a good eCRF becomes a decision of utmost importance.

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