Electronic Case Report Form (e-CRF) means an auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.
Guidance for Industry, Computerized Systems Used In Clinical Trials21
Computer-assisted data entry offers at least six advantages over paper case report forms:
• Immediate detection and correction of errors. Mistakes such as typographical errors and misplaced decimal points are detected and corrected at the time of entry. No data is lost as a result of lapses in memory.
• Reduced sources of error. Eliminating the need to recode and reenter case report forms eliminate two potential sources of error. There is a corresponding reduction in costs.
• Open-ended reporting. If inspection of the "other" category reveals that "protein imbalance" is being written in with a relatively high frequency, then "protein imbalance" can be added to the options on the pull-down menu. Printed case report forms are fixed, lifeless.
• Quality control. Even the best-designed forms can contain ambiguities just as even the best-designed trials can have unexpected consequences. Measuring devices can go out of tolerance. By tabulating and monitoring the information as it is collected, problems at some or all of the sites can be detected and corrected early on.
• Improved investigator relations. If a trend is detected, particularly if it only involves one or two sites, it can be difficult to communi-
cate the need for modification of procedures without offending some investigators. Let the clinical research monitor (CRM) and the investigator jointly blame the software.
• Ease of access. Generally, the same software that simplifies data entry makes it easy for the noncomputer professional to access and display the result. (We expand on this point in the next chapter.) Both your staff and the regulatory agency will have earlier access to trial data compared with paper CRFs.
Many regulatory agencies such as the FDA now accept and even prefer electronic submissions, thus doing away with the need to manage or store paper case report forms. If paper forms are required, they are readily produced. And if a paper form turns up missing, it is easily regenerated from the electronic record and submitted to the investigator for signature. (Security procedures for electronic records are discussed in the next chapter, also.)
Implementation of computer-assisted entry involves three steps:
1. Developing and testing the data entry software
2. T raining medical and paramedical personnel in the software's use
3. Monitoring the quality of the data
We discuss the first two of these steps in the following sections, and the last step in Chapters 13 and 14.
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