Electronic documentation clinical trials

Before a clinical trial starts, the use of technical aids such as IVRT, remote data entry and electronic diaries has to be considered. In Section 7.5.3.3, mention will be made of the use of electronic tracking system that provide status and monitoring reports. All these systems utilise computer systems that must be validated. Double and McKendry described computer validation as the process which documents that a computer system reproducibly performs the functions it was designed to do. The document Guidance for Industry - Computerised Systems used in Clinical Trials published by the FDA in 1999 gives clear recommendations of what is required (also see Section 7.5.4.1). 

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature ... 

Archives, like backups, should be stored at a separate and secure location. Critical documentation, records, and data should be kept in a fireproof safe. In some cases it is acceptable to print copies of electronic records for archiving, but advice should be sought from regulatory authorities. Clinical trial data are often stored on microfiche or other electronic medium. It should not be possible to alter such electronic copies so that they could be interpreted as master records."... 

This chapter has three objectives. First, it is necessary to discuss the ethics and desirability of publishing clinical trials, and the biases that may be involved with that process. Second, junior pharmaceutical physicians may benefit from some discussion of classic parts of an orthodox clinical trial report in a peer-reviewed journal, and some clues for effective oral presentations. Third, alternative forms of publication are discussed, including isolated abstracts and posters, electronic publication and press releases. The scope of this chapter is strictly formal publications regulatory documents (which are typically not published and are a different form of clinical trials reporting) and marketing materials are dealt with elsewhere. A summary and prospectus closes this chapter. 

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