In the current clinical trials, clinical data which was originally recorded on source data is transcribed into CRF by physicians or CRCs, and CRAs verify source data and CRF. However, transcription and verification are labor-intensive jobs. If the information of source data could be electronically transmitted to CRF, transcription and verification jobs are unnecessary. However, transmission of all necessary data is difficult. Therefore, we carried out surveys for CRCs and CRAs about which data items should be transmitted and what problems might occur. We obtained responses from 370 CRCs and 252 CRAs. It was suggested that data items which can improve efficiency of clinical trials are “Concomitant Medications”, “Medical History/Complications”, “Laboratory Test Results”, “Adverse Event”, and “Vital Signs”. And various problems were listed; in paticular, CRCs were concerned about “Security” and CRAs were concerned about “Reliability and Assurance of the System”.

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Protocols and case report forms are different among clinical trials, however adverse events (AEs) occur in every trial and need to be assessed in the same way. Therefore, we conducted a survey to examine the actual condition of the information of AEs. We surveyed choices and criterions of items for AEs of 59 trials which were performed in Kanazawa University Hospital. As a result of the survey, it became clear that choices currently used for each item were varied and different in each trial. Criteria of severity and outcome were also varied; there were even contradicting criteria among trials. There were also contradictory judgments of adverse drug reactions (ADRs), and the definition of “Probably not” expressed as an ADR differed. Moreover, in these trials, the criteria for “Probably not” was not markedly different. From these results, it was suggested that current the collection and assessment of the information of AEs were different in each trial and thereby assessments could also be different. Pharmaceutical companies, regulatory agenceis, and medical institutions should be in discussion to determine standardization of the expression of choices and criterions of AEs.

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