[Numeric case report: realization and practical utilization in cardiovascular research].
The reliability of trials in clinical research is principally conditioned by the quality of the conception, the realization and the data recording in the hypothesis of pertinent trials with an adequate methodology. The author describes the application in the cardiovascular domain, the realization and the use of numeric Case Report Forms DCRF working with a 'notebook' microcomputer and easy to use software which allows the conduct of quality clinical trials in accordance with good clinical practice. The numeric CRF is a tool to monitor in real time the data from trials (ongoing data trials) and ensures the continuity from the investigator site to the statistical department. An example of realization of a phase III multicentre clinical study is presented to evaluate the efficacy of two antihypertensive calcium-channel blockers.
Le Paillier
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Direction Médicale RLC, Clamart, France.
D002318:Cardiovascular Diseases / Q000188:drug therapy; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003661:Decision Support Techniques; D001330:Electronic Data Processing; D006801:Humans; D012106:Research; D012984:Software