Archives for Data and Documents from Completed Clinical Trials - Report from a Workshop |
Author(s): , , , ,
Journal/Book: Controlled Clinical Trials. 1988; 9: 19-22.
Abstract: The participants in this workshop included both the panelists and the audience. They discussed the policy, ethical, technical, and logistical issues that confront investigators when a clinical trial is completed: whether archiving of data and documents is required, what information should be archived, how and where to store data and documents, and methods by which access to the data can be gained by non-study investigators. The panelists made several brief presentations, which included the archiving experiences in the Diabetic Retinopathy Study (Dr. Mowery); the facilities provided by the National Technical Information Service (NTIS) of the U.S. Department of Commerce (Ms. Gannon); the current archiving requirements and procedures within the U.S. Veterans Administration (Dr. James); findings from a survey of 10 completed clinical trials (Dr. Markowitz); and considerations from the data processing perspective (Dr. Hosking). A handout was distributed that listed a number of questions to be considered by clinical trial investigators who were considering archiving data and documents. The issues raised in these questions are summarized at the end of this report.
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