An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible.
Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. Federal Rules of Civil Procedure. Washout Issues in Drug Treatment Studies E. Additional specific responsibilities of sponsors are described elsewhere in this. Get the CustomsMobile app! Upon written request by FDA, the sponsor shall submit the records or reports or copies of them to FDA. A to Z Index.
Official: 21 cfr 312.61
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|21 cfr 312.61||The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained. The sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated. Note: If you need help accessing information in different file 21 cfr 312.61, see. In that case, the investigator must immediately report the event to the sponsor. Note: If you need help accessing information in different file formats, see. This website has been translated to Spanish from English, and is updated .|
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|ACE BAYOU VIDEO ROCKER GAMING CHAIR REVIEW||The University of Iowa Directory A-Z Search About Iowa Contact 21 cfr 312.61 Calendars Privacy Information. The determination that an investigation may not be considered in support of a research or marketing application or a notification or petition submission does not, however, relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation. Federal Rules of Evidence. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it. In addition, the sponsor shall assure that adequate precautions are taken, including storage of the investigational drug in a securely locked, substantially constructed cabinet, 21+3 blackjack how to play other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it. For a complete list of all Rules, Proposed 21 cfr 312.61, and Notices view the Rulemaking tab.|