Study File definition

Study File means a site file for a Study that contains Ethics Committee member identifications, correspondence and approvals (including approval of the Protocol, the informed consent form and, in each case, any amendments thereto), the approved informed consent form, signed and dated informed consent forms, completed Case Report Forms and other clinical observations, log of all Study site visits, laboratory or other tests taken or performed and Study Drug receipt and disposition information and any and all other records or information required by the Regulations to be, or customarily, maintained in the conduct of human clinical trials. In the context of a particular Study, reference herein to “the Study File” means the Study File for the Study.
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Examples of Study File in a sentence

  • This Study File may be inspected at any time by representatives of the IRB, the FDA (as applicable), and/or other regulatory agencies responsible for the oversight of research.

  • I will maintain a Study File that must be kept for three years following completion of the study (if no IND/IDE used [32 CFR 219.115 (b)]).

  • After such period, in no event shall FORENAP dispose of all or any part of a Study File, except in accordance with Section 18.3.

  • FORENAP shall maintain each Study File in accordance with the Protocol for the Study and all applicable Regulations.

  • Should, in addition to the Master File stored by the Sponsor, it be agreed for the Centre to preserve copies of the documentation that forms part of the File, and should it not be possible for the file of the Study to be stored during the period of preservation due to exceptional circumstances, the Centre or the Managing Body must contact the Sponsor to organize the transfer of the Study File to the person designated by the Sponsor.

  • The Researcher and/or the Centre must request instructions from the Sponsor on how to manage the Study File once the preservation period has ended.

  • Answers will be updated onto the database and DCRs stored within the Study File.

  • Prior to the initiation of the Study, Sponsor through CRO shall acquaint the appointed pharmacist with the Study, provide relevant documentation required by law or by the State Institute for Drug Control or by any other regulatory authority (Protocol synopsis, Study File, Approval of the State Institute for Drug Control, Approvals of Ethics Committee(s) etc.) and acquaint the appointed pharmacist with any requirements regarding Investigational Product records at SIV.

  • Nežiaduce príhody v priebehu Štúdie 1) Skúšajúci je povinný zhromažďovať, zaznamenávať a ohlasovať informácie o akýchkoľvek nežiaducich príhodách, závažných, ako aj nezávažných, podľa ich definície v Protokole, a to spôsobom opísaným v Zaraďovači štúdie (Investigator Study File) a podľa požiadaviek legislatívy alebo etickej komisie.

  • The CPC is responsible for the set up and the maintenance of the Study File (SF).

Related to Study File

  • Study Data shall have the meaning set forth in Section 8.1.

  • Data File means a single record or collection of data records that are logically related to each other, and are handled as a unit;

  • Case file means a record that is assembled and maintained for each application approved for state cost sharing.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Master File has the meaning set forth in the CAISO Tariff.