Site File definition

Site File means the file maintained by the Investigator containing the documentation specified in section 8 of ICH GCP (edition CPMP/ICH/135/95).
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Site File means the file maintained by the Principal Investigator Site Study Completion means the conclusion of all Protocol required activities for all enrolled Non-Interventional Study Subjects at the Site. means one or more persons appointed by the Sponsor, or Affiliate, to monitor compliance of the Non-Interventional Study with Sponsor requirements and to conduct data verification.
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Site File means the file maintained by the Principal Investigator containing the documentation specified in section 8 of ICH GCP (edition CPMP/ICH/135/95); Sponsor an Individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, managing and financing (or arranging the financing) of the research;
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Examples of Site File in a sentence

  • All correspondence with the REC will be retained in the Trial Master File/Investigator Site File.

  • Sites will be provided with an Investigator Site File containing essential documentation, instructions, and other documentation required for the conduct of the trial.

  • A second copy will be placed in the patients’ medical records whilst the original will be retained in the Trial Site File.

  • A copy of the form should be placed in the patient’s medical notes and a copy filed in the Investigator Site File (ISF).

  • A copy will be given to the patient, a copy placed in the patient’s medical notes and the original kept in the Investigator Site File.

  • The Forum received a report was tabled at the meeting and is attached to the minutes as Appendix B, which provided details on academy appointments to the Forum.

  • A copy will be given to the Personal Consultee, a copy placed in the patient’s medical notes and the original kept in the Investigator Site File.

  • A copy of the ICF will be given to the participant, a copy will be filed in the medical notes, and the original placed in the Investigator Site File (ISF).

  • The original signed consent form will be retained in the Investigator Site File, with a copy in the clinical notes and a copy provided to the participant.

  • The participant will receive a copy of this document and a copy filed in the Investigator Site File (ISF) and participant’s medical notes.


More Definitions of Site File

Site File means the file prepared by the Owner in accordance with clause 4.1.4(e);
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Site File means the file maintained by the Principal Investigator; Site Study Completion means the conclusion of all Protocol required activities for all [enrolled] Non-Interventional Study Participants at the Site; Study Completion means the conclusion of all Protocol required activities for all [enrolled] Non-Interventional Study Participants in all locations where the Sponsor (or any Affiliate of the Sponsor) is carrying out the Non-Interventional Study described in the Protocol; Study Monitor means one or more persons appointed by the Sponsor, or Affiliate, to monitor compliance of the Non-Interventional Study with Sponsor requirements and to conduct source data verification;
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Related to Site File

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

  • Lease File means, for each Lease, the Collateral Lease File applicable to such Lease.

  • Contract File means with respect to each Contract, the physical and/or electronic files in which Credit Acceptance maintains the fully executed original counterpart or “authoritative copy” (in each case, for UCC purposes) of the Contract (to the extent required in accordance with Section 3.03 of this Agreement), either a standard assurance in the form commonly used in the industry relating to the provision of a certificate of title or other evidence of lien, the original or electronic instruments modifying the terms and conditions of such Contract and the original or electronic endorsements or assignments of such Contract.

  • Receivable File means the documents (whether tangible or electronic) specified in Section 2.02 pertaining to a particular Receivable.

  • Electronic File means any text, illustration or other matter supplied or produced by either Party in digitised form on disc, through a modem, or by ISDN or any other communication link.

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

  • Custodial File Any mortgage loan document in the Mortgage File that is required to be delivered to the Trustee or Custodian pursuant to Section 2.01(b) of this Agreement.

  • CREFC® Special Servicer Property File format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Servicing File The items pertaining to a particular Mortgage Loan including, but not limited to, the computer files, data disks, books, records, data tapes, notes, and all additional documents generated as a result of or utilized in originating and/or servicing each Mortgage Loan, which are held in trust for the Trustee by the Servicer.

  • Asset File shall have the meaning assigned thereto in the Custodial Agreement.

  • CREFC® Loan Periodic Update File The data file in the “CREFC® Loan Periodic Update File” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • Servicer File means, collectively, all documents, records and copies pertaining to a Mortgage Loan which are required to be included in the related Servicer File pursuant to Section 3 thereof.

  • CMSA Property File means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Property File" available as of the Closing Date on the CMSA Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage securities transactions generally.

  • Mortgage File The mortgage documents listed in Section 2.01 pertaining to a particular Mortgage Loan and any additional documents required to be added to the Mortgage File pursuant to this Agreement.

  • CMSA Loan Periodic Update File means the monthly report substantially in the form of, and containing the information called for in, the downloadable form of the "Loan Periodic Update File" available as of the Closing Date on the CMSA Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage securities transactions generally.

  • CREFC® Property File The data file in the “CREFC® Property File” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CREFC® Loan Setup File The data file in the “CREFC® Loan Setup File” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CMSA Loan Setup File means the report substantially in the form of, and containing the information called for in, the downloadable form of the "Loan Setup File" available as of the Closing Date on the CMSA Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage securities transactions generally.

  • Servicer Mortgage File All documents pertaining to a Mortgage Loan not required to be included in the Trustee Mortgage File and held by the Master Servicer or the related Servicer or any Sub-Servicer.

  • Personnel file means, for the purposes of Part III (8VAC20-90-60 et seq.), any and all memoranda, entries or other documents included in the teacher's file as maintained in the central school administration office or in any file regarding the teacher maintained within a school in which the teacher serves.

  • CREFC® Special Servicer Loan File The data file in the “CREFC® Special Servicer Loan File” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Credit File means all Credit Documents and all other credit, collateral, or insurance documents in the possession or custody of the Assuming Institution, or any of its Subsidiaries or Affiliates, relating to an Asset or a Loan included in a Put Notice, or copies of any thereof.

  • Receivable Files means the documents specified in Section 3.3.

  • Retained Mortgage File With respect to each Mortgage Loan, the file consisting of the Mortgage Loan Documents listed as items 6 through 12 of Exhibit C attached hereto. Securities Act: The Securities Act of 1933, as amended.

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