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).
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. 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 data verification.
Site File means the file prepared by the Owner in accordance with clause 4.1.4(e);

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 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).

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

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

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

  • Prior to the start of work, the Applicant/Permittee or other party on the Applicant’s/Permittee’s behalf, shall conduct a search of known historical properties by contracting a professional archaeologist, and contacting the Florida Master Site File at 850-245-6440 orSiteFile@dos.state.fl.us.

  • Another copy will be placed in the patient’s medical records whilst the original will be retained in the Trial Site File.


More Definitions of Site File

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;
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;

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 As to each Mortgage Loan, any mortgage loan documents which are delivered to the Custodian or which at any time come into the possession of the Custodian as set forth in Section 2 of this Custodial Agreement.

  • Servicing File With respect to each Mortgage Loan, the file retained by the Company consisting of originals of all documents in the Mortgage File which are not delivered to the Custodian and copies of the Mortgage Loan Documents listed in the Custodial Agreement the originals of which are delivered to the Custodian pursuant to Section 2.03.

  • Asset File means the materials with respect to the Assets (i) previously delivered to Buyer or its representatives by or on behalf of Seller, whether written or orally, (ii) made available to Buyer or its representatives at the Hotel or at the offices of Broker, in each case, whether written or orally, or (iii) made available to Buyer or its representatives in the data room web site created by Broker.

  • 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.

  • 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.

  • 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.

  • Home inspection report means a written report that is

  • 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.