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.

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;

Examples of Site File in a sentence

The Sponsor shall make the Protocol available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 and the Principal Investigator shall include such documents in the Site File.
If requested by ICON, the Institution/Investigator shall promptly return all such Confidential Information to ICON at the end of the Study, (other than items required under Retention/Transfer of Clinical Study Site File, Section 3.3.3 above).
The Sponsor shall ensure that any and all safety and/or toxicology data relating to the IMP, which the Sponsor is aware of or which comes to the attention of the Sponsor from time to time, and which may, in the reasonable opinion of the Sponsor, be materially relevant to the conduct of the Clinical Trial, will also be provided to the Principal Investigator for inclusion in the Site File.
The Sponsor shall make the Protocol available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.7 and the Principal Investigator shall include such documents in the Investigator Site File.
If requested by CRO or Sponsor, the Institution/Investigator shall promptly return all such Confidential Information to CRO and/or Sponsor at the end of the Study, (other than items required under Retention/Transfer of Clinical Study Site File, Section 3.3.3 above).
The Sponsor shall ensure that any and all safety and / or toxicology data relating to the IMP, which the Sponsor is aware of or which comes to the attention of the Sponsor from time to time, and which may, in the reasonable opinion of the Sponsor, be materially relevant to the conduct of the Clinical Trial, will also be provided to the Principal Investigator for inclusion in the Investigator Site File.
The model will be hosted on the Pasco County website and will be submitted to the Florida Master Site File.
Research the Alabama State Site File and the National Register of Historic Places (NHRP) for recorded cultural resources sites within or in close proximity to the Project boundary.
The Sponsor shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.7 and the Principal Investigator shall include such documents in the Investigator Site File.
The [Sponsor] [CRO] (delete as appropriate) shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.8 and the Principal Investigator shall include such documents in the Investigator 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 prepared by the Owner in accordance with clause 4.1.4(e);