Definition of investigational product
FDA Internal Standard Operating Procedures for the
The definition of a Teletrial ‘primary site’ includes: The primary site contains the Principal Investigator for the clinical study and is responsible for the conduct, coordination and supervision of the clinical trial across the primary site and all related satellite sites. ... Investigational product name. Location of …
[DOCX File]Investigational Product Accountability Log: Subject Record
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Investigational Product under Non-IND or -IDE Human Subjects Research Clinical Trials . Regulatory Documentation Checklist: ... guide for creating a regulatory binder that compiles essential documents for the conduct of a study that meets the NIH definition of a clinical trial.
Investigational Product | NIH: National Institute of Allergy and Infec…
Jul 17, 2015 · A new line should be completed each time study product is dispensed and/or received. The “Subject Record” may be used to record dispensing and return of study product on the subject level. The associated “Stock Record” is a separate tool that may be used to record overall bulk study product supplies and accountability.
[DOCX File]SOP FDA-Regulated Research
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Investigational Product Information (Drug or Biologic) Drug or Biologic Manufacturer or Supplier. D. escription: ... subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition (examples of such events include allergic bronchospasm requiring intensive treatment in the ...
[DOC File]Annex
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When a situation requires the emergency use of an investigational product (see 21 CFR 56.104(c)) for which RIHSC review would otherwise be required, the emergency use must be reported to the RIHSC ...
[DOCX File]University of Arizona
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Jun 26, 2020 · Investigator’s Brochure: A comprehensive document summarizing the body of information about an investigational product. The purpose of it is to compile data relevant to studies of the investigational item in human subjects, gathered during preclinical and clinical trials.
[DOCX File]Teletrial’s Primary Site Investigational Medicinal ...
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In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product should, in cooperation with the sponsor, inform the marketing authorisation holder of any quality defect …
[DOCX File]Consenting and Treatment Compliance
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The definition of an “investigational medicinal product” (IMP) is provided in Subsidiary legislation 458.43, as “a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication…
[DOC File]New Chapter 8 of GMP guide for consultation
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is an adverse reaction, the nature or severity of which is not consistent with the applicable scientific information (e.g. Investigator’s Brochure for an unapproved investigational product or Product Information (PI) document or similar for an approved, marketed product).
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