Investigational product sop

• [DOC File]Generic SOP

  https://info.5y1.org/investigational-product-sop_1_dde04c.html

  SOP TITLE: Development of an Investigator Brochure (IB) or Investigational Medicinal Product Dossier (IMPD) SOP Version No: 01 Date: Page 1 of 1 21 This template …

  investigational products fda

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• [DOCX File]www.uthscsa.edu

  https://info.5y1.org/investigational-product-sop_1_0eabef.html

  The area where the investigational product, i.e. drugs, are stored must be a limited access area. All storage rooms have key pad access; refrigerators and freezers have padlocks. Only those employees that have delegated roles on the research team that require …

  fda guidance investigational product label

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• [DOCX File]Duke Standard Operating Procedure Template

  https://info.5y1.org/investigational-product-sop_1_90a7b4.html

  Feb 16, 2014 · SOP TITLE: Investigational Product Management. Version # 1. SOP Number: Page . 1. of . 1. Effective Date: Revision Date: Addresses . PURPOSE: To define the procedures for management of Investigational Product(s) [IP] according to the contractual requirements of the clinical trial. SCOPE:

  fda definition of investigational product

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• health.usf.edu

  Standard Operating Procedures for Clinical Research at USF Health CRC. INVESTIGATIONAL PRODUCT ACCOUNTABILITY. SOP#: 3. 0. 5. Effective Date: 06/01/2016. Version: 1.0 ...

  investigational product storage requirements

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• [DOCX File]NAME

  https://info.5y1.org/investigational-product-sop_1_6a4cee.html

  To describe process and requirements for the receipt, storage, dispensing, and return or destruction of Investigational Product (IMP/IP) at site. 11.2 Scope This Standard Operating Procedure (SOP) will apply to all studies being conducted at [INSTITUTION].

  investigational product labeling requirements

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• [DOC File]Health Sciences Authority (HSA)

  https://info.5y1.org/investigational-product-sop_1_aa48bc.html

  9.2.1 Sample IP label for Investigational Product [Insert sample label] Sample IP label for Auxiliary Product [Insert sample label] IP MANAGEMENT FORMS. Table 2 summarizes the IP management forms that will be used for this clinical trial. Table 2: Summary of IP Management Forms

  investigational product accountability

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• [DOCX File]Managing Investigational Drugs/Devices

  https://info.5y1.org/investigational-product-sop_1_9c1002.html

  This SOP is meant to be followed without deviation. However, it is an allowable exception to follow procedures specified in a protocol or by the sponsor. If a deviation from this SOP occurs, a description of this event will be written and filed with this list of SOPs and the protocol. ... Verify receipt of investigational product per sponsor ...

  investigational medicinal product fda

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