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PROPOLIS DOCUMENTS

 

Document Title

Purpose

Expiration Date

Certificate of Action for study 1303590

Approval for:

·      Master Protocol (12-27-2020)

·      PROPOLIS Research Monitor Duties

·      Authorization to Use and Disclose PHI

·      Telephone Script

3/26/2022

 

DOC-5735406 Core Protocol Master protocol

3/26/2022

 

Research Monitor duties Description of Research Monitor Duties – as submitted

3/26/2022

 

Authorization to Use and Disclose PHI PHI Authorization Form [IRB stamp] 3/26/2022
Telephone Script for obtaining a signed consent USAISR telephone script (also study level) [IRB stamp]

3/26/2022

 

Certificate of Action 40511555 Approval for PROPOLIS Study Resources for Patients – as submitted

3/26/2022

 

PROPOLIS Study Resources For Patients Describes the content for the patient portion of the website (study level)

3/26/2022

 

Certificate of Action 40464389 Approval of Guidance for Electronic Informed Consent

3/26/2022

 

USAISR Guidance for Electronic Informed Consent Describes the process for obtaining electronic informed consent

3/26/2022

 

Template Consent Form Study level consent template [IRB stamp]

3/26/2022

 

Certificate of Action for study 1303590 Approval for:
-Master Protocol (7-20-21)
-Study level consent template [IRB stamp] 
3/26/2022
Template Consent Form – 7-20-21 Study level consent template – amended [IRB stamp] 3/26/2022
Template Consent Form – 7-20-21 Redline version Study level consent template redline version 3/26/2022
Core Protocol Amend 1 Redline version Master protocol amendment 1, redline version 3/26/2022
Core Protocol Amendment 1 Master protocol amendment 1, clean version 3/26/2022