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 |