14 Apr What documents will be required to be uploaded?
1. Study teams will upload IRB approved documents to the PC Console > Reviews > IRB > IRB Review Update tab, within the IRB review the document was approved. IRB documents must be uploaded under the Initial Review, Continuing Reviews, and Modifications. Required documents include:
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- Protocol
- Consent(s) and Assent(s)
- Investigator/Drug Brochure
- Protocol Memos and Clarification Letters
- Additional documents as desired
2. Study teams will upload study manuals to the PC Console > Documents/Info > Attachments/Links tab prior to open to accrual and whenever a new version is released. Required study manuals include:
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- Lab Manual
- Imaging Manual
- Pharmacy Manual
- Product Manual
- Apheresis Manual
- Other Manual