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OnCore: Required Documents to be Uploaded
Below is a list all documents required to be uploaded in OnCore.
- If you are using eBinders you can use the Deeplinks feature to link to the documents in the eRegulatory Binder instead of uploading both places.
| Document Type | Version(s) to Upload | Location | OnCore Document Type |
|---|---|---|---|
| Protocol |
Current version, whether initial or amended, including protocols for federal grant applications Consider archiving or removing old versions when amended protocols are approved, so only the current version displays in OnCore Versions of the protocol that were in use before UW-Madison became a site do not need to be uploaded |
Upload to PC Console > Documents/Info tab OR Create deeplink through eBinders (which will display in Documents/Info Tab) |
Protocol |
| IRB Approval Letters |
All IRB Approval Letters
|
Upload to PC Console > Documents/Info tab OR Create deeplink through eBinders (which will display in Documents/Info Tab) |
IRB Document |
| Clinical Trial Billing Checklist |
Completed and signed Clinical Trial Billing Checklist for all studies, regardless of intent to enroll or bill Medicare patients |
Upload to Financials Console > Attachments tab |
Financials: Clinical Trial Billing (CMS) Checklist |
| CMS (Medicare) Approval Letter (as applicable) |
Investigational device studies |
Upload to Financials Console > Attachments tab |
Financials |
| Requisitions/Work Orders |
Required if having any procedures performed by UWHC/UWMF staff |
Upload to Financials Console > Attachments tab |
Financials: Work Orders |
| IRB Stamped and Approved Consent Forms |
Current version of the consent form(s) that were IRB stamped and approved, and current version of approved HIPAA Authorization forms (if separate from consent) Consider archiving or removing old versions when amended consent forms are approved, so only the current version displays in OnCore Do NOT upload consent forms that have NOT been approved, to avoid a study team member printing and using a non-approved version |
Upload to PC Console > Documents/Info tab OR Create deeplink through eBinders (which will display in Documents/Info Tab) |
Consent Attachments |