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OnCore: Required Documents to be Uploaded

To complete the Study Registration process, there are several documents required to be uploaded in OnCore.

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.
Documents Required to be Uploaded into OnCore and their Locations
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

  • IRB Initial Approval
  • Continuing Reviews
  • Change Reviews
  • Full or Expedited reviews

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

See Also


Keywords:
crmfaq requirements necessary documentation irb approval letters contracts agreements consent forms investigational drug brochure investigator's application serious adverse event IND FDA protocol document required register registration 
Doc ID:
13216
Owned by:
Ilsa G. in SMPH Research Applications
Created:
2010-01-31
Updated:
2025-02-10
Sites:
SMPH Research Applications, SMPH Research Informatics TEST