15 Jun What Document Type name should I select for my document?

Document Type names should match the type document you are uploading.

IMPORTANT: Document Type names should be unique to each document and remain consistent throughout the life of the study. For example, if there is more than one consent form, assign “Main Consent” to the first consent form and “Main Consent A” to the second. Whenever an updated version is uploaded or re-entered during annual reviews, keep the same Document Type name. This is important for version control in Document Search and the CRA Console and for re-consent workflows to function.

15 Jun Should I delete previously uploaded documents after a new version is uploaded?

NO! Do not delete previously uploaded versions. OnCore will replace the most recent uploaded version in Document Search. However, certain central offices may still need access to previous versions and will be able to access them under the tab they were uploaded to.

20 Apr Is it possible to print the consent footer and date of printing from OnCore?

The functionality to print a consent footer will be available in OnCore CTMS when document access goes live. See the Document Search & Print Job Aid.

20 Apr How can we search OnCore CTMS for documents?

Using the Document Search functionality in OnCore CTMS (Menu > Protocols > Document Search).

You can search for documents with any of the following protocol identifiers:

• Protocol Number (RG#)
• IRB Number
• Pharmacy Number
• Sponsor Number
• IND Number
• IDE Number
• Investigator
• Keywords: Any word found in the title, short title or objectives

20 Apr Who do I contact if a document in OnCore is missing or the version is not correct?

20 Apr What documents are available in OnCore’s Document Search?

The following study documents must be maintained by the study team in OnCore:

• Study Protocol
• Protocol Memo’s and Clarification Letters
• All Consent-type documents
• Investigator/Drug Brochure
• Drug Package Insert, Drug Booklet, or Drug Information Sheet
• All study manuals, including Pharmacy, Apheresis, Imaging, Laboratory, and Device Manuals.

The BMT Standard Practice Manual, BMT Standard Treatment Plans and CCO Book are still available in CORE.

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:

• • 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:

• • Lab Manual
  • Imaging Manual
  • Pharmacy Manual
  • Product Manual
  • Apheresis Manual
  • Other Manual

14 Apr Which protocols are required to upload documents to OnCore CTMS?

• Epic status can be viewed in the PC Console > Status tab

• a) Has consent form documents
• b) Has a Data Table 4 Type of Interventional, Observational, or Ancillary/Correlative

14 Apr Who will access documents from OnCore CTMS?