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Copying A Protocol

Site users with appropriate permissions can create new protocols based off existing protocol builds to help expedite protocol creation in appropriate circumstances.

 

When you copy a protocol the following data is copied into the new protocol:

  1. All protocol information including: protocol title, sponsor, identifiers (a new unique P# is assigned)
  2. Protocol Main and Local tab settings
  3. Protocol Arms
  4. Drug Builds (the control location will have to be set on all copied drug builds)
  5. Order Builds (including dispensing fees)

 

What won't copy to the new protocol:

  1. Contacts
    1. If the copied protocol was connected to a CTMS system, the new protocol will also contain the CTMS Protocol Number and contacts will be added at the next update interval.
  2. Particpants/Subjects
  3. Inventory
  4. Protocol or Transaction Documents
  5. Competencies
  6. Workload
  7. Accounts, budgets, and Billing, except for order build fees
  8. Checklists

 

Required Permissions

ProtocolCreate - Allows the creation or copying of a new protocol. Users must have this permission in the facility they want to add the protocol to.

 

  1. On the Vestigo home screen, click on Add New.
  2. You can search by any of the following options: NCT Number, Alternate ID, or Other Terms.
  3. If you are wanting to copy any existing build, you can search by any of those. However, if you know the exact protocol you want to copy, it is best practice to search by the P Number in Alternate ID. The P Number is unique, and one is automatically assigned to protocols upon protocol creation.


  4. Once you enter the search criteria, click on Search.
  5. The first screen with show results from ClinicalTrials.gov. However, you can click the yellow button, Skip Step.
  6. If your site is not contracted for a CTMS interface, skip to step 7. If your site is contracted for a CTMS interface, the next results screen will show any matches from your CTMS, if applicable. You can click the yellow button, Skip Step.
  7. This screen will now ask you what Facility you would like this protocol to be in. You can select the appropriate facility from the drop down menu and click Next.
    1. Additionally, you can also add the Sponsor Site Number if you know it. This can always be added at a later date.
  8. The last screen will display any possible duplicates based off your search criteria. If you searched by a P Number, it will display one result. 
  9. To copy an existing protocol as a new one, click on the Copy as New link on the right side.
  10. You will see a warning pop up indicating that this pathway copies all arms, drugs, and orders to the new protocol. Click on Save Copy to create the new protocol.