Revolving CRAs

It’s inevitable. You’re three months into a new study and you receive the email you dread.

Your CRA was reassigned/quit/promoted/terminated and a new CRA assigned to you.

---

What does that really mean to the study coordinator and what’s the cost to the site?

The following is the typical process:

1. Initial email with the new CRA.
2. Initial phone call to “meet”.
3. Time spent educating the new CRA about the site’s scheduling and other policies.
4. The CRA notifies the site that they found that documents were missing in the Trial Master File (TMF) and could the site please send the following (… documents that had been previously sent)
5. The CRA won’t be able to make it to your site for another 2 and a half months because of scheduling issues. Yes, they understand that the previous CRA hasn’t done any drug accountability yet and used drug is piling up, but it will have to wait.
6. During the first monitoring visit with the new CRA, the CRA notices that something needs correction. Site staff inform the CRA that the previous CRA instructed them to do it a different way. Visit ends with no conclusion to the issue. 7 emails and 2 phone calls ensue. Clarification is received from the Study Manager. No correction necessary.
7. During the same visit, CRA requests calibration logs and reviews site processes that were previously reviewed. CRA has issues with something that was fine previously. Escalates issue to Study Manager. PI has to get involved to resolve.

It’s hard to get exact numbers, but in discussions with Study Coordinators at a few sites, they estimate that every time a CRA changes, it costs the staff at the site 5-10 hours of additional work they hadn’t planned for in the study.

“CRA was reassigned/quit/promoted/terminated and a new CRA assigned”

What can be done to minimize the impact of a CRA change on sites?

• Ensure proper documentation: CRAs should enter all received documents in the TMF promptly to prevent the need for new CRAs to request documents from the site again.
• Promptly connect with the site: New CRAs should reach out to the site to determine when they are needed and escalate the request if necessary.
• Consult study manager: If significant changes are required during the first monitoring visit, CRAs should seek clarification from the study manager before requesting modifications from the site, avoiding conflicts and streamlining the process.
• Budget adjustment: Study managers should acknowledge that a change in CRAs will create additional work for the site and include a specific line item in the budget for reimbursement.

If a sponsor increased work for their CRO in the study, the CRO would refuse to accept the new work if there wasn’t an adjustment in compensation. It should be the same thing for sites, but sadly… it isn’t.