March 22, 2021

Adding a site to CLARA when the UAMS IRB is the IRB of record

So, you’ve got a great multisite study started, for which the UAMS IRB will be the IRB of record. You’re ready to take the step of submitting site addition modification forms in CLARA to add additional sites.

We’ve recently updated our method for entering sites into CLARA. Rather than choosing sites from a dropdown list, you’ll enter site specifics directly into the site addition modification form.

  • Organization Name and mailing address (you can use the institution’s IRB or institutional official’s mailing address).
  • The name of the research network, if applicable (if you don’t know whether it’s applicable, it’s not applicable. Trust us on this.)
  • Name, email and phone number for the site’s IRB liaison. This is usually the person in the site’s IRB office (or equivalent) that coordinates xIRB reviews.
  • Name, email, and phone number for the signatory official, i.e. the person who is authorized to sign reliance agreements. This is usually the institutional official or their designee; investigators typically don’t sign reliance agreements themselves.
  • The relying site’s FWA number and IRB registration numbers. The sites can provide these to you; UAMS’, for example, are listed in our compliance statement on the IRB website.
  • The yes/no answer to whether the site is:
    • Subject to HIPAA
    • A CTSA Organization
    • A SMART IRB member

If you need help collecting any of this information, please contact the UAMS IRB’s xIRB coordinator at irb@uams.edu for assistance. Our office can help throughout the entire xIRB process.

And yes, you will have to reenter this information even if the same site is participating in multiple studies. We’ve found that we get the most accurate relying site information that way.

With the site addition modification form, please include a copy of the signed reliance agreement, the local site context questionnaire, and any site-specific documents, e.g. the informed consent template adapted to that site, with each site’s site addition modification form. One neat site addition modification form trick: this is the ONLY CLARA form that can be modified after it is approved the first time. That means that if something about that site changes as the study progresses, such as its consent form is revised, you will modify that site’s approved site addition modification instead of creating a new CLARA form. That keeps all of a particular site’s documents associated with a single CLARA form.