CLARA Update: New Questions and Section for Unaffiliated Collaborators
To better capture information about collaborators who are not affiliated with UAMS or Arkansas Children’s, updates have been made to the CLARA New Submission Form.
Updated Questions in the “Start” Section
The question regarding external sites and collaborators has been revised to include unaffiliated collaborators. In addition, two new questions have been added to determine whether a reliance agreement or an unaffiliated collaborator agreement is required.
The updated questions are:
Question 6:
Will any external sites or collaborators other than UAMS and AC/ACRI rely on the UAMS IRB for oversight for this study?
Question 6-1:
Will any participating sites join the study under a Reliance Agreement?
Question 6-2:
Will any community partners or others participate in the study under an Unaffiliated Collaborator Agreement, either now or in the future?
New “Unaffiliated Collaborator” Staff Section
This section has been added immediately after the “Staff” section of the New Submission Form. If you select “yes,” when answering Question 6-2, you will have the ability to add the collaborators (individual or site) to the study. You will be asked to:
- Enter each collaborator’s name and contact information.
- Provide the requested details regarding each collaborator’s role in the research.
Please upload a completed Unaffiliated Collaborator Agreement with the other required study documents.
*Note that some of these items may not be available at the time of initial submission but can be added later with a modification form.
If you have questions about whether an individual or site qualifies as an unaffiliated collaborator, or if you need assistance completing this section of the CLARA submission, please contact the UAMS IRB Office at irb@uams.edu.
These updates are intended to improve the documentation of unaffiliated collaborators and help ensure that all required agreements are in place before research activities begin.