Page 28 - eBook Version 8 Book 1 of 2 JUL 2022

Study Start-Up: Registration, IRB, and PSA Submissions
Velos
Select
Comments
Have you registered your study in Velos? For more information see AIS Tip Sheet: Study Registration.
Yes No
In Velos, have you selected Children’s Health as a performance site?
Yes No
Have you submitted a request for study confidentiality agreement?
Yes No
Have you routed your study to the IRB for review? For more information, see AIS Tip Sheet: Study Registration.
Yes No
Have you initiated a request for clinical trial coverage analysis (CTCA)? For more information, see AIS Tip Sheet: Clinical Trial Coverage Analysis.
Yes No
Have you uploaded all pertinent documents in Velos under the “Documents” tab? Examples include protocol, investigator brochure (IB), informed consent (IC), clinical trial agreement (CTA), confidentiality disclosure agreement (CDA), etc.
Yes No
For studies involving radiology review, have you submitted a request in Velos for review?
Yes No
Have you submitted a request in Velos for a performance site review (PSR)? This includes completion of the PSR form.
Yes No
Contracts
Select
Comments
For studies that require a Data Use Agreement or Material Transfer Agreement, have you reached out to UTSW Office of Technology Management to initiate a request for a DUA or MTA? For more information: http://www.utsouthwestern.edu/about- us/administrative-offices/technology-development/utsw/coop- sponsored/agreements.html
Yes No
Have you initiated a Facility Use Agreements (FUA) for studies that are industry (pharmaceutical) sponsored? For more information pertaining to contracts and agreements, please reference the Study Agreements Matrix.
Yes No
For FUAs, have you emailed the Director of Research Administration at Children’s Health, to initiate the contract (email to Victoria.brown@childrens.com)?
Yes No
Version Date: 7/28/17
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