Page 126 - eBook Version 8 Book 1 of 2 JUL 2022

Department: _________ Funding: ____________ Conducted at Plano? Y / N
IRB#______________ Checklist for Performance Site Review (PSR) submissions Velos# ___________
Date of Initial Submission: ____/_____/_______ PI: _______________ Date of Initial Review: ____/_____/_______
STAGE 1
Initials: ________ Date: __/___/___ Date: __/___/___
Credentialing
Non-employee research personnel credentialed by Medical Staff or HR as appropriate
When applicable, all research personnel have completed Research training (CCRCT, COI, HSP, HIPAA Research personnel who veiw PHI completed all Research training CBTs in CHEX
STAGE 2 Budget
Initials: ________
Date: __/___/___
Does this stu
PQF Request
dy have
billable charges (Pricing Quote Form - PQF)? Yes _____ No _____
ed/Received? Yes _____ No _____ Has Budget been approved? Yes _____ No _____
Deborah Town Signature & Date: ___________________ & ___________
Has PQF been forwarded to department financial analyst to set up? Yes _____ No ______
STAGE 3
Initials: ________ Date: __/___/___
Performance Site Review
eIRB
Notification to PI/Coord that PSR received and will begin review Information is complete or indicated as not applicable Everyone listed on the PSR is listed on the eIRB study team
IRB Approval Date MOD @ time of PSR Review CR @ time of PSR Review
IRB Approved Project Summary/ Protocol/ IB (if applicable)
IRB Approved Consent Waiver
Waived consent is acknowledged in IRB approval letter
and/or
IRB Approved Consent to Participate in Research form
English and Spanish versions (if Spanish speaking patients to be enrolled) UTSW IRB stamp of approval
Children's name on consent form
All names on the consent are listed on the study team in eIRB
Assent line present when study includes subjects 10-17 yrs of age
IRB Approved HIPAA Waiver form
Approved by the IRB and/or
IRB Approved HIPAA Authorization form
English and Spanish versions (if Spanish speaking patients to be enrolled) Approved by the IRB
Clinical Trials Registration required for clinical drug and device trials
Documentation that study has been registered in ClinicalTrials.gov
Investigator Agreement required for clinical trials
The PI has signed the 1572 for a drug trial (Investigator Agreement)
The PI and any co-investigator has signed the agreement required for device trials
Delegation Log
Signed by each research team member (Document that indicates who is responsible for what and has each research personnel's signature next to duties)
Drug Trial information sent to Investigational Drug Services (IDS) - Ruth Merryman (Non-hospital equipment) Approved by Biomedical Engineering
(Non-hospital medical supplies) Approved by Supply Chain
(Device studies) Approval by Materials Mgt
Who will be performing the clinical procedures, medication administration?
REVEAL Training
Who will be entering into REVEAL? _____________________
Does ___________________ have REVEAL training? Circle choice Yes No