[OCRcommunications] Performance Site Review Updates - mandatory eRegulatory use for qualifying studies and PSR Modifications

[OCR]

Good afternoon Research Community,

We are reaching out with some updates on the Performance Site Review (PSR) Process:


  1.  Using Florence eBinders for qualifying clinical trials:

All studies conducted at UTSW which fulfill the NIH definition of a clinical trial<https://urldefense.com/v3/__https://grants.nih.gov/policy/clinical-trials/definition.htm__;!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPhAv0Hag$ > will now be required to use eFlorence or an alternative, equivalent eRegulatory system for storage of their regulatory documents.

The requirement for use of Florence for all studies that fulfill the definition of a clinical trial has been in place since the initiation of the Florence-Velos integration and was communicated to study teams through our educational sessions, website and SOPs. We have however provided a grace period for this requirement as teams became familiar with the system.

Confirmation of eFlorence (or alternative eReg) use for qualifying clinical trials is now a required part of UTSW performance site review, as study teams are growing increasingly familiar with the eFlorence system. Qualifying studies will not receive Performance Site Approval without the use of an appropriate eRegulatory system.

Please find below for a link to the current OCR Policy related to eFlorence use:
sop-florence-001.pdf (utsouthwestern.net)<https://www.utsouthwestern.net/intranet/research/ocr/assets/sop-florence-001.pdf>

If you have any questions about this, please contact OCR at utsouthwestern.edu<mailto:OCR at utsouthwestern.edu>


  1.  When and How to complete a Performance Site Modification:

Changes to study procedures or performance sites are not uncommon during the lifespan of a research study, when these happen a Performance Site Modification may be required in order to keep details up to date. UTSW PS modifications need to be submitted for review and approval by the OCTM office when there has been a change or update to either a study related procedure or a location where the study takes place.

Please find below for a link to a tip sheet outlining the PS Modification Process:
https://www.utsouthwestern.net/intranet/research/ocr/assets/performace-site-modification-submission-tipsheet-v2.pdf

We will be hosting two virtual educational sessions outlining the new PS Modification Process, details can be found below:
Thursday 13th June, 11-11:30am – Link to join meeting<https://urldefense.com/v3/__https://teams.microsoft.com/l/meetup-join/19*3ameeting_ZTgxN2RjODktODA3Ni00NGQ2LTgzMGMtMjViOTc0MjQyYzMy*40thread.v2/0?context=*7b*22Tid*22*3a*229d418695-71ac-4c31-b5b2-c196c8ec3c8a*22*2c*22Oid*22*3a*223674f270-12e5-47bd-8135-31dd73d20a6a*22*7d__;JSUlJSUlJSUlJSUlJSUl!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPjyQw9UA$ >
Friday 21st June, 12-12.30pm – Link to join meeting<https://urldefense.com/v3/__https://teams.microsoft.com/l/meetup-join/19*3ameeting_NWRiYmMyMWYtODI4OC00OTVkLTkzNzctMjhlZmRkZTlhODE2*40thread.v2/0?context=*7b*22Tid*22*3a*229d418695-71ac-4c31-b5b2-c196c8ec3c8a*22*2c*22Oid*22*3a*223674f270-12e5-47bd-8135-31dd73d20a6a*22*7d__;JSUlJSUlJSUlJSUlJSUl!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPVTHXRpo$ >
If you would like a calendar invite for either of these events, please email OCR at utsouthwestern.edu<mailto:OCR at utsouthwestern.edu>

If you have any questions about this, please contact OCTM at UTSouthwestern.edu<mailto:OCTM at UTSouthwestern.edu>

Please do not hesitate to reach out with any questions or if we can be of further support.

Best wishes

Office of Clinical Research (OCR) 
UT Southwestern Medical Center 
OCR at utsouthwestern.edu<mailto:OCR at utsouthwestern.edu> 
https://www.utsouthwestern.net/intranet/research/ocr/ 




________________________________

UT Southwestern

Medical Center

The future of medicine, today.
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