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Preparing for a Clinical                                        Research Monitoring Visit                                 ...
What studies undergo routine site visits (RSVs)             from the QIU?             • Studies that do not already underg...
Records preparation             • Regulatory Binder             • CHR approval history documentation – pre               “...
The Routine Site Visit             • An Educational Process             • Approximately 3 hours             • 1 hour Discu...
Common Findings                Have All KSP Completed CITI                          Training?                             ...
Overall RSV Summary Evaluation                                               Satisfactory - No                            ...
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What to Expect During an HRPP Quality Improvement Unit Routine Site Visit : Preparing for a Clinical Research Monitoring Visit

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Presented by Susie Corl, MSW, MPH, CIP, CCRP, from UCSF.

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What to Expect During an HRPP Quality Improvement Unit Routine Site Visit : Preparing for a Clinical Research Monitoring Visit

  1. 1. Preparing for a Clinical Research Monitoring Visit What to Expect During an HRPPSusie Corl, MSW, MPH, CIP, CCRP Quality Improvement Unit (QIU)Quality Assurance Coordinator,HRPP QIUSusan.corl@ucsf.edu Routine Site Visit415514-3822January 10, 2012 Outline • This discussion will cover… – What is the HRPP Quality Improvement Unit? – What studies undergo Routine Site Visits (RSVs) by the QIU? – How to prepare for the QIU RSV – What happens during the visit – Common RSV Findings – Resource informationHumanResearchProtectionProgram 2 What is the HRPP QIU? • Responsible for: – Routine monitoring (Routine Site Visit, or RSV) – Directed site visits – Educational site visits – Addressing Participant Complaints – Processing post approval event reports – Internal HRPP Quality ImprovementHumanResearchProtectionProgram 3 1
  2. 2. What studies undergo routine site visits (RSVs) from the QIU? • Studies that do not already undergo routine monitoring • Studies that are reviewed by convened CHR Committee and initially considered greater than minimal risk i i l i k • Studies that have been active for 5 years or less • Studies currently enrolling or actively following participantsHumanResearchProtectionProgram 4 How to prepare for the QIU RSV • Scheduling – who should attend • Records preparation • Routine O S Review Form On-Site • Pre-review your recordsHumanResearchProtectionProgram 5 Scheduling – who should attend • Principal Investigator • Study team members involved in recruitment, consent, regulatory g document management • New team members – educational opportunityHumanResearchProtectionProgram 6 2
  3. 3. Records preparation • Regulatory Binder • CHR approval history documentation – pre “iMedRIS” • Eligibility screening documentation • Enrollment log • Consent, HIPAA, surrogate, etc. documentation • Drug accountability • Medical charts – look for copies of ICFs, double check eligibility criteria in source documentsHuman • Electronic records – currently, no review by QIUResearch during RSVProtectionProgram 7 Routine On-Site Review Form • Posted on QIU site at: – http://www.research.ucsf.edu/chr/Qip/ hsppQipTools.asp See “UCSF Routine On-Site Review Form UCSF On Site Form”HumanResearchProtectionProgram 8 Pre-review Research Records • Conduct an internal review of the records using the Routine on Site Review Form as a guide • Consult with QIU by phone with questions • C t N t t Fil to address Create Notes to File t dd discrepancies identified during pre-review processHumanResearchProtectionProgram 9 3
  4. 4. The Routine Site Visit • An Educational Process • Approximately 3 hours • 1 hour Discussion • 1 hour Review of Records • 1 hour Wrap-up and Feedback with Findings: – No recommendations – RecommendationsHumanResearch – Significant FindingsProtectionProgram 10 Routine Site Visit Report • Sent to PI and team members present at visit • Documents the discussion • Provides formal recommendations • May require follow-up action by PI • Shares educational informationHumanResearchProtectionProgram 11 Where do RSVs Take Place? VAMC Research Sites Visited 7% Affiliate Other 3% UCSF Parnassus Sites 14% Mt. Zion SFGH 18% SFGH Parnassus 48% Affiliate Mt. Zion 10%Human n=213Research Findings provided on the next pages are taken fromProtection report posted on HRPP website at http://www.research.ucsf.edu/chr/Train/QIU_RSV_training.pdfProgram 12 4
  5. 5. Common Findings Have All KSP Completed CITI Training? 18% No Yes 82%HumanResearchProtection n=213Program 13 Common Findings Is the Consent Process Adequately Documented? 7% 28% 65% N/A No YesHumanResearch n=213ProtectionProgram 14 Common Findings Is the Correct Version of Consent Form Used? 3% 31% N/A 66% No YesHumanResearch n=213ProtectionProgram 15 5
  6. 6. Overall RSV Summary Evaluation Satisfactory - No 13% Recommendations (28) 11% (25) Satisfactory - Recommendations 76% (160) Significant FindingsHumanResearchProtectionProgram n=213 16 Questions & Resource Information • Call or email the CHR and ask for the QIU Analyst of the Day • Main CHR Line: 415-476-1814 • QIU section of HRPP Website: http://www.research.ucsf.edu/chr/Qip/hsppQip http://www research ucsf edu/chr/Qip/hsppQip .asp • Presentation on QIU RSV Findings: http://www.research.ucsf.edu/chr/Train/QIU_R SV_training.pdfHumanResearchProtectionProgram 17 6

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