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

1. Preparing for a Clinical
Research Monitoring Visit
What to Expect During an HRPP
Susie Corl, MSW, MPH, CIP, CCRP Quality Improvement Unit (QIU)
Quality Assurance Coordinator,
HRPP QIU
Susan.corl@ucsf.edu Routine Site Visit
415514-3822
January 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 information
Human
Research
Protection
Program
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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 Improvement
Human
Research
Protection
Program
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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
participants
Human
Research
Protection
Program
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How to prepare for the QIU RSV
• Scheduling – who should attend
• Records preparation
• Routine O S Review Form
On-Site
• Pre-review your records
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Research
Protection
Program
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Scheduling – who should attend
• Principal Investigator
• Study team members involved in
recruitment, consent, regulatory
g
document management
• New team members – educational
opportunity
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Research
Protection
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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 documents
Human • Electronic records – currently, no review by QIU
Research during RSV
Protection
Program
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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”
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Research
Protection
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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
process
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Research
Protection
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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
– Recommendations
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Research – Significant Findings
Protection
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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 information
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Research
Protection
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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=213
Research Findings provided on the next pages are taken from
Protection report posted on HRPP website at
http://www.research.ucsf.edu/chr/Train/QIU_RSV_training.pdf
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5. Common Findings
Have All KSP Completed CITI
Training?
18%
No
Yes
82%
Human
Research
Protection n=213
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Common Findings
Is the Consent Process Adequately
Documented?
7%
28%
65% N/A
No
Yes
Human
Research n=213
Protection
Program
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Common Findings
Is the Correct Version of Consent Form
Used?
3%
31%
N/A
66% No
Yes
Human
Research n=213
Protection
Program
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6. Overall RSV Summary Evaluation
Satisfactory - No
13% Recommendations
(28) 11%
(25)
Satisfactory -
Recommendations
76%
(160)
Significant
Findings
Human
Research
Protection
Program n=213
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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.pdf
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Research
Protection
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