Preparing for Monitoring Visit

Audit Worksheet (blank)

Audit Worksheet (With Comments For Pre Audit Review)

Audit Record Request 

Regulatory Audit Guide 

Regulatory Audit Scheduling Form 

How to prepare for monitoring visit

(Summary from Deborah Allen lecture 8.17.18)

3 major types: 

• Peraton
• Theradex
• Pharma

  General info - When you know that you have an audit

• Please see HIM Regulatory Audit guide

• Review the SOP – PM 13 Research Study Monitoring and Audit Visits

• Please email your PSO person with date so they can update the reg binder

• Notify the CCR Office of the Clinical Director – email - NCI_CCR_QA

• Send Audit scheduling form with CV

• Send email to Schaun to confirm pharmacy visit

• Send audit records request

• Put reg binder on Thumb drive

• Bring reg binder and patient files to monitor

• Pick up files from Med Legal when completed

 Peraton

•  CCR protocols
• 6 mos or more often
• Monitor sets up space in Med Rec
• You need to set up pharmacy visit and notify  the CCR Office of the Clinical Director – email - NCI_CCR_QA
• They have been granted access to the shared drive and so we no longer need to take down a thumb drive – N. Grant email 7/24

 Theradex

•  2 types  - every 3 years or Feb/June and Oct
• Deb Grady sets up space and pharmacy and gets space for exit interview
• You need to send the Audit record request form to MR please cc Deb Grady – this need to be in Medical records the Wed before the audit so CRIS access can be granted.
• Email the CC-HIMD Regulatory Audits mailbox
• Needs to meet with PI in Oct

 Pharma

•  Need to set up monitoring visits with MR – confirm space
• Send the Regulatory Audit Scheduling form along with CV to MR
• Email the CC-HIMD Regulatory Audits mailbox
• You need to send the Audit record request form to MR – this needs to be in Medical records the Wed before the audit so access to patients in CRIS can be granted
• Set up pharmacy visit
• Currently email Schaun Norman
• Will usually want to meet with PI each visit

 Pre audit records

•  Pull all AE report and con med report
• Look at source documents
• Look at consent
• Look at eligibility check list – print a blank one and do it again – was it correct the first time

 New monitor – bathrooms – cafeteria etc

 Wrap up

 Monitoring/Audits visits are a good way to learn where the holes are?

 Check out Liz’s Clinical Trials orientation module at the Clinical Research Operations website -  https://ccrod.cancer.gov/confluence/display/CCRCRO/Monitoring+and+Auditing+in+Clinical+Trials

 Check out the FDA guidance – A Risk-Based Approach to Monitoring “Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high-quality studies”