6 Steps 70:20:10

Issue

Background work

• Protocol
• Monitoring history
• TMP
• SIV report
• TMP

Kick Off Meeting

• CSM; CSS
• Aim to define/quantify
• SAEs; AESI; SUSAR

Untitled Slide

Untitled Slide

Initial RCA

• PI oversight
• Site resource
• Monitoring changes/resource
• Protocol lack of clarity
• Site initiation (legacy GMA)

Output of KO

• Web ex with ICTM to understand protocol - flag as potential wider issue (Challenge)
• Discussions with Quintiles to increase monitoring and have an experienced monitor to correct at site
• Visit to site to get PI buy in to reconcile (challenge)

Impact

• Other sites? No indicators. However monitors trained and to conduct a deeper dive.
• Patient safety? No
• Other studies? Challenge! NHS EHR and resource. There are signals. RISK.......

RISK - Challenge

• Frequency of studies under reporting - how we have oversight, how do we measure
• Likelihood happening again
• Raised to APT Manager
• FiTA checks for high risk studies

Contain

• Halt Rx
• Inform SSU/TRMs
• Inform site/R&D

Corrective

• SDA with site to map all source
• 100% retrospective monitoring on safety
• AE Log for PI sign off review

Preventative

• Monitor training - study level
• Monitor training/local SOP (challenge)
• Consider using this site/team again - SSU workstream on site intelligence - challenge to reject sites
• Work with cCOG - EHRs issue

Outcome

• Reconciliation completed
• Data locked

Done Differently

• Focus more this year on...
• Site intelligence
• Monitor skills in CAPAs
• How we support SMTs
• Work on empowering CSMs/give tools