Essentials of Quality Control D. Chris Metzger, MD, FACC, FSCAI Wellmont CVA Heart Institute Kingsport, TN, USA

D. Christopher Metzger, MD Consulting: Abbott, Cordis, IDEV, Medtronic Hands- On PV and CAS Courses: Abbott, Medtronic National Co-PI: SAPPHIRE WW CAS (Cordis) CEC Committee: Covidien(DEFINITIVE) National PI: CANOPY

Why Quality Control? Good research results come only from quality work It is easy for quality to be less than you assume without quality checks Your site’s reputation (& future invitations) depend on quality work FDA audits come without significant advanced notice

Principal Investigators Pay Attention, because….

Primary Investigators.. PI is Ultimately responsible for the conduct of ALL aspects of the study (no matter who makes the mistake) Essential to take “hands on” approach- take personal responsibility for conduct of your study Educate/train/monitor sub-I’s, RC’s,etc. Meet personally w/ study monitors Learn from mistakes, modify approach

The Best Way to Handle Research Mistakes is to Avoid Them

Ways to Avoid Mistakes Make sure all investigators & RC’s know protocol AND follow it Create enrollment Inc/Exc. List AND Worksheet with all studies/info that will be needed for data entry Have 2 team members confirm I/E & Informed Consent “Reconfirm” consent (ex: day after AMI) Follow Research pt’s until hospital DC, give appt card Have protocol available AND RC present (as possible) for all procedures DOCUMENT, re-document, BE Careful with good Informed Consent (FDA focus!); Keep the ORIGINAL ICF

Avoiding AND Discovering Deviations PI, Research Manager, and Lead RC for study should meet with study monitor! Regular Research Mtgs (monthly) with Investigators and entire Research team Have representative @ all IRB Meetings Have an FDA audit! Treat every study like it will have an FDA audit

Study Monitors They are your allies! They provide quality control & help prepare for FDA Do not be defensive with them Have lead RC prepare for each visit Meet personally with them Review their letter & respond in writing Generate a “to do list” based on their visit/ letter, and sign off on each task

Lead Research Coordinator We have a “Lead RC” for every study Responsible for ensuring data gathered from hospital/procedure, scheduling F/U, seeing F/U pt’s, preparing for monitors, resolving queries,… “Theirs!” Generates worksheets for study Meets w/ PI & Research Mgr. regularly

Mistakes/ Deviations- Now What? Do a timely, meaningful Note to File NTF should include corrective action which is implemented. This is track-able Learn from mistakes- share @ Res. Mtgs. Document & File NTF and corrective plans Report mistakes, AE’s, SAE’s to sponsor and IRB asap (even if late) Meet w noncompliant investigators and RC’s

Other Tips for Maintaining Quality Have all research members undergo Good Clinical Practice training- Docs too! The more training & interaction the better- research meetings, GCP, investigator/RC mtgs, Scientific Mtgs, NIH training, etc. Document this Research Team interactive meetings Use outside Consultants prn for training and site review

CONCLUSIONS Quality research depends on quality work and quality control PI’s should be hand-on leaders Quality control must be an on-going process, and is facilitated by meeting with monitors, regular research team interaction, prospective worksheet approach, trained personnel, and timely corrective action when problems arise.

Thank You for Your Attention!