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

2. 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

4. 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

5. Principal Investigators Pay Attention, because….

6. 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

7. The Best Way to Handle Research Mistakes is to Avoid Them

8. 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

9. 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 all IRB Meetings
Have an FDA audit! Treat every study like it will have an FDA audit

10. 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

11. 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

12. 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- 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

13. 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

14. 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.

15. Thank You for Your Attention!