The Principal Investigator Role: How to Avoid Conflicts with the Research Coordinator Giora Weisz, MD Director of Cardiovascular Clinical Research, Center for Interventional Vascular Therapy Columbia University Medical Center Cardiovascular Research Foundation New York, NY

Giora Weisz, MD Tryton Medical, Inc. Consulting: InfraReDx, Inc. Svelte Therapeutics Philips Medical Systems, Inc. Stocks, Stock Options, other ownership interest: Simbionix Bloxr Sync-RX

Columbia University Medical Center Center for Interventional Vascular Therapy My Dream Team Thank You!

Who are the research coordinators? The people that make clinical research happen! Screen for eligible patients, follow the procedure, fill the CRF, answer to queries, and take the hit from the monitor Enthusiastic workers the PI hire to help him

Who are the research coordinators? People that make career in research Nurses with many years in clinical experience Post college, pre-medical school

Not in front of the patients, please

Who are the PIs? Interventional cardiologists Interested in research, new echnology / pharma Busy, busy, busy Want to be the No. 1 enroller in the world “Publish or perish”

The Managerial Balance

Communication

9/3/2018 Case Study 1 There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC emails requesting an appointment to complete. You: TCT 2008 - DRAFT

9/3/2018 Case Study 1 There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC emails requesting an appointment to complete. You: Do not respond to the email TCT 2008 - DRAFT

9/3/2018 Case Study 1 There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC emails requesting an appointment to complete. You: Do not respond to the email Respond to catch you between cases in the cath lab. When the RC shows up make them wait for hours TCT 2008 - DRAFT

Case Study 1 9/3/2018 There is a data deadlock tomorrow with missing data that needs to be addressed by the PI. The RC emails requesting an appointment to complete. You: Dr A did not respond to the email Dr B asked to catch you between cases in the cath lab. When the RC shows up make them wait for hours Dr Weisz scheduled a one-on-one meeting to complete together and sign any pending items Obviously C is the correct answer but A and B happen frequently and lead to disgruntled employees, poor data quality, etc. TCT 2008 - DRAFT

Case Study 2 The RC receives a telephone call about a critical lab value (CK-MB >3x ULN) and emails you to notify and receive instructions on how to proceed.

Case Study 2 Scenario A: PI unresponsive to initial email 9/3/2018 Case Study 2 Scenario A: PI unresponsive to initial email After the 2nd follow up email the PI responds with “ok” and no plan of action Requests the RC contact the patient The late documentation is flagged during a monitoring visit and the PI claims no knowledge of the event The RC is looking for a new job RC does not have a medical license so should not discuss implications of clinical information TCT 2008 - DRAFT

Case Study 2 Scenario B: PI reviews most recent ECG and previous labs (if available) Further review of medical record if necessary Calls patient to inform them and provides a follow up plan Documents steps for source The RC adores the PI, and swear to be on his side until his last day

Top 10 Ways to Avoid Conflict 9/3/2018 Top 10 Ways to Avoid Conflict Stay in constant/good communication Create a team atmosphere Daily oversight Allow for independence of the RC Give credit where credit is due 1-be aware of data deadlines, outstanding action items, troubles with recruitment and retention 2-involve the RCs in the decision making which makes them feel invested in the project. Our RCs recently expressed interest in the budget process so we started incorporating them 5-when possible include the RC as authors on papers TCT 2008 - DRAFT

Top 10 Continued… Encourage career development 9/3/2018 Top 10 Continued… Encourage career development Address issues immediately and without emotion Set an example Positive reinforcement Have a sense of humor 6- Many RCs are using the job as a stepping stone between undergrad and medical/PA school. Therefore RCs appreciated training sessions and grand rounds. Help write letters of recommendations. You can also mention that we do quarterly outings TCT 2008 - DRAFT

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