Study Monitoring: What Does It Mean & How To Do It Right

1. Study Monitoring: What Does It Mean & How To Do It Right Partners Human Research Quality Improvement Program QUICK BITE Series December 9, 2004

2. Regardless Of Funding . . .They All Agree All clinical trials should have a system in place for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. NIH Guidelines:

3. Regardless Of Funding . . .They All Agree FDA: Proper monitoring is necessary to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data.

4. Regardless Of Funding . . .They All Agree ICH Good Clinical Practice (GCP): The purpose of trial monitoring is to verify that the rights and well-being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents; the conduct of the trial is in compliance with the currently approved protocol, with GCP and with applicable regulatory requirements.

5. What Is Study Monitoring? Study monitoring is the act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded and reported in accordance with the protocol, standard operating procedures, GCP and applicable regulatory requirement(s). (ICH GCP 1.38)

6. Why Must It Be Done? Proper Monitoring is necessary to assure: • Adequate protection of research participants • Accurate, complete & verifiable study data • Compliance with the approved protocol and . . .

7. Study Monitoring Will Keep You Out Of Trouble ! Don’t Drop The Ball!

8. Common Findings • Informed Consent: • “You did not ensure subjects dated their signature on the consent form” • Protocol Deviations: • “Numerous assessments were not completed as required by the protocol” • Study Records: • “The CRF contained blank fields” • IRB Approval: • “You failed to obtain IRB approval for media ads . . .”

9. How Can It Be Done? • Detailed monitoring plan should be included in the protocol • The extent and nature of study monitoring depends on the size and complexity of the study

10. The Monitoring Plan Monitoring plans should answer the following questions: • Who is responsible for study monitoring? • How often will monitoring occur? • What types of monitoring will be utilized? • What will the monitoring activity look for? • What tools will the monitor use? • What are the procedures for reporting • deficiencies? • How will monitoring be documented ?

11. Who Is Responsible For Study Monitoring? The PI is ultimately responsible for the conduct of the study and must support all monitoring activity!

12. Who Can Be A Monitor? • Principal Investigator • Sponsor Monitor • Qualified and trained study staff • Qualified individuals not directly involved in the study (e.g. The QI Program) • Data Safety Monitoring Board (DSMB)

13. How Often Will Monitoring Occur? • Depends on the nature of the study • Things to consider: • subject accrual rates • frequency of visits • adverse events • level of risk • amount of data collected

14. What Types Of Monitoring Can Be Utilized? • On-site monitoring PI/study staff (includes everyday activities) • On-site monitoring by an external party (e.g. sponsor monitor) • On-line/on-site monitoring by the QI Program • Self-assessment • Regularly scheduled staff meetings

15. What Will The Monitoring Activity Look For? • Adherence to approved protocol (including visit schedules) • Adverse event reporting/management • Drug/device accountability • Complete documentation • (IRB & Regulatory)

16. What Will The Monitoring Activity Look For? • Accurate and complete study records (case report forms (CRFs)/data • collection verification) • Appropriate documentation and quality of the consent process • Site issue resolution • (e.g. violations and deviations)

17. Types Of Monitoring: Documentation • Everyday activities = e-mails/log • External party = monitor report/queries • QI Program = reports • Self-assessment = checklist* • Regularly scheduled staff meetings = minutes • DSMB= reports • *example of a monitoring tool

18. Benefits Of Effective Study Monitoring • Continuing education & quality improvement • New & improved methods for recruitment, data collection, storage, etc. • Peace of mind • Preparation for an unexpected audit • Opportunity to complete missing data/clarify discrepancies while subject is still involved

19. QI Program Monitoring Services This service is available to those who are interested. Utilizing QI program for monitoring is an option. • Prioritize: • PI held IND/IDE • Department funded • External funding without external monitoring • Assistance with developing tools for data collection, monitoring, etc. • Onsite/Online monitoring

20. Spring, 2005 QI Program Online Monitoring System (OMS)

21. Why Use the QI Online Monitoring System (OMS)? • Flexibility - partial (monitor certain portions of study) vs. comprehensive monitoring • Provides for timely issue/query resolution • Minimizes on-site monitoring time • Ability to export data to Excel

22. What is the OMS? • Web based monitoring application • Study specific application set-up

23. OMS, how do we get started? • Preliminary consultation • Develop monitoring plan • Study set-up in OMS (eCRF) • Site staff training • Technical support • Demo

24. When in Doubt . . . Contact: The QI Program http://www.partners.org/phsqi/ 617-424-4135