Quality Management Workshop August 2012

1. Quality ManagementWorkshopAugust 2012 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS).

2. Reminders and Helpful Hints • Review of presentation materials • Please turn off or silence mobile phones • Exits • Restrooms • Assistance

3. Audience Response System (ARS) • Respond to Questions • Change an Answer • Responses are Anonymous • Question cue is a on preceding slide • Ensure remote is on by pressing and holding the “On/Off” button • Please leave remotes on the tables Choose your answer Send or change your answer

4. Audience Response System (cont’d) Good documentation practices include following the principles of: • Electronic Record Management • “ALCOA” • Electronic Signatures Choose your answer Send or change your answer

5. Audience Response System (cont’d) Name one of the words that is applied within the acronym “ALCOA”. Choose your answer Send or change your answer

6. Quality Management Workshop

7. Objectives • Differentiate between Quality Assurance (QA) and Quality Control (QC) • Discuss the roles and responsibilities associated with maintaining a Quality Program at the site • Apply the DAIDS Clinical Quality Management Plan (CQMP) Policy for the development, implementation, evaluation, and adaptability of a site CQMP • Determine corrective and preventive actions (CAPA) based on scenarios of common findings • Discuss clinical site monitoring and how monitoring and data management queries can influence quality at the site • Discuss actions a site can take to implement a quality management culture at the site

8. Additional QM Resources • DAIDS Learning Management System (DLMS): https://daidslms.plateau.com/learning/user/login.do • Orientation to Quality Management eLearning - Course 676 • Quality Management Roles and Responsibilities eLearning - Course 991 • CAPA for Clinical Staff eLearning - Course 950 • CAPA for Laboratory Staff eLearning - Course 990 • CAPA for Pharmacy Staff - Course 970 • CQMP Plan Policy, Session 1 - Webinar • Clinical Quality Management Plans - Policy eLearning • Clinical Quality Management Webinars - Courses 267, 287, and 288 • Clinical Quality Quick Reference Card • DAIDS Clinical Research Policies • CQMP Annual Summary Report

9. Pre-Assessment Question #1 The clinical site has had three site monitoring visits since the first subject enrolled in the study. Each subsequent site monitoring visit report has reflected a 50% decrease in site issues. The site diligently reviews its site monitoring report (SMR) to clearly identify the issues listed and adjust its CQMP accordingly to ensure the amount of queries generated during monitoring visits and by the data management center has significantly decreased. Based on the findings in the SMR what step has the site taken to decrease the number of monitoring findings and data management queries? • Developed corrective action plans to address the monitoring findings • Submitted the SMR to the Institutional Review Board/Ethics Committee (IRB/EC) • Filed the SMRin the regulatory files

10. Pre-Assessment Question #2 Once a CQMP is developed, how often should the Plan be reviewed? • Every two years • Annually • Per policy

11. Pre-Assessment Question #3 Which of the following individuals is ultimately responsible for the quality management activities at a research site? • The Investigator • The Study Coordinator • The Pharmacist • The Research Participant

12. Pre-Assessment Question #4 Which quality management activity is conducted in real-time? • Quality control • Quality assurance

13. Pre-Assessment Question #5 The corrective action component of Corrective and Preventive Action (CAPA) is defined as the action taken to remove or improve a process to prevent potential future occurrences of a nonconformance. • Yes • No

14. Pre-Assessment Question #6 What actions can site staff take to implement a quality management culture at their site? • Identify a Quality Manager who is responsible for monitoring and addressing trends identified in site monitoring reports • Create a site CAPA plan • Engage stakeholders in implementing the site’s CAPA • All of the above

15. Your Mission… work Implement quality

16. Quality Management Workshop

17. Quality Management Activities Quality Management Quality Control Quality Assurance

18. Quality Control Quality Control is the real time, ongoing (day-to-day) operational techniques and activities that are undertaken to verify requirements for quality trial-related activities. Example: Verification that all headers, required fields, and dates are completed correctly on case report forms (CRFs) prior to data entry.

19. Quality Assurance Quality Assurance is a retrospective, objective, systematic, and periodic review of trial-related activities to ensure that the trial is performed and the data are generated, documented and reported in compliance with Good Clinical Practice and any applicable regulatory requirements. Example: Staff may evaluate key elements of source documentation and compare them to completed CRFs for agreement on a weekly basis.

20. Clinical Quality Management Plan (CQMP) • According to the DAIDS Policy on “Requirements for Clinical Quality Management Plans (CQMP)”, all clinical research sites conducting or participating in NIAID DAIDS supported and/or sponsored clinical research must have a CQMP. • CQMP Clinical Site or Screen Shot

21. Why is implementation of a CQMP important? VOICE Enrolled versus Monitored

22. Quality Roles and Responsibilities

23. Develop and Implement a CQMP Collaborate with team members to: • Identify areas of performance to monitor • Identify measurable components to record • Communicate plan • Measure performance at established intervals • Document all CQMP activities • Report performance measurements to appropriate members of the team Celebrate successes!

24. CQMP Documentation • Name of the reviewer • Date of the review • Research participant identification number • Specific items that were reviewed • Time period covered by the review • Findings/results of the review

25. Established measures to determine how well an organization is meeting its regulatory and operational expectations Key Indicators What are Key Indicators?

26. Key Indicators (cont’d) Informed Consent Form and process Concomitant/prohibited medications Eligibility criteria Study product administration/dosing Scheduled tests and procedures Clinical endpoint identification Missed visits, tests, or procedures Identification and reporting of SAEs, EAEs, and AEs

27. Key Indicators Activity 1

28. Scenario Key Indicators (cont’d) • A large Phase IIB randomized trial of a vaccine to prevent HIV-1 acquisition is being conducted at three sites in South Africa. • Sites were selected, in part, for estimated enrollment of 500-750 volunteers per site. • There is a strong interest in this trial within the communities. • A large number of volunteers are illiterate. • Many volunteers may have health issues related to poor nutrition and crowded living conditions.

29. Group Discussion Define Quality Indicators • Name quality performance goals for documenting eligibility. Measure Quality Indicators • Name some measurable indicators for eligibility verification. Process Evaluation and Improvement • Analyze results • Improve processes • Control processes

30. Define Key Indicators Choose one or more quality performance goals for documenting informed consent. 100% of enrolled research participants will have: • Signed/dated informed consent on file • Source documentation in the clinic/medical record • Informed consent obtained prior to collection of any research-specific data • All of the above

31. Measure Key Indicators Choose the measurable indicator(s) for the informed consent process: • The percent of research participants who have signed informed consent • The percent of research participants who have documentation in the clinic/medical record of informed consent process • The percent of research participants who signed informed consent prior to collection of any research-specific data • All of the above

32. Group Discussion: Key Indicators Let’s discuss ideas for evaluating informed consent performance for a site enrolling 500-750 research participants in a Phase IIB/III trial. What would you consider as you develop this aspect of your CQMP?

33. Performance Metrics: Use Available Data Use available data and reports to monitor and measure trends in performance: • Site monitoring reports • Data quality management reports

34. Create Your Own Tools Tracking timelines • Set reminders for EC/IRB due dates: • Protocol continuing review • Record submission dates: • Safety reports to EC/IRB Protocol-specific checklists • Source documentation tools to ensure compliance with: • Informed consent process • Confirming eligibility criteria

35. Tools The CQMP includes tools or checklists to be used in the QA and QC processes. Examples include: • Visit reminder checklist • Data entry reports • Query reports • Error reports • Site monitoring reports • Chart review tools

36. Sponsor Quality Oversight

37. Your Mission… work Implement quality

38. Quality Management Workshop

39. Quality Control and Assurance Activity 2

40. Quality Control and Assurance Activity • Review the scenario • Review the documents included in the scenario packet for issues • Complete the Issue/Trend Worksheet for each issue/trend identified • Worksheets are labeled for Quality Control and Quality Assurance

41. Documents You Need For This Activity • Clinical Quality Management Plan (CQMP) Training Protocol and Site Information – Reagan’s Research Clinic • Protocol Summary • Letter of Amendment March 2010 • Clinical Site Monitoring Group Site Monitoring Report • Protocol MTN-003 Line Check Error Log

42. Documents You Need For This Activity (cont’d) • Clinical Laboratory Report PID 555100101 • Clinical Laboratory Report PID 555100095 • Queries Report • Quality Management Chart Review • Site Investigational Product Accountability Record - Tablets • Site Investigational Product Accountability Record – Tubes

43. Documents You Need For This Activity (cont’d) • Subject I.P Accountability Record – Subject 101 • Subject I.P. Accountability Record – Subject 95 • Subject I.P Accountability Record – Subject 96 • Delegation of Responsibility Log/Signature List • Document to Note Information: • Quality Control (QC) Issue and Trend Worksheet

44. Quality Control and Assurance Scenario Reagan’s Research Clinic is located at: 63847 Capitol Hill Boulevard Durban, KwaZulu-Natal

45. (cont’d) Quality Control and Assurance Scenario The site has had numerous audit findings identified during monitoring visits and during internal quality management review activities over the course of the year. The Investigator is holding a staff meeting to review audit findings from quality management activities over the past year. 

46. Quality Control and Assurance (cont’d) Scenario During the meeting Dr. Reagan has asked all the research team members to review the following documents to identify trends:

47. Quality Control and Assurance Activity FEEDBACK

48. Quality Control and Assurance Activity 3

49. Document You Need For This Activity • Clinical Site Monitoring Group Site Monitoring Report (28-Sep-2010)

50. Next Monitoring Visit: October What Can You Do? • Work with the participants at your table to review the Site Monitoring Visit Report (SMR) • Rank issues/trends according to number of times the issue is found and priority • Identify the trends