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Quality Management Workshop August 2012 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National.

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Presentation on theme: "Quality Management Workshop August 2012 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National."— Presentation transcript:

1 Quality Management Workshop August 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. HHSN C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS).

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

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 3

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

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 5

6 Quality Management Workshop 6

7  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 Objectives 7

8  DAIDS Learning Management System (DLMS): https://daidslms.plateau.com/learning/user/login.do 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 PoliciesDAIDS Clinical Research Policies  CQMP Annual Summary ReportCQMP Annual Summary Report Additional QM Resources 8

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? A.Developed corrective action plans to address the monitoring findings B.Submitted the SMR to the Institutional Review Board/Ethics Committee (IRB/EC) C.Filed the SMR in the regulatory files 9

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

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

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

13 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. A.Yes B.No 13 Pre-Assessment Question #5

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

15 work Your Mission… 15

16 Quality Management Workshop 16

17 17 Quality Management Activities Quality Management Quality Control Quality Assurance

18 Example: Verification that all headers, required fields, and dates are completed correctly on case report forms (CRFs) prior to data entry. Example: Verification that all headers, required fields, and dates are completed correctly on case report forms (CRFs) prior to data entry. 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. Quality Control 18

19 Example: Staff may evaluate key elements of source documentation and compare them to completed CRFs for agreement on a weekly basis. Example: Staff may evaluate key elements of source documentation and compare them to completed CRFs for agreement on a weekly basis. 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. Quality Assurance 19

20  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  CQMP Clinical Site or Screen Shot CQMP Clinical SiteScreen Shot Clinical Quality Management Plan (CQMP) 20

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

22 22 Quality Roles and Responsibilities

23 Develop and Implement a CQMP 23

24  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 CQMP Documentation 24

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

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

27 Key Indicators Activity 1 27

28  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 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. Scenario 28 Key Indicators (cont’d)

29 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 Group Discussion 29

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

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

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

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

34 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 Create Your Own Tools 34

35 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 Tools 35

36 36 Sponsor Clinical Site Oversight Clinical Site Monitoring Regulatory Affairs Protocol Registration Safety Reporting Statistical and Data Management Edit checks, queries, delinquency reports Pharmaceutical Affairs Clinical Research Product Management Sponsor Quality Oversight

37 work Your Mission… 37

38 Quality Management Workshop

39 Quality Control and Assurance 39 Activity 2

40 1.Review the scenario 2.Review the documents included in the scenario packet for issues 3.Complete the Issue/Trend Worksheet for each issue/trend identified 4.Worksheets are labeled for Quality Control and Quality Assurance 40 Quality Control and Assurance Activity

41 Documents You Need For This Activity 41  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) 42  Clinical Laboratory Report PID  Clinical Laboratory Report PID  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) 43  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 Reagan’s Research Clinic is located at: Capitol Hill Boulevard Durban, KwaZulu-Natal 44 The Research Team InvestigatorDr. Dominick Reagan Sub-InvestigatorDr. Phillip Dole Study CoordinatorCecilia Cooper PharmacistOlivia Seagull CounselorKevin Jones Quality Control and Assurance Scenario

45 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. (cont’d) 45 Quality Control and Assurance Scenario

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

47 Quality Control and Assurance Activity FEEDBACK 47

48 Quality Control and Assurance 48 Activity 3

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

50  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 Next Monitoring Visit: October 50 What Can You Do?

51  Why is it important to note issues/trends?  What can happen if these issues are left unresolved?  What do these issues mean at the site?  What are your practices on site when you identify an issue? 51 Next Monitoring Visit: October (cont’d)

52 Quality Control and Assurance FEEDBACK 52

53 53 PID(s) Visit Code Observation Date Obse rvatio n Code Observation Description M0430/Sep/2010A23 Missed Visit Adequate Source Documentation: The study participant did not return to the research clinic for their scheduled M04 study visit. The subject took a holiday and was away during the visit window M0530/Sep/2010A17 Transcription Error: The following laboratory values were not transcribed from the source to the CRF: Sodium, Total Bilirubin, ALT (SGPT) and AST (SGOT) M0530/Sep/2010A72 Procedural Inadequate Source Documentation: The fax copy of the chemistry laboratory results was not certified per the DAIDS Source Documentation requirements by the research clinician who received the document. * M0401/Oct/2010A17 Transcription Error: The participant’s systolic blood pressure reading was incorrectly transcribed from the source to the CRF. * M0501/Oct/2010A23 Missed Visit Adequate Source Documentation: The study participant did not return to the research clinic for her scheduled M05 study visit. The study coordinator contacted the participant on the following dates without success: 16/Sep/2010, 21/Sep/2010, 23/Sep/2010, 27/Sep/2010, 28/Sep/2010 and 29/Sep/2010. The participant’s visit was scheduled to occur 13/Sep/2010. Messages were left on the participant’s voic to contact the clinician to reschedule the study visit before the protocol window closed. The window closed and the site still had not heard from the participant M0028/Sep/2010A1A Informed Consent Violation Level 1: Pages 5 and 6 were missing from the Enrollment Informed Consent Form, V1.0, dated 02/Nov/2009, signed on 07/Sep/2010. Action was corrected during the monitoring visit M0028/Sep/2010A17 Transcription Error: The participant’s year of birth is incorrectly transcribed from the Demographic source document to the Demographic CRF. Action was corrected by the research clinician during the monitoring visit M0128/Sep/2010A72 Procedural Inadequate Source Documentation: Unable to verify in source documents the pregnancy test results entered on the CRF. Missed Visit Adequate Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? Missed Visit Adequate Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A72: Inadequate Source Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A72: Inadequate Source Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A17: Inadequate Source Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A17: Inadequate Source Documentation Is it a trend? What could happen if this finding left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A1A: Inadequate Source Documentation Is it a trend? What can happen if this finding is left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue? A1A: Inadequate Source Documentation Is it a trend? What can happen if this finding is left unresolved? What does this finding mean for the site? What are your practices on site when you identify an issue?

54 Quality Management Workshop

55 55 Corrective Action Preventive Action CA PA CAPA Corrective and Preventive Action (CAPA)

56 Process of identifying the root cause of a problem, nonconformity, or undesirable situation. The root cause is the most basic reason for the effect, which if eliminated or corrected, can prevent the event from existing or reoccurring. 56 Corrective and Preventive Action (CAPA)

57 Develop CAPA Plans  Perform root cause analysis  Identify and implement corrective actions  Propose and implement preventive actions  Continue measuring performance at established intervals  Compile and report performance measurements within the team Corrective and Preventive Action Plans 57

58 58 Activity 4 Corrective and Preventive Action (CAPA) Root Cause Analysis

59 Document You Need For This Activity 59  Root Cause Analysis Worksheet

60 Using the trends identified, complete the root cause analysis worksheet. Root Cause Analysis 60 Corrective and Preventive Action (CAPA) 60

61 61 Root Cause Analysis Feedback Session

62 62 Activity 5 Corrective and Preventive Action (CAPA) Developing a CAPA Plan

63  Using the CAPA Worksheet, develop a CAPA Plan using your noted trends  Be prepared to discuss this as a group Develop a CAPA Plan 63 Corrective and Preventive Action (CAPA)

64 64 Root Cause Analysis Feedback Session Proposed Corrective Action: Who is involved in this Corrective Action? What resources are needed to complete this Corrective Action? What is the timeline for completing this Corrective Action? How will the effectiveness of this Corrective Action be measured? What other areas could this Corrective Action impact? What are the risks and benefits for implementing the proposed Corrective Action to the affected areas? What strategies could you employ to minimize risks to the affected areas?

65 65 Proposed Preventive Action: Who is involved in this Preventive Action? What resources are needed to complete this Preventive Action? What is the timeline for completing this Preventive Action? What are the risks and benefits for implementing the proposed Preventive Action to the affected areas? What strategies could you employ to minimize risks to the affected areas? Root Cause Analysis Feedback Session

66 66 Activity 6 Corrective and Preventive Action (CAPA) Implementation

67 Document You Need For This Activity 67  CAPA Worksheet

68  Using the Implementation Plan Worksheet, develop an Implementation Plan for your CAPA  Outline roles and responsibilities at the site Implementation Plan Worksheet 68 Corrective and Preventive Action (CAPA)

69 CAPAHow you will accomplish this? 69 Corrective and Preventive Action (CAPA) Implementation Plan Feedback Session

70 Quality Management Workshop

71  Proactively review your CQMP to assess the effectiveness of your current plan  Make sure it adequately reflects all necessary QM activities  Review your CQMP after a monitoring visit to determine if changes need to be made to the CQMP to address recent findings Reminder: CQMP Review 71

72  Become a change agent  Motivate site staff to implement the change  Communicate the change effectively  Ensure you have stakeholder buy-in  Allow for adequate time to implement the change  Recognize site/staff improvements  Maintain realistic expectations 72 What Can You Do?

73 73 Activity 7 CQMP Review

74 Documents You Need For This Activity 74  Clinical Quality Management Plan (CQMP)  Clinical Quality Management Plan Summary Report

75  Review the completed sample CQMP  Update the plan to reflect corrective actions determined in the CAPA Plan Activity: Update CQMP 75

76  Required annual review and submission of Annual Summary Report  Submit CQMP to Program Officer on an annual basis, if there have been any changes  Program Officers may ask to review plan based on findings at the site CQMP Annual Summary Report CQMP Evaluation and Reporting – Be Ready! 76

77 Basic and ongoing training:  Provide and reinforce rationale for quality  Protect the safety, welfare, privacy and confidentiality of research participants  Generate complete, accurate and timely data to promote the safety of research participants and future consumers  Establish efficient and streamlined processes  Document and train on work processes  Evaluate and revise processes as needed Implement a Quality Management Culture 77

78 Build QC steps into processes  Promote rapid, self- identification and correction of errors Perform root cause analysis activities Engage Team Members in CQMP Processes 78  Applicable team members to gather input  Share perspectives in an open (non-blaming) manner Share results of QA activities  Acknowledge and celebrate performance improvements

79 ALCOA 79

80  “If it isn’t written down, it didn’t happen”  Good documentation practices:  Use pens. No pencils! No white out!  Sign, credential and date  Follow ALCOA standards  Train staff on DAIDS source documentation requirements  Build internal review and feedback of source documentation practices into CQMP Enforce Excellence in Source Documentation 80

81  Discuss source documentation at your CRS  Identify methods used to ensure clinic notes are: Activity – ALCOA Practices 81  Share your best practices and lessons learned! AttributableLegibleContemporaneousOriginalAccurate

82 Staff has clear understanding of roles and responsibilities Promotes an integrated Quality Management Program Increases efficiencies and decreases redundancy Increases teamwork, establishes common goals, promotes staff unity Creates a positive quality culture Benefits Communication Pathways 82

83 work Remember your mission… 83

84 Quality Management Workshop

85  Differentiate between QA and QC  Discuss the roles and responsibilities associated with maintaining a quality program at the site  Apply the DAIDS Clinical Quality Management Plan Policy for the development, implementation, evaluation, and adaptability of a site CQMP  Determine corrective and preventive actions based on scenarios of common findings  Discuss clinical site monitoring and how monitoring and data management queries can influence quality at the site  Discuss methods to implement a Quality Management culture at the site Summary 85

86  DAIDS Learning Management System (DLMS): https://daidslms.plateau.com/learning/user/login.do 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 PoliciesDAIDS Clinical Research Policies  CQMP Annual Summary ReportCQMP Annual Summary Report Remember Your Additional QM Resources 86

87 The clinical site has had three site monitoring visits since the first subject has enrolled in the study. Each subsequent site monitoring visit report has reflected a 50% decrease in site issues and trends. The site diligently reviews their site monitoring report (SMR)to clearly identify the issues listed and adjust their 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 audit findings and data management queries? A.Developed corrective action plans to address the audit findings B.Submitted the site monitoring report to the Institutional Review Board/Ethics Committee (IRB/EC) C.Filed the site monitoring report in the regulatory files Post-Assessment Question #1 87

88 Once a CQMP is developed, how often should the Plan be reviewed? A.Every two years B.Annually C.Per policy Post-Assessment Question #2 88

89 Which of the following individuals is ultimately responsible for the quality management activities at a research site? A.The Investigator B.The Study Coordinator C.The Pharmacist D.The Research Participant Post-Assessment Question #3 89

90 Which quality management activity is conducted in real- time? A.Quality control B.Quality assurance Post-Assessment Question #4 90

91 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. A.Yes B.No Post-Assessment Question #5 91

92 What actions can site staff take to implement a quality management culture at their site? A.Identify a Quality Manager who is responsible for monitoring and addressing trends identified in site monitoring reports B.Create a site CAPA plan C.Engage stakeholders in implementing the site’s CAPA D.All of the above Post - Assessment Question #6 92

93 Quality Management Workshop THANK YOU

94 94 Return to Slide

95 95 Return to Slide

96 96 Return


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