Critical Processes, Critical Data... Critical Thinking
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It's all about critical thinking. To fully manage risk, risk-based organizations need to develop an approach that supports critical thinking. This slide deck is dedicated to the fundamental Critical Processes & Critical Data knowledge every risk-oriented clinical expert must have.
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Critical Processes, Critical Data... Critical Thinking
- 1. MYRBMQ® Academy Critical Processes Critical Data = Critical Thinking
- 3. © 2021 CYNTEGRITY Agenda: • Focus of the Webinar • What does “Critical” mean? • How to Assess Critical Processes? • How to Identify Critical Data & Processes? • Examples
- 4. ICH GCP E6 (Section 5) Focus of our Webinar © 2021 CYNTEGRITY
- 5. RISK ASSESSMENT RISK MITIGATION & CONTROL ISSUE MANAGEMENT Gather data for risk identification Assess study to identify risks Quantify risks Take actions to reduce risks Define KRIs & set tolerance limits Develop issue mitigation plans Monitor KRIs for issues Manage events / conditions Critical Processes / Critical Data Archive risk management results Risk communication Metric results Lessons learned RISK HISTORY RISK-BASED QUALITY MANAGEMENT SYSTEM Focus of our Webinar © 2021 CYNTEGRITY
- 6. IDENTIFY WHAT’S CRITICAL CRITICAL PROCESSES & CRITICAL DATA 6 © 2021 CYNTEGRITY
- 7. 7 © 2021 CYNTEGRITY WHY IS IT VITAL TO KNOW THE CRITICALITY? ▪ A human body carries 78 vital organs ▪ However, only 7 major organs are critical to life Btw, we still carry “vestigial” organs, which are no longer vital to us. CRITICAL = WHAT MATTERS FOR SUCCESS
- 8. 8 © 2021 CYNTEGRITY WHERE TO START?
- 9. 9 CRITICAL PROCESSES CRITICAL DATA ▪ Underpin data quality ▪ Underpin subject safety ▪ Support ethical and GCP compliance IDENTIFICATION OF CRITICAL PROCESSES & DATA ▪ Crucial for subject safety ▪ Ensure primary and key secondary objectives ▪ Support decision making about efficacy of the IP © 2021 CYNTEGRITY
- 10. 10 TO KEEP IN MIND Identification of CP & CD is the foundation of the Study Monitoring Plan Consideration should be placed on how to monitor key study processes (centrally, on-site/off-site) Key to a study specific SDV/SDR plan IDENTIFICATION OF CRITICAL PROCESSES & DATA © 2021 CYNTEGRITY
- 11. DEFINE PROCESS CRITICALITY CRITICAL PROCESSES & CRITICAL DATA 11 © 2021 CYNTEGRITY
- 12. How to define process criticality? 12 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems
- 13. How to define process criticality? 13 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Only once a final version of a CRF / eCRF has been developed and validated, the first subject can be enrolled.
- 14. How to define process criticality? 14 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Data entry by site staff into the appropriate CRF / eCRF must be performed shortly after data had been generated. Preferably, the data entry timelines are being specified in the contract between sponsor and site. The entry is in particularly important for cases with serious adverse events.
- 15. How to define process criticality? 15 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Queries generated by the EDC system, by a monitor or by anybody else from the sponsor company must be responded to in a timely fashion. This is in particularly true for queries related to serious adverse event data.
- 16. How to define process criticality? 16 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Sites and sponsors must ensure a complete drug accountability, i.e., sites received drug, passed the drug to the subject or administered it to the subject, documented their actions and eventually, returned all unused drug to the sponsor company.
- 17. How to define process criticality? 17 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems For each subject, an informed consent must be captured prior to any study related activities. For minors, informed consent by a legal guardian must be obtained.
- 18. How to define process criticality? 18 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Enrolled subjects have to meet all in- and exclusion criteria as specified in the protocol. Preferably no exceptions must be made with respect to the criteria when enrolling a subject.
- 19. How to define process criticality? 19 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A focus must be put on the endpoint data and their accuracy. These data must be as complete as possible. For the most part, these data also need a 100% SDV.
- 20. How to define process criticality? 20 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems In randomized studies, the randomization must be conducted as planned, i.e., subjects allocated to the appropriate random number and given the drug as specified. The randomization may be facilitated by an IVRS / IXRS.
- 21. How to define process criticality? 21 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems It is important for the overall study management to know at every point in time how many subjects are currently in screening and how many subjects had already been randomized and how many dropped out. For some studies number of valid subjects may also be important to know. This is critical for study completion and avoidance of over-enrollment.
- 22. How to define process criticality? 22 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A particular focus must be put on subjects who withdrew their informed consent, dropped out due to adverse events or serious adverse events and those lost to follow up. Every effort must be made to get a complete picture of the reasons and the well-being of the subjects after withdrawal.
- 23. How to define process criticality? 23 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A final, signed off statistical analysis plan must be in place prior to the declaration of the clean database.
- 24. How to define process criticality? 24 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A target project profile for a new compound needs to be set up as the basis for the operational project and study planning
- 25. How to define process criticality? 25 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Adherence to the monitoring plan is crucial and monitoring reports must be reviewed on an ongoing basis at the sponsor company. The volume / data items checked / frequency of on- site monitoring must be checked and documented.
- 26. How to define process criticality? 26 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A target product profile (TPP) for a new compound / medical device needs to be set up as the basis for the operational project and study planning. Critical processes and critical data may already be developed as part of the TPP
- 27. How to define process criticality? 27 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems A clear-cut process must be in place for the management of interim analyses and the expectation of the cleanliness of the data. This also includes the process for data entry at site during the data cleaning for the interim analysis.
- 28. How to define process criticality? 28 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Project (or therapeutic area) planning of templates for protocol and CRF need to be planned and developed. A standard CRF and database structure is of utmost importance for the delivery of a Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) at the end of a successful drug development
- 29. How to define process criticality? 29 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Sites must be identified and judged to be ready for study participation. Steps can be taken already prior to site initiation to check the availability of potential patients via a review of the Electronic Healthcare Records at the sites.
- 30. How to define process criticality? 30 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Like randomization, a stratification of subjects according to pre-specified criteria needs to be adhered to and adherence checked carefully.
- 31. How to define process criticality? 31 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems For some therapeutic areas, an information on whether a subject is valid or not for the statistical analysis, is required. Validity determinations must be made on an ongoing basis in order to have a complete picture of subject validity in a study.
- 32. How to define process criticality? 32 © 2021 CYNTEGRITY Data Integrity CRF Development Data Entry Query Response Patient Rights & Safety Drug Accountability Informed Consent Eligibility Endpoints Randomization Subject Enrolment Withdrawals Project Success & Compliance Signatures Project Planning Monitoring Protocol Development Interim Analysis Standards Planning Study Sites Identification Stratification Validity Determination Systems Critical systems must be in place for managing the studies, such as Clinical Trials Management System, EDC, Pharmacovigilance system. Preferably, these systems have interfaces that 'talk' to each other in order to avoid error-prone manual interventions
- 33. Risk Assessment Mitigation Action Key Risk Indicator Issue Root Cause Corrective & Preventive Action TRACEABILITY Linkage between ALL Risk entities is the key for future analysis © 2020 CYNTEGRITY – CONFIDENTIAL & PROPRIETARY 33 A CP & CD
- 34. 34 © 2021 CYNTEGRITY Source: https://link.springer.com/article/10.1007/s43441-020-00207-2
- 35. Lean risk-based data analytics ➔ MyRBQM® Portal allows all data to remain in the eClinical systems (EDC, CTMS, eCOA, Lab, IRT, etc.) maintaining the “single source of truth” principle. 35 © 2021 CYNTEGRITY
- 36. 36 © 2021 CYNTEGRITY Artem Andrianov, PhD Managing Director Cyntegrity Germany
- 37. 37 © 2021 CYNTEGRITY Contact information: post@cyntegrity.com fatemeh.sharifpanah@cyntegrity.com
- 38. 38 © 2021 CYNTEGRITY by MyRBQM® Academy 100% online | self-paced | 30-day money back guarantee Learn more here… The RBQM Essentials White Belt course is dedicated to the fundamental RBQM knowledge every risk-oriented clinical expert must have.