dbranuthscedu Margaret mlynnuthscedu httpstnctsiuthscedutrainingandeducationseminarsandworkshopstnctsicertificationexampreparationcourse HandoutReference sheet ICH GCP Principles ID: 1043784
Download Presentation The PPT/PDF document "Session 4: ICH GCP Derita:" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1.
2. Session 4: ICH GCPDerita: dbran@uthsc.eduMargaret: mlynn@uthsc.eduhttps://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/
3. Handout/Reference sheet:ICH GCP PrinciplesWorksheets:ICH GCP E6 (R2) ICH GCP E6 (R2) section 4Webinar to review: Research 101, session 3
4. What is GCP? GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies
5. Who is Responsible?
6. ICH GCPs
7. Consists of E1-E20ICH GCPs
8.
9.
10. ICH GCP E8
11. ICH GCP E8 Sections
12.
13.
14. ICH GCP E6 (R2)
15. ICH GCP E6 (R2)
16. ICH GCP E6 (R2) Sections
17. ICH GCP E6 (R2): Section 1Glossary65 terms and definitions
18. Principles of ICH GCPICH GCP E6 (R2): Section 2
19. 13 Principles of ICH GCPs
20. 13 Principles of ICH GCPs cont’d
21. Sections 3-5Section 3: IRB/IECSection 4: InvestigatorSection 5: Sponsor
22. IRB/IECICH GCP E6 (R2): Section 3
23. Section 3: IRB/IEC
24. Section 3: IRB/IEC
25. InvestigatorICH GCP E6 (R2): Section 4
26. Section 4: InvestigatorThe investigator should be : qualified by education, training, and experience to assume responsibility for the proper conduct of the trialthoroughly familiar with the appropriate use of the investigational product(s)aware of, and should comply with, GCP and the applicable regulatory requirementswilling to permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies)maintaining a list of appropriately qualifies persons to whom the investigator has delegated significant trial-related duties
27. Section 4: InvestigatorThe investigator should be responsible for:all trial-related medical decisionscommunication with the IRB/IECcompliance with the protocolaccountability for IPinformed consent of the trial subjectsrecords and reportspremature termination or suspension of a trial
28. SponsorICH GCP E6 (R2): Section 5
29. Section 5: SponsorThe sponsor should be responsible for:quality managementquality assurance and quality controlcontract research organizationmedical expertisetrial designtrial management, date handling, and recordkeepinginvestigator selectionallocation of responsibilitiescompensation to subjects and investigators
30. Section 5: SponsorThe sponsor should be responsible for:investigator selectionallocation of responsibilitiescompensation to subjects and investigatorsinformation on the IPmanufacturing, packaging, labeling, and coding IPsupplying and handling IPrecord accesssafety information
31. Section 5: SponsorThe sponsor should be responsible for:adverse drug reaction reportingmonitoringauditingnon-compliancepremature termination or suspension of a trialclinical trial/study reportsmulticenter trials
32. Clinical Trial Protocol and Protocol Amendment(s)ICH GCP E6 (R2): Section 6
33. General informationBackground informationTrial objectives and purposeTrial designsSelection and withdrawal of subjectsTreatment of subjectsAssessment of efficacyAssessment of safety and statisticsDirect access to source data and documentsQuality control and quality assuranceEthicsData handling and record keepingFinancing and insurancePublication policy
34. Investigator’s BrochureICH GCP E6 (R2): Section 7
35. IntroductionContentsICH GCP E6 (R2): Section 7
36. Essential DocumentsICH GCP E6 (R2): Section 8
37. What Can We Do To Help Ensure Compliance?
38.
39. The questions for this session are asked in accordance to the ICH GCP E6 (R2) guidance
40. Which of the following should be included in the Informed Consent?A. The trial involves researchB. Probability for random assignment to each treatmentC. Study proceduresD. Anticipated expenses to the subject for participationE. Subject’s responsibilities
41. Which of the following are included in the Informed Consent?A. Any foreseeable risksB. Any benefitsC. Any alternative procedures/treatmentsD. Compensation for injury E Demographics of the patients
42. Which documents do IRBs/IECs need to obtain prior to the study beginning?ProtocolInformed Consent formSubject recruitment materialsCase report formsInvestigational BrochureSafety informationInvestigator’s qualification (CV)
43. How long must an IRB/IEC retain records for each research project?A. Two yearsB. Three yearsC. Four yearsD. Indefinitely
44. The investigator should promptly report which of the following?A. Deviations from the protocol to prevent immediate harmB. Serious/unexpected adverse drug reactionsC. Revisions to the protocolD. All serious adverse events
45. Essential documents should be retained untilA. At least 2 years after the last approval of a marketing application in an ICH regionB. There are no pending or contemplated marketing applications in an ICH regionC. At least 2 years have lapsed since the formal discontinuation of clinical development of an IPD. Longer than 2 years if required by the applicable regulatory requirements or by an agreement with the sponsor
46. ICH GCP guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization.True False
47. The sponsor is responsible for the providing written procedures for handling and storage of the investigational product for the trial and documentation of receipt, handling, storage, dispensing, retrieval, etc.TrueFalse