WCG ACADEMY™ COURSE OVERVIEW

1 V100615 WCG academy COURSE OVERVIEW Investigator COURSE Title Duration Documentation of Informed Consent Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Ethical Principles Underlying Consent Documentation Long Form Short Form Consent Records Special Considerations o Children (Assent Documentation) o Adults Unable to Consent (Assent Documentation) o Non-English Speaking Adults (Consent Documentation) o Illiterate Subjects (Consent Documentation) COURSE Description: The informed consent process is an integral part of clinical research. In order for research to begin, documentation of a subject s informed consent must be obtained.

2 This COURSE helps explain the documentation needed. 30 minutes Informed Consent Process WCG Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Ethical Principles Underlying Consent General Consent Special Considerations o Children Assent o Parental Permission o Assent of Adults Unable to Consent o Consent of Legally Authorized Representatives COURSE Description: The COURSE introduces the informed consent process and its integral part in clinical research. The informed consent process helps ensure subjects make informed decisions and their continued participation in research. 20 minutes v100615 Investigator Obligations Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Ethical Principles Underlying Investigator Obligations Key Terms Resources Submit and Report Equitable Selection Vulnerable and Special Populations o Children o Pregnant Women and Fetuses o Prisoners o Adults Unable to Consent o Other Vulnerable Populations Additional Obligations COURSE Description: This COURSE describes the responsibilities and obligations of investigators conducting research overseen by an Institutional Review Board (IRB).

3 45 minutes GCP/ICH Obligations of Sponsors, Monitors and investigators (GCP01) This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Obligations of a sponsor in conducting a clinical research programs Responsibilities of a monitor in conducting clinical investigations Obligations of an investigator in conducting clinical investigations COURSE Description: Addresses the obligations of sponsors, monitors and investigators who participate in clinical research governed by US FDA regulations and ICH guidelines.

4 Communicates how human subjects are protected during clinical investigations to ensure their ongoing welfare. 45 minutes v100615 Obligations of investigators in Conducting Drug and Biologic Trials (GCP02) Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Research Phases Obligations of clinical investigators under GCP regulations Investigator s reporting and documentation requirements Investigator s obligation for product accountability Inspections the investigator should be prepared for Consequences of failing to comply with GCP obligations and HIPAA in the USA. COURSE Description: Addresses compliance with GCP regulations when conducting clinical trials for investigational new drug and biologics.

5 Addresses the investigator s obligation to protect human subjects who participate in clinical trials, as well as, the handling of safety data, drug accountability, clinical reporting requirements and compliance with FDA regulations and ICH guidelines. 45 minutes Obligations of investigators in Conducting Medical Device Trials (GCP03) Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Protocol Reporting Documentation Inspections Non-Compliance COURSE Description: Addresses requirements for conducting clinical trials for investigational premarket medical devices. Provides an OVERVIEW of the clinical investigator s general and specific obligations to protect human subjects while providing valid data that sponsors may submit to regulatory authorities for approval.

6 Introduction to documentation and reporting requirements, the inspection process, and the consequences for failure to comply with GCP guidelines. 90 minutes v100615 IRB Member COURSE Title Duration Introduction to the Criteria for IRB Approval Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Criteria Approval COURSE Description: This COURSE introduces the criteria needed for an Institutional Review Board (IRB) approval to conduct research on human subjects. 15 minutes Criteria for Approval 1: Risk Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Risk Minimizing Risk COURSE Description: Minimizing risk is always an integral part of protecting subjects during research.

7 In order to reduce risks sound research procedures should be followed at all times. This COURSE helps to identify ways to mitigate risk during research. 15 minutes Criteria for Approval 2: Risks and Benefits Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Benefits Analyzing Risks COURSE Description: Benefits and risks are analyzed when reviewing research. This COURSE helps to recognize when these risks to subjects are reasonable in comparison to the potential benefit of the research. 20 minutes v100615 Criteria for Approval 3: Equitable Selection Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Equitable vs.

8 Equal Effects of Research Review Materials COURSE Description: There should be a fair sharing of the burdens and benefits of research. Each IRB member should consider the risks, benefits, purpose, setting, and involvement of vulnerable populations to decide when selection is equitable and when it is inequitable. This COURSE helps determine whether the selection of subjects is equitable. 20 minutes Criteria for Approval 4: Informed Consent Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Obtain Consent Attributes Disclosures COURSE Description: After the IRB determines whether criteria 1 through 3 and 6 through 8 are met, the IRB should then evaluate the consent process.

9 This COURSE discusses the requirements of an approvable consent process. 45 minutes Criteria for Approval 5: Document Consent in Writing Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Documentation Different Forms COURSE Description: This COURSE discusses the requirements of whether and how to document consent in writing. 30 minutes v100615 Criteria for Approval 6: Safety of Subjects Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Monitor Research Review Information COURSE Description: Ensuring the safety of subjects is the most important part of research.

10 This COURSE discusses how to provide adequate research plans and provisions for monitoring the data collected to ensure the safety of subjects. 30 minutes Criteria for Approval 7: Privacy and Confidentiality Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Privacy Confidentiality COURSE Description: The IRB should review protocols to ensure they protect the privacy of subjects and maintain the confidentiality of data. This COURSE discusses the ways that protocols can protect subjects privacy and maintain confidentiality of data. 30 minutes Criteria for Approval 8: Coercion of Vulnerable Populations Topics (each COURSE has an OVERVIEW and Conclusion summarizing the COURSE along with learning activities and quizzes): Vulnerable Populations Safeguards COURSE Description: Research involving populations vulnerable to coercion or undue influence must include additional safeguards to protect their rights and welfare.