Mastering Clinical Research For previous presentations and upcoming schedule, visit:

1. Mastering Clinical ResearchFor previous presentations and upcoming schedule, visit: 9 Null • http://winshipcancer.emory.edu/mcr

2. Pre Questions

3. 1. To be compliant with the SOP on obtaining informed consent from a subject to an interventional clinical trial of greater than minimal risk, the physician named as investigator on the Form FDA 1572: must obtain informed consent. A may delegate obtaining informed consent to any other member of the research team who is listed on the 1572 and trained on the protocol. B may delegate to another licensed professional who is listed on the 1572, after he (investigator) has discussed the clinical trial with the subject and documented the discussion. C D both b and c

4. 2.  To be compliant with the SOP on obtaining informed consent from a subject to a non-interventional clinical trial of minimal risk, A an individual listed on the delegation of authority log as responsible for obtaining informed consent may discuss the study with subject and obtain signed consent. B an investigator must first discuss the study with the subject and document the discussion. C the investigator may delegate obtaining consent only to another licensed professional who is listed on the FDA Form 1572. 

5. 3.  To be compliant with the SOP on obtaining informed consent from a subject to an interventional clinical trial of minimal risk,  A the investigator must obtain informed consent. B the investigator on the FDA Form 1572 will discuss the protocol with the subject, answering questions and documenting the discussion in the research record before delegating obtaining informed consent to another licensed professional who is listed on the 1572 C the investigator on the FDA Form 1572 will discuss the protocol with the subject, answering questions and documenting the discussion in the research record before delegating obtaining informed consent to another research team member who is listed on the 1572.

6. Standard Operating Procedures: Revisions about which You Will Want to Know Kathleen Rodger, BSN, MSHCM Director, Clinical Trials Office Winship Cancer Institute

7. SOP Updates • New SOPs • 1.0: Development and Implementation of SOPs • 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials • Revised SOPs • 1.7: Research Misconduct • 2.1: Obtaining Informed Consent for Greater than Minimal Risk Interventional Clinical Trials

8. SOP 1.0: Development and Implementation of SOPs • Describes the standard format and method for establishing SOPs for the management and coordination of oncology clinical trials. • Responsibilities • Procedures • Writing the SOP • Format of the SOP • Implementation • Revisions • Affiliate Site Language • To acknowledge that there may be some overriding P&P at other sites that trumps a Winship SOP • The SOP will be effective January 2, 2014. • Please contact Winship CTO management team for questions and guidance.

9. SOP 1.7: Research Misconduct • Defines what constitutes research misconduct: • Fabrication • Falsification • Plagiarism • Excludes honest errors, differences in opinion, authorship that does not involve plagiarism and violations of other University policies • Details reporting procedures: • Must report observed or suspected misconduct • Investigation are conducted according to Emory policies • Explains Responsibilities: • Must immediately report misconduct or violations • Retaliation against a reporter is specifically prohibited. • The revised SOP effective January 10, 2014. • Additional training sessions are being conducted.

10. SOP on Obtaining Informed Consent • Specific elements had been mandated by CTEP in 2009 • required an investigator on the study to obtain informed consent • Frequent requests for revisions because it was considered inflexible and failed to address: • specific types of trials • risks of trials • reconsenting

11. SOP Obtaining Informed Consent • Obtained specific guidance from CTEP prior to drafting revisions. • Several months of discussions at the Clinical Trials Coordinating Committee and collaborating other groups who conduct oncology clinical trials. • Obtained Emory IRB review and approval to the revised SOP on Obtaining Informed Consent.

12. SOP Obtaining Informed Consent • End results are 2 SOPs to adequately cover the increased flexibility, types of trials, the risks of trials, and reconsenting: • 2.1: Obtaining Informed Consent for Greater than Minimal Risk Interventional Clinical Trials • 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials

13. SOP 2.1: Obtaining Informed Consent for Greater than Minimal Risk InterventionalClinical Trials

14. SOP 2.1: Obtaining Informed Consent for Greater than Minimal Risk InterventionalClinical Trials • Some things remain the same: • Must be IRB approved, on the DOA, on the 1572, trained, etc • Should obtain the current IRB-approved consent from OnCore® • Study procedures cannot be done prior to obtaining consent • Documentation of the consent process is required

15. SOP 2.1: Obtaining Informed Consent for Greater than Minimal Risk InterventionalClinical Trials • What’s changed: • The investigator or sub-investigator on the 1572 will have the initial discussion about the study, answer questions, document this discussion in the record. • The investigator may obtain consent or may delegate obtaining informed consent to another designated licensed professional on the 1572. • Nurse Practitioner • Physician’s Assistant • Clinical Research Nurse • Registered Nurse

16. SOP 2.1: Obtaining Informed Consent for Greater than Minimal Risk InterventionalClinical Trials • What’s changed (cont’d): • If the investigator delegates obtaining the signed consent, the licensed professional must document the provision of the signed consent and document that the consent was obtained prior to research procedures. • Provided specific instructions for obtaining consent when: • Subject cannot read (blind or illiterate) • Subject cannot speak English • Subject has limited autonomy • Subject cannot sign or make their mark

17. SOP 2.1: Obtaining Informed Consent for Greater than Minimal Risk InterventionalClinical Trials • Additional training sessions will be held during staff meetings, working group meetings, etc. • The SOP becomes effective January 10, 2014.

18. SOP 2.2: Obtaining Informed ConsentMinimal Risk Interventional and Non-Interventional Clinical Trials

19. SOP 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials • General requirements: • Must be IRB approved, on the DOA, trained, etc • Should obtain the current IRB-approved consent from OnCore® • Study procedures cannot be done prior to obtaining consent • Documentation of the consent process is required

20. SOP 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials • Minimal Risk Interventional Clinical Trials • The investigator on 1572 will have the initial discussion with the patient and document this discussion. • The investigator may obtain consent or may delegate obtaining the consent to another designated member of the research team listed on the 1572 and DOA.

21. SOP 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials • Minimal Risk Non-Interventional Clinical Trials • The investigator or an individual listed on the DOA log as responsible for obtaining informed consent will discuss the study and document the discussion in the research record. • The person obtaining consent must document the provision of the signed consent and document that consent was obtained prior to research procedures.

22. SOP 2.2: Obtaining Informed Consent for Minimal Risk Interventional and Non-Interventional Clinical Trials • Minimal Risk Interventional and Non-Interventional Clinical Trials (cont’d) • Provided specific instructions for obtaining consent when: • Subject cannot read (blind or illiterate) • Subject cannot speak English • Subject has limited autonomy • Subject cannot sign or make their mark

23. SOP 2.2: Obtaining Informed ConsentMinimal Risk Interventional and Non-Interventional Clinical Trials • Additional training sessions will be held during staff meetings, working group meetings, etc. • The SOP becomes effective January 10, 2014

24. Important Reminders • All SOPs are available: • In the CTO • At each Winship site • On the Winship intranet under Clinical Trials • The Monthly Protocol Card is now available on the Winship intranet under Clinical Trials. • The most recent Winship Clinical Trials Times newsletter was distributed Friday, December 13, 2013 via the Winship listserv • The Clinical Trials Times newsletter is also available on the Winship intranet under Clinical Trials.

25. Mastering Clinical ResearchFor previous presentations and upcoming schedule, visit: • http://winshipcancer.emory.edu/mcr