TRTO (Translational Research Trials Office)

1. TRTO (Translational Research Trials Office) Training Standard Operating Procedures for Good Clinical Practice for the Sponsor Section: Investigator Selection and Qualification

2. Training Tips Job Aids, such as forms, checklists, etc. contained in the procedure will be pointed out at the applicable section of the training. It will look like this: Job aid! “Form/Checklist Name” This presentation is a supplement for training purposes, please read and refer to the actual SOP for complete information.

3. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Purpose: Investigator selection is based on the training of the investigator, his/her ability to enroll an expected number of subjects in a reasonable period of time and the commitment to conduct the study according to the protocol, other <<Sponsor >> stipulations and applicable regulatory requirements. A PhD may be a Principle Investigator as long as FDA Form 1572 lists a subinvestigator who is qualified by training and experience, preferably an MD, who will be delegated by the Principle Investigator as responsible for the medical assessments of the subjects for studies that have direct patient contact.

4. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Investigators will be qualified by the Sponsor Designee and the investigator and staff should understand and accept the: • Investigational nature of the study and the investigational product • Roles and obligations as defined in the study contract and protocol • Applicable regulatory requirements • Responsibilities to the IRB • Content, maintenance and retention of source documents and records

5. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Verify that the Investigator: • Meets experience and eligibility requirements • Has sufficient time to complete the study • Can meet subject accrual and patient population requirements • Can complete subject information requirements for study documentation • Has support staff with the necessary training, experience and credentials • Has facilities that are suitable to conduct the study

6. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Applicable Regulations and Guidelines: • 21 CFR 312.50 General Responsibilities of Sponsors • 21 CFR 312.53 Selecting Investigators and Monitors • 21 CFR 312.70 Disqualification of a Clinical Investigator • ICH E6, 2.7 The Principles of ICH GCP • ICH E6, 5.1 Quality Assurance and Quality Control • ICH E6, 5.6 Investigator Selection • ICH E6, 5.7 Allocation of Responsibilities • ICH E6, 5.8 Compensation to Subjects and Investigators • ICH E6, 5.9 Financing • FDA Guideline The Monitoring of Clinical Investigations (January 1988)

7. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Procedures: Investigator Qualification

8. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Procedures: Investigator Qualification, continued:

9. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Procedures: Investigator Agreements

10. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Procedures: Disqualified Investigators

11. TRTO 4.1 Sponsor – SOP for Investigator Selection and Qualification Checklists and Templates: • Investigator Qualification Checklist • Site Qualification Checklist • Investigator Disqualification Letter • Investigator Qualification Letter

12. Go take the quiz! • TRTO Sponsor SOPs – Investigator Selection and Qualification Quiz