Module e: investigator qualification & site selection

1. Module e: investigator qualification & site selection Jane Fendl & Denise Thwing 14 Apr 2010 Version: Final 14-Apr-2010

2. Objectives • Investigator Responsibilities in Clinical Research • Identifying potential study sites & Investigators • Contacting potential Investigators • Selecting Investigators

3. Responsibilities of the Investigator in Clinical Research To conduct the investigation according to; • Investigator statement • Investigational plan • Applicable regulations • Protecting the rights, safety and welfare of subjects • Control of drugs under investigation • Obtain IRB/EC approval of the protocol • Enroll the required number of qualified subjects • Obtain informed consent from every subject

4. Responsibilities of the Investigator in Clinical Research con’t • Administer the test drug • Observe and measure the effects of the study drug • Record all pertinent data • Evaluate & manage adverse events • Comply with all procedures as required in the protocol • Follow regulatory authority regulations & guidelines

5. Needs Assessment • Total number of Investigators required • Level of experience • Preferred medical specialty • Specialized facilities • Number of subjects • Preferred geographic location • Expected expenditure per Investigator • Qualifications of Investigator and staff

6. Identifying potential study sites & Investigators Importance of Investigator Selection Ill-equipped, careless, dishonest or over extended Investigator compromised study data Compromised study data time repairing damage Time repairing damage delays in submission Delays in submission $$$$$$

7. Steps to Prepare for Initial Contact • Primary CRA will prepare a telephone • qualification document • Team will meet and CRA/Project Manager will • train the team on the protocol and course of • dialogue • CRA/Project Manager will train on preclinical • development & disease • Procedures for maintaining confidentiality • will be communicated • Verify Investigator is not on the FDA • Disqualified/Restricted List • http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/default.htm

8. SOURCES FOR POTENTIAL INVESTIGATORS • Investigators from previous studies • Medical and professional referrals • Medical meetings, conferences, or scientific symposia • Journals, magazines • Literature searches • Medline • clinicaltrials.gov • Association mailing lists • American Medical Association, etc • Marketing or sales representatives • Employees/Consultants

9. Initial Contact • Develop list of potential Investigators • Contact is usually by phone, email or mail • Must be documented • The objective is: • Determine interest • Evaluation capacity • During the initial contact the study should be describe in broad non-specific terms: • Name and nature of test & comparative drugs • Objectives & diagnostic categories • Type & number of subjects • Length of study • Staff requirements

10. QUESTIONS FOR THE INVESTIGATOR Credentials Clinical study experience Medical training Publications Affiliations Access to adequate number of subjects Site and staff capability to conduct the study Availability of IRB Frequency of meetings

11. Confidentiality Agreement • A confidentiality agreement (CDA) is a legal agreement between at least two parties which outlines information the parties wish to share with one another for certain evaluation purposes, but wish to restrict from wider use and dissemination. • The parties agree not to disclose the non-public information covered by the agreement. CDAs are commonly executed when two parties are considering pursing a relationship together and need to understand the other’s processes, methods, or technology solely for the purpose of evaluating the potential for a future relationship. • CDAs are also valuable to protect the ability to patent an invention, something that can be compromised if a disclosure of the invention becomes public knowledge. These agreements can also be referred to as nondisclosure agreements (NDAs) or secrecy agreements.

12. Follow-UpContacts Follow-up Contact #1 Follow-up Contact #2 • Received CDA • Disclosure additional information • Description of medication • Reasons for study • Study design • # and type of subjects • Duration of treatment • Special requirement • Rationale for study • Provide a study synopsis • May provide Investigator’s Brochure and/or Protocol • Confirm interest with Investigator • Provide evaluation of Investigator to team • Protocol dependent criteria • Criteria desired in all Investigators • Schedule a Pre-study Site Visit

13. NEW SITE FEASIBILITY QUESTIONNAIRE • Review protocol/draft questionnaire • PI experience • Identify facility/ies PI will use • Affiliation SMO/affiliated network • Assess if site can work with a Central IRB • Experience with study related equipment • Assess contract timelines • Adequate staff • Enrollment capability/risks/challenges • Competing studies? • Expected number to screen/enroll/week 13

14. Selection Criteria • Investigator training • CV • Publications • GCP training • Ability & experience • Exp with study drug or similar drugs • Exp with complex studies • Reputation • Evaluate through publications, presentations, symposia & medical societies • Current diagnostics & therapies • Access to subjects • How will subjects be recruited • # of competing studies • Facilities & equipment • Access to equipment • Adequate space • Recordkeeping • Drug storage facilities • Geographic & demographic concerns • Characteristics of population • Age, sex & race • Convenient access • Supports recruitment • Enhances compliance with visits • Other research sites in the area • Time & cost factors • Start date of study • Rate of enrollment • Length of study • IRB approval time • Staff • Quality & size of staff • Training, familiarity with study drug • Turnover • Research supervisor • # of Study Coordinators • Investigator Traits • Investigator Accessibility

15. COLLECTION OF REGULATORY DOCUMENTS • Form 1572, signed and dated by PI • CV PI, and any sub-investigators, signed dated and current within 2 years • Current license PI/sub-Is • Copy of IRB approval letter protocol and ICF • Protocol signature page • IRB approved ICF

16. Conclusion Careful selection and screening ensures: Safe conduct of study Productive study Cost effective study Affects: Timeliness Quality of submission 16