Submit this form directly to CGIRB via Connexus

Important: Please type responses. Refer to the CGIRB Investigator Guidebook for information regarding Investigator Responsibilities.

Blank & incomplete answers will result in delayed reviews! Protocol #:

Sponsor:

Protocol Title:

Your Sponsor Site Number: (if known) Is this research federally funded?

No Yes - Submit IRB Authorization Agreement to add CGIRB to your Federalwide Assurance (FWA)

Principal Investigator Full Name and Credentials:

E-mail:

Medical License #(s): Expiration date(s): State(s): Who is the Primary Contact Person at this site? What is their E-mail address? Are they registered to use Connexus? Yes or No? (Connexus is our document management web portal.)

Site Phone Number(s): Site Fax Number:

Please provide contact information for all other study contacts at this site. Name of Secondary Contact Person at this site E-mail: Registered for Connexus, Yes or No?

Please provide here or as an attachment, the names of all Additional Contact Persons at this research site, their e-mails and status of Connexus registration.

Mailing Address, if different from the research site address below:

Site Name:

Address:

Suite/Floor, etc.:

City: State: Zip: Research Site Name and Address where subjects will be seen (appears on Informed Consent):

Site Name:

Address:

Suite/Floor, etc.:

City: State: Zip:

Investigator Site Questionnaire

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CGIRB Investigator Site Questionnaire

Will there be any additional research sites where subjects will be seen and if so how many? (Please submit an Investigator Site Questionnaire for Additional Sites for each additional site.

If you will be conducting the research study at multiple sites, have all the facilities been granted permission by the sponsor/CRO for this research to be conducted at their facility?

No Yes N/A

CONTACT NUMBERS FOR SUBJECT USE (Per federal regulations, this information must be included in your site-specific subject information and consent form)

Day phone # (Mandatory):

24-hour phone # (Mandatory):

Are you taking over the CGIRB-approved study from another PI? No Yes

If YES, state the name of the current PI: and Submit the Principal Investigator Transfer Form

SUBJECT COMPENSATION FOR PARTICIPATION IN THE RESEARCH STUDY (This information will be included in your site-specific subject information and consent form)

Subjects will not receive any reimbursement for taking part in this research study.

OR

Use template wording: $ per visit

OR

List compensation wording as it should appear on the Informed Consent. Attach a separate sheet – information provided must be legible and detailed.

INFORMED CONSENT(S)

Do you wish to submit site-specific wording (other than the PI’s name and site address)?

No

Yes – If YES, please include the following:

Tracked changes on the most current version of the CGIRB-approved Template IC

Written documentation of sponsor/CRO approval

Rationale for each requested change

Does this study have additional/sub-study Informed Consents?

No

Yes – If YES, please answer one of the following:

Subjects will not receive any reimbursement for taking part in the additional/sub-study research.

OR

Use approved additional/sub-study template wording: $ per visit

OR

List compensation wording as it should appear on the additional/sub-study Informed Consent. Attach a separate sheet – information provided must be legible and detailed.

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CGIRB Investigator Site Questionnaire

SUBJECT INFORMATION AND CONSENT FORM TRANSLATION

Will a translated* version of the subject information and consent form be needed to facilitate a subject’s understanding of the research study?

No Yes Specify which language(s) are needed

*Please note that certified translations must be approved by CGIRB prior to use.

If yes, is there a staff member available to conduct the consent process in the language for which a translation is requested?

No Yes

REGULATORY INFORMATION

1. Has FDA, OHRP, or another regulatory agency inspected/evaluated the principal investigator or the research site(s) within the past 5 years?

No Yes

If YES, was a Form FDA 483 or other list of observations issued? No

Yes List date(s) of Form FDA 483

If YES, is Form FDA 483(s) already on file with CGIRB? No (If NO, provide a copy of the Form FDA 483/list of observations and response letter) Yes

2. Has the principal investigator or research site(s) ever been issued any of the following? If YES to any, provide copies of all related documents.

a. NIDPOE

(Notice of Initiation of Disqualification Proceedings and Opportunity to Explain) No Yes

b. Suspension by a federal agency (such as the FDA or DHHS) No Yes

c. FDA Warning Letter (Excludes 483s) No Yes

3. Have any of the following ever been denied, revoked, suspended, reduced, limited, placed on probation, not renewed, relinquished, given a public reprimand, or subject to disciplinary action? If YES to any, provide copies of all related documents including resolution steps.

a. Research privileges at this site? No Yes

b. Medical licensure in any state? No Yes

c. Other professional licensure/ registration? No Yes

d. Membership on any hospital staff? No Yes

e. Clinical privileges? No Yes

f. Professional society memberships or fellowship/board certifications? No Yes

4. Have any type of professional sanctions, including fines, or DEA prescribing privileges ever been levied against you?

No Yes (If YES, provide copies of all related documents including resolution steps)

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CGIRB Investigator Site Questionnaire

5. Has any patient or subject ever made a complaint against the principal investigator, sub-investigator(s), or this research site?

No Yes (If YES, provide copies of all related documents including resolution steps)

6. Is any action or investigation currently pending before any state licensing board, federal agency or court of law concerning the professional conduct of the principal investigator in his capacity as a research investigator or as a clinician?

No Yes (If YES, provide copies of related documentation)

7. Does the principal investigator, sub-investigator(s), or any immediate family member(s) of the aforementioned individuals have a conflict of interest with the study sponsor, sponsor representative(s), or other study-related entities as outlined in the CGIRB Investigator Guidebook?

No Yes (If YES, submit a completed Conflict of Interest Disclosure Form for Investigative Sites for each individual

with conflicting interest.)

8. Training and qualifications of the principal investigator

a. Are you and your research staff knowledgeable of Good Clinical Practices (GCP), particularly 21 CFR 312, Subpart D, “Responsibilities of Sponsors and Investigators” or 21 CFR 812, Subpart E “Responsibilities of Investigators” for device studies?

No (If NO, attach an explanation) Yes

b. What training have you and your research staff had in the protection of human research subjects: None OHRP Training modules NIH Human Participant Protections Education Certified Investigator Training Initiative (CITI) DIA; Certified Clinical investigator (CCI) SOCRA; Clinical Research Professional (CRP) ACRP; Certified Clinical Trial Investigator Investigator Meetings Other human subject protection training (specify):

9. Experience a. How long have you been conducting human subject research?

b. How many studies have you conducted as PI and as Sub-investigator ?

c. What types of studies have you conducted? OR See CV for complete list

d. How many studies are you currently conducting? (if more than 16, please answer questions (i)-(iv)

i. How many studies per research coordinator?

ii. What is the average number of subject visits per day?

iii. Of the active studies, how many are currently enrolling?

iv. Which phase study (Phase I-IV) are most of your active studies?

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CGIRB Investigator Site Questionnaire

10. What percentage of your time is devoted to conducting research?

11. State the number of the key study staff that will assist in this research.

Sub-investigators - Of that number how many are MDs? How many are DOs?

Research Coordinators

Pharmacists

Other (eg, laboratory technicians, regulatory specialists)

RESEARCH SITE AND COMMUNITY INFORMATION

12. How would you generally describe your research setting? (Check only one box) Rural Suburban Urban Other (describe):

13. Setting of the study site: Hospital Research Clinic Private Practice Other (describe):

14. What are the community attitudes towards the conduct of research in your local community that CGIRB should be knowledgeable of prior to reviewing this study for your local site? Check only one.

Neutral Positive Negative (explain):

15. Are you aware of any state or local laws, where you intend to conduct the research, which would impose stricter or additional requirements than those imposed by federal regulations?

No Yes, provide details See atttached: "North Carolina State Laws Governing Clinical Research"

16. Does a local IRB have jurisdiction over this research site? No Yes If YES, submit a Transfer of IRB Obligations Form or equivalent documentation.

17. What is the distance between the nearest hospital and the research site?

18. Describe the on-site emergency equipment available for the subjects, *Note: If required in the protocol or IB, you must be capable of responding to an anaphylactic, hypersensitivity, or drug infusion event. * Please check all that apply:

Crash Cart Emergency Meds CPR certified staff and dial 911 Other (describe):

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CGIRB Investigator Site Questionnaire

19. Describe additional resources unrelated to emergency care, if applicable: Interpreters Counseling services Bilingual staff members Other (Specify): N/A

STUDY CONDUCT & SUBJECT INFORMATION AND CONSENT FORM PROCESS

20. How will subjects be recruited for this study? (check all that apply) Existing Patients If this is checked please indicate the process:

Database of patients (who have agreed to be contacted) In person (during office visit) Phone screening

Referrals If this is checked please indicate the process: Doctor to Doctor Referral Other (please specify):

Advertisements** If this is checked, please indicate the process: Print Advertisements Internet advertisement Radio or TV advertisements Phone screening Other (please specify):

Other (please specify):

**All subject recruitment materials must receive CGIRB approval prior to use

21. Who typically conducts the recruitment process with potential subjects? (Check all that apply) Principal Investigator Sub-Investigator Research Coordinator Other (specify):

22. Indicate the approximate demographics of your site’s anticipated subject population:a. Gender (must total 100%):Male: % Female: %

b. Race/Ethnicity (must total 100%) For guidance visit, http://www.cgirb.com/investigators/faq.php#ethnicity

Asian: %

American Indian or Alaska Native: %

Native Hawaiian or Pacific Islander: %

Other: %*

(*please specify: )

White: %

Black or African American: %

Hispanic or Latino: %

23. Do you anticipate recruiting subjects from the following vulnerable populations? No Yes – Check all applicable categories (see a. through h.) below.

Note: Marking the box beside a vulnerable population indicates your understanding of how to protect that group as outlined

a. Children:• Assent will be solicited from subjects age 7 years and older• Investigator will ensure that outside parties (parent/guardian) are not unduly influencing subject to participate• Investigator will provide adequate opportunity for subjects to ask questions and comprehend information

b. Adults with Diminished Decision-making Capacity (Refer to Protocol to see if subjects requiring legallyauthorized representative [LARs] are allowed)

• Assent will be solicited from subjects with limited decision making capacity• Investigator will ensure an LAR is used when appropriate or required by protocol

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CGIRB Investigator Site Questionnaire

• Investigator will ensure that outside parties (caregiver/LAR) are not unduly influencing subject to participate• Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

c. Economically Disadvantaged/Unemployed• compensation is reasonable in order to eliminate possibility of undue influence due to financial incentive

d. Educationally Disadvantaged – If this box is checked, an impartial witness signature line will be added tothe informed consent form (if this is not already included)• Investigator will ensure the consent document is read to the subject and that an impartial witness is present.• Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

e. Visually Impaired/Illiterate – If this box is checked, an impartial witness signature line will be added to theinformed consent form (if this is not already included)• Investigator will ensure the consent document is read to the subject and that an impartial witness is present.• Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

f. Limited English skills and/or Non-US Citizens• Subject will be provided with translated documents in native language if unable to read English• Staff /independent interpreter has ability to interpret subject’s native language if unable to

comprehend English • Investigator will provide adequate opportunity for the subject to ask questions and comprehend information

g. Employees/Colleagues/Students of the Principal Investigator and/or Study Staff (must be acceptable bythe sponsor/protocol). CGIRB will issue a non-coercion addendum to the Subject Information and ConsentForm for enrolled employees and family members.• Investigator will ensure & explain that participation does not affect subject’s current position

h. Pregnant Women• Possible risks to mother and fetus will be clearly outlined

24. If question #23 was answered NO, please skip this question.When enrolling vulnerable population(s) from #23, will you meet CGIRB’s listed expectations to protect thesepopulations?

No (Attach an explanation) Yes

24a. Describe any additional safeguards at the site, to protect their rights and welfare.

25. Is an LAR or guardian acceptable as per the protocol?

No (Skip to Question 26) Yes

25a. If YES, will subjects with an LAR or a guardian be enrolled at this site? No (Must answer Question 25b) Yes (Skip to Question 25c)

25b. If NO to Question 25a, and IF this study enrolls minors, will only biologic parents provide permission for enrollment?

No (Attach an explanation) Yes

25c. If YES to Question 25a , how will you verify who constitutes an LAR or a guardian in your state? Legal counsel Sponsor/CRO State law reference material State law codes and statutes Other (specify):

26. Who typically discusses the subject information and consent form process with the potential subject? (Checkall that apply)

Principal Investigator

CGIFRM 004E9 Page 7 of 9 Effective Date: 18 April 2012

X

CGIRB Investigator Site Questionnaire

Sub-Investigator Research Coordinator Other (specify): N/A – there is no subject information and consent form used in this study

27. Will you or whoever conducts the subject information and consent form process spend as much time asneeded to thoroughly explain and respond to any questions the potential subject may have about the study,and allow him/her as much time as needed to consider whether to enroll or not?

No (Attach an explanation) Yes N/A – there is no subject information and consent form used in this study

28. Describe the steps taken to minimize coercion or undue influence: Provide adequate time to review the informed consent document Payment is commensurate with research procedures Study staff with conflict of interest will not participate in the consent process Other: N/A – there is no subject information and consent form used in this study

29. Will potential subjects and/or their legally authorized representative be given adequate opportunity to read andconsider the consent document before it is signed?

No (Attach an explanation) Yes N/A – there is no subject information and consent form used in this study

30. How will you maintain the confidentiality of data?Confidentiality refers to the agreement between the investigator and participant in how data will be managed and used.

Paper-based records will be kept in a secure location accessible only to study staff Computer files will be accessible only to study staff and will be made available through passwords Study staff will sign confidentiality agreements regarding the protection of identifiable health information prior to

accessing study information Other (please specify):

31. Please describe provisions to protect the privacy interests of participants.Privacy refers to persons’ interest in controlling the access of others to themselves, such as the ability to control whosees them, hears them, touches them, and has access to their private information. Additional privacy interests includethe time and place where subjects provide information, the nature of the information provided by the subjects, thenature of the subjects experiences during the trial, and who receives and can use the information.

a. Will subjects be consented in a private area away from the public? No (Attach an explanation) Yes N/A – there is no subject information and consent form used in this study

b. Will study-related assessments be conducted in a private area? No (Attach an explanation) Yes N/A

c. Will the private information collected be limited to what is required by the research? No (Attach an explanation) Yes

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CGIRB Investigator Site Questionnaire

d. Other than the above, are there additional provisions to protect the privacy of subjects? No Yes (If YES, describe):

By submitting this form, I am confirming that I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI. The information within this form is accurate and complete with the PIs full awareness of the information submitted.

Please Type: Name of Individual at Site Completing Form

Please Type: Title of Individual at Site Completing Form Date

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