Nebraska S Health Science Center Office of Regulatory Affairs (Ora) s1

______

NEBRASKA’S HEALTH SCIENCE CENTER OFFICE OF REGULATORY AFFAIRS (ORA)

Institutional Review Board (IRB)

Addendum P

Principal Investigator Responsibilities:

Investigator-Initiated Multi-Center Drug Study

DATE:

Addendum P (07-27-10) Page 1 of 3

IRB #:

Addendum P (07-27-10) Page 1 of 3

TITLE OF PROTOCOL:

Addendum P (07-27-10) Page 1 of 3

PRINCIPAL INVESTIGATOR:

Addendum P (07-27-10) Page 1 of 3

Instructions: All Principal Investigators, conducting investigator-initiated research involving multiple sites, must posses the required experience, skill and appropriate medical licensure to safely conduct the research in full compliance with HHS regulations at 45 CFR 46, FDA regulations at 21 CFR 50, 56, and 312, and other federal, state, or local laws or regulations which apply.

Please respond to each of the following questions:

1. This investigator-initiated trial involves submission of an Investigational New Drug (IND) Application to the FDA.

No. Continue to Question 2

Yes. Stop here and complete Addendum O: Principal Investigator Responsibilities: Conducting Research under an Investigator-Initiated IND

2. All study personnel (i.e., secondary investigators, participating personnel) are qualified by education, training, experience, and medical licensure to safely conduct the research.

Yes. Please describe how this determination will be made.

Addendum P (07-27-10) Page 1 of 3

Note: The IRB must be assured that all study personnel, in particular from external collaborating sites, are qualified to participate in the conduct of the research.

3. A copy of the Curriculum Vitae (CV) is on file for all secondary investigators.

Yes ______(initials)

Note: This documentation and all study related documentation/correspondence must be maintained throughout the study by the PI. A copy is not required by the IRB.

4. All study personnel have been given a copy of HRPP Policy #5.1: Process and Documentation of Informed Consent/Assent.

Yes ______initials

5. All study personnel have been given copies or web links for the following documents: a) Belmont Report, b) 45 CFR 46, and c) applicable FDA regulations.

Yes ______initials

6. Describe any other human subject protections or study specific-research training that will be, or has been, provided to study personnel (i.e., in-services, telephone conferences, etc).

Addendum P (07-27-10) Page 1 of 3

7. Upon receipt of UNMC Adult or Pediatric IRB approval of this research, each secondary investigator and participating personnel will be provided with a copy of the: a) UNMC/Peds IRB approved application, b) detailed protocol, and c) other review information to assure all individuals fully understand the study.

Yes ______initials

8. Does this study involve secondary investigators or participating personnel from external collaborating study sites?

Yes. Respond to the following:

A. Identify the external collaborating study sites that have their own OHRP/FDA registered IRB.

Addendum P (07-27-10) Page 1 of 3

B. Two signed UNMC Inter-Institutional Agreement for a Multicenter Clinical Trial have been obtained from applicable external collaborating study sites. Both copies have been provided to the UNMC/Peds IRB for signature. (One signed original will be returned to the PI to forward to the study site.)

No. Please explain:

Addendum P (07-27-10) Page 1 of 3

Yes

C. The PI will maintain on file a copy of each external IRB initial and continuing review and provide a copy to the UNMC/Peds IRB.

Yes ______initials

D. A monitoring plan is in place to ensure appropriate oversight of drugs utilized in the study at the external site.

Not applicable

Yes. Please describe:

Addendum P (07-27-10) Page 1 of 3

9. All secondary investigators and participating personnel have been officially notified they are to promptly report to the PI: 1) all internal adverse events which are unexpected and related, or possibly related to the study interventions, 2) unanticipated problems involving risk to the subject or others, 3) noncompliance, 4) protocol deviations, 5) complaints, 6) audits by sponsors, CRO’s, FDA, OHRP, or other federal authorities. 7) study reports, as required by the protocol, and 8) continuing review reports.

Yes ______initials

10. A mechanism has been put in place to receive and maintain on file copies of all signed consent forms obtained from subjects enrolled in the research by the secondary investigators or participating personnel.

Yes. Please describe:

Addendum P (07-27-10) Page 1 of 3

11. A qualified and experienced monitor has been selected to monitor the progress of the investigation.

Yes. Identify the monitor:

Addendum P (07-27-10) Page 1 of 3

12. A plan has been developed for periodic audits of research records.

Yes. Please describe.

Addendum P (07-27-10) Page 1 of 3

Note: Results of any audits or site visits must be reported to the UNMC/PedsIRB and maintained in the research record.

Addendum P (07-27-10) Page 1 of 3