CPHS STUDY #:

Dartmouth College and Dartmouth-HitchcockMedical Center

Committee for the Protection of Human Subjects

Application to Defer Review to the NCI Adult or Pediatric CIRB

Template v. 10/14/2013

Investigator Responsibilities
When review by the NCI CIRB is accepted, the local investigator is required to:
-Inform the CPHS when the local PI has changed.
-Send the CPHS notifications from the NCI CIRB when study enrollment has been suspended or when the study can be terminated locally.
-Send the CPHS any localserious adverse event (SAE), unanticipated problems involving risks to subjects or others (UPR) reports, and protocol deviations. These reports may be on the forms required by the reviewing IRB, you do not need to use the CPHS forms.
-Comply with all requests from the reviewing IRB

I. StudyInformation

Local PI name and email:

Section:Department:

Localco-Investigators:

Local Contact Person name and email:

Study Title:

Participating sites under CPHS-review:

Current Protocol version:

Note: studies enrolling participants at the VA are not eligible for external IRB review.

Each key personnelhas completed the CPHS education requirements.

(

Each PI has completed and submitted an Annual PI Worksheet on IRB Manager. (a reminder)

II. Documentation

Please send the Local Consent form that includes Dartmouth boilerplate language.

III. Special Instructions:

For example, describe any national cooperative group requirements for the period of review or other information that you believe the CPHS should apply to the initial determination of this study.

IV. Conflict of Interest Review:

Dartmouth College, Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital, and the Hitchcock Foundation have adopted a policy on Conflict of Interest that applies to each study reviewed by the CPHS. Copies of the policy are available on the CPHS web site at .

Do any key personnel have a significant financial relationship related to this research?

YesNo

If yes, list the name of the individual(s): ______

Has this individual(s) completed / updated an Annual Disclosure Form within the past year?

YesNo

If not yet completed, the individual must complete the CPHS disclosure form found at:

V. Future Notifications:

To notify the CPHS that the local PI has changed, study enrollment has been suspended or the study can be terminated locally, please send an email to . Be sure to reference the CPHS number and study title, and attach any relevant documentation.

VI. Attestation

Electronic versions of this signed form are acceptable. Please e-mail to . Submitting this form to the CPHS signifies that appropriate personnel at the Norris Cotton Cancer Center have been notified of this request to rely on the NCI CIRB.