Research/Project Review Application

Registry Study Short Form

This form fulfills both Research and IRB requirements for HealthEast. Please complete all questions, even if you are not applying for IRB approval.

1Project Title:

2Contact Information (Please indicate primary contact person)

a.Principal Investigator(s):

b.Corresponding Investigator:
Mailing Address:
Telephone:
FAX:
Email:

c.Co-Investigator(s):

3Abstract (500 words or less, do not refer to "see protocol" for abstract):
This abstract should consist of two paragraphs, labeled Background and Methods. They should briefly describe, respectively, the problem being addressed in the study, including the hypothesis or study question; and how the study will be performed.

4Study Design/Protocol (Answer the questions below and attach study protocol or methodology.):

a.What are the objectives of the proposed research/project?

b.What is the significance of the proposed study? Provide the context for the study, and the rationale. What is known about the topic? Why is the study important? What kind of answers will the study provide?

Page 1 – General Information

Last Modified: June 2000September 30, 2004

5Subject Population

a.Please indicate the number of each type of subject in each of the following categories:
Male Female Total Number of Subjects
Adults Minors Age Range of Subjects: to

b.How are subjects initially chosen? (e.g. records, classes, referral, canvassing, etc.) and/or contacted (ad, telephone, letter, etc); be specific) and any applicable or required characteristics:

6VERIFICATION OF APPLICATION

I certify that the information furnished concerning the procedures to be taken for the protection of human subjects is correct. I will seek to obtain prior approval for any substantive modification in the proposal and will report promptly any unexpected or otherwise significant adverse effect in the course of the study.

Signature of Principal InvestigatorDate

Page 1 – IRB Application: Short Form

Last Modified: October 19, 2003

7How will the results of the study be reported? Who will the results be reported to?

8RESEARCH APPROVAL:
NO YES – Signatures:

System Director of Research / V.P. Medical Affairs
Date / Date

Page 1 – ORME Application

Last Modified: October 19, 2003

-- ORME Staff Use Only --

Checklist

ORME Primary Contact:

ORME Secondary Contact:

ORME Server Path:

Project Tracking Title:

IRB Approval Needed?YN

Financial Disclosure Form signed? YN

Will there be ORME involvement in final presentation? YN

Approval Process:

ORME Project Review:DATE:ACTION:

Administration at facilities where
researchis to be conducted (Initials:)DATE:ACTION:

HealthEast Research Advisory Council DATE:ACTION:

HealthEast Medical Research Institute
Research CommitteeDATE:ACTION:

HealthEast Medical Research Institute
Clinical Board of GovernorsDATE:ACTION:

HealthEast Institutional Review BoardDATE:ACTION:

Action Codes: 1 – Approved, 2 – Denied, 3 – Pending Changes, 4 – Not Applicable

Timeline:

Approval and Review ProcessFrom to

ImplementationFrom to

Data CollectionFrom to

Data ProcessingFrom to

Data AnalysisFrom to

Report WritingFrom to

Submission of Manuscript:Target Date:

Publication:Target Date:

Page 1 – ORME Staff Use Only

Last Modified: October 19, 2003