Research Application – OSF Administration

1.  Project Title:

2.  Please indicate type of study:

☐ Drug ☐ Observational* ☐ Device** ☐ Procedural (e.g., Surgery)
☐ Other. Please specify:

*If you are performing a retrospective/prospective chart review study indicate who will be pulling data:

* Please list the specific data points to be pulled from EPIC or attach in a separate word document and provide an estimate for when this data is needed.

**If device, is it a stocked product at OSF? ☐ Yes ☐ No*

*If no, has product been approved by the New Product Committee? ☐ Yes ☐ No*

*If no, please contact Julie Stevens, Supply Chain Site Manager

Phone: 309-655-3606

***Will this study require a Material Transfer Agreement? ☐ Yes ☐ No

3.  Enrollment Plan:

3A. Please select the subject population (Mark all that apply):

☐ Adults
☐ Pediatrics
☐ Both Adults & Pediatrics / ☐ Inpatients
☐ Outpatients
☐ Both Inpatients & Outpatients / ☐Other:

3B. What is your target subject enrollment?

3C. Estimated recruitment period (Month and Year):

4.  Is this study: ☐Full Board ☐Expedited ☐ Exempt

5.  Expected Start Date: Expected End Date:

6.  Principal Investigator: Resident/Fellow? ☐ Yes* ☐ No

Employing Institution:

*If conducting as school/program requirement, list school or program:

7.  Department : Pediatrics *If Other:

8.  Office Address:

9.  Phone:
Fax:

10.  Co-Investigators:

Name / Department / Resident?
Pediatrics*If Other: / ☐ Yes / ☐ No
Pediatrics *If Other: / ☐Yes / ☐ No
Select One. *If Other: / ☐Yes / ☐No
Select One. *If Other: / ☐Yes / ☐No
Select One. *If Other: / ☐Yes / ☐No
Select One. *If Other: / ☐Yes / ☐No

11.  Study Coordinator:

Name/Credentials Phone

12.  List all sites participating/where study procedures will be performed (including surgical procedures):

13.  Purpose/Benefit

13A. Purpose and scientific merit of the Research Study:

13B. Justification and potential benefit to OSF Saint Francis Medical Center:

14.  Study Status: ☐ Non-Funded ☐ Internally Funded ☐ Externally/Sponsor Funded

ÞIf funded, complete 15a.

Sponsor Information:


Name of Sponsor/Funding Source Sponsor Contact Name


Address City State Zip Code


Phone Fax#

15.  Sponsor/CRO:

15A. Contact Information:


Name (Contact 1) Name (Contact 2)


Email Email


Phone Phone

15B. Are there any financial conflict of interests that may need a conflict

management plan? ☐ Yes* ☐ No

*If yes please describe:

16.  Does the research intervention require hospital privileging? ☐ Yes ☐ No

*If “Yes” does the PI have privileges for the treatment/procedure? ☐ Yes ☐ No

Þif unsure, please contact OSF Credentialing Office @ (309)655-3215

17.  Does this research involve the following:

A.  Genetic Intervention ☐ Yes ☐ No

B.  Radiation, X-rays, or Radioactive materials ☐ Yes ☐ No

18.  Has this study been added to the clinicaltrials.gov website? ☐ Yes ☐ No ☐ N/A

19.  Operational Considerations:

a. Will your study involve Off-Label use of a Test Article? ☐Yes* ☐ No

*If yes, explain:

b. Will your study involve other hospital departments? ☐Yes* ☐No

*If yes, please select departments and required services:

☐Radiology – service required:

☐Pharmacy – service required:

☐Laboratory – service required:

☐Other – list department(s) and service(s) required:

c. The above department(s) must receive information on the protocol, approve the procedures to take place, and indicate how staff will be informed about the study. Please provide the names of individuals information was sent to and also indicate the educational plan below:

Name(s): Click here to enter text. Educational Plan: Click here to enter text.

☐ N/A

d. Will this study require a research account to be established through Research Projects and Administration (RPA) for non-billable tests and procedures?

☐ Yes* ☐ No ☐ Already established *If yes, list items that are not billable:

e. Will the study Sponsor require electronic medical (EMR) access for study
monitoring? ☐ Yes ☐ No

20. Please complete the following:

☐ Share/grant “read only” access with Stephanie Madrigal through IRBNet at the time of IRB submission (for required signature from OSF Administration)

☐ Share/grant “read only” access with all department chairs involved in the research study

☐ Attach the following items in an email to mailto:

☐ Full Protocol

☐ Contractual documents (CTA & Site/Indemnification Agreement)

21. Name of Person Submitting Form:

Name Date

ClinicalTrials.gov verification:
Identifier #:
Date Added: / To be completed by
CRA Administration Office
Comments:

Approval Signature

______

Institutional Approval Date

Version: 10March2015

Page 1 of 4