BSSFHS Application Page 1 of 3

Rev. 6 - 092613

APPLICATION TO PARTICIPATE IN A RESEARCH STUDY AT BON SECOURS ST. FRANCIS HEALTH SYSTEM

APPLICATION TO BE REVIEWED BY:

GREENVILLE HEALTH SYSTEMINSTITUTIONAL REVIEW BOARD

Title (Do not exceed space provided)

DEMOGRAPHICS

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Principal Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Co-Investigator Address, City, State, and Zip Telephone #

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Contact Person Address Telephone #

E-Mail Address: ______

Telefax #

SPECIAL AREAS OF CONCERN – Check all that apply.

 Drugs: /  Medical Devices / AIDS/HIV Related Research
 Investigational Drug
 Commercially Available/ /  Radioactive Materials and
X-Rays /  Alcohol and Drug Abuse
Research
Marketed Drug /  Human Genetic Research – GHS /  Biohazards – GHS IBC
 Cooperative Group/NIH
Sponsored / IBC No.: ______/ No.: ______
 Expedited Chart Review –
see GHS application for
details

Does this study require the subjects to be hospitalized?  Yes  No

If yes, how long is the anticipated length of hospital stay? ______

PHARMACY

1.Will the BSSFHS Pharmacy be involved in the procurement, storage, preparation or distribution of any drugs utilized in this study?  Yes  No

2.Does this study require any special instructions, special handling, special preparation, or completion of study documentation by the pharmacy staff?  Yes  No

If you answered yes to either of the above questions, you must provide the BSSFHS Pharmacy Representative, Patty Putnam, RPH, MSP, MHSA, with a copy of the protocol at least 2 weeks before the IRB deadline to allow time for pharmacy budget development. This signature must be affixed to this application prior to submission of the study to the IRB.

If no, continue to the next section.

 I have reviewed the protocol and developed a pharmacy budget for this study.

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Signature of BSSFHS Pharmacy Representative Date

STUDY SUMMARY

Provide a summary and purpose of the study. Please note if drugs/procedures are new or established.

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AUTHORIZATION FROM BON SECOURS ST. FRANCIS HEALTH SYSTEM

By signing below, I authorize the investigators to conduct this research study at Bon Secours St. Francis Health System. This authorization is contingent upon the approval of this research study by the Institutional Review Board of the Greenville Health System.

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Teri Ficicchy, RN, MSNDate

Interim Executive Vice President of Business Performance