OHR 328/2013

HUMAN SUBJECTS RESEARCH-RELATED EXPOSURE TO X-RAYS OR RADIOACTIVE MATERIALSFOR STUDIES EMPLOYING RADIATION EXCEEDING THE AMOUNT DELIVERED DURING STANDARD OF CARE.

OFFICE OF HUMAN RESEARCH

DIVISION OF HUMAN SUBJECTS PROTECTION

Instructions: Complete this form and submit directly to the Radiation Safety Officer, or electronically as a scanned PDF document with PI signature to .

If proposed study employs a device, please also include a completed OHR-25, Investigational Device Worksheet, with your IRB submission.

1. STUDY TITLE:

2. PRINCIPAL INVESTIGATOR:

3. SUBJECT INFORMATION: # Research Subjects ______# Control Subjects ______

Children Subjects? YES ______NO ______

Potentially Pregnant Subjects? YES ______NO ______(If yes, attach description of plans for determining subjects’ pregnancy status prior to administration of radiation)

4. NATURE OF STUDY – Which of the following characterizes this research?

a.Research involves radioactively labeled drugs to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of the radioactive drug or regarding human physiology, pathophysiology, or biochemistry

b.Research to study safety and effectiveness of a radioactive drug or radiation producing device

c.Research uses existing standard FDA approved clinical radiation methodologies to assess some other (non-radiation producing) article under study.

d.Research to study the effectiveness of some article or regimen on the efficacy of a standard radiation therapy or diagnostic radiation procedure that is already in clinical use.

4. PROCEDURES: (List below all research-relatedimaging procedures involving radiation)

Procedure (e.g., CT scans, radiographic studies) / Number (e.g., 3 CT scans or exposures) / Timepoints (e.g., weekly, every two weeks, etc.)

5. RADIOACTIVE MATERIALS:

Name of test article/drug
Manufacturer
FDA Approved for Marketing? / YES ______NO ______
IND#
IND Holder
Dosage of Radioactive Material
Number of administrations and Interval between administrations
Location where study article will be administered and name of Physician supervising administration

6. FLUOROSCOPY (Provide best estimates for average subject):

Procedure: / Procedure Room:
Total Fluoro Time/proc: / mins: / Cine # runs: / SEEs/run:
Typical kV: / Typical mA: / Cine Beam Area at Subject: / cm2
*Reference dose/proc: / *Reference dose/proc:
*KAP or DAP: / *KAP or DAP:
No. of procedures: / No. of cine studies:

*For equipment that displays this information

FOR ASSISTANCE CONTACT:Radiation Safety Officer, John Keklak, office 215-955-1950

ATTACHMENTS: Investigators Brochure (for clinical trials)

Package Insert for FDA Approved Radiopharmaceutical

Organ dose estimates from radiopharmaceutical (if not in package insert or investigators brochure)

IND letter or Equivalent Product Information for Investigational Agents (Drug Brochure)

Signature:______

Date:______

Version 1: April 2013

FOR RADIATION SAFETY USE ONLY

APPROVE: DISAPPROVE:

COMMENTS:

Reviewed by

Signature, Radiation Safety OfficerDate

______

Chair, Radiation Safety CommitteeDate

RSC, Human Use Subcommittee ChairDate

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