The University of TexasHealthScienceCenter at San Antonio
Environmental Health & Safety Department
Radiation Safety Division
APPLICATION FOR THE HUMAN USE OF RADIOACTIVE MATERIAL - RESEARCH
PROJECT TITLE
PURPOSE OF THE STUDY
AUTHORIZED USER(person authorized to administer radionuclides to humans)
Name Faculty Title
Mailing Address
Telephone No ( ) Fax No ( )
Email Address
AUTHORIZED USER QUALIFICATION
Texas Medical License Number
Board Certified: □ Yes(please attach)□ No(complete Supplement A & B, NRC Training & Experience and Preceptor Statement)
PRINCIPAL INVESTIGATOR OF STUDY(if different from Authorized User)
Name Faculty Title
Mailing Address
Telephone No ( ) Fax No ( )
Email Address
PART 1: RADIONUCLIDES AND INSTRUMENTATION
RADIONUCLIDES
Radionuclide / Chemical Form / Volatile / Vendor / Possession Activity (mCi) / Purchase Activity (mCi) / Activity per Subject (mCi) / Room #INSTRUMENTATION
Dose Assay: What instrument(s) will be used to assay the activity prior to administration?
Type of instrument (dose calibrator): Calibration Date
MakeModelSerial No
Planned time interval between assay and use
Contamination Survey: What instrument(s) will be used to monitor for potential radioactive contamination?
Type of instrument (survey meter and probe type): Calibration Date
MakeModelSerial No
Type of instrument (liquid scintillation or well counter): Calibration Date
MakeModelSerial No
PART 2: RADIOACTIVE DRUG RESEARCH COMMITTEE INFORMATION
Radioactive agents not approved under an IND may not be administered without RSC, RDRC, and IRB approval. Please submit a copy of the submission for the IRB to the RSC and RDRC for approval prior to the IRB.
SUBJECT INFORMATION
Total Number of Subjects ______Age range of subjects will be from _____ to ______
Number of Adult Males: _____ Females: _____Number of Minor (up to age 18) Males:_____Females:_____
Will any subject be involved in any other studies using radioactive material in the same 12 month period? □ Yes □ No
How will the non-pregnant status of female subjects of childbearing potential be established and documented?
Provide justification for studying more than 30 subjects or minors:
RADIOACTIVE DRUG INFORMATION
1. Identity of Radioactive Drug2. Route of Administration
3. Estimated Radiation Dose to Human Subjects
a. Absorbed dose calculations:
b. Method of radioassay:
c. Assay instrumentation quality control:
4. Pharmacological Dosage of Active Ingredient
5. Quality of Radioactive Drug
a. Method of preparation/dispensing:
b. Minimum acceptance criteria/Routine Quality Control Procedures:
Visual appearance:
pH:
Radiochemical purity:
Chemical purity:
Specific activity:
Radionuclide purity or identification:
Pyrogens or bacterial endotoxins (parental only):
Sterility (parental only):
c. Preclinical validation studies:
d. Expiration dating:
6. Labeling of radioactive drug
RADIATION DOSIMETRY
- Does the pharmacological drug dosage cause any clinically detectable effect in human beings? □ Yes □ No
- Dose Calculation Reference:
- Maximum Number of administrations per subject:
- Organs Receiving the highest Effective Dose Equivalent:
PERSONNEL
- Have the personnel involved been trained for this procedure? □ Yes □ No
- List all personnel who will be involved in the preparation, handling, and administration of radioactive agent(s). Please include each individual’s training and credentials:
RADIATION SAFETY:
- Will body fluids/excreta contain radioactive material? □ Yes □ No
- Describe procedures for controlling the spread of radioactive contamination.
SUBMISSION REQUIREMENTS:
□Copy of IRB application (Form A, B, B-2, C, and D)
□ Radiation Worksheet (Form Q)
□Pertinent References regarding dosimetry (if applicable)
□FDA 2915 Special Summary Form (if over 30 subjects requested)
I certify that the material requested will be used in accordance with the Radiation Safety Regulations at this institution, with all requirements of the law, and with Regulation of the Texas Department of State Health Services, Bureau of Radiation Control. That all information contained herein, including any supplements attached, is true and correct.
Authorized User Signature Date
Principal Investigator Signature Date
Department Chair Signature Date