The University of Texashealthsciencecenter at San Antonio

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 Drug
2. 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

1. Does the pharmacological drug dosage cause any clinically detectable effect in human beings? □ Yes □ No
2. Dose Calculation Reference:
3. Maximum Number of administrations per subject:
4. Organs Receiving the highest Effective Dose Equivalent:

PERSONNEL

1. Have the personnel involved been trained for this procedure? □ Yes □ No

1. 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:

1. Will body fluids/excreta contain radioactive material? □ Yes □ No
2. 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