Download RDRC_application - Stony Brook Research

Stony Brook University
Application for Approval to Conduct
Radioactive Drug Metabolism Research
in Human Subjects
Confirm that the IRB study protocol is being included in your RDRC
submission
A. Title of the research project:
B. Brief description of the purpose of the research project:
C. Principal Investigator Information
Name:
Department:
SBU Employee #:
Phone #:
E-mail address:
D. Additional Personnel involved in the Research
Name
(Last, First)
SBU Employee
ID# (not SSN)
Department
SBU
Telephone
#
E-mail
address
***Upload a separate sheet that includes the role of each individual listed above, as well as
their qualifications
E: Information Regarding the Radioactive Drug
1. State name of radioactive drug and give chemical structure:
(e.g. O-(2-[18F]fluoroethyl)-L-tyrosine)).
:
2. Details of the physical characteristics:
a. Physical half-life:
b. Total decay energy:
c. Type(s) of decay and decay fraction (s):
of major emissions:
Energy, and relative abundance
3. Production source
Give:
a. Source of isotope (e.g., reactor, cyclotron) :
b. Source of radioactive drug (e.g., SBU lab, non-SBU lab, commercial
supplier):
4. Preparation:
Commercial products must be supported with either an NDC number or a certificate
of analysis which states that materials are intended for human use. For all other
materials:
a. Provide details of synthesis/preparation. Show synthetic scheme and give
descriptive narrative of synthesis. Including raw material(s), quantity and
location where materials are produced:
b. Provide detail regarding how batch records and quality control records are
maintained, including their location:
5. Composition:
Provide details regarding final drug product minimum specifications and quality
control testing methods. Include a summary (or a certificate of analysis) for at least
three different batches of drug for the following qualities:
6.
a. Chemical purity:
b. Radiochemical purity:
c. pH:
d. Dosage:
e. Sterility:
f. Bacterial endotoxin levels:
g.
h.
i.
j.
k.
l.
Radionuclide identification:
Radionuclidic purity:
Residual organic solvents:
Visual inspection:
Residual chemicals (e.g. Kryptofix 2.2.2)
Excipients (if any)
7. Specific activity of administered material:
a. Provide information on radiopharmaceutical specific activity (specification
and testing methods)
b. State maximum total mass injected of each radiotracer:
c. Describe any pharmacological or toxic actions of the parent compound or
vehicle:
i. State no-observed-effect-level (NOEL) mass dose (supply reference):
ii. State no-observed-adverse-effect-level (NOAEL) mass dose (supply
reference):
8. Radioassay:
List instruments or devices used to measure the radioactivity prior to administration
to the subject (e.g. dose calibrator) as well as the calibration/validation procedures:
9. Study Drug Administration
a. Give route of administration:
b. Give volume to be administered and vehicle:
F. Radiological Health Aspects
1. Hazards to other subjects and to personnel from external or internal radiation (e.g.,
mr/hr at 1 meter at the time of radioisotope injection):
2. Steps to minimize the hazards identified in D.1 above:
3. Personnel monitoring procedures, if necessary:
4. Special procedures for handling waste products, excreta, and biological samples:
5. Supply a plan for isotope accountability:
G. Radiation Dosage
1. Biological half-life or effective half-life of study drug (be sure to state whether the
physical half-life of the radioisotope is shorter than the biological half-life, and by how much):
2. Dosimetry:
a. Do you have a literature reference for the dosimetry
Yes (provide):
No → Provide method and sample calculations*:
*If standard software packages (such as OLINDA) are being used, the residence time in the organ
must be provided. Dosage should be calculated for the whole body and for "target" or other separate organs, where
indicated. Prototype equations are desired; not extensive calculations. Where applicable, the Medical Internal
Radiation Dose (MIRD) Committee's recommended methods (J. Nuclear Medicine Supplements) should be used.
Otherwise, standard dosage equations from references such as Hine and Brownell's Radiation Dosimetry, and the
National Bureau of Standards Handbook 69, should be given and the reference cited. The relationship to the
administered dose should be clarified.
b. Supply a dosimetry table for the maximum amount of radioactivity to be injected.* The
table should include contributions for all administered radioactivity, and refer to Effective Dose
Equivalents (EDE).
Organ
Dose to Organ
Cmpd 1 Dose
(mCi)
Dose to Organ
Cmpd 2 Dose
(mCi)
Dose to Organ
Dmpd 3 Dose
(mCi)
Total Dose
To
Organ
1.
2.
3.
4.
*The maximum allowable dose for a single injection is 3000mR to the whole body,
active blood-forming organs, lens of the eye and gonads. The dose to any other organ
cannot exceed 5000mR.
*The maximum allowable dose for one year is 5000mR to the whole body, active blood
forming organs, lens of the eye and gonads. The dose to any other organ cannot exceed
15,000 mR.
c. List minimum and maximum inject activity to be administered:
d. Indicate total number of subjects proposed for this activity . Provide statistical
justification for this number.:
e. Provide age, sex, and approximate weight of study population.
f. Will subjects under the age of 18 years old be enrolled in this study?
No
Yes
g. Indicate number of doses per subject per year:
h. Indicate number of doses per subject per protocol:
3. Other Study Drugs:
a. Will there be any non-radioactive agent administered?
No
Yes →Will the agent alter the distribution of the radioactivity?
No
Yes → Briefly describe what effect the non-radioactive
agent will have upon that distribution:
a. Critical or ‘target’ organs:
b. Gonadal exposure:
H. Maintenance of radionuclide administration and subject
response documentation:
Provide detail regarding how records of radionuclide administration and subject responses are
maintained, including their location:
I.
J.
External Irradiation of Subject:
1.
Provide radiation source:
2.
Provide whole-body dose to the subject:
3.
Identify organ or area where the radiation is concentrated and give dose:
4.
Describe how radiation dose to the subject is verified:
5.
Describe how the radiation source is calibrated:
6.
Describe monitoring of possible leakage from the external radiation source:
Miscellaneous:
a. Storage location of radioactive drug:
b. Location(s) of the study (room, building):
c. Expected duration of the study:
K.
Principal Investigator Certification
By signing this application below, the Principal Investigator certifies the following:
a. The activity for which RDRC approval is being requested will be conducted in compliance
with SBU’s RDRC policy and SOP’s, as well as FDA 21 CFR 361.1.
b. The activity will be conducted in compliance with SBU RAM license terms and conditions.
c. The activity will not commence until RDRC and IRB approvals are obtained.
d. All adverse reactions associated with the use of the radioactive drug will be reported within 5
working days to the RDRC and IRB.
e. All research personnel working with radioactive materials have received radiation safety
orientation and annual radiation safety training commensurate with their duties.
f. No changes will be implemented to this activity without prior approval of the RDRC and
IRB, unless a deviation from protocol is required for the immediate safety of a subject (in
which case, immediate report of the deviation will be made to the RDRC and IRB).
g. Provide the RDRC committee with an annual list of subjects recruited as well as the dates
and amounts of radioactive drug administered.
Principal Investigator Signature
Date