Columbia University
Radioactive Drug Research Committee
Version 6
October 2012
RDRC APPLICATION FOR THE USE OF RADIOPHARMACEUTICALS IN CERTAIN
BASIC RESEARCH STUDIES
Note: All research activities involving the use of ionizing radiation in human subjects must
be approved by the Columbia University or New York State Psychiatric Institute
Institutional Review Board.
You may not submit this Application unless you have received the approval of the Director
of the Radiochemistry and Radiopharmaceutical Laboratories in the Columbia University
PET Center that the radiopharmaceutical that you intend to use in your study is eligible to
be reviewed by the RDRC.
Please refer to the Radiation Safety Program website
(http://www.ehs.columbia.edu/RadiationJRSC.html) for helpful information in completing
this Application, including:

Radiation Dose Estimates for Human Research Protocols Using Nuclear Medicine
Scans, CT Scans and/or General Radiographic Examinations:
http://www.columbia.edu/RadiationHumanDoseEstimates.html

Guidelines for Conducting Research Studies, Under the Auspices of the Columbia
University Radioactive Drug Research Committee:
http://www.ehs.columbia.edu/RadiationFormsMC.html
Contact the Columbia University Medical Center Radiation Safety Program Office at (212)
305-0303 for additional information.
Please check one of the following boxes:
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New Application
Amendment
If this Application is submitted as an Amendment to a previously approved Application, it
must be submitted with a cover letter indicating what information in this Application has
been changed and the rationale for each change.
I. STUDY
Study Title [Please use the same study title as is used on the related protocol]:
_____________________________________________________________________________
_____________________________________________________________________________
IRB Protocol Number [Please attach copy of the IRB related protocol or IRB protocol
modification (if applicable)]: ____________________
______________________________________________________________________________
Brief Description of Intent of Study:
Rationale for Study [Please submit data from published literature or other valid studies to
support your rationale]:
Design of Study:
II. PERSONNEL
PRINCIPAL INVESTIGATOR
Name: ____________________________________________ CU Title:__________________
First
MI
Last
Mail Address: __________________________________________________________________
Department or Service
Tel No.
(__)_____________________
Building
Room No.
Cell No. (___)___________________
E-mail Address _______________________
Provide your C.V.
CLINICAL AUTHORIZED USER [A physician authorized by the JRSC to administer
radioactive materials to humans, if the Principal Investigator is not a Clinical Authorized User]
Name: ____________________________________________ CU Title:__________________
First
MI
Last
Mail Address: __________________________________________________________________
Department or Service
Building
Room No.
Tel No.
(__)______________________
Cell No. (___)_____________________
E-mail Address ________________________
CO-INVESTIGATORS [list all]
Name: ______________________________________ CU Title:_________________________
Name: ______________________________________ CU Title: ________________________
Provide C.V. for each Co-Investigator.
III.
RADIOPHARMACEUTICAL INFORMATION
A. RADIOPHARMACEUTICALS TO BE USED IN THIS STUDY
Please complete the following information for each radiopharmaceutical to be used in this study.
Radiopharmaceutical
Chemical Form
Minimum
Pharmacological Dose (µg)
Supplier
Location where radiopharmaceutical will be administered: ______________________________
B. ADDITIONAL RADIOPHARMACEUTICAL INFORMATION
Provide the following information for each radiopharmaceutical to be used in this study. If more
than one radiopharmaceutical will be used, copy this section and fill out the requested
information for each.
If the study consists of more than one cohort with different dosing levels, the information below
should be repeated for each radiopharmaceutical used and for each radiation dosing level to be
used.
What supporting documentation are you using to provide information on the preparation and
evaluation of each radiopharmaceutical?
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Drug master file
IND
Manufacturer insert
RDRC
Please attach such documentation to this Application.
Please cite relevant published literature or other valid human studies supporting the use of this
dose. If such supporting documentation is not available, provide a detailed description of the
preparation and evaluation of each radiopharmaceutical to be used.
Name of non-radioactive drug (i.e., moiety, active ingredient, compound or ligand):
______________________________________________________________________
Prescribed mass amount (in µg or mg): __________________________________________
Route of administration (e.g., IV, PO, etc.): ______________________________________
Inactive ingredients, if any: ___________________________________________________
Are there any contaminants or impurities associated with this non-radioactive drug? Yes
No
If so, which ones? ____________________________________________________________
Maximum permissible mass amount of non-radioactive drug, including impurities, to be
administered per subject per single dose at the expiration time of the radiopharmaceutical (in µg
or mg):_____________________________
No observed effect level (NOEL) mass dose: ______
[This is pharmacological dose of the nonradioactive drug that will not cause a clinically
detectable effect. Please provide supporting documentation for your conclusion.]
Maximum number of doses per subject for this study:
Per year: ______
Per protocol: _______
IV. RADIATION DOSE TO SUBJECTS FROM RESEARCH STUDY PROCEDURES
Complete the following table for each radiopharmaceutical identified in Section A above,
assuming that each dose will be received by a representative subject in your study. Include dose
calculations from any significant radiopharmaceutical contaminants or impurities as well as from
the radiopharmaceutical. List sources from the published literature or other valid studies to
support the dosimetry. For those radiopharmaceuticals for which no references are available, list
your assumptions and show your calculations. Add a table for each radiopharmaceutical.
Are there any significant contaminants or impurities associated with the radiopharmaceutical to
be used in this study?
Yes
No
If so, which ones? _______________________________________
Radiopharmaceutical
Organ/Tissue
Absorbed Dose
per
Administration
(mGy)
Total No. of
Administrations
per Study
Total Dose for
Study (mGy)
Effective Dose Per
Study (mSv)
Name:
Critical
Organs/Tissues1
Active Bloodforming Organs
(red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving thr highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1):
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Or list assumptions and show calculations: __________________________________________
____________________________________________________________________________
____________________________________________________________________________
V. RADIATION DOSES FROM RADIOGRAPHIC OR THERAPEUTIC RADIATION
FOR RESEARCH
If any subject is to receive ionizing radiation (other than from radiopharmaceuticals) from any
procedure in this study, including those procedures that constitute standard clinical practice and
are specifically required by the research protocol, complete the following table for each
procedure and list sources from the published literature or other valid studies to support the
dosimetry.
What other procedures will the subject undergo as part of this study?
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X-ray, including mammograms, DXA scans and dental scans
CT Scan
Radiotherapy, including brachytherapy
Fluoroscopy, including cardiac catheterization
X-rays, CT Scans, Radiotherapy
If any procedure involves x-rays, CT scans or radiotherapy for research, complete the following
table for each procedure, assuming that each dose will be received by a representative subject in
your study. If your study involves more than one procedure, complete an additional table for
each.
Procedure
Name:
Organ /Tissue
Absorbed Dose
per Procedure
(mGy)
No. of
Exposures
per Study
Total
Absorbed
Dose per
Study (mGy)
Effective Dose
per Study (mSv)
Critical Organs/Tissue1
Active Blood-Forming
Organs (red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1):
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Fluoroscopy
If the additional procedure involves fluoroscopy for research, complete the following table,
assuming that each dose will be received by a representative subject in your study:
Organ /Tissue1
Procedure
Name:
Maximum
Dose per
Procedure
(mGy)
Number of
Procedures
per Study
Total
Maximum
Dose for Study
(mGy)
Total Maximum
Effective Dose for
Study (mSv)
Critical Organs/Tissues1, 2
Skin
Active Blood-Forming
Organs (red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1): _________
_____________________________________________________________________________
_____________________________________________________________________________
VI. SUMMARY DOSIMETRY TABLES
Please provide the total radiation dose for this study (sum of doses from all procedures listed in
Sections IV and V above), assuming that each dose will be received by a representative subject
in your study.
Organ /Tissue
Total Dose for Study
(mGy)
Total Effective Dose for Study
(mSv)
Critical Organs/Tissues1
Active Blood-Forming Organs
(red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
If any subject has received or will receive radiation doses, within 12 months of the subject’s
participation in this study, from additional studies that you have conducted or intend to conduct
or of which you have knowledge, complete the following table with respect to all radiation doses
administered within such 12-month period, assuming that each dose will be received by a
representative subject in your study. Replicate this table for each study.
Study Name
Organ /Tissue
Total Dose for
Study (mGy)
Total Effective Dose for Study
(mSv)
Critical Organs/Tissues1
Active Blood-Forming Organs
(red marrow)
Lens of the Eye
Gonads
Other Organs/Tissues1
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is
available.
VII.
SUBJECT INFORMATION
A. ADULT SUBJECTS
Note: no more than 30 subjects are permitted in a study.
How many adult subjects do you propose using in this study?
Number of males: __________
Number of females: _________
Total number of subjects: _____________
Age range of subjects: From __________ to _________
How do you propose to establish and document the non-pregnant status of subjects of childbearing potential? ____________________________________________________________
___________________________________________________________________________
B. MINOR SUBJECTS
Note: no more than 30 subjects are permitted in a study.
[Minor subjects are those under the age of 18.]
How many minor subjects do you propose using in this study?
Number of males: __________
Number of females: _________
Total number of subjects: _______
Age range of subjects: From ______________ to ______________
Please provide the justification for using minor subjects in the study. _____________________
_____________________________________________________________________________
_____________________________________________________________________________
VIII.
SIGNATURES
Each of the Principal Investigator and, if applicable, the Clinical Authorized User certifies that
the information provided in this Application is complete and correct and agrees that he/she will:
A. Comply with all applicable federal, state and local laws and Columbia University policies
regarding the safe use of radiopharmaceuticals and the protection of human subjects in
research.
B. Perform the study in accordance with the Application and the related IRB Protocol.
C. Implement no changes in this Application or the IRB Protocol without prior IRB and
RDRC approval.
D. Promptly report any adverse effects from the use of the radiopharmaceuticals in the study
to the RDRC.
Principal Investigator:
_____________________________
Print Name
____________________________
Signature
__________
Date
____________________________
Signature
__________
Date
Clinical Authorized User:
_____________________________
Print Name