Form FDA 2915 FDA 2915 Study Summary

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC) REPORT ON RESEARCH USE OF RADIOACTIVE DRUGS STUDY SUMMARY				Form Approved: OMB No. 0910-0053. Expiration Date: 2/29/08				FOR FDA USE ONLY
				DATE OF SUBMISSION      
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A. GENERAL INFORMATION
1. TYPE OF REPORT (please mark one) : Special Summary Annual Report (Use a separate copy of this Form FDA 2915, to summarize each study conducted during the reporting period and attach to Form FDA 2914.)		3. NAME OF INSTITUTION      
		4. NAME AND ADDRESS OF IRB      
2. RDRC COMMITTEE NUMBER     
B. SPECIFIC INFORMATION
1. RESEARCH PROJECT
	Title of Research Project      
	b. Study ID Number      		c. Original Study Approval Date      		Study Termination Date      
2. BRIEF DESCRIPTION OF THE PURPOSE OF THE RESEARCH PROJECT      
3. NAME OF RESPONSIBLE INVESTIGATOR (NOTE: Also name the prescribing physician if other than the responsible investigator.)      

B. SPECIFIC INFORMATION (Continued)
4. PHARMACOLOGICAL DOSE (Based on pharmacological data available from studies in human subjects, the dose should be known not to cause any clinically detectable pharmacological effect in human beings.)
Study Drug #1
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.2) No-observed-effect-level (NOEL) mass dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   
Study Drug #2
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.2) No-observed-effect-level (NOEL) mass dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   
Study Drug #3
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.2) No-observed-effect-level (NOEL) mass dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   

B. SPECIFIC INFORMATION (Continued)
4. PHARMACOLOGICAL DOSE (Continued)
Study Drug #4
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   
Study Drug #5
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   
Study Drug #6
Provide the Reference, supplied by the investigator and/or used by the RDRC, to show that the amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, based on pharmacological dose calculations on data available from published literature or from other valid human studies [21 CFR 361.1 (b)(2) and (d)(2)].
     
(a) Name of the nonradioactive drug      
(b) Mass dose
(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      				(b.1) Maximum mass dose (i.e.µ, g or mg) of nonradioactive drug administered per subject, per single dose      
c. Number of doses per subject.			(d) Route of administration (i.e., I.V., P.O., etc.)      		(e) If the radio active drug or nonradioactive drug is under an IND, list IND Number.      
(c.1) Maximum number of doses per subject per year   		(c.2) Maximum number of doses per subject per protocol   

B. SPECIFIC INFORMATION (Continued)
5. LIST THE RADIONUCLIDE(S) WITH THE ASSOCIATED STUDY DRUG FROM ITEM 4 AND IDENTIFY AND QUANTITATE THE MAXIMUM RADIONUCLIDIC CONTAMINANTS IN THE ADMINISTERED RADIOACTIVE STUDY DRUG(S).
	Radionuclide Label	Associated Study Drug	Radionuclidic Contaminant	Percent (%)
#1	     	     	     	     
#2	     	     	     	     
#3	     	     	     	     
#4	     	     	     	     
#5	     	     	     	     
#6	     	     	     	     
6. RADIATION ABSORBED DOSE -- List reference, (e.g., ICRP) and/or show calculations used to estimate the radiation absorbed dose for each radioactive study drug used in this project.
#1	     
#2	     
#3	     
#4	     
#5	     
#6	     
Show calculations here (may continue calculations on attachment if necessary).      

B. SPECIFIC INFORMATION (Continued)
6. RADIATION ABSORBED DOSE (Continued)
FOR A SPECIAL SUMMARY: Enter information below for a representative subject, using the provided format (refer to "Specific Instructions" pages for more information).
a.			b.	c.	d.
AGE	SEX		ACTIVITY OF RADIOACTIVE STUDY DRUG(S) ADMINISTERED AND OTHER ASSOCIATED PROCEDURES	ABSORBED DOSE PER SINGLE ADMINISTRATION (for each radioactive study drug)	TOTAL DOSE PER ORGAN / PER YEAR
     			Radioactive Drug       MBq or       µCi or       mCi of       radioactive study drug Other Associated Procedures PET transmission scans CT DEXA X-Ray Other (Specify:)      	From Radioactive Drug       mSv (Rem) / whole body       mSv (Rem) / lens of eye       mSv (Rem) / gonads       mSv (Rem) /       (critical organ)       mSv (Rem) /       (Blood forming organ) From Other Associated Procedures       mSv (Rem) / whole body       mSv (Rem) / lens of eye       mSv (Rem) / gonads       mSv (Rem) /       (critical organ)       mSv (Rem) /       (Blood forming organ)	      mSv (Rem) / whole body       mSv (Rem) / lens of eye       mSv (Rem) / gonads       mSv (Rem) /       (critical organ)       mSv (Rem) /       (Blood forming organ)
					Additional comments or information, if any, regarding Total Dose:      
FOR AN ANNUAL REPORT: Enter information below for each subject studied, using the provided format (refer to "Specific Instructions" pages for more information).
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     

B. SPECIFIC INFORMATION (Continued)
6. RADIATION ABSORBED DOSE (Continued)
a.		b.	c.	d.
AGE	SEX	ACTIVITY OF RADIOACTIVE STUDY DRUG(S) ADMINISTERED AND OTHER ASSOCIATED PROCEDURES	ABSORBED DOSE PER SINGLE ADMINISTRATION (for each radioactive study drug)	TOTAL DOSE PER ORGAN / PER YEAR
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     
     	     	     	     	     

B. SPECIFIC INFORMATION (Continued)
6. RADIATION ABSORBED DOSE (Continued)
a.		b.		c.	d.
AGE	SEX	ACTIVITY OF RADIOACTIVE STUDY DRUG(S) ADMINISTERED AND OTHER ASSOCIATED PROCEDURES		ABSORBED DOSE PER SINGLE ADMINISTRATION (for each radioactive study drug)	TOTAL DOSE PER ORGAN / PER YEAR
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
     	     	     		     	     
e. NUMBER OF RESEARCH SUBJECTS STUDIED THIS REPORTING YEAR					     
f. NUMBER OF RESEARCH SUBJECTS STUDIED THIS REPORTING YEAR UNDER 18 YEARS OF AGE					     
g. CUMULATIVE NUMBER OF RESEARCH SUBJECTS STUDIED FROM INITIATION OF THIS PROTOCOL THROUGH END OF THIS REPORT					     
h. TOTAL NUMBER OF RESEARCH SUBJECTS FOR WHICH THIS PROTOCOL IS APPROVED					     
If additional space is needed, attach separate sheets.
7. CLAIM OF CONFIDENTIALITY Contents of this report are available for public disclosure unless confidentiality is requested by the investigator and it is adequately shown by the investigator that the report constitutes a trade secret or confidential commercial information as defined in 21 CFR 20.61. I do not claim confidentiality. I claim confidentiality; justification is attached.
RETURN COMPLETED FORM TO: Food and Drug Administration Center for Drug Evaluation and Research Office of Oncology Drug Products 5901-B Ammendale Road Beltsville, MD 20705-1266 Attention: RDRC			8. CERTIFICATION
			The undersigned certify that the study outlined above complies with Title 21 CFR Section 361.1 and that the responses are true and accurate as outlined above.
			SIGNATURE OF INVESTIGATOR			DATE
			SIGNATURE OF CHAIRPERSON OF RADIOACTIVE DRUG RESEARCH COMMITTEE			DATE

Instructions for Completing Radioactive Drug Research Committee (RDRC)
Report on Research Use of Radioactive Drugs -- Study Summary
(Form FDA 2915)

Basic research with radioactive drugs may be conducted without an Investigational New Drug Application (IND)

when the research is conducted under a FDA-approved Radioactive Drug Research Committee (RDRC) and other

conditions, as specified in the RDRC regulations, are met.

RDRC regulations are contained in Title 21, Code of Federal Regulations, Part 361.1 (21 CFR 361.1) and maybe

accessed at the following web address:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1

Guidance regarding RDRC procedures is available from the FDA Center for Drug Evaluation and Research,

Office of Oncology Drug Products, 5901-B Ammendale Road, Beltsville, MD 20705-1266. Information about the

FDA RDRC program is available at the RDRC web site at the following web address:

http://www.fda.gov/cder/regulatory/RDRC/default.htm

Access to RDRC reporting Forms (2914 - Membership Summary and 2915 - Study Summary) in both Adobe

Acrobat and Microsoft Word versions, which can be filled out and saved on your computer, can be obtained

through the RDRC web site or from the following FDA Forms website:

http://www.fda.gov/opacom/morechoices/fdaforms/default.html

The following instructions address only the administrative aspects of preparing and submitting Form FDA 2915

(Study Summary) for the following RDRC submissions:

1. Annual Report (requirement – 21 CFR 361.1 (c)(3) Reports)

The annual report, due on or before January 31 of each year, consists of submission of Form FDA 2914

(Membership Summary) and Form FDA 2915 (Study Summary) for each study conducted during the

preceding calendar year. A Form FDA 2915 (Study Summary) should be submitted even for studies that did

not enroll any subjects in the preceding calendar year but have been previously approved by the RDRC and

are still open and ongoing.

2. Special Summary (requirement – 21 CFR 361.1 (c)(3) Reports)

A special summary must be submitted to FDA at the time the RDRC approves research studies involving

more than 30 subjects or involving subjects under the age of 18. A special summary consists of the

submission of Form FDA 2915 (Study Summary) and a justification for the number of subjects or the

inclusion of subjects under 18 years of age. In addition, provide the maximum radiation dose commitment for

the organs listed in 21CFR361.1(b)(3)(i) for a representative subject.

WHERE TO SEND THE SUBMISSION: Food and Drug Administration
Center for Drug Evaluation and Research
Office of Oncology Drug Products
5901-B Ammendale Road
Beltsville, MD 20705-1266

ATTN: RDRC

Specific instructions for filling out this report begin on the next page.

SPECIFIC INSTRUCTIONS FOR FILLING OUT FORM FDA 2915

(Titles and numbers, when used, correspond to the item blocks on Form FDA 2915)

When completing this form, and not enough space is provided for reporting in a section, attach a separate

sheet with each information reporting section appropriately identified.

Section A. General Information

1. Type of Report – Check the appropriate box indicating whether this is a special summary or an annual report. If this is a special summary, provide a justification for the need to study more than 30 subjects
   or to study subjects under the age of 18. Studies involving minors must be supported with review by a qualified pediatric consultant to the RDRC and documented in the special summary.

2. RDRC Committee Number – Provide the committee number assigned by FDA when the RDRC was initially approved.

3. Name of Institution – Provide the name of the medical institution to which the RDRC is affiliated.

4. Name and Address of IRB – Provide the name and address of the Institutional Review Board (IRB)
   that approved the study protocol.

Section B. Specific Information

1. Research Project – Check the appropriate box indicating whether this is a special summary or an
annual report. If this is a special summary, provide a justification for the need to study more than 30 subjects or to study subjects under the age of 18. Studies involving minors must be supported with
review by a qualified pediatric consultant to the RDRC and documented in the special summary.

a. Title of Research Project – Provide a unique and brief title of the research protocol that includes the name of the radioactive drug¹.

b. Study ID Number – Provide the unique number assigned to the research protocol by the Institution or RDRC for tracking purposes. A study ID number must be provided.

c. Original Study Approval Date – Provide the date the research protocol was approved by the
RDRC for the first time.

d. Study Termination Date – Provide the date the research protocol was completed or terminated.

2. Concise and Complete Description of the Research Project – Self-explanatory.

2. Name of Responsible Investigator – Provide the name of the Principal Investigator and the name of
   the prescribing physician, if other than the Principal Investigator.

4. Pharmacological Dose – This is the mass dose of the nonradioactive drug to be investigated that will
not cause a clinically detectable pharmacologic effect in humans. Please cite relevant published literature or other valid human studies supporting the use of this dose. If necessary, attach a separate sheet.

a. Name of the Nonradioactive Drug – Provide the name of the nonradioactive drug being
investigated. The use of the term "drug" in this section is synonymous with the terms moiety,
active ingredient, compound, or ligand.

b. Mass Dose

b.1. Maximum mass dose – This is the maximum amount of nonradioactive drug administered per
subject per single dose at the expiration time of the radiolabeled drug to be administered. Indicate amount in terms of mass or weight expressed in units of µg or mg only.

b.2. No observed effect level (NOEL) mass dose – This is the pharmacologic dose of the
nonradioactive drug that will not cause a clinically detectable pharmacologic effect in humans.
This is not necessarily the administered dose.

3. Maximum number of doses per subject – Specify the number of administrations of the radioactive drug a research subject may receive per year and the total number of doses specified in the protocol.

c.1 -- Maximum number of doses per subject per year

c.2 -- Maximum number of doses per subject per protocol

d. Route of administration – Indicate the route of administration (e.g. I.V., P.O., etc.).

e. If the drug is under an IND, list IND Number – If the radioactive drug or the nonradioactive drug is being investigated under an Investigational New Drug Application (IND), identify the IND number.

5. List the radionuclides with the associated drug and identify and quantitate the maximum
radionuclide contaminants in the administered radioactive drug upon expiration. –
Self-explanatory.

^1. The term "radioactive drug" is defined in 21 CFR 310.3(n) and includes a "radioactive biological product" as defined in 21
CFR 600.3(ee).

FILLING OUT FORM FDA 2915 (Continued)

Section B. Specific Information (Continued)

6. Radiation Absorbed Dose

• All study summaries should list the specific reference(s) that were used to estimate the dose commitments (e.g., ICRP Publication 80 Table 3.2.1). For those radioactive drugs for which no reference(s) are available, list your assumptions and show your calculations. The report should
  include the dose contribution from the administered radioactive study drug and any other
  associated procedures (i.e., would not have occurred but for the study) contributing to the radiation absorbed dose.

• For a special summary, provide the maximum radiation dose commitment to the whole body, the critical organ, and each organ as specified in 21 CFR 361.1(b)(3)(i) received by a representative subject.

• For an annual report, provide the radiation dose commitment to the whole body, the critical
  organ, and each organ as specified in 21 CFR361.1(b)(3)(i) received by each subject receiving the radioactive study drug during the reporting calendar year. For each subject, provide (a) Age and
  Sex; (b) the amount of radioactivity administered for each radioactive study drug used; (c)
  the absorbed dose to the whole body, the critical organ, and each organ specified in 21 CFR 361.1(b)(3)(i) per single administration for each radioactive study drug and other procedures associated
  with the study; and (d) the resultant cumulative radiation dose to the subject for the whole body
  and organs referenced above within the calendar year.

1. Age and Sex – Specify the age and sex for each individual research subject studied.

2. Activity of Radioactive Study Drug(s) Administered and Other Associated Procedures – For each individual research subject identified in column a, provide the amount of radioactivity administered along with the name of each radioactive study drug received. Express each amount of radioactivity in MBq, µCi, or mCi. FDA prefers you use the International System of Units (SI). Note: 37 MBq =1mCi.

For other associated procedures (i.e., would not have occurred but for the study), identify the sources of radiation.

3. Absorbed Dose per Single Administration – Provide theradiation absorbed dose in mSv [1mSv =
   100 mrem] for each target organ, e.g. whole body, lens of eye, gonads, and critical organ(s).

4. Total Dose Per Organ/Per Year – Provide the total cumulative radiation dose from the radioactive study drug(s) and associated procedures received per organ for a 12-month period of time, usually a calendar year, unless otherwise specified.

5. Number of Research Subjects Studied this Reporting Year – Self-explanatory.

6. Number of Research Subjects Studied this Reporting Year Under 18 years of Age –
   Self-explanatory.

7. Cumulative Number of Research Subjects Studied from Initiation of this Protocol Through End of this Report – Self-explanatory.

8. Total Number of Research Subjects for Which this Protocol is Approved – Self-explanatory.

7. Claim of Confidentiality – Indicate whether or not you are claiming confidentiality. If confidentiality is claimed, attach a justification demonstrating that this report constitutes a trade secret or confidential information as defined in 21 CFR 20.61.

8. Certification – The Principal Investigator and the RDRC chairperson must sign the form. Indicate the date(s) the form is signed by the Principal Investigator and by the RDRC chairperson.

FORM FDA 2915 (11/06) PREVIOUS EDITION IS OBSOLETE. PAGE 3 of 14 PAGES