FOOD AND DRUG ADMINISTRATION  
COMPLIANCE PROGRAM   PROGRAM   7348.809A  
 
CHAPTER 48   Bioresearch Monitoring  
SUBJECT:   IMPLEMENTATION  DATE:  
RADIOACTIVE DRUG RESEARCH COMMITTEES   04/16/2018  
DATA REPORTING  
PRODUCT  CODES   PRODUCT/ASSIGNMENT  CODES  
Product codes  are not required under   48809A Radioactive Drugs for Human Use  
this program.  
 
FIELD REPORTING REQUIREMENTS:  
Copies of  all establishment  inspection reports (EIRs) complete with attachments,  
exhibits, and any related correspondence are to be submitted promptly to the Center  
(usually  the  reviewer  in  the  Centers  Bioresearch  Monitoring  (BIMO)  program  
identified in the assignment).  
 
All EIRs should be completed in accordance with 
https://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM 
382035.pdf, Establishment Inspection Report (EIR)  - Inspection Conclusions and 
District Decisions and the Investigations Operation Manual (IOM),  Chapter 5,  
Establishment Inspections. When an FDA Form  483, Inspectional  Observations  
(483), is issued, a copy should be forwarded to the Center contact  (by facsimile or e
mail, or filed in a shared folder, as agreed to with the Center), as soon as possible,  
generally within 3 business days after being issued.  
   
 
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Contents  
PART I   BACKGROUND ............................................................................................................ 3 
 
PART II  - IMPLEMENTATION.................................................................................................... 5 
 
  Objective ...................................................................................................................................... 5 
 
  Program Management Instructions ..............................................................................................5 
 
  Operations .................................................................................................................................... 5 
 
PART III - INSPECTIONAL  ....................................................................................................... 14 
 
  Operations .................................................................................................................................. 14 
 
  Reporting.................................................................................................................................... 14 
 
  Establishment Inspections ..........................................................................................................15 
 
  Prior Notification of Intent to Inspect ........................................................................................15 
 
  Refusal to Inspect .......................................................................................................................15 
 
  Subsequent  Related Sponsor/Investigator Inspections  ..............................................................15 
 
  Inspection Procedures ................................................................................................................16 
 
  Electronic Records and  Electronic Signatures ...........................................................................19 
 
PART IV - ANALYTICAL .......................................................................................................... 23 
 
PART V - REGULATORY/ADMINISTRATIVE STRATEGY ................................................. 24 
 
  Administrative Procedural Information .....................................................................................24 
 
  Regulatory  Procedures for Classification  ..................................................................................25 
 
  Follow-Up Inspections ...............................................................................................................28 
 
  Post-Inspection Information Sharing .........................................................................................28 
 
PART  VI   REFERENCES, ATTACHMENTS,  AND PROGRAM CONTACTS ...................... 29 
 
  References .................................................................................................................................. 29 
 
  Program Contacts .......................................................................................................................30 
 
PART VII  - HEADQUARTERS RESPONSIBILITIES  .............................................................. 31 
 
  Center for Drug Evaluation and Research (CDER): ..................................................................31 
 
  ORA/OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS (OEIO)/DIVISION OF  

ENFORCEMENT (DE)  ....................................................................................................................31 
 
  ORA/OFFICE OF  BIORESEARCH MONITORING OPERATIONS (OBIMO) ....................31 
 
 
 
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PART I    BACKGROUND  
A.   GENERAL  
 
Under 21 CFR 361.1, human research using a radioactive drug or biological  
product  may be conducted without an Investigational New Drug (IND) 
application under an FDA approved Radioactive Drug Research Committee 
(RDRC), but only when that research is basic science research, and not  
research that is intended for immediate therapeutic, diagnostic, or  similar  
purposes, or to determine the safety and effectiveness of  the radioactive drug 
or biological product for such purposes. Such research cannot be considered 
a clinical trial for the product.  
 
 
B.   AUTHORITY AND PROCEDURES  
 
The Federal Register  of July 25,  1975, includes a final order establishing 
regulations, which specify the conditions under which radioactive drugs for  
certain research uses, other  than clinical trials for safety and efficacy, are not  
subject to the new drug requirements of  the Federal Food, Drug and  Cosmetic  
Act as amended.  
 
Radioactive drug is defined in 21 CFR Section 310.3(n):  
 
The term radioactive drug means any substance defined as a drug in section  
201(g)(1)  of the Federal Food, Drug, and Cosmetic Act which 
exhibits spontaneous  disintegration  of unstable nuclei  with the 
emission of nuclear particles or photons and includes any  
nonradioactive reagent kit or nuclide generator which is intended 
to be used in the preparation of any such substance but does not  
include drugs such as carbon-containing compounds or  
potassium- containing salts which contain trace amounts of  
naturally occurring radionuclides. The term radioactive drug  
includes a radioactive biological product as  defined in section 
600.3(ee)  of this chapter.  
 
To be exempt from  the requirements of  the new drug regulations, radioactive 
drugs intended for basic research in humans  must  meet the requirements of 21 
CFR 361.1. This section provides exemptions for  radioactive drugs used in 
research that are approved and monitored by a Radioactive Drug Research 
Committee. Section 361.1 specifies the criteria for  the performance of such a 
committee.  
 
 
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An additional regulation has been promulgated at 21 CFR 201.129, which provides  
an exemption from  section 502(f)(1) (adequate directions for use) of  the Federal  
Food, Drug, and Cosmetic Act if the packaging, labels, and labeling of the research 
drugs are in compliance with section 361.1(f) of FDA regulations.  
 
 
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PART II  - IMPLEMENTATION  
  Objective  
The objective of  this program  is to determine whether Radioactive Drug 

Research Committees (RDRCs) are operating in compliance with 21 CFR 361.1. 
 
In addition, the objective of the program  is to ensure that FDA  meets its  

requirement to  monitor the activities of  RDRCs by conducting on-site inspections  

as required by 21 CFR 361.1(c)(5). Any RDRC that is determined to be seriously  

out of compliance with the regulations  may have its approval withdrawn as  

described in 21 CFR 361.1(c)(4).  

  Program  Management Instructions  
A.   Coverage  -- This program  provides for  the  inspection  of  all  RDRCs.  These  
FDA  approved committees review  and  approve  certain  research  uses of  
radioactive  drugs that  are generally recognized  as safe  and  effective  
(GRASE).  These  radioactive  drugs must  be administered  under  the  
conditions set  forth  in  21  CFR  361.1(b),  primarily (1)  the  study  must  be  
approved  by the  RDRC,  (2)  the  RDRC  must  assure  that  the  amount  of  
active ingredient  administered  causes no  clinically detectable  
pharmacological  effect  and  (3)  that the  subjects receive  the  smallest  
practical  radiation  dose  to  do  the  study without jeopardizing  the  benefits to  
be  obtained  from  the  study.  
 
B.   Due  Dates -- All  assignments will  be  issued  by  the  Center  for  Drug  
Evaluation  and Research  (CDER),  Office  of  Scientific Investigations 
(OSI)  and  will  have  a  ninety (90) day completion  date  unless otherwise  
indicated.  
  Operations  
 
Each inspection should include a comparison of the practices and procedures  
of the RDRC with the requirements of 21 CFR 361.1.  
 
RDRC inspection assignment  memorandums will be issued by CDER/OSI in  

consultation with the Division of Medical Imaging Products (DMIP). 

Assignments will be issued both on a routine and for cause basis. 
 
 
The Office  of Regulatory Affairs (ORA) field  investigators will conduct the inspections of  
RDRCs and  will complete an establishment inspection report at  the conclusion of each 
inspection. If, during an inspection attempt, the field investigator determines that the FDA  
lacks jurisdiction over the site (i.e., the RDRC has dissolved, the RDRC is not currently  
 
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monitoring research, etc.),  the inspection will be completed as per the directions in the 
IOM. A copy of the  memorandum  will be promptly submitted to the Center.  
 
When scheduling the inspection, the FDA investigator will contact both the administrator 
of the institution and the chairman of the RDRC. An individual contact person for the site  
visit should be identified, and the time interval between the notification and the inspection 
should be as short as possible.  
 
Each ORA BIMO Division will assign a Field Establishment Inspection 
(FEI) number  for RDRCs located within their Division. ORA BIMO  
Divisions will be responsible for  maintaining the individual RDRC 
operational status in the database.  
 
The Institutional Review Board compliance program  is different and does not  
include coverage of the Radioactive Drug Research Committees (RDRCs).  
Requesting and assessing inspections of RDRCs are the responsibility of  
CDER/OSI, after consultation with the Division of Medical Imaging  
Products/Office of Drug Evaluation (ODE)  IV. Issuing inspection request  
assignments which include both an IRB and a RDRC will be the responsibility  
of CDER/OSI.  
 
A.   Inspection  Assignments  
 
i.   CDER/OSI  issues inspection  assignments of  RDRC  sites.  
 
ii.   To  ensure  the  appropriate  and  efficient  use  of  FDA  
resources,  RDRC  assignments will  follow FMD  No.  17,  
ORA  Field  Assignments - Guidelines for  Issuance  by  
Headquarters,  whether  from  an  ORA  headquarters unit  
or  a  Center.  
 
iii.   The  assignment  should  identify:  
 
a. 	  The program  assignment code (PAC) and 
Field Accomplishments and Compliance 
Tracking System  (FACTS)  and/or eNSPect  
number  , Firm  Establishment Identification 
(FEI) number, if known;  
 
b. 	  The name, address and phone number  of the 
RDRC, when available, to be inspected;  
 
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c.	   The type and purpose of  the inspection (e.g., routine 
inspection (surveillance), directed inspection 
(complaint,  OAI follow-up, For Cause));  
 
d. 	  The background materials that are being sent from 
 
the Center  to facilitate  the inspection (e.g., annual  

reports); 
 
 
e. 	  Specific issues or concerns (if applicable) that need 

to be addressed during the inspection; 
 
 
f. 	  The due date for the Center contact to receive the completed 
EIR;  
 
g. 	  The headquarters address where the EIR should be sent;  and  
 
h. 	  The name, telephone number, and fax number of  the Center  
contact(s).  
 
d.	   Inspection  of  the  Department  of  Veterans Affairs 

(VA)  as the  RDRC  of  FDA- regulated  clinical 
 
trials.  

 
iv.   Pre-Inspection  
a. 	  Center. The BIMO unit in the assigning Center will provide 
the VAs Office of  Research Oversight (ORO) with written  
notification of  FDAs intention to inspect a VA RDRC 
program  at the time an assignment is being issued to the 
field. Information on the VAs ORO is at:  
http://www.va.gov/ORO/about_us.asp#sthash.ABGMdXOR 
.dpuf.  
 
The notice should be sent to:  
Executive Director 
  
Office of Research  Oversight (10R) 
  
Veterans Health Administration 
 
Department of Veterans Affairs  

810 Vermont Avenue, N.W., Suite 574  

Washington, D.C. 20420  

 
b.   Field. The field investigator will contact the VA  
RDRC program  described in the assignment prior  
to the inspection, as they would any other  RDRC  
they are assigned to  inspect. Contact information 
 
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for the VA  RDRC will  be provided in the 
assignment.  
 
v.   Post-Inspection  
 
a. 	  Center. The Center will provide the VAs ORO  
redacted copies of  post- inspection 
correspondence issued to VA RDRC programs 
that include a discussion of deficiencies noted 
during the inspection (including the FDA-483s).  
Such materials should be sent to:  
 
Executive Director  
Office of Research Oversight (10R)   
Veterans Health Administration  
Department of Veterans Affairs  
810 Vermont Avenue, N.W., Suite 574  
Washington, D.C. 20420  
 
b.   Field.  If, following receipt of the FDA  
correspondence, the VA-ORO requests a copy of  
the EIR, a redacted copy of the report will be 
provided to VA-ORO by the ORA BIMO Division  
office.  
 
vi. 	  All  headquarters and  field  personnel  who  become  aware  of  
complaints or  problems related  to  an  RDRC  are  
encouraged  to  refer  them  to  the  CDER/OSI  contact  with  a 
recommendation  for  inspection.  All  recommendations 
should  include  the  following:  
 
a. 	  The name and address of  the RDRC;  
 
b. 	  If  available, the name(s)  of  the test article(s) being 
investigated; and  
 
c. 	  The basis for the recommendation and any relevant  
documentation.  
 
B.   Communication  between  the  Centers and  the  ORA BIMO Divisions  
Inspectional observations documenting that an RDRC is not operating in 
compliance with the regulations in 21 CFR Part 361.1 may be used as evidence 
for taking appropriate administrative and/or enforcement actions. Ensuring that  
the evidence collected to support  such actions is both appropriate and adequate 
 
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requires that communication lines between the ORA BIMO Division office and the 
Center be established early and maintained throughout the entire process, i.e.,  
until post-inspectional correspondence is issued by the Center.  
 
i.   Prior  to  an  Inspection  
 
a. 	  The Center issues an assignment that includes contact  
information  for the BIMO reviewer.  
 
b.   The field investigator contacts the BIMO reviewer:  
 
1.   Upon receipt of  the assignment, to establish 
initial contact and/or provide an inspection 
start date;  
 
2.   When the inspection date is firmly set, to 
alert the BIMO  reviewer and/or a back-up to 
be available and to establish the most  
appropriate  means of  contact for  both the 
investigator and the BIMO  reviewer/back-up;  
 
3.   To obtain any new information that  
may change the focus of  the 
inspection;  and  
 
4.   To coordinate inspection 
arrangements if Center personnel plan 
to participate in the inspection.  
 
ii. 	  Special  Considerations  
a. 	  In particular cases,  the Center  may arrange for a 
consultative teleconference immediately prior to the 
inspection(s) if, for example, the complexity  of issues,  
urgency of  feedback, compliance history, etc., trigger the 
need to discuss issues further. Such conference calls  are 
most likely when the agency encounters special situations  
(e.g., directed inspections where pertinent  information is  
either complex or needs discussion between the Center  
and the field). Unless information necessitating this  
discussion emerges after the assignment is issued, the 
assignment will usually include information as to when this  
teleconference will occur.  
 
 
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b.   These teleconferences  may include the following 
participants, as warranted and feasible:  
 
1.   BIMO  reviewer (and supervisor/division director or  
other staff,  as appropriate);  
 
2.   DMIP reviewer (along with branch and division chiefs,  
if appropriate);  
 
3.   ORA Field investigator(s) assigned to the 
inspection(s), the ORA BIMO Program Expert (PE) 
(when not yet specifically assigned), and ORA BIMO  
management and staff, as appropriate.  
 
iii.   During an Inspection  
a.   The BIMO  reviewer contacts the field investigator  if  
significant new information becomes available.  
 
b.   The field investigator contacts the BIMO reviewer or  
designated back-up person if the field investigator:  
 
1.   needs advice or clarification. The BIMO  reviewer and 
field investigator should strive to be accessible to one 
another as  much as possible during the time that the 
inspection is ongoing.  
 
2.   uncovers other evidence of concern warranting 
discussion with Center staff.  
iv.   After  an Inspection  
a.   As soon as possible but within three (3) business days  
after conclusion of the inspection, the field investigator  
forwards to the BIMO  reviewer (by facsimile, e-mail, or  
placement in the appropriate shared drive folder) any 483 
that is issued.  
 
b.   The field investigator/ORA BIMO Division will forward as  
soon as possible to the BIMO reviewer a copy of any  
written response to the 483 by the inspected party. The 
BIMO  reviewer will forward to the field investigator, a 
copy of any response to a 483 that does not  appear to 
have been shared with the inspecting ORA BIMO  
Division. If  desirable, the field investigator provides  
Center contact information so that the response to the 
 
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483 can be sent directly to the Center for review in 
addition to sending it to the field inspector/ORA BIMO 
Division Office.  
 
c.	   The BIMO  reviewer consults with the field investigator  
and their supervisor as needed when reviewing the EIR.  
 
d.   When applicable, the Center consults with appropriate 
ORA BIMO Division personnel if contemplating an EIR  
classification different from  the one recommended by  
ORA.  
 
e. 	  If  the Centers final classification is different from  the one 
recommended by the field, the Center will discuss the re
classification with ORA BIMO Division personnel to  
ensure they are aware of the change and reasons for  the 
change.  
 
f. 	  The Center promptly forwards to the field investigator and 
other appropriate ORA BIMO Division management by  e
mail, if possible, copies of post-inspectional  
correspondence issued to the inspected party.  
 
g.   The Center enters the final classification.  
 
C.  Responsibilities of  Field  Investigators,  Inspection  Team  Leaders,  and  Headquarters  
Participants  
i. 	  When  conducting  solo  inspections,  the field investigators  
responsibilities include, but are not limited to,  the following:  
a. 	  Scheduling and conducting the assigned inspection;  
 
b.   Communicating inspectional observations with the 
institutional officials and RDRC staff during the inspection,  
as appropriate;  
 
c.	   Communicating inspectional observations and issues with 
the Center contact  during the inspection and review, as  
appropriate;  
 
d.   Preparing, issuing, and discussing the items listed on the 
483 with the RDRC at  the close of the inspection;  
 
e. 	  Preparing and submitting an establishment inspection 
report (EIR) within FDA timelines; and  
 
 
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f. 	  When appropriate and if time allows, participating in 
discussions with the  
Center regarding potential changes in the EIR  
classification.  
ii.	   When inspections are conducted by a team, a field 
investigator serves as inspection Team  Leader who is  
responsible for  the cooperative conduct of the inspection. The 
Team  Leaders responsibilities include, but are not limited to 
the following (see also IOM, Chapter 5,  section 5.1.2.5 - Team  
Inspections):  
a. 	  Scheduling and coordinating the participation of team  
members;  
 
b. 	  Discussing inspection plans and objectives with 
team  members;  
1.   Assuring that team  members understand 
their roles and responsibilities in 
conducting the inspection, taking notes,  
collecting documentation, preparing 
sections of the inspection report and 
exhibits, and signing the report;  
 
c.	   Setting team  policy regarding communications  
with institutional officials and/or the RDRC 
staff;  
 
d.   Discussing personal conduct with team  
members as  necessary; and  
 
e. 	  Resolving disputes or differences of  opinion  
among team  members, including items to be 
listed on the 483. If an agreement cannot be 
reached during the inspection, the final items 
included on a 483 will  be decided by the ORA  
field investigator.  
 
iii.  Headquarters Participants  

A headquarters participant is a member of the inspection team 
 
who serves in a compliance or scientific advisory capacity to  

the Team  Leader. The headquarters participants  

responsibilities include, but are not limited to, the following: 
 
a. 	  Obtaining training on inspection conduct and  
behavior prior to participating in inspections;  
 
 
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b.   Obtaining inspection credentials from  the 
FDA Office of Security Operations by  
completing  Form  FDA 2115;  
 
c.	   Contacting the ORAHQ BIMO Inspection  
POC  to request  permission to participate in 
field inspections  and  submitting the 
completed Inspection Participation Request  
Form;  
 
d.   Providing information pertinent to the inspection;  
 
e. 	  Attending pre-inspection discussions, if and when 
requested by the Team Leader;  
 
f. 	  Participating in the on-site inspection as permitted by  
agency priorities; and  
 
g.   Providing technical guidance and expertise 
during the inspection and completing 
inspection tasks as directed by the Team  
Leader (e.g., auditing documents, preparing 
inspection notes and specific sections of the 
establishment inspection report within 
guidelines and timeframes).  
 
D.  Resolution of Disagreements  
If  there  is disagreement  among  members of  the  inspection  team,  the  issue  
should  be discussed  off-site  and  resolved  cooperatively.  Any difficulties in  
conducting  team inspections should  be  discussed  with  both  ORA BIMO  
Division  management  and  the  assigning  Center, and,  if  not  resolved,  
immediately referred  to  ORAHQ BIMO Inspection POC.  
 
 
 
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PART III  - INSPECTIONAL  
 Operations  
 
The goal of the RDRC inspection program  is to assess an RDRCs current  
operations. An individual RDRC  may be responsible for reviewing and 
approving many research studies. CDER/OSI will provide a listing of studies for  
audit selection. The selected studies should represent research protocols that  
may suggest potential problems or possible violations of the RDRC  regulations  
(21 CFR 361.1). In the case of a for-cause inspection, such specific  
assignments will usually be accompanied by specific instructions, which would 
be in addition to this compliance program.  
 
In selecting studies for review, and collecting exhibits, the following points  
should be kept in mind:  
 
A.   Section  361.1  may not  apply to  all  radioactive  drugs at  the  institution,  
therefore  the investigator  must  be  careful  to  differentiate  RDRC  radioactive  
drugs with  those  that  are not  regulated  under  21  CFR  361.1(a),  such  as 
approved  radioactive  drugs or  those  under an  IND.  
 
B.   An  informed  consent  document  must  be  evaluated  with  the  studys 

protocol.  Therefore, EIR  exhibits should  contain  both  the  study protocols 

and  associated  informed  consent documents.  

  Reporting  
A.   The  ORA  BIMO Divisions  are  responsible  for  conducting  inspections  and  
preparing  EIRs.  All  reports, including  copies of  exhibits,  are  to  be  submitted  
directly to  the  Center  initiating  the assignment.  CDER  personnel  
participating  in  the  inspection  will  be  responsible  for preparing  those  
sections of  the  EIR  pertaining  to  areas he/she  covered  during  the 
inspection,  as discussed  in  section  II  of  the  compliance  program.  
 
B.   The  EIR  should  contain  the  headings as prescribed  in  the  IOM.  Centers 

encourage submitting  electronic inspectional  documents,  if  possible.  Any 

adverse  findings should  be fully explained  and  documented  in  the  EIR.  

 
C.  The  EIR  should  address each  question  listed  under  Section  III  G.  below.  
 
 
D.  A  483  should  be  issued  under  this program  when  deviations from  the  
 
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requirements in  21 CFR  Part  361.1  are  observed.   NOTE:  Reports  must  
include the name and address of  the RDRC  Chairperson and should 
include the name and address of  the head of  the institution at which the 
RDRC is located.  
 
E.   For  No  Action  Indicated  (NAI)  inspections,  please  follow  the  guidelines 

outlined  in  the inspection  assignment  for  collecting  records and 
 
documents.  

 
F.   Please  remember  to  collect  records and  documents related  to  all  483 
 
observations to support  the  violations noted  on  the  form.
  
 
  Establishment Inspections  
The inspections should be guided by the regulations found in 21 CFR Part 361.1.  
 
  Prior Notification of Intent to Inspect  
A.   To assure that  responsible individuals are present and that RDRC records  
are available, the FDA  field investigator shall contact the institution to confirm  
the name and location of  the RDRC Chairperson to schedule the inspection.  
The  primary  purpose  of  such  prior  notice  is  efficient  use  of  the  field  
investigators time.  
 
B.   ORA  B	 IMO  Division   management   may  elect   to   conduct   unannounced  
inspections  with  approval  of  the assigning  Center,  if  conditions warrant.  
 
  Refusal to Inspect  
If  the institution refuses to permit  either the inspection, access to records, or  
copying of records, or  if  delays instituted by the inspected firm  are such that they  
constitute a de facto refusal, inform your supervisor so he/she can advise the 
assigning Center promptly by telephone. Send a follow- up e-mail to the listed 
Center (per the assignment) and ORAHQ BIMO Inspection POC. Program  
Contacts. IOM 5.2.5    Inspection Refusal  provides additional guidelines.  
 
  Subsequent Related Sponsor/Investigator Inspections  
An RDRC inspection may reveal significant regulatory deviations which may  
lead to sponsor/investigator inspections. ORA BIMO Divisions  may carry out  
such inspections after obtaining the necessary instructions from  the 
appropriate Center. The Center  may issue these assignments  as directed 
inspections.  
 
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  Inspection Procedures  
A.   The  field  investigator  shall  determine  whether  the  Radioactive  Drug  Research  
Committee has met  the  criteria  of  21  CFR  361.1  by asking  the  following  questions.  
Additional information  is also  available  in  the  Inspection  Operations Manual:  
i. 	  Do  records  show  that  the  RDRC  is composed  of  members who  meet  
the  requirements of  the  regulations?  [section  361.1(c)(1)]  
ii.  	 Do  records  show  that  FDA  has been  notified  of  current  members and  
changes in committee  members?   If  so,  was  this done  as soon  as  or  
before  there  were  changes [as required  by 361.1(c)(4)],  or  did  they wait  
to  submit  changes with  required  annual report?   Compare  attendees  
listed  in  minutes of  meetings to  current  Form  FDA  2914. Include  as an  
exhibit  the  most  recent  membership  roster  showing  members  names 
and qualifications.  Previous membership  rosters should  be  collected  as  
needed.  
iii.   Does the  committee  meet  at  least  once  each  quarter  in  which  research  
activity has been authorized  or  conducted?  [section  361.1(c)(2)].  If  a  
study has been  authorized  by the RDRC  and  is considered  open  or  
active  in  the  records of  the  RDRC,  but  no subjects were  accrued  
during  that  calendar  quarter,  there  is an  expectation  from  FDA that  the  
committee  should  meet  (requiring  a  quorum  with  representation  from  
each  of the  required  membership  categories)  at  least  to  report  within  
the  meeting  minutes of the  committee,  the  business that  was 
discussed  with  the  quorum  members and  the status of  the  studies and  
any old  or  new  business before  the  committee.  
iv.  	 Is there  documentation  that  the  RDRC  does quarterly reviews?  
Describe  how  the committee  monitors and  documents the  progress of  
each  study.  [section  361.1(c)(2)].  
v.  	 Does the  RDRC  give  final  approval  for  proposed  research  only at  
convened  meetings? [section  361.1(c)(2)]  
vi.   Does each  committee  meeting  have  quorum  of  more  than  50%  of  the  
membership present?  Did  that  quorum  include  the  required  nuclear  
medicine  physician,  radioactive drug  formulator,  and  a  person  with  
competence  in  radiation  safety and  dosimetry? [section  361.1(c)(2)]  
vii.  Does the  chairman  sign  the  application,  minutes,  and  reports?  [section  
361.1(c)(2)].  
 
B.   Are  committee  minutes  kept,  and  do  they include  the  numerical  results of  
votes on protocols involving  use  in  human  subjects?  [section  361.1(c)(2)].  
Exhibits should  include copies of  minutes that  document  the  approval  of  the  
selected  protocols.  
 
C.  Obtain  complete  copies of  relevant  materials that  document  current  RDRC  
 
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performance over  the  past  two  years,  including  meeting  minutes and  
protocols with  approved  informed consent  documents related  to  RDRC  review  
and  approval  of  protocols tracked  through  the RDRC  review  process  during  
the  inspection.  
 
D.  Are  committee  members precluded  from  voting  on  protocols for  which  they 
are investigators?  Do  meeting  minutes accurately document  the  numerical  
results of  votes on protocols involving  use  in  human  subjects?  [section  
361.1(c)(2)]  
 
 
E.   Has the committee submitted its  annual report to FDA on or before January  
31st  of every year?  Does this annual report cover the previous calendar  
year? [section 361.1(c)(3)].  
 
F.   Has the  committee  reported  immediately (no  later  than  7  calendar  days)  to  
FDA  all approved  protocols involving  more  than  30  subjects or  any subject  
under  18  years of  age (Form  FDA  2915  and  a  justification  statement)?  
[section  361.1(c)(3)]  
 
G.  Are  studies  involving  research  subjects under  18  years of  age  supported  with  
review  by qualified  pediatric consultants to  the  committee?  Is the  pediatric 
consultant  listed  on  the FDA  Form  2914  Membership  Summary?  [section  
361.1(d)(5)]  
 
H.  Have  any adverse  reactions been  reported  to  the  RDRC?  [section  
361.1(d)(8)]  If  so,  have those  reactions determined  to  be  probably attributable  
to  the  use  of  the  radioactive  drug been  reported  immediately to  FDA?  [section  
361.1(d)(8)].  
 
I. 	  Did  the  committee  determine  that  the  labeling  of  the  research  drug  
complied  with  section  361.1(f)?  (If  there  is an  example  of  the  labeling  
available,  provide  a  copy as an  exhibit.) Do  the  protocol  records include  an  
example  of  the  product  vial  label?   
 
J.	   How  does the  committee  consider  and  assure  that  the  requirements for  the  
quality of  the radioactive  drug  are  met?  [section  361.1(d)(6)]  (For  example,  is 
there  a  list  of  tests to  be performed  in  the  study protocol  or  the  batch  record?)  
Does the  RDRC  have documentation  of  the  results of  product  quality tests?  
Do  they review  the  results of pyrogen  and  sterility tests performed  on  the  drug  
products they authorize?  
i.   Due to the time delay for sterility and pyrogen testing, certain 
radioactive drugs utilizing short lived isotopes (e.g., F18 - t1/2 = 110  
min, Tc99m  - t1/2 = 6.02 hours, I124 - t1/2 =  4.2 days, I131 - t1/2 =  
8.04 days)  cannot wait for such testing prior to release, as  
 
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radioactivity levels will have diminished beyond useful levels. Sterility  
and pyrogen testing may be appropriate for  other intermediate or  
long lived isotopes (e.g.,  I125 - t1/2 = 60 days, H3 - t1/2 = 12.3 years,  
C14 - t1/2 = 5,730 years). Field investigators should focus their  
inspection on the extent to which the RDRC  requires, and the 
frequency in which it reviews results of  sterility and pyrogen tests  for  
studies it has approved.  
 
K.   Is there  documentation  that  the  RDRC  assured  that  the  investigator  obtained  the  consent  
of the  subjects or  their  legally authorized  representatives  in  accordance  with  21  CFR  part  
50? Does the  informed  consent  document  inform  the  research  subject  that  they will  be  
exposed  to  radiation  for  research  purposes which  has no  direct  benefit  to  them?  [section  
361.1(d)(5)]  
 
L.   Is there  documentation  that  the  RDRC  assured  that  the  study was reviewed  
and  approved by the  Institutional  Review  Board,  consistent  with  21  CFR  part  
56?  [section  361.1(d)(5)]  
 
M.  Is there documentation that the RDRC  assured that each investigator is  
qualified by training and experience to conduct the proposed research 
studies? [section 361.1(d)(3)]  
 
N.  Is there  documentation  that  the  RDRC  assured  that  the  investigator  or  
institution  is licensed  to  possess and  use  radionuclides?  [section  361.1(d)(4)]  
 
O.  Are  RDRC  approved  studies or  protocols limited  to  basic science  research,  as specified  
in  
21  CFR  361.1,  i.e.  they cannot  be  intended  for  immediate  therapeutic,  
diagnostic,  or similar  purposes or  to  determine  the  safety  and  
effectiveness of  the  drug  in  humans for such  purposes (i.e.,  to  carry out  a  
clinical  trial)?  [section  361.1(b)]  
i.   For  any protocols for  which  the  answer  to  question  15  is no,  are  the  
protocols being conducted  under  an  IND?  (If  this information  cannot  
be  determined  at  the  site,  contact the  Center  representative  listed  
on  the  assignment  to  discuss further.)  
1.  	 For those radioactive drug protocols covered by an 
IND, the field investigator should assess whether the 
RDRC chairman (or institutional representative) is  
aware that  FDA does  not require review and approval  
of non-RDRC studies by the RDRC, and the RDRC 
does not need to report  these activities to the FDA.  
2. 	  Some institutions use RDRCs for  additional radiation 
safety responsibilities, and reviews of  INDs using 
radioactive drugs. In such cases,  meeting minutes  
should separate RDRC business from  other committee 
 
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responsibilities. This  may best be achieved by having 
separate and distinct RDRC  meeting minutes.  
 
ii. 	  Whenever  possible,  a  protocol  satisfying  the  criteria  of  section  
361.1(a)  should  be included  in  the  EIR  to  provide  the  necessary 
basis for  evaluating  the  review  and approval  procedures of  the  
RDRC  under  these  regulations.  
 
iii.   If  a  certain  study is not  covered  by  an  IND  and  it  appears that  an  
IND  may have  been required,  immediately notify the  Center  
representative  listed  on  the  assignment,  who in  consultation  with  the  
Division  of  Medical  Imaging  Products will  determine  if  an IND  is 
needed.  
 
P.   Does the  RDRC  determine  that  the  pharmacological  dose  is within  the  limits 
set forth in  section  361.1(b)(2).  
 
Q.  Does the  RDRC  require  radiation  doses to  be  calculated  for  each  of  the 
 
required  areas listed  in  section  361.1(b)(3)(i)?  (whole  body,  active  blood-

forming  organs,  lens of  the  eye, and  gonads).  

 
R.  For  those  studies which  involve  the  use  of  a  radioactive  drug  claimed  to  be  
used  under  the intentions of  basic science  research  as outlined  in  361.1(a),  
but  is being  used  in conjunction  with  a  non-radioactive  drug  being  
investigated  under  an  IND,  is there evidence  that  the  RDRC  assured  the  
study investigator  has submitted  a  summary of  results for  the  outcomes of  the  
RDRC  study in  the  required  yearly  summary report  for  the  IND? [section 
361.1(e)]  
 
  Electronic Records and Electronic Signatures  
Computerized systems are more commonly being used by institutions to 
collect and preserve records.  
Computerized systems range from  a desktop or lap top personal computer using 
an internal  network to different systems located at  multiple sites which use an  
Internet connection (e.g., a Web-based system  managed by an independent  
software vendor to which the RDRC, the sponsor and clinical sites have 
controlled access).  
Regardless of  the type of system  used by the RDRC, an important principle to  
understand when evaluating RDRC records is that  the regulatory requirements  
for adequate documentation of RDRC activities do not change whether the 
documentation is captured on paper, electronically, or using a hybrid approach.  
21 CFR Part 11 (Part  11) describes the technical  and procedural requirements  
 
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that  must be met if a firm  chooses to maintain records electronically and/or use 
electronic signatures. Part 11 is a companion regulation to other FDA regulations  
and  laws. It is  within these other regulations and laws, called predicate rules,  
where specific requirements for issues such as recordkeeping, record content,  
signatures, and record retention are addressed.  
A.   Scope  of  Electronic Records/Electronic Signatures as Described  in  Guidance  
i.   Section  III.  B.  2  of  the Part 11 guidance document  (page  5)  states that  
Part  11  is applicable  to  the  following  electronic records and  electronic 
signatures:  
 
ii.    Records that  are  required  to  be  maintained  under  the  predicate  rules 
and  that  are maintained  in  electronic format  in  place  of  paper  format.  
 
iii.   Records that  are  required  to  be  maintained  under  the  predicate  rules,  
that  are maintained  in  electronic format  in  addition  to  paper  format,  
and  are  relied  on  to perform  regulated  activities.  
 
iv.   Records that  are  required  to  be  submitted  to  FDA  under  predicate  
rules that  are  in electronic format.  
v.   Electronic signatures that  are  intended  to  be  the  equivalent  of  
handwritten  signatures, initials or  other  general  signings that  are  
required  by  the  predicate  rules and/or  the RDRCs written  procedures 
(if  applicable).  
In Section III. C. of the  Part 11 guidance document (page 6),  
specific requirements for which the agency intends to exercise 
enforcement discretion include the:  
1.   validation of computerized systems;  
2.   use of computer-generated, time-stamped audit trails;  
3.   use of legacy systems;  
4.   generation of copies of records; and  
5.   protection of  records (i.e., record  retention and availability; see 
Guidance:  General Principles of  Software Validation).  
 
B.   Inspectional Guidelines  
 
The field investigator should consult with an ORA BIMO  management  
and/or ORA BIMO National Expert  for additional information regarding Part  
11.  
 
C.  Equipment,  Procedures,  Processes  
i. 	  Find and document the following:  
1. 	  Describe  any computerized  system(s)  used  at  the  RDRC  site(s)  to  
generate,  collect,  or preserve  documented  RDRC  activities (e.g.,  stand-
 
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alone  personal  computer,  Web- based  system,  hand-held  computers).  
2.  	 Determine  whether  electronic records or  reports are  defined  in  the  RDRCs 
written procedures (if  applicable).  
3.  	 Explain  how  the  RDRC  determines which  records (e.g.,  meeting  minutes,  
voting logs,  etc.)  are  collected  and  stored  in  electronic format  (i.e.,  does the  
RDRC  prescribe any off-the-shelf  program  or  follow  any written  procedures 
which  describe  selection of  records for  electronic formatting).  
4.  	 Determine  whether  electronic records are  available  for  inspection.  
5.  	 Determine  whether  the  RDRCs electronic system  has operating  
instructions,  user- manuals,  access policies and  procedures,  training  
policies,  or  management  controls to create,  modify,  maintain,  or  transmit  
electronic records.  
6.  	 Determine  whether  individuals who  develop,  maintain  or  use  
the  computerized systems have  the  necessary training  to  
perform  their  assigned  tasks.  
D.  Maintenance  of  Electronic Records  
i.  	 Find and document the following:  
1. 	  Determine  whether  the  RDRC  is able  to  ensure  adequate  
electronic and  human readable  copies of  electronic records 
suitable  for  review  and  copying.  (If  you  are unable  to  gain  
access to  records from  the  computerized  system  following  
the procedures outline IOM 5.3    Evidence Development,  
contact  the  Center immediately).   NOTE:  Follow IOM 
5.3.8.3.2 - Electronic Information Received on CD-R or  
Other  Electronic Storage Media. It states, Do not 
personally access a firms electronic records, databases, or  
source/raw data during the course of the inspection.  
2. 	  Determine  whether  electronic records and  documentation  
meet  the  requirements applicable  to  RDRC  records 
maintained  in  paper  format.  
3.  	 Describe  how  records,  reports,  or  correspondence  are  
transmitted  from  the  RDRC  to the  sponsor,  clinical  
investigator,  institutional  official,  FDA,  etc.,  and  vice-versa.  
4.  	 Determine  how  the  computerized  system  allows changes to  
be  made  (e.g.,  is it  based on  individual  access privileges?  
Are  all  changes to  electronic source  data accompanied  with  
write-protected  audit  trails to  include  the  name,  date,  and  
reason for  change?)  
E.   Security  
i.  	 Find and document the following:  
 
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1.  	 Determine  who  is authorized  to  access the  system.  
2.  	 Describe  how  the  computerized  systems are  accessed  (e.g.,  
password  protected, access privileges,  user  identification).  
3.  	 Determine  how  information  is captured  related  to  the  
creation,  modification,  or deletion  of  electronic records (e.g.,  
audit  trails,  date/time  stamps).  
4.  	 Describe  whether  there  is a  backup,  disaster  recovery,  and/or  
contingency plan  to protect  against  record  loss.  Were  there  
any installed  software  upgrades,  security or  performance  
patches,  or  new  instrumentation  that  affected  the  electronic 
records?  
5.  	 Describe  how  error  messages or  system  failures are  reported  
to  the  RDRC,  including the  corrective  actions taken,  if  any.  
 
 
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PART IV - ANALYTICAL  
 
No analytical activities are planned under this program. 
 
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PART V - REGULATORY/ADMINISTRATIVE STRATEGY  
 Administrative Procedural Information  
A.   ORA BIMO Division EIR Classification Authority  
 
The ORA BIMO Division  must follow the procedures for  assigning 

Division inspection conclusions and decisions to an Establishment 
 
Inspection Report (EIR) within established timeframes as defined in 

Field Management Directive #86,  Establishment  Inspection Report 
 
Conclusions and Decisions  (FMD #86).  

 
B.   Center EIR Classification Authority  
 
The Center has final classification authority for all EIRs generated under 
 
this compliance program. If the Center is considering a classification that 
 
differs from  the ORA BIMO Divisions recommended classification, the 

Center will contact the Division to discuss the issues as soon as possible to 

avoid delays in the final classification process. In addition, the Center will  

provide the ORA BIMO Division with notice of  all final classifications, 
 
including the rationale for any that differ  from  the ORA BIMO Divisions  

initial classification. 
 
 
C.  EIR Classifications  
 
The following information  is to be used in conjunction with the instructions in 

FMD-86 for initial ORA BIMO Divisions and Center classification of EIRs  

generated under this Compliance Program:
  
 
i.   No Action Indicated   NAI  - No  objectionable  conditions or  practices 
were  found during  an  inspection  (or  the  objectionable  conditions found  
do  not  justify further regulatory action);  
ii.  Voluntary Action Indicated   VAI  - Objectionable  conditions or  practices 
were found,  but  the  agency is not  prepared  to  take  or  recommend  any 
administrative  or regulatory action;  and  
iii.  Official Action Indicated    OAI  - Regulatory and/or  administrative 
 
actions will  be recommended.  

 
D.  Administrative / Civil / Criminal Actions will be in accordance with 21 CFR Part 361.1.  
FDA can invoke other  legal sanctions under the FD&C Act and/or Title 18, USC,  
where appropriate.  
 
 
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i.   Administrative  Actions for  noncompliance  -- If  apparent  noncompliance  with  
FDA regulations (21  CFR  361.1),  the  FDA  can  move  forward  with  the  following  
regulatory  
1.  	 Untitled Letters (UL)  
2.  	 Warning Letters (WL)  
3.  	 Reinspection to verify corrective actions  
4.  	 Regulatory meetings  
5.  	 Referral of  pertinent matter, with headquarters concurrence, to other  
Federal  State or local agencies for  such action as that agency deems  
appropriate.  
 
ii.  Withdrawal  of  FDA  Approval  
 
Approval of an RDRC  may be withdrawn at any time for failure of  the 
committee to comply with any of the requirements of  this section as  
required by 21 CFR 361.1(c)(4).  
E.   Communications  
 
The ORA BIMO Divisions should promptly inform  Headquarters/Centers  

about any written or oral communication from  the institution following the 

inspection. Similarly, Headquarters/Centers should promptly inform  the ORA 

BIMO Divisions of communication (including any written correspondence) 
 
with the institution following the inspection, including any judicial  /
  
administrative actions. Copies of any written communications should be 

shared. 
 
  Regulatory  Procedures for Classification  
A.   No Action Indicated   NAI  - No  objectionable conditions or practices were 
found during the inspection, or the significance of the documented  
objectionable conditions found does not justify further FDA action.  
i. 	  Any post-inspectional correspondence acknowledges  
the RDRCs basic compliance with pertinent  
regulations.  
 
B.   Voluntary Action Indicated   VAI  - Objectionable conditions were found and 
documented, but  the Center is not prepared to take or  recommend any  
further  regulatory (advisory, administrative, or judicial) action because the 
objectionable conditions do not  meet the threshold for regulatory action 
(i.e.,  regulatory violations uncovered during the inspection are few  and do 
not seriously impact subject safety or data integrity.)  
i. 	  Post-inspectional correspondence may identify the issues and, when needed,  
state  that FDA expects prompt, voluntary corrective action by the RDRC.  
 
 
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C.  Official Action Indicated   OAI - An OAI recommendation is appropriate  
when  regulatory  violation(s)  uncovered  is/are  significant/serious  and/or  
numerous, and the scope, severity, or pattern of violations(s) support  a  
finding that:  
i. 	  Subjects participating in studies approved by the RDRC  
would be or have been exposed to an unreasonable and 
significant risk of illness or injury;  or  
ii. 	  Subjects rights would be or have been seriously compromised; or  
iii. 	  Data integrity or  reliability is or has been compromised.  
 
Once an OAI decision is reached, additional  information (e.g., previous  
inspectional findings, correspondence, or other information  about the 
RDRC)  may assist the Center in determining the type of post-inspectional  
correspondence that is appropriate. If the Center chooses to issue a 
Warning Letter and allow the RDRC to submit a detailed corrective action 
plan or alternate approach that is  acceptable to FDA, the Center should 
nevertheless be prepared to withdraw approval of the RDRC should the 
RDRC not respond appropriately (i.e.,  fails to respond, fails to develop an 
adequate corrective action plan, or is found, during a subsequent inspection,  
to have failed to comply with a corrective action plan).  
 
A Warning Letter  may be considered when the violations can be corrected 
through specific action(s) by  the RDRC (e.g., preparation of, and 
compliance with, a detailed corrective action plan, that is acceptable  to 
FDA) and adherence to the corrective action plan has a high probability of  
preventing similar or other violations  from  occurring in the future.  
 
EXAMPLES:  
 
The following are intended to serve as examples of violations that, alone or in  
combination, would be considered significant and may warrant  OAI  classification.  
This list is not all inclusive; other  circumstances  may also merit OAI classification.  
When applying the classification criteria, Center reviewers will generally  
evaluate the impact of the RDRCs actions (number, scope, and severity of  
the regulatory violations) on subjects rights, safety and welfare. There are 
gradations  in the severity of each example, and the specific observation(s)  
should support the seriousness of the violation(s) and the effect(s)  on 
subjects safety and welfare and/or the reliability and acceptability of data for  
FDA decision-making purposes. The Center should also consider whether  
FDA has cited the RDRC for the same or similar violations during a previous  
inspection.  
 
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Table V(B) Inadequate Human Subject Protection  
Violation/Related  Examples  
Citation  
RDRC has approved studies that  do not  
Radioactive Drugs for Certain  
meet the criteria outlined in the 
Research Uses  
  regulation,  i.e. basic science research.  
21 CFR 361.1(a)  
Study(ies)  may require an IND.  
 
Conditions  under which use   
of radioactive drugs for   RDRC has approved studies in which 
research are considered safe  there has been no previous experience in 
and effective.   humans.  
 
21 CFR 361.1(b)(2)  
 
Minutes   Minutes  of RDRC meetings have not  
  been kept.  
21 CFR 361.1(c)(2)  
 
 
Approval   RDRC has failed to inform  FDA of  
  changes in membership.  
21 CFR 361.1(c)(4)  
 
Quality of  Radioactive Drug   RDRC has no mechanism  in place to 
  ensure the quality, purity, and sterility of  
21 CFR  361.1(d)(6)  
the drug, such as requiring the 
submission of batch reports.  
  RDRC has no mechanism  in place to ensure that  
  clinical investigators immediately report all  
adverse effects associated with the use of the 
Adverse Reactions  
  radioactive drug in the research study.  
21 CFR 361.1(d)(8)  
 
 
RDRC has no documentation to support  
that adverse effects have been reported 
to FDA.  
IRB Approval   RDRC has  no documentation to support  
  that research studies have been 
21 CFR 361.1(d)(9)   approved by an IRB.  
 
 
 
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  Follow-Up Inspections  
A.   Centers should  evaluate  whether  the  violations found  indicate  systemic problems with  
the conduct  of  the  study or  the  reliability of  the  data  and  whether  additional  inspection 
assignments should  be  issued  (e.g.,  IRB,  clinical  investigator(s)).  
 
B.   Following  issuance  of  a  Warning  Letter,  Centers should  schedule  a  follow-up  
inspection  to verify if  the  RDRC  is fulfilling  the  terms  of  any corrective  action  plans and  
is in compliance  with  applicable  regulations.  Such  follow-up  inspections should  take  
place about one year after the date of the last Warning Letter correspondence.  
 
  Post-Inspection Information Sharing  
As per the April 27, 2015, agreement between the Department of Veterans  

Affairs (VA) and the FDA Office of Regulatory Affairs  (ORA) and upon the 

written request by the Office of Research Oversight, VA, the Center contacts  are 

authorized to provide to the Office of Research Oversight, VA, and its staff, 
 
redacted copies of FDA-reviewed EIRs and any post-inspection correspondence 

issued to VA facilities  or employees following any inspection (including the 

483s). 
 
Post inspection documents should be sent to:  
Executive Director 
 
Office of Research Oversight (10R) 
 
Veterans Health Administration  

Department of Veterans Affairs  
  
810 Vermont Avenue, N.W., Suite 574  

Washington, D.C. 20420  

 
Responses are subject to FDA priority and available resources, and are pursuant to ORA, 
 
VAs 
 
June 18, 2010, non-disclosure agreement. 
 
 
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PART VI   REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS  
  References   
A.   FDA Laws  
i.   Federal Food, Drug, and Cosmetic Act  (FD&C Act)  
 
B.   Most Relevant  21 CFR Regulations  
i.   21 CFR 361.1   Radioactive Drugs for Certain Research Uses  
ii. 	  21 CFR 201.129   Labeling   Exemption for Radioactive Drugs for Research 
Use  
iii.   21 CFR 312.2(b)(1)  Exemptions for Lawfully Marketed Drugs  
C.   Other 21 CFR Regulations  
i.   Part 11   Electronic  Records; Electronic Signatures  
D.   FDA Guidelines, Guidance, and Inspection Guides  
i. 	  Guidance  for  Industry:  The  Radioactive  Drug  Research  Committee:  
Human  Research Without  An  Investigational  New  Drug  Application  
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U 
CM16389  

2.pdf,  August  2010)  

ii.   Guidance  for  Industry:  Computerized  Systems Used  in  Clinical  Investigations  
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM07026  
6.pdf,  May  2007)  
iii.   Guidance  for  Industry:  Part  11:  Electronic Records,  Electronic Signatures- 
Scope and  Application   
(https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.p 
df, August  2003)  
iv. 	 Guidance  for  Industry:  Investigational  New  Drug  Applications (INDs) 
Determining  Whether  Human  Research  Studies Can  Be  Conducted  
Without  an  IND 
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U 
CM229175.pdf,  Draft  October 2010)  
v.	   Investigations Operations Manual  (IOM)  

(http://www.fda.gov/ICECI/Inspections/IOM/default.htm)
  
vi.  General  Principles of  Software  Validation;  Final  Guidance  for  Industry 
and  FDA  Staff 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0 
85281.ht  m,  January  2002)  
vii.  Guidance  for  Industry:  Protecting  the  Rights,  Safety,  and  Welfare  of  Study 
Subjects   Supervisory Responsibilities of Investigators  
(https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772 
 
Date of Issuance:  04/16/2018 	  Page 29  of  31    
  PROGRAM   7348.809A  
 
.pdf  Final  October 2009)  
 
  Program Contacts  
A.   When  medical,  technical  or  scientific  questions  or  issues  arise  from  a  specific  
assignment or  if  additional  information  is  required  about  a  specific  assignment,  consult  
the  Center  contact  identified  in  the  assignment.  
 
B.   For  operational  questions,  contact:  
 
Office of Regulatory Affairs (ORA)
  
Office of Medical Products and Tobacco Operations (OMPTO)  

Office of Bioresearch Monitoring Operations (OBIMO)  - ORAHQ BIMO  

Inspection POC  

 
C.  For  questions  about  compliance  program  issues  contact:  
Center for  Drug Evaluation and Research (CDER) 
 
Office of  Scientific  Investigations: 
 
301-796-3510, FAX 301-847-8748 
 
 
Center for  Drug Evaluation and Research (CDER) 
 
Division of Medical Imaging Products  

301-796-2050, FAX 301-796-9849 
 
 
 
 
Date of Issuance:  04/16/2018   Page 30  of  31    
  PROGRAM   7348.809A  
 
PART VII  - HEADQUARTERS  RESPONSIBILITIES  
 Center for  Drug Evaluation and Research  (CDER):  
 
A.   Identify Radioactive  Drug  Research  Committees to  be  inspected  and  
forward  inspection assignments and  background  material  (e.g.,  annual  
reports,  correspondence,  complaints, and  Center  concerns)  to  the  
ORAHQ BIMO Inspection POC  and  FACTS/eNSpect.  
 
B.   Review  and  make  final  classifications of  EIRs,  and  enter  the  classification  into  
FACTS/eNSPect.  
 
C.  Issue  correspondence  to  the  inspected  institution  after  EIR  review.  This 
letter  will  typically be  addressed  to  the  most  responsible  individual  along  
with  a  copy  to  the  RDRC  
chairperson  and  will  state  the  Centers assessment  of  the  RDRCs 
performance.  Copies of letters will  be  sent  to  the  appropriate  ORA BIMO  
Division  Office.  
 
D.  Conduct  follow-up  regulatory and/or  administrative  actions.  Promptly 
provides copies of relevant  correspondence  between  the  institution  or  
RDRC  and  FDA  to  the  ORA BIMO Division  Offices.  
 
E.   Provides expert  technical  guidance,  advice,  information,  interpretation,  
analysis,  and support  related  to  implementation  of  the  clinical  BIMO  
Program  for  internal  and  external constituents.  
 
 
  ORA/OFFICE OF ENFORCEMENT  AND IMPORT OPERATIONS (OEIO)/DIVISION OF 
ENFORCEMENT (DE) 
A.   Serves as the Agency  clearance point and coordinator for inspection warrants.  
 
 
  ORA/OFFICE OF BIORESEARCH  MONITORING OPERATIONS (OBIMO)  
 
A.   Provides inspection  quality assurance,  training  of  field  personnel,  and 
 
operational guidance.  

B.   Maintains liaison  with  Centers and  ORA BIMO Divisions  and  resolves 

operational  questions.  

C.   Coordinates and  schedules independent  and  team  inspections  
 
Date of Issuance:  04/16/2018   Page 31  of  31