ELECTRONIC SUBMISSION OF IND  
SAFETY REPORTS 
TECHNICAL CONFORMANCE GUIDE 
   
 
 
 
 
 
This Document supplements the following Guidance Document: 
 
Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND Safety 
Reports (October 2019) 
 
 
For questions regarding this technical specifications document, contact CDER or CBER at 
faersesub@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Oncology Center of Excellence (OCE) 
 
 
April 2022
   
 
 
 
 
 
ELECTRONIC SUBMISSION OF IND 
SAFETY REPORTS 
TECHNICAL CONFORMANCE GUIDE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
April 2022
   
REVISION HISTORY 
DATE  VERSION  SUMMARY OF MAJOR REVISIONS 
 
October 2019  1.0  Initial Version 
  Added information regarding data elements needed for IND safety reports from 
aggregate analysis 
  Included provisions for submitting names of products without established 
April 2022  1.1  names to the IND prior to electronic submissions to FAERS 
  Updated throughout to refer to IND safety reports submitted electronically to 
FAERS as IND ICSRs 
  Updated names of companion documents throughout 
  Contains Nonbinding Recommendations 
Table of Contents 
1.  Introduction .......................................................................................................................... 1 
1.1  Background ......................................................................................................................... 1 
1.2  Purpose ............................................................................................................................... 1 
1.3  Document Revision and Control ........................................................................................ 2 
1.4  Relationship to Other Documents ....................................................................................... 2 
2.  General Considerations ........................................................................................................ 3 
2.1  IND Safety Report Submissions ......................................................................................... 3 
2.1.1  ICSR and ICH E2B Data Standards.......................................................................... 3 
2.1.2  IND Safety Reports ................................................................................................... 3 
2.1.3  IND Safety Reports That Should NOT Be Submitted to FAERS ............................ 3 
2.1.4  Transition to Submitting IND ICSRs to FAERS ...................................................... 5 
2.1.5  IND ICSR Attachments ............................................................................................ 5 
2.1.6  Follow-Up Reports.................................................................................................... 5 
2.1.7  Identification of the IND for Submissions of IND ICSRs ........................................ 5 
2.1.7.1  IND ICSRs From an Aggregate Analysis ............................................................ 6 
2.1.8  Product Names for Investigational Drugs ................................................................. 7 
2.1.9  Safety Reports for Marketed Drugs .......................................................................... 8 
2.1.10  Other Considerations ................................................................................................ 8 
2.1.11  Options For Electronic Submission of IND ICSRs: Electronic Submissions 
Gateway or Safety Reporting Portal ......................................................................... 9 
2.1.11.1  Separate Submission Pathway for Submitting IND ICSRs to FAERS .............. 9 
2.1.11.2  Creating an Account Before the First Electronic Submission .......................... 10 
2.1.11.3  Unique Case Identification Numbers for IND Safety Reports ......................... 10 
2.1.11.4  Single Submission Versus Batched Submission of IND ICSRs ...................... 11 
2.1.12  Notification of Receipt of Submissions by the FDA .............................................. 11 
  Contains Nonbinding Recommendations 
Electronic Submission of IND Safety Reports 
Technical Conformance Guide1 
 
 
This document represents the current thinking of the Food and Drug Administration (FDA or 
Agency).  It does not establish any rights for any person and is not binding on FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations.  To discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance or send an email to faersesub@fda.hhs.gov.  
 
 
1.  Introduction 
 
1.1 Background 
 
This Technical Conformance Guide (Guide) provides specifications, recommendations, and 
general considerations on how to submit electronic investigational new drug application (IND) 
safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for 
Biologics Evaluation and Research (CBER).  This Guide supplements the draft guidance for 
industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 
2019),2 which implements the electronic submission requirements of section 745A(a) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for 
certain IND safety reports submitted to CDER or CBER.   
 
1.2 Purpose 
 
This Guide discusses the format for the submission of IND safety reports required under 21 CFR 
312.32(c)(1)(i) as individual case safety reports (ICSRs) to the FDA Adverse Event Reporting 
System (FAERS) and provides recommendations to sponsors who elect to submit such ICSRs to 
FAERS before the requirement for submission to FAERS is in effect for applicable INDs.3  This 
Guide provides general information for sponsors of commercial and noncommercial INDs 
pertaining to electronic submission of IND safety reports and attachments in electronic format to 
 
1 This technical specifications document has been prepared by the Office of New Drugs in the Center for Drug 
Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research and the Oncology 
Center of Excellence, at the Food and Drug Administration.  You may submit comments on this guidance at any 
time.  Submit comments to Docket No. FDA-2018-D-1216 (available at 
https://www.regulations.gov/docket?D=FDA-2018-D-1216) (see the instructions for submitting comments in the 
docket).  
 
2 This guidance also provides information on the effective date of the requirement to provide certain regulatory 
submissions in electronic format.  When final, this guidance will represent the FDAs current thinking on this topic.  
For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents. 
 
3 FDA intends to post information on the FAERS Electronic Submissions web page (available at 
https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-
electronic-submissions) when the Agency will begin accepting electronic submission of IND ICSRs to FAERS. 
1  Contains Nonbinding Recommendations 
FAERS.  It also provides information to sponsors on the format for submission of IND safety 
reports required under section 312.32(c)(1) that should not be submitted to FAERS and should 
continue to be submitted in electronic common technical document (eCTD) format.4  
 
1.3 Document Revision and Control 
 
Sponsors will be able to access future revisions of this Guide through the FAERS Electronic 
Submissions web page,5 and the revision history page of this Guide will provide information on 
the changes made to previous versions. 
 
1.4 Relationship to Other Documents 
 
Sponsors should consult the following guidances and web pages for other aspects of electronic 
IND safety reporting:  
 
  Draft guidance for industry Providing Regulatory Submissions in Electronic Format: 
IND Safety Reports6 
 
  Technical specifications document FDA Regional Implementation Guide for E2B(R3) 
Electronic Transmission of Individual Case Safety Reports for Drug and Biological 
Products (April 2022)7  
 
  The FAERS Electronic Submissions web page for instructions on submission of ICSRs 
 
  Guidance for industry Providing Submissions in Electronic Format  Postmarketing 
Safety Reports (April 2022) for instructions on contingency plans for submission of 
safety reports, for notification of receipt of submissions, and contingencies when the 
submissions systems are temporarily unavailable  
 
 
 
4 See also the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety 
Reports.  When final, this guidance will represent the FDAs current thinking on this topic.   
 
5 Available on the FAERS Electronic Submissions web page at https://www.fda.gov/drugs/fda-adverse-event-
reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.  
 
6 When final, this guidance will represent the FDAs current thinking on this topic.   
 
7 Available on the FAERS Electronic Submissions web page at https://www.fda.gov/drugs/fda-adverse-event-
reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.  
2  Contains Nonbinding Recommendations 
2.  General Considerations 
 
2.1 IND Safety Report Submissions 
 
2.1.1  ICSR and ICH E2B Data Standards 
 
An ICSR is a description of an adverse drug event experienced by an individual subject.  ICSRs 
are used to communicate information on clinical trial and postmarketing adverse drug events or 
adverse drug reactions between a variety of entities involved with the review and tracking of 
safety information (e.g., investigators, regulators, pharmaceutical companies, institutional review 
boards or ethics committees, reporters).  
 
The International Council for Harmonisation (ICH) E2B data standards working group was 
created to provide common data elements for the electronic transmission of ICSRs globally 
between relevant stakeholders.  FDA currently requires mandatory postmarketing safety reports 
to be submitted to FAERS8 and Vaccine Adverse Event Reporting System (VAERS) and certain 
IND safety reports will also be required to be submitted to FAERS when the requirement is in 
effect.9 
 
2.1.2  IND Safety Reports 
 
Certain IND safety report types required under 21 CFR 312.32(c)(1) contain individual data from 
one or more subjects and should be submitted as ICSRs to FAERS (hereafter, for the purposes of 
this document, these types of reports are referred to as IND ICSRs).  Other types of required IND 
safety reports are reports of overall findings or pooled analyses from published and unpublished 
in vitro, animal, epidemiological, or clinical studies.  The sponsor should submit these other 
types of reports in a narrative format in eCTD format and should not submit the reports to 
FAERS (see details in section 2.1.3 below).   
 
 
2.1.3  IND Safety Reports That Should NOT Be Submitted to FAERS 
 
IND safety reports that are not submitted to FAERS (see Table 1) are reports of overall findings 
or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical 
studies and increased rate of occurrences of serious suspected adverse reactions.  Reports of 
overall findings or pooled analyses as noted above are to be submitted in a narrative format (21 
CFR 312.32(c)(1)(v)).  These reports should be submitted in the following manner: 
 
 
8 See the guidance for industry Providing Submissions in Electronic Format  Postmarketing Safety Reports.   
 
9 For information on the effective date of the requirement, see the draft guidance for industry Providing Regulatory 
Submissions in Electronic Format: IND Safety Reports.  When final, this guidance will represent the FDAs current 
thinking on this topic. 
3  Contains Nonbinding Recommendations 
  For INDs10 in eCTD format11 using the following labels:  
 
  For findings from animal or in vitro testing (21 CFR 312.32(c)(1)(iii)): to the 
appropriate study using the Safety Report file-tag in eCTD section 4.2.3, 
Toxicology 
 
  For findings from other studies (21 CFR 312.32(c)(1)(ii)) and for an increased rate of 
occurrence of serious suspected adverse reactions (21 CFR 312.32(c)(1)(iv)): using 
the Safety Report file-tag in eCTD section 5.3.5.4, Other Safety Reports and 
Related Information 
 
These IND safety reports in narrative format should not be submitted on MedWatch Form FDA 
3500A or Council for International Organizations of Medical Sciences forms.  
 
Table 1: Types of IND Safety Reports and Location of Submission  
 
Submit to  Submit to 
Type of report 
FAERS*  eCTD* 
A single occurrence of an adverse event that is uncommon and   
known to be strongly associated with drug exposure (21 CFR  X 
312.32(c)(1)(i)(A)) 
One or more occurrences of an adverse event that is not   
commonly associated with drug exposure, but is otherwise 
X 
uncommon in the population exposed to the drug (21 CFR 
312.32(c)(1)(i)(B)) 
An aggregate analysis of specific adverse events observed in a   
clinical trial (e.g., known consequences of the underlying 
disease or condition under investigation, other events that 
commonly occur in the study population independent of drug  X 
therapy) that indicates those events occur more frequently in 
the drug treatment group than in a concurrent or historical 
control group (21 CFR 312.32(c)(1)(i)(C)) 
Findings from other studies (21 CFR 312.32(c)(1)(ii))    X 
Findings from animal or in vitro testing (21 CFR   
X 
312.32(c)(1)(iii)) 
Increased rate of occurrence of serious suspected adverse   
X 
events (21 CFR 312.32(c)(1)(iv)) 
 
10 For a safety report submitted to a noncommercial IND that is not in eCTD format, see the guidance for industry 
Providing Regulatory Submissions in Alternate Electronic Format (July 2021). 
 
11 See guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human 
Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications (February 2020). 
4  Contains Nonbinding Recommendations 
* FAERS = FDA Adverse Event Reporting System; eCTD = electronic common technical document. 
 
2.1.4  Transition to Submitting IND ICSRs to FAERS 
 
FDA will accept IND ICSRs to FAERS as part of a voluntary submission program prior to the 
time that the requirement is in effect for applicable INDs.12  
 
If sponsors choose to participate in the voluntary submission program, they should submit all 
IND ICSRs to FAERS and should not switch back to submission in eCTD format. This will 
allow for initial and follow-up reports and reports for cross-reported INDs to reside in the same 
system from a given timepoint forward.  
 
2.1.5  IND ICSR Attachments 
 
Attachments to IND ICSRs include supporting information, such as autopsy reports, or published 
articles for IND ICSRs based on scientific literature.  Attachments can also be used for narrative 
portions of the IND ICSR that exceed character limitation for that E2B data field; however, FDA 
encourages sponsors to construct informative narratives that fit within the character limitations.   
 
2.1.6  Follow-Up Reports 
 
A follow-up report includes new information about an adverse drug reaction that has been 
previously reported in an initial IND ICSR, and all follow-up reports should use the same unique 
case identification number as the initial IND ICSR.  Follow-up IND ICSRs should include all 
information in the structured fields of the IND ICSR that has been previously reported along 
with any new information.  However, to avoid duplication, IND ICSR attachments such as 
scientific literature or autopsy reports submitted with an initial IND ICSR should not be 
resubmitted with a follow-up IND ICSR. 
 
2.1.7  Identification of the IND for Submissions of IND ICSRs 
 
As discussed in the guidance for industry and investigators Safety Reporting Requirements for 
INDs and BA/BE Studies (December 2012), IND safety reports should be submitted to all of the 
sponsors INDs under which the drug is being administered.  To submit IND safety reports to all 
relevant INDs electronically to FAERS, the sponsor should create one IND ICSR using the 
appropriate E2B data elements as described below.   
 
For an IND ICSR to be successfully processed in FAERS, it needs to have one valid IND 
number in the appropriate E2B data field.  Sponsors should use the IND number under which the 
clinical trial where the event occurs is conducted as the primary IND number in the indicated 
E2B data field.  Sponsors should also use the indicated repeatable E2B data field to list 
individually other relevant INDs for which notification is necessary (i.e., cross-reporting) as 
described in the guidance for industry and investigators Safety Reporting Requirements for INDs 
 
12 Additional information on the voluntary submission process is available on the FAERS Electronic Submissions 
web page at https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-
system-faers-electronic-submissions. 
5  Contains Nonbinding Recommendations 
and BA/BE Studies and the draft guidance for industry Sponsor Responsibilities  Safety 
Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence 
Studies (June 2021).13  The relevant FDA review staff for each IND identified in the FAERS 
report will be notified that an IND ICSR has been submitted for that drug.   
 
Sponsors should see the technical specifications document referenced in this Guide, FDA 
Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety 
Reports for Drug and Biological Products, for information on E2B data elements to populate 
with the appropriate IND numbers as discussed above. 
 
2.1.7.1  IND ICSRs From an Aggregate Analysis 
 
IND ICSRs that are a result of an aggregate analysis (21 CFR 312.32(c)(1)(i)(C)) of clinical 
trials that are conducted under multiple INDs should be submitted to the parent IND using 
electronic reporting to FAERS.  The parent IND is the IND under which clinical trials were first 
initiated in the United States.  If the drug is being evaluated in multiple INDs, the parent IND is 
generally the IND with the lowest number.  
 
As discussed in the guidance for industry and investigators Safety Reporting Requirements for 
INDs and BA/BE Studies, IND safety reports that are a result of an aggregate analysis should 
include a narrative report (hereafter referred to as a narrative summary report) that provides a 
summary of the cases and the analysis the sponsor conducted and should identify the individual 
cases that contributed to the analysis.  The sponsor should submit one IND ICSR to FAERS that 
includes the following minimum information listed by E2B data element name with additional 
clarifying information in parentheses:  
 
  Senders (case) Safety Report Unique Identifier 
  Type of Report (should = Report from study) 
  Date of Most Recent Information for This Report 
  Information on Sender of Case Safety Report (type, name, address, etc.) 
  Local Criteria Report Type (15- or 7-day report)  
  MedDRA Version for Reaction/Event14 
  Reaction/Event (MedDRA code)   
  Seriousness Criteria at Event Level (list most common criteria among all of the 
individual cases) 
  Characterisation of Drug Role 
  Substance/Specified Substance Name 
  Source of Assessment 
  Result of Assessment 
 
  The term aggregate in the E2B field Patient to indicate that the report is a report from 
an aggregate analysis 
 
13 When final, this guidance will represent the FDAs current thinking on this topic.   
 
14 MedDRA is an acronym for Medical Dictionary for Regulatory Activities. 
6  Contains Nonbinding Recommendations 
 
  The unique case identification number of each IND ICSR that contributed to the analysis, 
listed in the appropriate E2B field as a linked report.  If individual cases that contributed 
to the analysis were previously submitted as IND safety reports in eCTD format, the 
sponsor should list the eCTD sequence number15 and date of submission along with the 
unique case identification number/manufacturer control number in the narrative summary 
report that is attached to the IND ICSR as a PDF. 
 
  The narrative summary report attached to the IND ICSR as a PDF and clearly titled 
Narrative summary report for an IND safety report from an aggregate analysis_IND 
number_product_date of report.   
 
Sponsors should reference the technical specifications document FDA Regional Implementation 
Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and 
Biological Products for instructions on the appropriate data elements to include in IND ICSRs 
from aggregate analyses as per 21 CFR 312.32(c)(1)(i)(C), on how to link all supportive IND 
ICSRs to the report, and on where to include the narrative summary report.  This information 
may also be applicable for IND ICSRs submitted as per 21 CFR 312.32(c)(1)(i)(B) that include 
more than one case and where a narrative summary report is provided. 
 
2.1.8  Product Names for Investigational Drugs 
 
Sponsors should use the established name (generally the United States Adopted Name or 
international nonproprietary name), if applicable, in the appropriate E2B product field for 
investigational drugs.  For investigational drugs without an established name, or if the 
established name or the name of the active ingredient(s) in the product exceeds established E2B 
character lengths, before submission of IND ICSRs to FAERS, the sponsor should submit to the 
IND a general correspondence in eCTD format containing the full name of the medicinal 
product, product name to be used for E2B reporting (FDA recommends company code, if 
available), full name of the active ingredient(s), and active ingredient(s) name to be used for E2B 
reporting as in Table 2 below.  
 
 
15 The eCTD sequence number is the unique four-digit number for each IND submission the sponsor submits in the 
us-regional.xml file for the eCTD submission. 
7  Contains Nonbinding Recommendations 
Table 2: Information to Include in General Correspondence  Product E2B File* 
 
IND number  Full name of  Product name  Full name of  Active 
medicinal  to be used for  the active  ingredient(s) 
product  E2B reporting  ingredient(s).  name to be used 
(FDA  Separate  for E2B 
recommends  multiple  reporting 
company code,  ingredients 
if available)  with a 
backslash 
character (\) 
         
         
* IND = investigational new drug application; E2B = International Council for Harmonisation E2B data standards. 
 
The document should be placed in 1.2 Cover letters, and sponsors should clearly identify the 
submission as General Correspondence  Product E2B File. 
 
2.1.9  Safety Reports for Marketed Drugs 
 
For an adverse event associated with a marketed drug evaluated under an IND that meets IND 
and postmarketing safety reporting requirements (21 CFR 312.32(c)(1)(i) and 314.80, 600.80, or 
310.305), the sponsor should submit two separate ICSRs to FAERS: one ICSR referencing the 
new drug application (NDA) or biologics license application (BLA) in the 
Authorization/Application Number field and one IND ICSR referencing the IND as described 
under section 2.1.7., Identification of the IND for Submissions of IND ICSRs. 
 
For adverse events that occur with a marketed vaccine evaluated under an IND that meet IND 
and postmarketing safety reporting requirements (21 CFR 312.32(c)(1)(i) and 600.80), the 
sponsor should submit two separate ICSRs: one to VAERS for the BLA and one IND ICSR to 
FAERS for the IND. 
 
2.1.10 Other Considerations 
 
Sponsors should reference the technical specifications document FDA Regional Implementation 
Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and 
Biological Products and the FAERS Electronic Submissions web page for the following 
information: 
 
  Required E2B data elements for IND ICSRs 
 
  Regional specifications of the E2B data elements 
 
  Use of E2B data elements for a variety of reporting scenarios  
 
8  Contains Nonbinding Recommendations 
  Submission of a narrative summary report as per 21 CFR 312.32(c)(1)(i)(C) or for several 
reports submitted as per 21 CFR 312.32(c)(1)(i)(B)) and linking the unique case 
identification numbers of the IND ICSRs supporting the narrative summary report 
 
2.1.11 Options For Electronic Submission of IND ICSRs: Electronic Submissions 
Gateway or Safety Reporting Portal 
 
IND ICSRs (initial and follow-up reports and all attachments) for drugs addressed by this Guide 
are submitted as IND ICSRs to the FAERS database.16  FDA provides two options for electronic 
submission of IND ICSRs and attachments to FAERS: (1) direct submission through the 
Electronic Submissions Gateway (ESG) or (2) submission through the Safety Reporting Portal 
(SRP), both of which are available 24 hours a day, 7 days a week.  
 
Direct submission of IND ICSRs through the ESG is described on the FAERS Electronic 
Submissions web page.  This option involves direct transmission of IND ICSRs from a firms 
database to FDA through the ESG.  The ESG is a central transmission point for sending 
information electronically to FDA.  Once received through the ESG, the submitted reports are 
processed into the FAERS database.  For instructions on organizing, preparing, and submitting 
IND ICSRs and attachments using the direct submission method through the ESG, see the 
technical specifications document FDA Regional Implementation Guide for E2B(R3) Electronic 
Transmission of Individual Case Safety Reports for Drug and Biological Products.  The 
technical specifications document addresses topics such as data elements, electronic transport 
format, and types of IND ICSR attachments FDA currently accepts.   
 
The submission of IND ICSRs and IND ICSR attachments through the SRP is described on the 
FDAs SRP web page.17  Users enter the IND ICSR information manually into a web-based 
form, and this information is then submitted to FDA to be uploaded into the FAERS database.   
 
2.1.11.1  Separate Submission Pathway for Submitting IND ICSRs to FAERS 
 
FDA established a separate submission pathway within the ESG and SRP for submitting IND 
ICSRs to FAERS to keep premarket and postmarketing reports separate in the FAERS database.  
In addition, FDA created a new FDA region-specific data element to distinguish premarket and 
postmarketing safety reports.  Certain postmarketing data are periodically posted on the public 
FAERS dashboard, and reports submitted through the premarket pathway will not be posted to 
the public dashboard. . If an adverse event met both IND and postmarketing safety reporting 
requirements the ICSR submitted to the postmarketing pathway will be subject to posting on the 
FAERS public dashboard. 
 
FDA has implemented business rules to identify IND ICSRs that are incorrectly submitted to the 
postmarketing pathway in FAERS.  Files submitted to the postmarketing pathway in FAERS 
 
16 See the Questions and Answers on FAERS web page at https://www.fda.gov/drugs/surveillance/fda-adverse-
event-reporting-system-faers.  
 
17 Available at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=0183c2c0-8952-49cb-81f1-
0c3d37baa819.  
9  Contains Nonbinding Recommendations 
with certain criteria will be rejected and sponsors will receive a negative acknowledgement with 
the reason for the rejection.18  
 
2.1.11.2  Creating an Account Before the First Electronic Submission 
 
To submit IND ICSRs electronically, either through the ESG or SRP, the sponsor needs to have 
an account with FDA.  To create an account, the sponsor should contact the FAERS electronic 
submissions coordinator at faersesub@fda.hhs.gov.  The FAERS electronic submissions 
coordinator will assist sponsors to ensure that all steps have been completed for successful 
submission of IND ICSRs and attachments. 
 
2.1.11.3  Unique Case Identification Numbers for IND Safety Reports 
 
Each IND ICSR should have a unique case identification number.  The sponsor should use the 
same unique case identification number for an initial IND ICSR and any of its follow-up reports 
so that the reports can be associated with an individual case.  Case identification numbers are 
assigned based on one of the three methods of submission described below:   
 
a.  Via the SRP:  The unique case identification number for an initial report is automatically 
generated by the SRP once the IND ICSR is submitted.  
 
b.  Via the ESG:  The unique case identification number for an initial report is generated by 
the sponsor before submitting the report. 
 
c.  On Paper (e.g., MedWatch Form FDA 3500A):19  The unique case identification number 
is the manufacturer control number that the sponsor assigns for the initial report.  
 
The sponsor should use the same unique case identification number for an initial IND ICSR and 
its follow-up reports even if there is a transfer of ownership of an application.  If the current 
sponsor submits a follow-up IND ICSR to an initial report submitted by a previous sponsor, the 
current sponsor should use the unique case identification number from the initial IND ICSR to 
ensure that the follow-up report can be matched with the initial submission. 
 
Similarly, if the sponsor submits an initial IND ICSR through the ESG, the sponsor cannot 
submit the follow-up reports for this case through the SRP because the initial and follow-up 
reports will have different unique case identification numbers. 
 
 
18 For additional details on rejection criteria for IND safety reports, see the FDA E2B(R3) Core and Regional Data 
Elements and Business Rules document available on the FAERS Electronic Submissions web page at 
https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-
electronic-submissions. 
 
19 Sponsors who submit a follow-up report to FAERS for an earlier report that was submitted on paper or in eCTD 
format should use the same manufacturer control number for the initial and all follow-up reports.  
10  Contains Nonbinding Recommendations 
2.1.11.4  Single Submission Versus Batched Submission of IND ICSRs 
 
When submitting IND ICSRs through the ESG, the sponsor can submit the reports either as a 
single report or as several reports in a batch.  See the technical specifications document FDA 
Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety 
Reports for Drug and Biological Products for information on submitting a single IND ICSR 
versus a batch of IND ICSRs through the ESG.   
 
If the sponsor is submitting IND ICSRs through the SRP, the sponsor can only submit a single 
IND ICSR at a time because the SRP is not able to process a batched submission.  
 
2.1.12 Notification of Receipt of Submissions by the FDA 
 
For information on the notification of FDAs receipt of a submission, see the guidance for 
industry Providing Submissions in Electronic Format  Postmarketing Safety Reports and the 
FAERS Electronic Submissions web page. 
11