Providing Regulatory 
Submissions  
In Electronic Format   
Standardized Study Data 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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) 
 
June 2021 
Electronic Submissions 
 
Revision 2
   
Providing Regulatory 
Submissions  
in Electronic Format   
Standardized Study Data
 
Guidance for Industry 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 
 
and/or 
 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances    
 
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) 
 
June 2021 
Electronic Submissions 
 
Revision 2
   
Technical specifications associated with this guidance are provided as separate, stand-alone 
documents and are updated periodically.  These are: 
 
  Data Standards Catalog 
  Study Data Technical Conformance Guide 
  FDA Specific SEND Validation Rules 
  FDA Specific SDTM Validation Rules 
 
To make sure you have the most recent versions, please check: 
 
https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources 
 
 
REVISION HISTORY 
 
 
DATE  SUMMARY OF REVISIONS 
October 2020  Updates to Guidance 
 
Section II.B. What types of submissions are exempted from the 
electronic submission requirements for standardized study data? 
 
  Updated the term noncommercial products to 
noncommercial IND to clarify the products that are 
exempt from requirements under this guidance. 
 
 
Section II.E. When will electronic submission of standardized 
study data be required? 
 
  Updated to clarify the information FDA relies on for 
assessing compliance with study data requirements 
 
  Updated example of timetable to reflect actual timetable 
for the implementation of the electronic submissions 
requirement and otherwise clarify the date of the initial 
requirements 
May 2021  Section II.A. For what submission types is an electronic 
submission of standardized study data required? 
 
  Updated to clarify where stakeholders can find more 
information about when electronic standardized study 
data are required as part of a submission during a 
declared public health emergency 
 
   
Section II.E. When will electronic submission of standardized 
study data be required? 
 
  Updated to clarify the implementation periods for new 
study standards and version updates, in alignment with 
the Federal Register notice entitled Electronic Study 
Data Submission; Data Standards; Timetable for Updates 
to the Food and Drug Administration Data Standards 
Catalog for Study Data Submitted Electronically Under 
the Federal Food, Drug, and Cosmetic Act that appeared 
on January 23, 2018 (83 FR 3161) 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION ...................................................................................................... 1 
II.  REQUIREMENT TO SUBMIT ELECTRONIC STANDARDIZED STUDY DATA
  2 
A.  For What Submission Types Is an Electronic Submission of Standardized Study Data 
Required? .................................................................................................................... 2 
B.  What Types of Submissions Are Exempted from the Electronic Submission Requirements 
for Standardized Study Data? ........................................................................................ 3 
C. What Are the Requirements That Must Be Followed for Electronic Submission of 
Standardized Study Data? ................................................................................................. 3 
1. Exchange Format Standards ............................................................................................ 4 
2. Study Data Standard ....................................................................................................... 4 
3. Controlled Terminology Standard ..................................................................................... 5 
D. Will FDA Issue Waivers of the Electronic Submission Requirements for Standardized Study 
Data? ............................................................................................................................... 5 
E.  When Will Electronic Submission of Standardized Study Data Be Required?.................... 6 
1. Initial Timetable for the Implementation of Electronic Submission Requirements...................... 7 
2. Version Updates to FDA-Supported Standards.................................................................... 8 
3. New Standards ............................................................................................................... 9 
III.  ADDITIONAL SUPPORT ......................................................................................... 9 
A.  Meetings With FDA ...................................................................................................... 9 
B.  Implementation Support ..............................................................................................10 
 
   
1  Providing Regulatory Submissions in Electronic Format  
2  Standardized Study Data 
3  Guidance for Industry1 
4   
5   
6   
7  I.  INTRODUCTION 
8   
9  Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
10  379k-1(a)), at least 24 months after the issuance of a final guidance document in which the Food 
11  and Drug Administration (FDA or the Agency) has specified the electronic format for submitting 
12  certain submission types to the Agency, such content must be submitted electronically and in the 
13  format specified by FDA.2  This guidance and the technical specifications documents it 
14  incorporates by reference describe the requirements for an electronic submission of standardized 
15  clinical and nonclinical study data under section 745A(a) of the FD&C Act.  In accordance with 
16  section 745A(a), following the issuance of a final guidance on this topic, study data contained in 
17  the submission types identified in this guidance must be submitted electronically in a format that 
18  FDA can process, review, and archive.  
19   
20  This guidance implements the electronic submission requirements of section 745A(a) of the 
21  FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug 
22  applications (ANDAs), biologics license applications (BLAs), and investigational new drug 
23  applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for 
24  Biologics Evaluation and Research (CBER)3 by specifying the format for electronic submissions.  
25  Submissions that are not submitted electronically and electronic submissions that are not in a 
26  format that FDA can process, review, and archive will not be filed or received, unless exempt 
27  from the electronic submission requirements or if FDA has granted a waiver (see sections II.B 
28  and II.D). 
29   
30  In section 745A(a) of the FD&C Act, Congress granted explicit authorization to FDA to 
31  implement the statutory electronic submission requirements in guidance.  Accordingly, as 
32  indicated by the use of the words must or required, this document is not subject to the usual 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research and the Center for Biologics 
Evaluation and Research at the Food and Drug Administration.  You may submit comments on this guidance at any 
time. Submit comments to Docket No. FDA-2012-D-0097 (available at https://www.regulations.gov/docket/FDA-
2012-D-0097) (see the instructions for submitting comments in the docket). 
 
2 For additional information on how FDA interprets and intends to implement the electronic submission 
requirements of section 745A(a) of the FD&C Act, please see the guidance for industry Providing Regulatory 
Submissions in Electronic Format  Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic 
Act (December 2014) (745A(a) Implementation Guidance).  We update guidances periodically.  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 For purposes of this guidance, quality control or validation data submitted in support of licensure of blood 
components are not considered study data. 
 
1   
33  restrictions in FDAs good guidance practice regulations, such as the requirement that guidances 
34  not establish legally enforceable responsibilities.  See 21 CFR 10.115(d). 
35   
36  To comply with the good guidance practice regulations and make sure that regulated entities and 
37  the public understand that guidance documents are nonbinding, FDA guidances ordinarily 
38  contain standard language explaining that guidances should be viewed only as recommendations 
39  unless specific regulatory or statutory requirements are cited.  FDA is not including this standard 
40  language in this guidance because it is not an accurate description of the effects of this guidance.  
41  Insofar as this guidance specifies the format for electronic submissions or provides for 
42  exemptions pursuant to section 745A(a) of the FD&C Act, it will have binding effect. 
43   
44   
45  II.  REQUIREMENT TO SUBMIT ELECTRONIC STANDARDIZED STUDY DATA 
46   
47  A.  For What Submission Types Is an Electronic Submission of Standardized 
48  Study Data Required? 
49   
50  Electronic submissions of standardized study data will be required for the following submission 
51  types: 
52   
53    Certain investigational new drug applications (INDs)4,5  
54    New drug applications (NDAs) 
55    Abbreviated new drug applications (ANDAs) 
56    Certain biologics license applications (BLAs)6 
57   
58  This requirement also includes all subsequent submissions, including amendments, supplements, 
59  and reports to one of the submission types identified above.  Study data in submissions that are 
 
4 This guidance is not applicable to INDs for devices that are regulated by CBER as biological products under 
section 351 of the Public Health Service (PHS) Act and that also require submission of an IND before submission of 
a BLA.  Although a discussion of which devices CBER regulates as biological products is outside the scope of this 
guidance, we note that as a general matter, this category of INDs would include those investigational devices 
regulated under IND that are used to screen blood donors for certain transfusion-transmissible diseases and to test 
human cells, tissues, or cellular or tissue-based products to make a donor-eligibility determination.  These 
submissions are subject to the requirements under section 745A(b) of the FD&C Act.  See the guidance for industry 
and Food and Drug Administration Staff eCopy Program for Medical Device Submissions (April 2020), which 
implements the electronic copy provisions of section 745A(b) of the FD&C Act for medical device submissions to 
FDA. 
 
5 This guidance is not applicable to noncommercial INDs.  See section II.B. 
 
6 This guidance is not applicable to those devices that are regulated by CBER as biological products under section 
351 of the PHS Act, including those that do not require submission of an IND before the submission of the BLA.  
Although a discussion of which devices CBER regulates as biological products under section 351 of the PHS Act is 
outside the scope of this guidance, we note that as a general matter, this category would include those reagents used 
in determining donor/recipient compatibility in transfusion medicine.  These submissions are subject to the 
requirements under section 745A(b) of the FD&C Act.  See the final guidance entitled eCopy Program for Medical 
Device Submissions. 
 
2   
60  not submitted electronically will not be filed, unless exempt from the electronic submission 
61  requirements or unless FDA has granted a waiver. 
62   
63  Sponsors and applicants must submit study data electronically using the format described in this 
64  guidance for both clinical and nonclinical studies. 
65   
66  Please see the Study Data Technical Conformance Guide (Conformance Guide)7 for clarification 
67  regarding when electronic standardized study data are required as part of a submission to address 
68  a public health emergency declared by the Secretary of Health and Human Services in 
69  accordance with section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)). 
70    
71  B.  What Types of Submissions Are Exempted from the Electronic Submission 
72  Requirements for Standardized Study Data? 
73   
74  Section 745A(a) of the FD&C Act allows FDA to establish exemptions from the electronic 
75  submission requirements.  Accordingly, FDA has exempted all submissions regarding 
76  noncommercial INDs from the requirements under section 745A(a).8  For purposes of this 
77  guidance, the term noncommercial IND refers to an IND for a product that is not intended for 
78  commercial distribution and includes investigator-sponsored INDs and expanded access INDs 
79  (e.g., emergency use INDs and treatment INDs).9  Although such submissions will be exempt, 
80  FDA will accept their voluntary submission in a standardized electronic format as described in 
81  this guidance document. 
82   
83  C.  What Are the Requirements That Must Be Followed for Electronic 
84  Submission of Standardized Study Data? 
85   
86  Under section 745A(a) of the FD&C Act, electronic submissions shall be submitted in such 
87  electronic format as specified by [FDA].  FDA has determined that study data contained in the 
88  electronic submissions described in section II.A must be in a format that the Agency can process, 
89  review, and archive.  Currently, the Agency can process, review, and archive electronic 
90  submissions of clinical and nonclinical study data that use the standards specified in the Data 
91  Standards Catalog (Catalog).10   
92   
93  The Catalog provides a listing of currently supported11 and/or required standards, their uses, the 
94  date FDA will begin (or has begun) to support a particular standard, the date such support ends 
 
7 The Study Data Technical Conformance Guide is available at https://www.fda.gov/industry/fda-resources-data-
standards/study-data-standards-resources. 
 
8 See 745A(a) Implementation Guidance, section III.B. 
 
9 The previous version of this guidance used the term noncommercial products rather than noncommercial INDs.  
This change was made to clarify our meaning. 
 
10 Available at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources. 
 
11 For the purposes of this document, supported means the receiving Center has established processes and 
technology to support receiving, processing, reviewing, and archiving files in the specified standard. 
 
3   
95  (or will end), the date the requirement to use a particular standard will begin (or has begun), the 
96  date such requirement ends (or will end), and other pertinent information.  The Agency may 
97  refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs, an electronic 
98  submission that does not have study data in conformance to the required standards specified in 
99  the Catalog. 
100   
101  When planning a study (including the design of case report forms, data management systems, 
102  and statistical analysis plans), the sponsor or applicant must determine which FDA-supported 
103  standards to use or request a waiver of those requirements as described in section II.D.  There 
104  may be versions of a standard available that are not yet supported by FDA (e.g., specific SDTM 
105  or ADaM versions) or there may be FDA-supported standards that, currently, have only specific 
106  components developed (e.g., SEND study types).12  See section III for additional support on data 
107  standards questions or issues.  FDA-supported standards listed in the Catalog are categorized as 
108  follows: 
109   
110  1.  Exchange Format Standards 
111   
112  An exchange format standard specifies a particular way that information is encoded in a 
113  computer file.  Specifications for a format permit the file to be written according to a standard, 
114  opened for use or alteration, and written back to a storage medium for later access.  Some 
115  exchange formats in widespread use are proprietary; others are open source.  Examples of format 
116  standards currently supported by FDA include: Adobe Portable Document Format (pdf), SAS 
117  Institute Transport File format (xpt), and Extensible Markup Language (xml).   
118   
119  2.  Study Data Standard 
120   
121  Study data standards describe a standard way of exchanging study data between computer 
122  systems.  Study data standards may describe the data elements and relationships necessary to 
123  achieve the unambiguous exchange of information between disparate information systems.  The 
124  Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model 
125  (SDTM) and Standard Exchange for Nonclinical Data (SEND) are examples of study data 
126  standards for tabulations data.  
127   
128  Analysis standards describe a standard data structure intended to support analysis.  Analysis 
129  standards include extraction, transformation, and derivations of the original data.  The CDISC 
130  Analysis Data Model (ADaM) is an example of a study data standard for analysis data.    
131   
 
12 Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), Standard for Exchange of Nonclinical 
Data (SEND), available at http://www.cdisc.org. 
4   
132  3.  Controlled Terminology Standard 
133   
134  The use of controlled terminology standards, also known as vocabularies, is an important 
135  component of study data standardization and is a critical component of achieving semantically 
136  interoperable data exchange.13  Controlled terminology standards specify the key concepts that 
137  are represented as preferred terms, definitions, synonyms, codes, and code systems.  Controlled 
138  terminology standards are maintained by external organizations (i.e., external to the sponsor or 
139  applicant).  Sponsor- or applicant-defined custom terms are not considered controlled 
140  terminologies.  However, some controlled terminologies are extensible and permit additions to 
141  existing codelists.  It is the expectation that sponsors or applicants will use the controlled 
142  terminologies maintained by external organizations as the standard.  Examples of controlled 
143  terminology standards include:    
144   
145    The National Drug File (NDF)  Reference Terminology for drug classifications14 
146    CDISC Controlled Terminology15 
147    Medical Dictionary for Regulatory Activities (MedDRA)16 
148   
149  D.  Will FDA Issue Waivers of the Electronic Submission Requirements for 
150  Standardized Study Data? 
151   
152  Electronic submissions of study data must be in a format that FDA can review, process, and 
153  archive.  Currently, the Agency can process, review, and archive electronic submissions of study 
154  data that use the standards specified in the Catalog posted to the FDAs Study Data Standards 
155  Resources web page.17   
156   
157  FDA will not provide waivers to submit data that do not conform to any FDA-supported study 
158  data standard.  However, sponsors or applicants may apply for a waiver from the requirement to 
159  use specific versions of FDA-supported standards for the submission of study data.  Generally, a 
160  waiver will enable a sponsor or applicant to submit study data electronically using a version of a 
161  standard that was previously supported by FDA. 
162   
163  To apply for a waiver from the requirement to submit study data using a version of a standard 
164  that is not supported as set forth in the Catalog, an email request must be sent to the FDA 
165  technical staff at cder-edata@fda.hhs.gov for requests related to CDER-regulated submissions 
 
13 See the Study Data Technical Conformance Guide for a detailed discussion of semantic interoperability. 
 
14 NDF is available at 
http://ncit.nci.nih.gov/ncitbrowser/pages/vocabulary.jsf?dictionary=National%20Drug%20File%20-
%20Reference%20Terminology. 
 
15 CDISC Controlled Terminology is available at 
http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc. 
 
16 MedDRA is available at http://www.meddra.org/. 
 
17 See https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources.  
 
5   
166  and at cber-edata@fda.hhs.gov for requests related to CBER-regulated submissions.  The subject 
167  line of the email should start with Waiver Request.  The body of the email should contain the 
168  following:   
169   
170  1.  Contact persons name (this will be the main contact) 
171  2.  Contact persons company name 
172  3.  Contact persons mailing address 
173  4.  Contact persons phone number 
174  5.  Contact persons email address 
175  6.  Relevant submission types and numbers 
176  7.  The specific requirement or requirements from which the sponsor or applicant is requesting a 
177  waiver  
178  8.  The reason the sponsor or applicant believes that the waiver is necessary  
179  9.  A description of the alternative or alternatives that the sponsor intends to use  
180   
181  FDA encourages the sponsor or applicant to submit the waiver request to the FDA technical staff 
182  as early as possible during product development (e.g., when the study is being planned, which 
183  may be during the pre-IND phase) and certainly no later than the time of protocol submission to 
184  the IND.  FDA will notify the sponsor or applicant in writing (e.g., in an email) as to whether the 
185  waiver request is denied or granted.  The technical staff will coordinate with the applicable 
186  review division and contact the requestor concerning the status of the waiver request.  Generally, 
187  FDA intends to notify the requestor within 30 days from the date the waiver request is received. 
188   
189  E.  When Will Electronic Submission of Standardized Study Data Be Required? 
190   
191  The requirement to submit using a particular standard is dependent on its support by FDA as 
192  listed in the Catalog at the time of study start.18  FDA recognizes that standards development 
193  organizations may release version updates to standards in the interval between the start of a study 
194  and the submission of study data to the Agency.  The Catalog may list more than one version of a 
195  supported standard (e.g., PDF versions 1.4 - 1.7, SDTM versions 1.2 and 1.3, Define versions 1.0 
196  and 2.0, and MedDRA versions 8 or later).  Sponsors or applicants are encouraged to use the 
197  latest version listed in the Catalog.  However, when there are multiple versions of a standard 
198  listed, sponsors or applicants can select the version to use for their study.    
199   
200  The initial timetable for the implementation of electronic submission requirements for study data 
201  is described in section II.E.1.  Since the initial timetable has passed, FDA may announce the 
202  future availability of new standards and version updates to existing standards through Federal 
203  Register notices.  Such a Federal Register notice will specify the next calendar March 15 date 
204  following the publication of the Federal Register notice as the start date for the implementation 
205  period (transition date) used to calculate when the new standard or version update will be 
206  required in a submission.  The transition date does not indicate the date on which the requirement 
 
18 For purposes of this guidance, the study start date for clinical studies is the earliest date of informed consent 
among any subject that enrolled in the study.  For example, see Study Start Date in the SDTM Trial Summary 
Domain (TSPARMCD = SSTDTC), available at http://www.cdisc.org.  For nonclinical studies, the study start date 
is the date on which the study protocol or plan is approved (signed) by the Study Director, also known as the study 
initiation date.   For example, see Study Start Date in the SEND Trial Summary Domain (TSPARMCD = 
STSTDTC), available at http://www.cdisc.org. 
6   
207  to use a particular standard commences.  Instead, the transition date indicates the beginning date 
208  of the implementation period, which will be consistent with the timetables set forth in the 
209  745A(a) Implementation Guidance, to provide industry with notice before requiring the new 
210  standard or version update in submissions.  The use of a standard will be required in submissions 
211  only after the implementation period has ended.  This use of the transition date approach should 
212  provide sponsors and applicants with a consistent and predictable implementation timetable for 
213  new standards and version updates to existing standards.  Examples using the transition date 
214  approach are listed below:   
215   
216  Example 1: A Federal Register notice is published on September 5, 2022, announcing the 
217  availability of a new standard.  The transition date is the next calendar March 15 date, March 
218  15, 2023, which starts the implementation period for the new standard.  The new standard 
219  will be required in submissions for studies that start 24 months after the transition date, 
220  which is March 15, 2025.    
221   
222  Example 2: A Federal Register notice is published on February 14, 2022, announcing the 
223  availability of a new standard.  The transition date is the next calendar March 15 date, March 
224  15, 2022, which starts the implementation period for the new standard.  The new standard 
225  will be required in submissions for studies that start 24 months after the transition date, 
226  which is March 15, 2024.    
227   
228  Example 3: A Federal Register notice is published on April 6, 2022, announcing the 
229  availability of a version update to an existing standard.  The transition date is the next 
230  calendar March 15 date, March 15, 2023, which starts the implementation period for the 
231  version update.  The version update will be required in submissions for studies that start 12 
232  months after the transition date, which is March 15, 2024.  
233   
234  1.  Initial Timetable for the Implementation of Electronic Submission Requirements 
235   
236  After the publication of the initial final version of this guidance on December 18, 2014 (2014 
237  Final eStudy Data Guidance), all studies with a start date 24 months after that publication date 
238  (December 18, 2016) for NDA, ANDA, and certain BLA submissions and studies with a start 
239  date 36 months after the publication of the 2014 Final eStudy Data Guidance (December 18, 
240  2017) for certain IND submissions must use the appropriate FDA-supported standards, formats, 
241  and terminologies specified in the Catalog (see section II.C)).  As noted above, to ensure that 
242  FDA can assess whether sponsors and applicants are subject to particular study data format 
243  requirements, FDA must rely on information provided by the submitter about study start date and 
244  the file type being submitted.  Generally, the datasets necessary to assess conformance to the 
245  standard include the demographic dataset file (SDTM and SEND dm.xpt), the subject level 
246  analysis dataset file (ADaM adsl.xpt), and the define.xml file (SDTM, SEND, and ADaM).  For 
247  further details, see the Technical Rejection Criteria for Study Data, the Conformance Guide, and 
248  the Data Standards Catalog.19   
249   
 
19 See footnote 17.  See also Study Data for Submission to CDER and CBER, available at 
https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber.  
7   
250  2.  Version Updates to FDA-Supported Standards 
251   
252  Periodically, version updates to FDA-supported study data standards are released by Standards 
253  Development Organizations (SDOs).  Version updates may include (1) content or structural 
254  changes (e.g., new SDTM domains or variables) and (2) typographical errors, corrections, or 
255  clarifications that do not result in content or structural changes.  Generally, version updates that 
256  include content or structural changes would require FDA to execute a testing and acceptance 
257  process, whereas errata, corrections, or clarifications would not. 
258   
259  Given that the 24- and 36-month initial implementation timetables described in section II.E.1 
260  have passed since the publication of the 2014 Final eStudy Data Guidance, version updates will 
261  be required in submissions for studies with a start date that is no earlier than 12 months after the 
262  transition date specified in a Federal Register notice announcing FDAs determination of the 
263  new format as one that it can process, review, and archive.20  The Federal Register notice will 
264  specify the transition date for all version updates (with the month and day for the transition date 
265  corresponding to March 15).  When multiple versions of an FDA-supported standard are listed in 
266  the Catalog as formats which FDA can process, review, and archive, sponsors or applicants can 
267  select a version to use.   
268   
269  Below is an example and accompanying table (Table 1) of how a version update to a study data 
270  standard would be implemented. 
271   
272  Example:  On February 15, 2024, an SDO releases a version update to a study data standard 
273  already supported in the Catalog.  On May 6, 2025, FDA publishes a Federal Register notice 
274  announcing support for the version update and updates the Catalog.  The date support 
275  begins for this version update will be May 6, 2025.  The transition date posted in the Federal 
276  Register notice is March 15, 2026.  The date the requirement begins will be March 15, 2027.  
277  Sponsors or applicants are encouraged to begin using the updated version on May 6, 2025.  
278  The version update will only be required in submissions for studies that start after March 15, 
279  2027.  When multiple versions of an FDA-supported standard are listed in the Catalog, 
280  sponsors or applicants can select a version to use. 
281   
282  Table 1: Example of a Timetable for a Version Update to an FDA-Supported Standard 
Date Version  Date FR Notice  Date Support for  Transition Date  Date Requirement 
Update Released  Published  the Version Update  (yyyy-mm-dd)  for the Version 
by SDO  Announcing  Begins  Update Begins 
(yyyy-mm-dd)  Support of Version  (yyyy-mm-dd)  (yyyy-mm-dd) 
Update 
(yyyy-mm-dd) 
2024-02-15  2025-05-06  2025-05-06  2026-03-15  2027-03-15 
283   
 
20 See the 745A(a) Implementation Guidance, section III.F (describing the timetable for implementation of revisions 
and updates). 
8   
284  3.  New Standards 
285   
286  Given that the 24- and 36-month initial implementation timetables described in section II.E.1 
287  have passed since the publication of the 2014 Final eStudy Data Guidance, FDA may announce 
288  in a Federal Register notice (and guidance, if necessary) its support for new standards.  New 
289  standards are those that have not been supported by FDA and are not listed in the Catalog at the 
290  time this guidance is finalized.  New standards will be required in submissions for studies that 
291  start no earlier than 24 months after the transition date specified in a Federal Register notice 
292  announcing FDAs determination of the new standard as one that it can process, review, and 
293  archive.  The Federal Register notice of availability will specify the transition date for all 
294  version updates (with the month and day for the transition date corresponding to March 15). 
295   
296  Below is an example and accompanying table (Table 2) of how a new study data standard would 
297  be implemented.   
298   
299  On February 15, 2024, an SDO releases a new study data standard.  On May 6, 2025, FDA 
300  publishes a Federal Register notice announcing support of the new study data standard and 
301  updates the Catalog.  The date support begins for this new standard will be May 6, 2025.  
302  The transition date posted in the Federal Register notice is March 15, 2026.  The date the 
303  requirement begins will be March 15, 2028.  Sponsors or applicants are encouraged to begin 
304  using the new standard on May 6, 2025.  The new standard will only be required in 
305  submissions for studies that start after March 15, 2028. 
306   
307  Table 2:  Example of a Timetable for FDA Support of a New Standard 
Date New  Date FR Notice  Date Support for  Transition Date  Date Requirement 
Standard Released  Published  the New Standard  (yyyy-mm-dd)  for the New 
by SDO  Announcing  Begins  Standard Begins 
(yyyy-mm-dd)  Support of New  (yyyy-mm-dd)  (yyyy-mm-dd) 
Standard 
(yyyy-mm-dd) 
2024-02-15  2025-05-06  2025-05-06  2026-03-15  2028-03-15 
308   
309   
310  III.  ADDITIONAL SUPPORT 
311   
312  A.  Meetings With FDA 
313   
314  Sponsors and applicants may use established FDA-sponsor meetings (e.g., pre-IND and end-of-
315  phase 2) to discuss the study data standardization plan and to raise data standardization issues (if 
316  any) related to NDAs and BLAs.  Discussions about nonclinical study data standardization plans 
317  may be initiated at the pre-IND stage and should continue throughout development.  Initial 
318  discussions about which data standards to use for study data should take place as early as 
319  possible during drug development, especially for safety data, but should in any event occur no 
320  later than the end of phase 2.  In general, the premarketing application meeting is considered too 
321  late to initiate data standardization discussions.  For ANDAs, sponsors and applicants should 
322  discuss the study data standardization plan before the initiation of their bioequivalence program.   
323   
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324  Sponsors and applicants may submit technical questions related to data standards at any time to 
325  the technical support team identified by each Center (see the Study Data Standards Resources 
326  web page for specific contact information).  Sponsors and applicants may also request a separate 
327  Type C meeting to discuss substantive data standardization issues for NDAs and BLAs.  An 
328  example of such an issue might be a sponsors desire to use a standard (e.g., therapeutic area 
329  standard in SDTM format) that is not currently supported by FDA.  The request should include 
330  adequate information to identify the appropriate FDA staff necessary to discuss the proposed 
331  agenda items.   
332   
333  B.  Implementation Support 
334   
335  Technical specification documents provide nonbinding specifications, recommendations, and 
336  general considerations on how to submit standardized clinical and nonclinical study data using 
337  the standards specified in the Data Standards Catalog.  The Conformance Guide is a technical 
338  specification document that supplements the requirements described in this guidance and is 
339  intended to assist sponsors and applicants in the electronic submission of standardized study data 
340  (see section I).  The Conformance Guide will be updated, as needed, and its availability 
341  announced in a Federal Register notice.  
342   
343  Sponsors and applicants with questions on how to implement the FDA-supported study data 
344  standards should contact and work with FDA technical staff.  Contact information is provided on 
345  the Study Data Standards Resources web page.  Sponsors and applicants may also arrange to 
346  submit sample data for a presubmission technical review.  The technical staff welcomes any 
347  additional feedback or comments regarding the information posted on the web page. 
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