Standardized Format for Electronic 
Submission of NDA and BLA Content 
for the Planning of Bioresearch 
Monitoring (BIMO) Inspections for 
CDER Submissions 
 
Guidance for Industry 
 
 
 
 
DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact CDER-BIMO-NDA-BLA-
request@fda.hhs.gov. 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
February 2018 
Electronic Submissions 
   
Standardized Format for Electronic 
Submission of NDA and BLA Content 
for the Planning of Bioresearch 
Monitoring (BIMO) Inspections for 
CDER Submissions 
 
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 20993-0002 
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
 
 
February 2018 
Electronic Submissions 
 
 
 
 
Technical specifications associated with this guidance are provided as a separate document and 
are updated periodically:  
     Bioresearch Monitoring Technical Conformance Guide  
For the most current version of this document, refer to the CDER Guidances web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Electronic Submissions to FDA Under Section 745A(a) of the Federal Food, Drug, and 
Cosmetic Act ........................................................................................................................................... 2 
B.  NDA and BLA Content for BIMO ............................................................................................... 3 
III.  DESCRIPTION OF CLINICAL STUDY-LEVEL INFORMATION, SUBJECT- 
LEVEL DATA LINE LISTINGS BY CLINICAL SITE, AND SUMMARY-LEVEL 
CLINICAL SITE DATASET....................................................................................................... 6 
A.  Clinical Study-Level Information ................................................................................................. 6 
1. A Comprehensive and Readily Located Table Listing All Clinical Sites That Participated in 
Clinical Studies .................................................................................................................................... 7 
2. A Table Listing All Entities to Whom the Sponsor Has Contracted Clinical Study-Related 
Activities ............................................................................................................................................... 7 
3. Protocol, Protocol Amendments, and Annotated Case Report Form(s) .......................................... 7 
B.  Subject-Level Data Line Listings by Clinical Site ....................................................................... 8 
C.  Summary-Level Clinical Site Dataset .......................................................................................... 8 
IV.   SUBMITTING CLINICAL STUDY-LEVEL INFORMATION, SUBJECT-LEVEL 
DATA LINE LISTINGS BY CLINICAL SITE, AND SUMMARY-LEVEL CLINICAL 
SITE DATASET............................................................................................................................ 9 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
1  Standardized Format for Electronic Submission of NDA and BLA 
2  Content for the Planning of Bioresearch Monitoring (BIMO) 
3  Inspections for CDER Submissions  
1
4  Guidance for Industry  
5   
6   
7  I.  INTRODUCTION   
8   
9  This draft guidance describes the electronic submission of certain data and information in 
10  standardized formats, and supersedes the previously issued draft guidance for industry Providing 
11  Submissions in Electronic Format  Summary Level Clinical Site Data for CDERs Inspection 
12  Planning.2  This guidance applies to electronic submissions of data and information from all 
13  major (i.e., pivotal) studies3 used to support safety and efficacy claims in new drug applications 
14  (NDAs), biologics license applications4 (BLAs) regulated by the Center for Drug Evaluation and 
15  Research (CDER), and supplemental applications containing new clinical study reports.  It also 
16  applies when these data and information are submitted in certain investigational new drug 
17  applications5 (INDs) in advance of a planned NDA, BLA, or supplemental submission. 
18   
19  CDER uses the data and information described in this guidance to plan bioresearch monitoring 
20  (BIMO) inspections6 to facilitate the timely identification of sites for inspection and to ensure 
21  that field investigators from the Food & Drug Administrations (FDA or Agency) Office of 
22  Regulatory Affairs (ORA), which is the office responsible for the conduct of the inspections, 
23  have the information needed to conduct the inspections. Twenty-four months after this draft 
                                                 
1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research in 
consultation with the Office of Translational Sciences, the Office of Biostatistics, the Office of New Drugs, and the 
Office of Business Informatics.   
2 See FDA draft guidance for industry Providing Submissions in Electronic Format  Summary Level Clinical Site 
Data for CDERs Inspection Planning. For the most recent version of a guidance, check the FDA Drugs guidance 
web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
3 For questions regarding whether a study is considered major (i.e., pivotal), applicants should consult the relevant 
review division. 
4 This guidance applies only to BLAs regulated by CDER.  See Drug and Biological Product Consolidation in the 
Federal Register of June 26, 2003 (68 FR 38067), available at 
https://www.federalregister.gov/documents/2003/06/26/03-16242/drug-and-biological-product-consolidation. 
5 See FDA guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. 
6 See section 704(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374(a)) and 21 CFR 
312.58 (sponsors and contract research organizations), 312.68 (clinical investigators), 312.120(a)(ii), and 314.106(b) 
(foreign studies not conducted under an IND). 
1 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
24  guidance has been finalized, the data in NDAs and BLAs described in this guidance must be 
25  submitted electronically in the format specified in this guidance.7 
26   
27  In section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted 
28  explicit authorization to FDA to specify, in guidance, the electronic format for submissions 
29  under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions 
30  under section 351(a) or (k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a) or (k)). 
31  Accordingly, to the extent that this document provides such requirements, as indicated by the use 
32  of the words must or required, this document is not subject to the usual restrictions in FDAs 
33  good guidance practices (GGP) regulations, such as the requirement that guidances not establish 
34  legally enforceable responsibilities. See 21 CFR 10.115(d).   
35   
36  To comply with GGP regulations and make sure that regulated entities and the public understand 
37  that guidance documents are nonbinding, FDA guidances ordinarily contain standard language 
38  explaining that guidance documents should be viewed only as recommendations unless specific 
39  regulatory or statutory requirements are cited.  FDA is not including this standard language in 
40  this guidance document because it is not an accurate description of this guidance.  Insofar as this 
41  guidance specifies the format for electronic submissions pursuant to section 745A(a) of the 
42  FD&C Act, it will have binding effect.   
43   
44   
45  II.  BACKGROUND 
46   
47  A.  Electronic Submissions to FDA Under Section 745A(a) of the Federal Food, 
48  Drug, and Cosmetic Act 
49   
50  The 745A(a) Implementation Guidance sets forth general information on how FDA interprets 
51  and intends to implement the electronic submission requirements of section 745A(a) of the 
52  FD&C Act.  The 745A(a) Implementation Guidance states that it is not feasible to describe and 
53  implement the electronic format(s) that would apply to all the submissions covered by section 
54  745A(a) in one guidance document.  Instead, FDA will periodically issue guidances specifying 
55  the electronic format for certain types of submissions.  The FDA guidance for industry Providing 
56  Regulatory Submissions in Electronic Format  Certain Human Pharmaceutical Product 
57  Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance) 
58  specifies the general format for certain types of electronic submissions using the Electronic 
59  Common Technical Document (eCTD), including the specifications for Module 5.8 
60   
                                                 
7 See section 745A(a) of the FD&C Act and FDA guidance for industry Providing Regulatory Submissions in 
Electronic Format  Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (745A(a) 
Implementation Guidance). 
8 The current version of the associated technical specification entitled The eCTD Backbone Files Specification for 
Module 1 provides additional information. See FDA eCTD web page at 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/u
cm153574.htm. 
2 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
61  In addition to the more general information and implementation timelines found in those 
62  guidances, this draft guidance provides additional information regarding the format to be used 
63  for electronic submission of NDA and BLA content for the planning and conduct of CDER 
64  BIMO inspections, using the eCTD.     
65   
66  B.  NDA and BLA Content for BIMO  
67   
68  FDA is responsible for making regulatory decisions about the approval of marketing applications 
69  and supplements for drugs and biological products, based, among other things, on the Agencys 
70  review of data, including clinical safety and efficacy data, submitted in support of NDAs, BLAs, 
71  and NDA and BLA supplements.9  Section 314.50 (21 CFR 314.50) describes the general 
72  content and format of NDAs and supplements, and includes the following requirements:  
73   
74  An application for a new chemical entity will generally contain an application form, an 
75  index, a summary, five or six technical sections, case report tabulations of patient data, 
76  case report forms, drug samples, and labeling, including, if applicable, any Medication 
77  Guide required under part 208 of this chapter.  Other applications will generally contain 
78  only some of those items, and information will be limited to that needed to support the 
79  particular submission.  These include an application of the type described in section 
80  505(b)(2) of the [FD&C Act], an amendment, and a supplement.  The application is 
81  required to contain reports of all investigations of the drug product sponsored by the 
82  applicant, and all other information about the drug pertinent to an evaluation of the 
83  application that is received or otherwise obtained by the applicant from any source.   
84   
85  Section 314.50(d) describes the technical sections of an application and requires that each 
86  technical section contain data and information in sufficient detail to permit the [A]gency to 
87  make a knowledgeable judgment about whether to approve the application or whether grounds 
88  exist under section 505(d) of the [FD&C Act] to refuse to approve the application.  
89  Requirements for the clinical data technical section of the application are described in   
90  314.50(d)(5), including the following sections of particular pertinence to this guidance:  
91   
92    Requirements for inclusion of a description of, and certain other information regarding, 
93  each controlled (see  314.50(d)(5)(ii)) and uncontrolled clinical study (see  
94  314.50(d)(5)(iii)).  Section 314.50(d)(5)(ii) further specifies that the Clinical Data Section 
95  of the application includ[es] the protocol and a description of the statistical analyses 
96  used to evaluate the study. 
97   
98    Requirement for:  
99   
100  [a] description and analysis of any other data or information relevant to an evaluation of 
101  the safety and effectiveness of the drug product obtained or otherwise received by the 
102  applicant from any source, foreign or domestic, including information derived from 
                                                 
9 For the purposes of this guidance, all references to drugs include both human drugs and biological products 
regulated by CDER. 
3 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
103  clinical investigations, including controlled and uncontrolled studies of uses of the drug 
104  other than those proposed in the application, commercial marketing experience, reports in 
105  the scientific literature, and unpublished scientific papers [see  314.50(d)(5)(iv)]. 
106   
107    Requirement that:  
108   
109  [i]f a sponsor has transferred any obligations for the conduct of any clinical study to a 
110  contract research organization, a statement [be included] containing the name and address 
111  of the contract research organization, identification of the clinical study, and a listing of 
112  the obligations transferred.  If all obligations governing the conduct of the study have 
113  been transferred, a general statement of this transfer  in lieu of a listing of the specific 
114  obligations transferred  may be submitted [see  314.50(d)(5)(x)]. 
115   
116  In addition,  314.50(f) describes requirements for submission of case report forms and 
117  tabulations.  Case report forms and tabulations, as discussed in  314.50(f), include study data 
118  tabulations, statistical analysis datasets, data listings, and patient profiles.10  Specifically, as 
119  pertinent to this guidance:  
120   
121    Section 314.50(f)(1) states that:  
122   
123  [t]he application is required to contain tabulations of the data from each adequate and 
124  well-controlled study under  314.126 (Phase 2 and Phase 3 studies as described in  
125  312.21 (b) and (c) of this chapter), tabulations of the data from the earliest clinical 
126  pharmacology studies (Phase 1 studies as described in  312.21(a) of this chapter), and 
127  tabulations of the safety data from other clinical studies.  Routine submission of other 
128  patient data from uncontrolled studies is not required.  The tabulations are required to 
129  include the data on each patient in each study, except that the applicant may delete those 
130  tabulations which the [A]gency agrees, in advance, are not pertinent to a review of the 
131  drug's safety or effectiveness.  
132   
133    Section 314.50(f)(3) states that [t]he applicant shall submit to FDA additional case 
134  report forms and tabulations needed to conduct a proper review of the application, as 
135  requested by the director of the FDA division responsible for reviewing the application. 
136   
137  Because the reliability of clinical trial data is critical to the approval decision, all CDER review 
138  disciplines share responsibility for evaluating data integrity.  CDERs Office of Scientific 
139  Investigations (OSI), in the Office of Compliance, has specific responsibility for verifying the 
140  integrity of data submitted to CDER in support of applications and supplements, and for 
141  determining whether clinical trials are conducted in compliance with applicable FDA regulations 
142  and statutory requirements, including those intended to ensure the rights and welfare of human 
143  research subjects.   
144   
                                                 
10 See Study Data Technical Conformance Guide at 
https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm#guides  
4 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
145  Clinical data are a central component of most NDAs and BLAs submitted to CDER.  As part of 
146  the review process, CDER may request ORA investigators conduct on-site inspections of clinical 
147  investigators, sponsors/applicants, contract research organizations, and institutional review 
148  boards involved in clinical trials that were submitted in support of applications for product 
149  approval.11  During these inspections, ORA investigators may obtain, copy, and verify records 
150  for FDA-regulated clinical trials with regard to, among other things: (1) subject case histories; 
151  (2) storage and disposition of the investigational product under 21 CFR part 312; and (3) clinical 
152  data to ensure they are maintained, tabulated, and submitted in compliance with the regulations 
153  in parts 312 and 314 (21 CFR parts 312 and 314).12 
154   
155  To meet its review performance goals in accordance with CDER good review management 
156  principles and practices for products covered by the Prescription Drug User Fee Act (PDUFA), 
157  CDER generally initiates inspection planning early in the application review process (i.e., during 
158  the filing determination and review planning phase).13  CDERs inspection planning includes (1) 
159  the selection of clinical investigator sites and other regulated entities for on-site inspections, and 
160  (2) the preparation of assignment memos and background packages that are provided to  ORA 
161  investigators that perform FDAs BIMO inspections.  The following data from NDAs and BLAs 
162  are used to facilitate the timely planning and conduct of inspections: 
163   
164    Identification of all entities to which sponsors have transferred regulatory obligations for 
165  clinical trial-related activities  
166   
167    Locations of clinical study-related documentation (Applicant/Sponsor/Contract Research 
168  Organization records) 
169   
170    Locations of clinical investigator sites 
171   
172    Case report tabulations of data for each patient in each study that are needed to conduct a 
173  proper review of the application  
174   
175  In addition, in an effort to provide a more timely approach to site selection, CDER has developed 
176  a risk-based model to select clinical investigator sites for inspection.  The model uses an array of 
177  risk parameters across clinical investigator sites associated with marketing applications.  To 
178  facilitate site selection, the model uses a summary-level clinical site dataset that describes and 
179  summarizes the characteristics and outcomes of clinical investigations, both at the study level 
180  and at the level of the individual study site.  CDER anticipates that the risk-based model will 
181  provide for earlier identification of clinical investigator sites for inspection and, therefore, that 
                                                 
11 See section 704(a) of the FD&C Act and 21 CFR 56.115, 312.52(b), 312.58, 312.68, 312.120(a)(1)(ii), and 
314.106(b). 
12 See  312.57, 312.58(a), 312.62, and 314.50. 
13 See the FDA guidance for review staff and industry Good Review Management Principles and Practices for 
PDUFA Products.  Agency guidance on electronic submissions will be updated regularly to reflect the evolving 
nature of the technology and the experience of those using this technology.    
5 
  Contains Binding Provisions and Nonbinding Recommendations 
Draft  Not for Implementation 
 
182  these inspections will be conducted earlier in the review cycle.  Using the risk-based site 
183  selection model is advantageous because it facilitates good review management practices, as 
184  described in the 21st Century Review Process Desk Reference Guide.14  The completion of 
185  inspections earlier in the review cycle also provides applicants the opportunity to address 
186  significant inspection observations earlier in the process. 
187   
188  Study-specific data (both clinical study-level information and clinical site data)15 submitted to 
189  FDA as part of NDA and BLA packages are described below in section III.  The required 
190  electronic format for these submissions is described in section IV, below, and the accompanying 
191  Bioresearch Monitoring Technical Conformance Guide. 
192   
193   
194  III.  DESCRIPTION OF CLINICAL STUDY-LEVEL INFORMATION, SUBJECT- 
195  LEVEL DATA LINE LISTINGS BY CLINICAL SITE, AND SUMMARY-LEVEL 
196  CLINICAL SITE DATASET  
197   
198  Reviewers from OSI, the Office of New Drugs (OND), and the Office of Biostatistics rely on 
199  timely access to accurate data in NDA and BLA submissions to issue inspection assignments as 
200  early in the review process as possible.  This is important to ensure that inspection results are 
201  available:   
202   
203  (1) To inform OSIs assessment of data integrity and human subject protection  
204  (2) To make recommendations to OND regarding data reliability  
205  (3) To permit time for the applicant to address any significant inspection findings 
206     
207  In the past, applicants have frequently provided this information in variable data formats that are 
208  not conducive to timely inspection planning or conduct of inspections.  A consistent process for 
209  submitting data and information used for routine BIMO inspections is therefore critical to meet 
210  the PDUFA timeline goals.  To accelerate the process of inspection planning, including the 
211  identification of inspection sites, FDA relies on the following items in NDAs, BLAs, and NDA 
212  and BLA supplemental applications containing major (i.e., pivotal) study reports used to support 
213  safety and efficacy claims.   
214   
215  A.  Clinical Study-Level Information 
216   
217  The items described in this section are used to facilitate inspection planning, including site 
218  selection, and the conduct of inspections.   
219   
                                                 
14 See the CDER 21st Century Review Process Desk Reference Guide, available at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc
edures/default.htm.  
15 See, e.g.,  314.50(d)(5) (clinical data) and  314.50(f) (case report forms and tabulations). 
6 
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220  1.  A Comprehensive and Readily Located Table Listing All Clinical Sites That 
221  Participated in Clinical Studies  
222   
223  Information concerning clinical sites that participated in clinical studies is relied on to inform the 
224  selection of sites for inspection.  Accurate contact information is also important because it 
225  enables ORA to contact clinical investigators to schedule inspections, and to ensure that 
226  inspections are directed to occur at the correct location (i.e., where records are available for 
227  review).  
228   
229  For each study, the applicant should generate a table that includes the name of the clinical 
230  investigator at each site, the site identification number, the site address (street address, city, state, 
231  and country), and contact information for the site (phone number, fax number when available, 
232  and e-mail address when available).  When the clinical investigator at a site has changed during 
233  the course of the study, the name of the most recent clinical investigator should be listed, with 
234  the name(s) of the previous clinical investigator(s) listed in parentheses beneath it.  If the 
235  applicant is aware of changes to a clinical investigators site address or contact information since 
236  the clinical investigators participation in the study began, this updated information should also 
237  be provided.   
238     
239  2.  A Table Listing All Entities to Whom the Sponsor Has Contracted Clinical Study-
240  Related Activities16 
241   
242  Information concerning clinical study-related activities for major (i.e., pivotal) studies that have 
243  been contracted out to other entities is also relied on to inform the selection of sites for 
244  inspection, and includes a description of the following: 
245   
246    All entities to which the sponsor(s) of these studies transferred responsibility for any or 
247  all of their regulatory responsibilities 
248   
249    The study functions that were contracted 
250   
251   
252  For example, transferred responsibilities in a clinical trial may include, but are not limited to, 
253  clinical site monitoring, randomization, and drug distribution.   
254   
255  3.  Protocol, Protocol Amendments, and Annotated Case Report Form(s) 
256   
257  The protocol, protocol amendments, and copy of the associated annotated case report form(s) for 
258  major (i.e., pivotal) studies used to support safety and efficacy in the application are relied on for 
259  the conduct of inspections.17     
260   
                                                 
16 See 312.23(a)(1)(viii), 312.52, and 314.50(d)(5)(x). 
17 See  314.50(d). 
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261  B.  Subject-Level Data Line Listings by Clinical Site 
262   
263  To verify key study data during inspections, subject-level data line listings by clinical site are 
264  provided to ORA investigators.  By-site listings for major (i.e., pivotal) studies, including studies 
265  with different treatment indications, include listings for each clinical site that consented subjects 
266  and contain primary data points in addition to derived data.  For example, for a pain trial in 
267  which subjects recorded pain scores in a diary, the actual diary scores (i.e., the raw data) are 
268  primary data points that were used to calculate the derived primary endpoint and any other 
269  derived protocol elements (e.g., an eligibility criterion).   
270   
271  C.  Summary-Level Clinical Site Dataset 
272   
273  The summary-level clinical site dataset, named clinsite, contains data from major (i.e., pivotal) 
274  studies used to support safety and efficacy claims and is intended:  
275   
276  (1) To characterize individual clinical investigator sites  
277  (2) To describe aspects of the studies associated with those clinical investigator sites  
278  (3) To present the characteristics and outcomes of the study at the site level   
279   
280  The summary-level clinical site dataset, submitted in the format described in the FDA Data 
281  Standards Catalog, provides critical information to assist with site selection.18 
282   
283  The data in the summary-level clinical site dataset comprise data elements collected under the 
284  regulations in part 312 (specifically in  312.62(b), case histories, and  312.64, investigator 
285  reports) and maintained, tabulated, and submitted under the regulations in part 314 (specifically 
286  in  314.50(d)(5), clinical data section, and  314.50(f), case report forms and tabulations) or in 
287  21 CFR part 601 (specifically in  601.2 and 601.14(a), applications for biologics licenses; 
288  procedures for filing).   
289   
290  A single summary-level clinical site dataset contains data from all major (i.e., pivotal) studies 
291  used to support safety and efficacy in the application, including studies with different treatment 
292  indications.  The dataset includes data independently for each study when clinical investigator 
293  sites are involved in multiple studies in support of an application.  Summary-level site data are 
294  not requested for biopharmaceutical, clinical pharmacology, or animal studies.   
295   
296  Specifications for the electronic format of the submission of the items described in sections III.A, 
297  III.B, and III.C of this guidance are provided in the Bioresearch Monitoring Technical 
298  Conformance Guide.  This technical specifications document is provided separately and will be 
299  updated periodically.   
300   
301   
                                                 
18 For required data formats, see the FDA Data Standards Catalog, available at 
https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. 
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302  IV.   SUBMITTING CLINICAL STUDY-LEVEL INFORMATION, SUBJECT-LEVEL 
303  DATA LINE LISTINGS BY CLINICAL SITE, AND SUMMARY-LEVEL 
304  CLINICAL SITE DATASET 
305   
306  The clinical study-level information, subject-level data line listings by clinical site, and 
307  summary-level clinical site dataset files submitted with NDAs, BLAs, and NDA and BLA 
308  supplemental applications must be submitted electronically by using the FDA Electronic 
309  Submission Gateway (ESG) or by using appropriate physical media.19  
310   
311  More information on submitting the clinical study-level information, the subject-level data line 
312  listings by clinical site, and the summary-level clinical dataset is provided in the Bioresearch 
313  Monitoring Technical Conformance Guide, which contains data elements for electronic 
314  submission of these items.   
315   
316  In eCTD format,20 the clinical study-level information, the subject-level data line listings by 
317  clinical site, and the summary-level clinical site dataset are included in Module 5  Clinical 
318  Study Reports.  The files are linked into the Study Tagging File (STF) for each study.  Leaf titles 
319  for these data are named BIMO [list study ID, followed by brief description of file being 
320  submitted].  In addition, a BIMO STF is constructed and placed in Module 5.3.5.4  Other 
321  study reports and related information.  The study ID for this STF is bimo.  Files described in 
322  section III of this guidance, Description of Clinical Study-Level Information, Subject-Level Data 
323  Line Listings by Clinical Site, and Summary-Level Clinical Site Dataset, are linked to this BIMO 
324  STF, using file tags as indicated below.   
325   
Requested  STF File Tag  Used For  Required 
Item  File 
Formats 
III.A.1-2  data-listing-dataset  General clinical study-  .pdf 
level information 
III.A.3  Protocol-or-amendment  Protocol and Protocol  .pdf 
Amendments, by study 
III.A.3  annotated-crf  Sample annotated case  .pdf 
  report form, by study 
III.B*  data-listing-dataset  Data listings, by study  .pdf 
                                                 
19 See the FDA guidance for industry Providing Regulatory Submissions in Electronic FormatCertain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. See also the 
technical specifications document Transmitting Electronic Submissions Using eCTD Specifications, available at 
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSu
bmissions/UCM163567.pdf. 
20 See eCTD Backbone File Specification for Study Tagging Files v. 2.6.1 at 
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissi 
onRequirements/ElectronicSubmissions/UCM163560.pdf .  See also FDA eCTD web page at 
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm1
53574.htm. 
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(Line listings, by site) 
III.C*  data-listing-dataset  Site-level dataset, across  .xpt 
studies 
III.C*  data-listing-data-definition  Define file  .pdf 
*See also the Bioresearch Monitoring Technical Conformance Guide  
326   
327   
328  The BIMO Reviewers Guide is placed in the BIMO STF in PDF format, with the leaf title 
329  BIMO Reviewer Guide, and its file tag is study-report-body.  The BIMO Reviewers Guide 
330  contains a description of the BIMO elements being submitted, with hyperlinks to those elements 
331  in Module 5. 
332   
333  For general help with eCTD submissions, please send your questions to ESUB@fda.hhs.gov.21 
                                                 
21 See FDA eCTD web page at 
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm1
53574.htm. 
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