Contains Nonbinding Recommendations 
 
BIORESEARCH MONITORING 
TECHNICAL CONFORMANCE GUIDE 
 
 
 
Technical Specifications Document 
 
 
 
 
 
 
 
 
 
 
 
 
This Document is Referenced by the Following Draft Guidance Document: 
 
Standardized Format for Electronic Submission of NDA and BLA Content for the 
Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions 
 
 
 
For questions regarding this technical specifications 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) 
 
 
 
 
 
 
 
 
 
 
August 11, 2022  Contains Nonbinding Recommendations 
 
 
 
 
 
 
BIORESEARCH MONITORING 
TECHNICAL CONFORMANCE GUIDE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
August 11, 2022 
    Contains Nonbinding Recommendations 
 
Revision History 
 
Date  Version  Summary of Changes 
12/28/2017  1.0  Original Version 
07/23/2020  2.0  1.  Corrected footnote hyperlinks 
2.  Edited variable names in 
examples and tables to 
maintain consistency across 
document 
3.  Clarified document, listings, 
and data requests 
4.  Deleted request for SITEFFE 
and SITEFFS variables in 
clinsite.xpt 
5.  Added COHORT variable 
6.  Revised PROTVIOL variable 
to IMPDEV and NOIMPDEV 
variables 
7.  Provided additional 
instructions for placement of 
files per eCTD format 
08/11/2022  3.0  1.  Rename BIMO Review Guide 
to BIMO Data Review Guide. 
2.  Renamed TRTEFFR to 
TRTEFFR1 
3.  Added EFFPOP, TRTEFFR2, 
and CENSOR2 Variables 
4.  Deleted request for TRTEFFS 
5.  Change instructions for use of 
ISO codes to use of 
Geopolitical Entities, Names 
and Codes (GENC) codelist. 
6.  Minor editorial changes. 
 
    Contains Nonbinding Recommendations 
 
 
TABLE OF CONTENTS 
 
I.  CLINICAL STUDY-LEVEL INFORMATION  1 
A.  COMPREHENSIVE AND READILY LOCATED LIST OF ALL CLINICAL SITES ......................................................... 1 
B.  TABLE LISTING ALL ENTITIES TO WHOM SPONSOR HAS CONTRACTED CLINICAL STUDY-RELATED 
ACTIVITIES ....................................................................................................................................................... 1 
C.  PROTOCOL, PROTOCOL AMENDMENTS, AND ANNOTATED CASE REPORT FORM ............................................... 2 
II.  SUBJECT-LEVEL DATA LINE LISTINGS BY CLINICAL SITE  2 
A.  ORGANIZATION OF THE SUBJECT-LEVEL DATA LINE LISTINGS ........................................................................ 2 
B.  SITE-SPECIFIC LISTINGS FORMAT ..................................................................................................................... 4 
III.   SUMMARY-LEVEL CLINICAL SITE DATASET  5 
A.  ORGANIZATION OF THE SITE-LEVEL DATASET ................................................................................................. 5 
B.  VARIABLES AND VARIABLE NAMES FOR SITE-SPECIFIC EFFICACY RESULTS .................................................... 5 
C.  CREATING THE DATA FILE (TEMPLATE AND STRUCTURE) ................................................................................ 7 
IV.  SUBMITTING BIMO CLINICAL DATA IN THE ECTD FORMAT  7 
A.  STUDY TAGGING FILE ....................................................................................................................................... 7 
B.  ECTD FOLDER STRUCTURE FOR CLINICAL STUDY-LEVEL INFORMATION AND SUBJECT-LEVEL LINE LISTINGS 
BY CLINICAL SITE ............................................................................................................................................. 8 
C.  ECTD FOLDER STRUCTURE FOR SUMMARY-LEVEL CLINICAL SITE DATASET .................................................. 8 
D.  FILE FORMAT .................................................................................................................................................... 9 
E.  LEAF TITLES ..................................................................................................................................................... 9 
F.  SUBMISSION ...................................................................................................................................................... 9 
APPENDIX 1:  CLINICAL STUDY-LEVEL INFORMATION  11 
APPENDIX 2:  FORMATTING SUBJECT-LEVEL DATA LINE LISTINGS BY CLINICAL SITE  12 
APPENDIX 3:  CLINICAL SITE DATA ELEMENTS SUMMARY LISTING  14 
APPENDIX 4:  EXAMPLES  19 
 
 
 
 
   
  Contains Nonbinding Recommendations 
 
 
 
1   Bioresearch Monitoring Technical Conformance Guide
2   
3  This technical conformance guide, when finalized, will represent the current thinking of the Food 
4  and Drug Administration (FDA or Agency) on this topic.  It does not establish any rights for any 
5  person and is not binding on FDA or the public.  You can use an alternative approach if it 
6  satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an 
7  alternative approach, contact the FDA staff responsible for this technical conformance guide.  If 
8  you cannot identify the appropriate FDA staff, send an email to cder-edata@fda.hhs.gov or 
9  cber.cdisc@fda.hhs.gov. 
10   
11  This Bioresearch Monitoring Technical Conformance Guide (Guide) provides current FDA 
12  specifications, recommendations, and general considerations for preparing and submitting 
13  Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and a 
14  Summary-Level Clinical Site Dataset that are used by the Center for Drug Evaluation and 
15  Research (CDER) for planning of Bioresearch Monitoring (BIMO) inspections in electronic 
16  format for new drug applications (NDAs), biologics license applications (BLAs), and NDA or 
17  BLA supplemental applications containing clinical data that are regulated by CDER.1  It also 
18  applies when these data and information are submitted under certain investigational new drug 
19  applications2 (INDs) in advance of a planned NDA, BLA, or supplemental submission. 
20   
21   
22  I.  CLINICAL STUDY-LEVEL INFORMATION 
23   
24  A.  Comprehensive and Readily Located List of All Clinical Sites 
25   
26  The recommended format for the portable document format (PDF) of the comprehensive and 
27  readily located list(s) of all clinical sites that participated in clinical studies for each major (i.e., 
28  pivotal) study is provided in Appendix 1 of this Guide. 
29   
30  B.  Table Listing All Entities To Whom Sponsor Has Contracted Clinical Study-
31  Related Activities 
32   
33  In the table(s) listing entities to whom the sponsor has contracted clinical study-related activities, 
34  which are provided in a PDF for each pivotal study, the applicant should identify the location of 
35  study-related documents for each study and whether they are sponsor- or Contract Research 
36  Organization-generated.  For example, these documents may include, but are not limited to, 
37  monitoring plans and reports, training records, and data analysis plans (e.g., items that some 
38  applicants organize in a Trial Master File).  When the location of study-related documents has 
39  not been finalized, the applicant should provide contact information (i.e., phone number and 
 
1 We update technical conformance guides periodically.  For the most recent version of this Guide, check the FDA 
guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
 
2 See FDA guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (February 2020).  
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.  
1 
  Contains Nonbinding Recommendations 
 
 
40  email address) for the individual(s) who can provide updated location information upon request.  
41  This information ensures that when CDER issues an inspection assignment for the application, 
42  the inspection is of the most responsible entity for a given regulatory responsibility, and that the 
43  inspection assignment is issued for the location where records are present for review.    
44   
45  C.  Protocol, Protocol Amendments, and Annotated Case Report Form 
46   
47  The protocol and protocol amendments, with associated versions of the case report form, and the 
48  final version of the annotated case report form (case report form containing Clinical Data 
49  Interchange Standards Consortium and Study Data Tabulation Model (SDTM) annotations) are 
50  generally included in Appendix 163 of the Clinical Study Report or in the datasets folder for each 
51  study.  When these items are included in an appendix to the Clinical Study Report or the dataset 
52  folder for the study, there is no need to resubmit them.  If the applicant is submitting a BIMO 
53  Data Reviewers Guide,4 the applicant should note that these items are present in an appendix of 
54  the Clinical Study Report or the dataset folder where they are placed. 
55   
56  These items are included in the background materials provided to the Office of Regulatory 
57  Affairs for BIMO inspections; it is important to provide all versions of these documents so that 
58  the field investigator performing the inspection can reference the correct versions of protocols 
59  and case report forms in place at the time of the conduct of specific study procedures.   
60   
61   
62  II.  SUBJECT-LEVEL DATA LINE LISTINGS BY CLINICAL SITE 
63   
64  A.  Organization of the Subject-Level Data Line Listings  
65   
66  Examples of the formatting for the PDF of subject-level data line listings provided for each 
67  major (i.e., pivotal) study used to support safety and efficacy in the application, including studies 
68  with different treatment indications, are provided in Appendix 2 of this Guide.  If the sponsor 
69  believes alternative listings or formats are preferable for its submission, proposed alternatives 
70  should be discussed with the Office of Scientific Investigations in advance of the application 
71  submissionfor example, before or during pre-NDA or pre-BLA meetings. 
72   
73  For clinical investigator sites involved in multiple studies in support of an application, the 
74  subject listings should be provided independently for each study within the study-associated 
75  PDF.   
76   
77  Subject-level data line listings, by clinical site, should include consented subjects, treatment 
78  assignment, discontinuations, study population, inclusion and exclusion criteria, adverse events, 
79  protocol deviations, efficacy endpoints, concomitant medications, and safety monitoring, as 
80  further described below. 
81   
 
3 See ICH guidance for industry E3 Structure and Content of Clinical Study Reports (July 1996). 
 
4 A specific template for a BIMO Data Reviewers Guide is not specified.  However, an example can be found at 
https://advance.phuse.global/display/WEL/Deliverables. 
2 
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82  1.  Consented Subjects 
83   
84  This by-subject, by-clinical site listing includes all subjects that consented to enroll in the study.  
85  Consented subjects that were screen failures should also be included.  For subjects that consented 
86  but were not randomized to treatment or did not receive investigational product, the specific 
87  reason they were not randomized or treated should be included in this listing. 
88   
89  2.  Treatment Assignment  
90   
91  This by-subject, by-clinical site listing includes the treatment assignment to which the subject 
92  was randomized.  If a subject mistakenly received treatment different from the subjects assigned 
93  treatment for any duration of time, the actual treatment received should also be included. 
94   
95  3.  Discontinuations 
96   
97  This by-subject, by-clinical site listing includes:  
98   
99    All subjects that discontinued during run-in period (if applicable) 
100    All subjects that discontinued from study treatment  
101    All subjects that discontinued from the study completely  
102   
103  For each subject, the date of and reason for discontinuation should be provided. 
104   
105  4.  Study Population   
106   
107  This by-subject, by-clinical site listing identifies the protocol-defined study population in which 
108  each subject was analyzed (e.g., intent-to-treat, safety, per protocol).  For subjects that did not 
109  meet criteria for inclusion in the per-protocol population, the reason they were excluded from the 
110  per-protocol population should be provided. 
111   
112  5.  Inclusion and Exclusion Criteria 
113   
114  This by-subject, by-clinical site listing should display whether each subject met each inclusion 
115  and exclusion criterion defined in the protocol. 
116   
117  6.  Adverse Events 
118   
119  This by-subject, by-clinical site listing should include all adverse events (i.e., nonserious adverse 
120  events and serious adverse events, including deaths), date of occurrence and time if collected, 
121  treatment(s) administered, severity, whether considered serious by the clinical investigator, 
122  whether considered serious by the sponsor, action taken, whether the event led to discontinuation 
123  of study therapy, and outcome/date of resolution. 
124   
125  7.  Protocol Deviations 
126   
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127  This by-subject, by-clinical site listing should include all protocol deviations.  The listing should 
128  include a description of the deviation and identify whether the sponsor considered the deviation 
129  to be an important or non-important protocol deviation.5   
130   
131  8.  Efficacy Endpoints 
132   
133  This by-subject, by-clinical site listing(s) should contain primary and key secondary efficacy 
134  parameters or events.  For derived or calculated endpoints, the raw data points used to generate 
135  the derived or calculated endpoint should be provided.  For example, when efficacy endpoints 
136  are assessed based on a laboratory, imaging, components of a clinical outcome assessment(s), or 
137  other study procedures, the by-subject, by-clinical site listing should include all testing results 
138  that contribute to the derived efficacy endpoint.  When efficacy endpoints are collected as 
139  clinical events, a by-subject, by-clinical site listing should be provided that includes clinical 
140  event, date of event, and when adjudicated, the date of adjudication and the outcome of the 
141  adjudication process.  
142   
143  9.  Concomitant Medications 
144   
145  This by-subject, by-clinical site listing should contain all concomitant medications as specified 
146  by the protocol.  The date started, date stopped, dose, route of administration, and reason for 
147  administration should be included. 
148   
149  10.  Safety Monitoring 
150   
151  This by-subject, by-clinical site listing(s) should contain results of tests (e.g., laboratory, 
152  electrocardiogram) performed for safety monitoring as defined in the protocol.  When safety 
153  endpoints are collected as clinical events, a by-subject, by-clinical site listing should be provided 
154  that includes clinical event, date of event, and when adjudicated, the outcome of the adjudication 
155  process. 
156   
157  B.  Site-Specific Listings Format 
158   
159  The specified data line listings are anticipated to fit reporting requirements for most applications.  
160  If a sponsor believes additional listings are needed to permit FDA to verify key study data during 
161  inspections, additional listings should be included.  If the size of the PDF file exceeds 500 
162  megabytes, it should be split into smaller components.6 
163   
164  Although listings are currently requested in PDF format, CDER is in the process of developing 
165  tools to extract site-specific listings, needed for inspectional purposes, from submitted Clinical 
166  Data Interchange Standards Consortium, SDTM, and Analysis Data Model (ADaM) datasets and 
167  intends to make those tools available in the future.  FDA intends to update these technical 
 
5 See ICH guidance for industry E3 Structure and Content of Clinical Study Reports  Questions and Answers (R1) 
(January 2013).  
 
6 See ICH guideline Specification for Submission Formats for eCTD v1.3 (June 2021) at 
https://www.ich.org/page/ich-m8-specification-submission-formats-ectd.  
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168  specifications to include details for the submission of SDTM and ADaM datasets, including 
169  controlled terminology standards.  In anticipation of the development of CDER tools for 
170  extraction of by-site, by-subject data listings, sponsors should ensure that they are prepared to 
171  submit clinical study data using standards specified in the Data Standards Catalog.7 
172    
173   
174  III.   SUMMARY-LEVEL CLINICAL SITE DATASET 
175   
176  A.  Organization of the Site-Level Dataset  
177   
178  A single summary-level clinical site dataset that contains data from all major (i.e., pivotal) 
179  studies used to support safety and efficacy in the application, including studies with different 
180  treatment indications, should be provided.    
181   
182  For each major (i.e., pivotal) study used to support safety and efficacy, data by clinical site and 
183  treatment arm for the safety population (SAFPOP) and primary efficacy population (EFFPOP) 
184  should be provided.   
185   
186  For clinical investigator sites involved in multiple studies in support of an application, the site 
187  data should be reported independently for each study within the dataset.   
188   
189  B.  Variables and Variable Names for Site-Specific Efficacy Results 
190   
191  For each study and investigator site, it is critical to submit the following variables associated 
192  with efficacy and their variable names:  
193    Safety Population (SAFPOP)  Total number of subjects in safety population at a given 
194  site by treatment arm.  When a subject has transferred from one site to another, the 
195  applicant should handle reporting of such subjects consistently across sites and include in 
196  the define file, or the BIMO Data Review Guide when one is provided, the reporting 
197  convention used.   
198    Primary Efficacy Population (EFFPOP)  Total number of subjects in the primary efficacy 
199  population, as defined in the clinical study report, at a given site by treatment arm to support 
200  the proposed indication in the application.  The efficacy population used should be identified 
201  in the define file provided for the clinsite.xpt (e.g., Full Analysis Set, Per Protocol, Intent to 
202  Treat, Modified Intent to Treat). 
203    Treatment Efficacy Result One (TRTEFFR1)  The summary statistic for each primary 
204  efficacy endpoint, by treatment arm at a site, based subjects in the SAFPOP.  Values reported 
205  in TRTEFFR1 generally reflect simple summary statistics for the primary efficacy 
206  endpoint(s).  The method used for deriving the TRTEFFR1, including a description of which 
207  analysis datasets and associated variables are used to derive the TRTEFFR1, should be 
208  described in the define file provided with the clinsite.xpt (see discussion below for examples 
209  of summary statistics according to different types of efficacy endpoints). 
 
7 Available at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.  
 
5 
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210    Treatment Efficacy Result Two (TRTEFFR2) The summary statistic for each primary 
211  efficacy endpoint, by treatment arm at a site, based subjects in the EFFPOP.  Values reported 
212  in TRTEFFR2 generally reflect simple summary statistics for the primary efficacy 
213  endpoint(s).  The method used for deriving the TRTEFFR2, including a description of which 
214  analysis datasets and associated variables are used to derive the TRTEFFR2, should be 
215  described in the define file provided with the clinsite.xpt (see discussion below for examples 
216  of summary statistics according to different types of efficacy endpoints).  
217    Endpoint (ENDPOINT)  A plain-text label that describes the primary endpoint as 
218  described in the data definition file data dictionary included with each application. 
219    Treatment Arm (ARM)  A plain-text label for the treatment arm that is used in the Clinical 
220  Study Report. 
221  In addition, for studies whose primary endpoint is a time-to-event endpoint, it is critical to 
222  include the following data element: 
223    Censored Observations (CENSOR1 and CENSOR2)  The number of censored 
224  observations for the given site and by treatment arm for the SAFPOP and EFFPOP, 
225  respectively. 
226  If a study does not contain a time-to-event endpoint, this data element should be recorded as a 
227  missing value (if not applicable, leave blank in clinsite.xpt). 
228   
229  To accommodate the variety of endpoint types that can be used in analyses, it is critical that the 
230  following endpoint type definitions be referenced, and summaries be provided when tabulating 
231  the site-specific summary statistic by treatment arm (for TRTEFFR1 and TRTEFFR2):  
232    Discrete Endpoints  Endpoints based on efficacy observations that can take on a discrete 
233  number of values (e.g., binary, categorical).  Summarize discrete endpoints by an event 
234  frequency (i.e., number of events), proportion of patients with an event, proportion of 
235  patients responding to treatment, or similar method at the site for the given treatment. 
236    Continuous Endpoints  Endpoints based on efficacy observations that can take on an 
237  infinite number of values.  Summarize continuous endpoints by the mean, median, or other 
238  distributional quantile of the observations at the site for the given treatment.   
239    Time-to-Event Endpoints  Endpoints where the time to occurrence of an event is the 
240  primary efficacy measurement.  Summarize time-to-event endpoints by two data elements:  
241  the number of events that occurred (TRTEFFR1 and TRTEFFR2) and the number of 
242  censored observations (CENSOR1 and CENSOR2). 
243    Other  If the primary efficacy endpoint cannot be summarized in terms of the previous 
244  guidelines, a single value or multiple values with precisely defined variable interpretations 
245  should be submitted as part of the dataset. 
246  In all cases, the endpoint description provided in the ENDPOINT plain-text label should be 
247  expressed clearly to interpret the value provided in the TRTEFFR1 and TRTEFFR2 variables.   
248   
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249  When more than one primary efficacy endpoint exists, additional rows should be added to the 
250  dataset to report additional ENDPOINT, Primary Endpoint Type (ENDPTYPE), TRTEFFR1, 
251  and TRTEFFR2 values by arm for each site.  
252   
253  It is anticipated that efficacy data for all subjects included in the SAFPOP and EFFPOP variables 
254  will be included in TRTEFFR1 and TRTEFFR2 variables reported, respectively.  If efficacy data 
255  is not available for all subjects reported in the SAFPOP or EFFPOP variables, then efficacy data 
256  for these subjects should be reported as specified in the study Data Analysis Plan, and the 
257  method used for calculation of efficacy variables should be described in the data define table 
258  provided with the clinsite.xpt file. 
259   
260  The summary-level clinical site dataset should be accompanied by a data definition file.  The 
261  contents of the define file for a dataset and fictional examples are presented in Appendix 3 and 
262  Appendix 4 of this Guide. 
263   
264  C.  Creating the Data File (Template and Structure) 
265   
266  A sample summary-level clinical site data submission using the variables identified in Appendix 
267  3 of this Guide is provided in Appendix 4.   
268     
269   
270  IV.  SUBMITTING BIMO CLINICAL DATA IN THE eCTD FORMAT 
271   
272  Clinical study-level information, subject-level data line listings by clinical site, and the 
273  summary-level clinical site dataset submitted with an application, in Electronic Common 
274  Document (eCTD) format, should be placed in eCTD Module 5 (M5)  Clinical Study Reports, 
275  using the following conventions: 
276  A.  Study Tagging File 
277   
278  Construct a BIMO study tagging file (STF) and place it in eCTD Module 5.3.5.4, Other Study 
279  reports and related information.  The study identifier (ID) for this STF is BIMO. Files 
280  described in section III (e.g., Description of Clinical Study-Level Information, Subject-Level 
281  Data Line Listings by Clinical Site, and Summary-Level Clinical Site Dataset) of the draft 
282  guidance Standardized Format for Electronic Submission of NDA and BLA Content for the 
283  Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions (February 
284  2018) are linked to this BIMO STF using file tags as indicated below.8  Leaf titles for these data 
285  are named BIMO [list study ID, followed by brief description of file being submitted].   
286   
287  Table 1: STF File Tags 
Requested  Required 
STF File Tag  Used For 
Item  File Formats 
General clinical study- 
III.A.1-2  data-listing-dataset  .pdf 
level information 
 
8 When final, this guidance will represent the FDAs current thinking on this topic. 
7 
  Contains Nonbinding Recommendations 
 
 
Requested  Required 
STF File Tag  Used For 
Item  File Formats 
Protocol and Protocol 
III.A.3  Protocol-or-amendment  .pdf 
Amendments, by study 
Sample annotated case 
III.A.3  annotated-crf  .pdf 
report form, by study 
Data listings, by study 
III.B  data-listing-dataset  .pdf 
(Line listings, by site) 
Site-level dataset, across 
III.C  data-listing-dataset  .xpt 
studies 
data-listing-data-
III.C  Define file  .xml 
definition 
BIMO Data Reviewers 
Optional  data-listing-dataset  .pdf 
Guide 
288   
289  B.  eCTD Folder Structure for Clinical Study-Level Information and Subject-
290  Level Line Listings by Clinical Site 
291   
292  Clinical study-level information and subject-level line listings by clinical site are submitted for 
293  each major (i.e., pivotal) study used to support safety and efficacy in the application. 
294   
295  Within the eCTD folder structure, place clinical study-level information and subject-level line 
296  listings by clinical site in the M5 folder as follows: 
297   
298  Figure 2: Place Clinical Study-Level Information and Subject-Level Line Listings by 
299  Clinical Site in the M5 Folder 
300   
301   
302   
303  C.  eCTD Folder Structure for Summary-Level Clinical Site Dataset 
304   
305  For the site-level dataset, use the filename clinsite.xpt.  A single file containing data from all 
306  major (i.e., pivotal) studies9 used to support safety and efficacy in the application should be 
307  provided. 
 
9 For questions regarding whether a study is considered major (i.e., pivotal), applicants should consult the relevant 
Office of New Drugs review division during Type C Integrated Summary of Safety or pre NDA/BLA meetings. 
8 
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308   
309  Within the eCTD folder structure, place the site-level dataset define file and BIMO Data 
310  Reviewers Guide, if it is being submitted, in the M5 folder as follows: 
311   
312  Figure 2: Place the Site-Level Dataset Define File and BIMO Data Reviewers Guide in the 
313  M5 Folder  
314   
315   
316   
317  D.  File Format 
318   
319  The Clinical Study-Level Information and Subject-Level Data Line Listings by Clinical Site 
320  should be submitted in PDF (*.pdf).  When submitting a BIMO Data Reviewers Guide, it should 
321  also be submitted in PDF (*.pdf).  The summary-level clinical site data should be submitted in 
322  SAS transport file format (*.xpt).  The define file for the summary-level clinical site data should 
323  be submitted in Extensible Markup Language (define.xml) format.  For more information, see 
324  the Study Data Technical Conformance Guide.10   
325  E.  Leaf Titles 
326   
327  Leaf titles for study-level information and study-level, subject-level data line listings by clinical 
328  site are named BIMO [list study ID, followed by brief description of file being submitted].  For 
329  the leaf representing the clinsite.xpt dataset, please clearly identify it with the leaf title BIMO 
330  summary-level clinical site data. 
331   
332  F.  Submission 
333   
334  See the technical specifications in Transmitting Electronic Submissions Using eCTD 
335  Specifications for details on electronic transmission or physical media submissions.11 
336   
337  The following are helpful references for eCTD submission: 
 
10 Available at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources. 
  
11 Available at 
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSub
missions/UCM163567.pdf. 
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338    ICH eCTD STF Specification V 2.6.1, The eCTD Backbone File Specification for Study 
339  Tagging Files (June 2008) (available at 
340  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequ
341  irements/ElectronicSubmissions/UCM163560.pdf). 
342    FDA guidance for industry Providing Regulatory Submissions in Electronic Format  
343  Certain Human Pharmaceutical Product Applications and Related Submissions Using the 
344  eCTD Specifications (February 2020) (available at https://www.fda.gov/regulatory-
345  information/search-fda-guidance-documents). 
346    FDA eCTD web page 
347  (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/E
348  lectronicSubmissions/ucm153574.htm ). 
349    For general help with eCTD submissions, submit your questions to the following email 
350  address:  ESUB@fda.hhs.gov. 
351   
352 
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353  APPENDIX 1:  CLINICAL STUDY-LEVEL INFORMATION 
354   
355  Format for comprehensive and readily located list of all clinical sites that participated in each 
356  clinical study.  A separate table should be provided for each clinical study. 
357  Table A: Format for Clinical Site Lists 
Protocol Number: Protocol Title 
Site  Investigator  Site Address at Time of  Site Contact 
Identifier  Name  Clinical Study  Information at Time 
(Prior Clinical  (Updated Site Address  of Clinical Study 
Investigator(s))  when exists and available)  (Updated Contact 
Information when 
exists and available) 
SITEID  LASTNAME,  FACILITY NAME  PHONE 
FRSTNAME,  STREET  FAX 
MINITIAL  CITY, STATE, POSTAL  EMAIL 
  COUNTRY 
 0001*  Doe, John M.  Doe University Department of  Phone: 1-555-555-5555 
Medicine  Fax: 1-555-555-5555 
1 Main St., Suite 100  Email: 
Silver Spring, MD 20850  john.doe@mail.com 
USA 
0002  Doe, Jean  Doe University Department of  Phone: 1-555-555-5555 
(Smith, John)  Medicine  Fax: 1-555-555-5555 
1 Main St., Suite 100  Email: 
Silver Spring, MD 20850  john.smith@mail.com 
USA  (Phone: 1-555-555-5554 
  Email: 
jean.doe@mail.com  ) 
003  Dietric-Fischer,  Hartmannstrasse 7  Phone:49-555-555-5555 
Inge  5300 Bonn 1  Fax: 49-555-555-5555 
Germany  Email: 
Dietric.Fischer@web.de 
* Site terminated, or clinical investigator changed, at request of sponsor before study 
completion. 
358   
359 
11 
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360  APPENDIX 2:  FORMATTING SUBJECT-LEVEL DATA LINE LISTINGS BY 
361  CLINICAL SITE 
362   
363  By Site, by Listing Option A: 
364   
365  Figure A: By Site, by Listing Option A 
Protocol Number 
- 
Site Number 
Listing 1 
Listing 2  
Listing 3  
Listing 4  
Etc. 
Etc. 
 
Etc. 
 
+ 
Next Site Number 
+ 
366  Next Site Number   
367   
368   
369  By Site, by Subject Profile Option B: 
370   
371  Figure B: By Site, by Subject Profile Option B 
Protocol Number 
- 
Site Number 
-  Subject Number  
Subject Profile That Containing 
All Elements of Requested Line 
Listings for this Subject 
+ 
Next Subject Number 
+  Next Subject Number 
+ 
Next Site Number 
+  Next Site Number 
372   
373 
12 
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374  Example of By Site, by Listing Option A: 
375   
376  Figure C: Example of By Site, by Listing Option A 
Protocol #1234 
- 
Site #0001 
Consented Subjects 
Treatment Assignment 
Discontinuations 
Study Population 
Etc. 
Etc. 
 
Etc. 
 
+ 
Site #0002 
+ 
Site #0003 
377   
378   
379  Example of By Site, by Listing Option B: 
380   
381  Figure D: Example of By Site, by Listing Option B 
Protocol #1234 
- 
Site #0001 
-  Subject Number #0001-001 
Subject Profile Containing 
All Elements of Requested 
Line Listings for this Subject 
+ 
Subject Number #0001-064 
+  Subject Number #0001-101 
+ 
Site #0002 
+  Site #0003 
382 
13 
  Contains Nonbinding Recommendations 
 
 
APPENDIX 3:  CLINICAL SITE DATA ELEMENTS SUMMARY LISTING  
 
Table B: Clinical Site Data Elements Summary Listing 
Variable  Controlled Terms or 
Variable Name  Variable Label  Type  Notes or Description  Sample Value 
Index  Format 
1  STUDYID  Study Identifier  Char  String  Study or trial identification number.  ABC-123 
2  TITLE  Study Title  Char  String  Title of the study as listed in the clinical study report  Double blind, 
(limit 200 characters).    randomized, placebo-
If the title exceeds 200 characters, provide  controlled clinical 
shortened title and define (e.g., use the abbreviated  study on the influence 
title from clinicaltrial.gov).  of drug X on indication 
Y 
3  SPONCNT  Sponsor Count  Num  Integer  Total count of sponsors throughout the study.  If  1 
there was a change in the sponsor while the study 
was ongoing, with sponsors as defined in  312.3 
(21 CFR 312.3), enter an integer indicating the total 
count of sponsors.  If there was no change in the 
sponsor while the study was ongoing, enter 1. 
4  SPONSOR  Sponsor Name  Char  String  Full name of the sponsor organization conducting  DrugCo, Inc. 
the study at the time of study completion, as 
sponsor is defined in  312.3.  If the sponsor name 
exceeds 200 characters, provide short-form sponsor 
name and define.  
5  IND      IND Number  Num  6 digit identifier   IND number.  If study not performed under IND,  010010 
leave blank. 
6  UNDERIND  Under IND  Char  String  Value should equal Y if study at the site was  Y 
conducted under an IND (i.e., a Form FDA 1572 
was signed by the investigator) and N if study was 
not conducted under an IND at the site (i.e., a Form 
FDA 1572 was not signed by the investigator). 
7  NDA  NDA Number  Num  6 digit identifier   FDA NDA number, if available/applicable.  If not  021212 
applicable, leave blank. 
8  BLA  BLA Number  Num  6 digit identifier   FDA identification number for BLA, if  123456 
  available/applicable.  If not applicable, leave blank. 
9  SUPPNUM  Supplement  Num  Integer   Serial number for supplemental application, if  4 
Number  applicable.  If no information is available, leave 
blank. 
10  SITEID  Study Site  Char  String  Investigator site identifier assigned by the sponsor.  50 
Identifier 
11  ARM  Description of  Char  String  Plain-text label for the name given to an arm or  Active name and dose 
Planned  treatment group as referenced in the clinical study  (e.g., Active 25mg), 
Treatment Arm  report (limit 200 characters).  When no arm or  Comparator product 
treatment group is available due to only screen  name (e.g., Drug x), 
failure subjects at site, use label Screen Failure.  Placebo, Screen 
Failure 
14 
  Contains Nonbinding Recommendations 
 
 
Variable  Controlled Terms or 
Variable Name  Variable Label  Type  Notes or Description  Sample Value 
Index  Format 
12  COHORT  Description of  Char  String  For cohort studies, the plain-text label given to a  A 
Planned Cohort  cohort as referenced in the clinical study report (limit 
200 characters).  When not a cohort study, leave 
blank. 
13  SAFPOP  Number of  Num  Integer  Total number of subjects in safety population at a  20 
Subjects in  given site by treatment arm.  When a subject has 
Safety  transferred from one site to another, the applicant 
Population  should handle reporting of such subjects 
consistently across sites and include in the define 
file the reporting convention used.  The applicant 
may opt to further explain the reasons subjects 
transferred between sites in the BIMO Data 
Reviewers Guide, if a guide will be provided.  
14  EFFPOP  Number of  Num  Integer  Total number of subjects in primary efficacy  18 
Subjects in  population as reported in the Clinical Study Report 
Efficacy  at a given site by treatment arm.  Further describe 
Population  the population reported as EFFPOP (e.g.,. Per 
Protocol, Full Analysis Set, Intent to Treat, modified 
Intent to Treat) in the clinsite define.html.  When a 
subject has transferred from one site to another, the 
applicant should handle reporting of such subjects 
consistently across sites and include in the define 
file the reporting convention used.  The applicant 
may opt to further explain the reasons subjects 
transferred between sites in the BIMO Data 
Reviewers Guide, if a guide will be provided. 
15  SCREEN  Number of  Num  Integer  Total number of subjects screened (and consented)  100 
Subjects  at a given site (overall number per site as subjects 
Screened  have not yet been assigned to treatment arm).  
When a subject has transferred from one site to 
another, the applicant should handle reporting of 
such subjects consistently across sites and include 
the reporting convention used in the define file or the 
BIMO Data Reviewers Guide (if provided).  The 
applicant may opt to further explain the reasons 
subjects transferred between sites in the BIMO Data 
Reviewers Guide, if provided. 
16  DISCSTUD  Number  Num  Integer  Number of subjects in the safety population who  5 
Subjects  discontinued from the study by treatment arm at a 
Discont. Study  given site.   
17  DISCTRT  Number  Num  Integer  Number of subjects in the safety population who  10 
Subjects  discontinued from the study treatment by treatment 
Discont. Study  arm at a given site.   
Treatment 
18  ENDPOINT  Primary  Char  String  Plain-text label used to describe the primary  Average increase in 
Endpoint   endpoint as described in the define file included with  blood pressure 
each application (limit 200 characters). 
15 
  Contains Nonbinding Recommendations 
 
 
Variable  Controlled Terms or 
Variable Name  Variable Label  Type  Notes or Description  Sample Value 
Index  Format 
19  ENDPTYPE  Primary  Char  String  Variable type of the primary endpoint (i.e.,  Continuous 
Endpoint Type  continuous, discrete, time to event, or other). 
20  TRTEFFR1  Treatment  Num   Floating Point   Summary statistic for each primary efficacy endpoint  1.00 
Efficacy Result  by treatment arm at a given site for subjects in 
for SAFPOP  SAFPOP. 
21  TRTEFFR2  Treatment  Num  Floating Point  Summary statistic for each primary efficacy endpoint  0.98 
Efficacy Result  by treatment arm at a given site for subjects in 
for EFFPOP  EFFPOP. 
22  CENSOR1  Censored  Num  Integer  Total number of censored observations in SAFPOP  5 
Observations in  at a given site by treatment arm for primary endpoint 
SAFPOP  (e.g., applicable to time-to-event).  If not applicable, 
leave blank. 
23  CENSOR2  Censored  Num  Integer  Total number of censored observations in EFFPOP  3 
Observations in  at a given site by treatment arm for primary endpoint 
EFFPOP  (e.g., applicable to time-to-event).  If not applicable, 
leave blank. 
24  NSAE  Number of Non- Num  Integer  Total number of nonserious adverse events at a  10  
Serious  given site by treatment arm for subjects in the 
Adverse Events  SAFPOP.  This value should include multiple events 
per subject and all event types (i.e., not limited to 
only those that are deemed related to study drug or 
that are treatment emergent events).  When events 
with the same preferred term have occurred on 
different dates for a subject, each event should be 
counted separately in event count.  
25  SAE  Number of  Num  Integer  Total number of serious adverse events, excluding  5 
Serious  deaths, at a given site by treatment arm for subjects 
Adverse Events  in the SAFPOP.  This value should include multiple 
events per subject.  When events with the same 
preferred term have occurred on different dates for a 
subject, each event should be counted separately in 
event count. 
26  DEATH  Number of  Num  Integer  Total number of deaths at a given site by treatment  1   
Deaths   arm for subjects in the SAFPOP. 
27  IMPDEV  Number of  Num  Integer  Total number of important protocol deviations at a  2 
Important    given site by treatment arm for subjects in the 
Protocol  SAFPOP.  A protocol deviation is any change, 
Deviations  divergence, or departure from the study design or 
  procedures defined in the protocol or associated 
investigational plans that is not implemented or 
intended as a systematic change.  This value should 
include multiple deviations per subject and all major 
deviation types.  Important deviations are those 
deviations that might significantly affect the 
completeness, accuracy, and/or reliability of the 
study data or that might significantly affect a 
subject's rights, safety, or well-being. 
16 
  Contains Nonbinding Recommendations 
 
 
Variable  Controlled Terms or 
Variable Name  Variable Label  Type  Notes or Description  Sample Value 
Index  Format 
28  NOIMPDEV  Number of Non- Num  Integer  Total number of protocol deviations, excluding  98 
Important  important protocol deviations, at a given site by 
Protocol  treatment arm for subjects in the SAFPOP.  A 
Deviations  protocol deviation is any change, divergence, or 
departure from the study design or procedures 
defined in the protocol or associated investigational 
plans that is not implemented or intended as a 
systematic change. 
29  FINLDISC  Financial  Char  String  Total financial disclosure amount (US$) by site  >= $25,000 
Disclosure  calculated as the sum of disclosures for the clinical 
Amount  investigator and all sub-investigators, to include all 
required parities under the applicable regulations 
(21 CFR 54, 312, 314, 320, 330, 601, 807, 812, 814, 
and 860).  Enter >=$25,000, < $25,000, 
unknown if a proper value is applicable but is not 
known (i.e., unable to obtain information from 
investigator at site), or masked if information on 
this item is available but it has not been provided by 
the sender due to security, privacy, or other 
reasons.  
30  LASTNAME  Investigator  Char  String  Last name of the clinical investigator as it appears  Doe 
Last Name  on the Form FDA 1572 or the signed investigator 
agreement.  At sites where the clinical investigator 
has changed during the course of the study, the 
most recent clinical investigator should be listed. 
31  FRSTNAME  Investigator  Char  String  First name of the clinical investigator as it appears  John 
First Name  on the Form FDA 1572 or the signed investigator 
agreement. 
32  MINITIAL  Investigator  Char  String  Middle initial of the clinical investigator, if any, as it  M 
Middle Initial  appears on the Form FDA 1572 or the signed 
investigator agreement. 
33  PHONE  Investigator  Char  String  Phone number of the clinical investigator.  Include  44-555-555-5555 
Phone Number  country code for non-U.S. numbers. 
34  FAX  Investigator Fax  Char  String  Fax number of the clinical investigator.  Include  44-555-555-5555 
Number  country code for non-U.S. numbers.  If not available, 
leave blank. 
35  EMAIL  Investigator  Char  String  Email address of the clinical investigator.  John.doe@mail.com 
Email Address 
36  COUNTRY  Country  Char  Geopolitical Entities,  GENC code for the country in which the site is  USA 
Names and Codes  located. 
(GENC) 
17 
  Contains Nonbinding Recommendations 
 
 
Variable  Controlled Terms or 
Variable Name  Variable Label  Type  Notes or Description  Sample Value 
Index  Format 
37  STATE  State   Char   GENC  GENC subdivision unabbreviated preferred name in  Maryland 
  which the site is located.  If not applicable, enter   
NA.  
 
 
 
38  CITY  City  Char  String  Unabbreviated city or village in which the site is  Silver Spring 
located. 
39  POSTAL  Postal Code  Char  String  Postal code in which the site is located.  If not  20850 
applicable, enter NA. 
40  STREET  Street Address  Char  String  Street address and office number at which the site is  2005 John Fitzgerald 
located (limit 200 characters).  Kennedy Boulevard 
Northwest, 
International 
Technology Center, 
Department of 
Medicine and 
Pharmacokinetics, 
National Institute of 
Clinical Research 
Twin Towers Building, 
41  STREET1  Street Address  Char  String  Street address and office number at which the site is  The Executive Wing, 
Continued  located.  Use this field when the STREET variable  Suite # 209 
does not permit sufficient space to fully describe 
street address and office number at which the site is 
located. 
 
 
   
18 
  Contains Nonbinding Recommendations 
 
 
APPENDIX 4:  EXAMPLES 
 
The following is a fictional example of a dataset for a placebo-controlled trial.  Four international sites enrolled a total of 205 subjects 
who were randomized in a 1:1 ratio to active or placebo.  In the first example there is a single primary endpoint (percent of 
responders).  In the second example there are co-primary endpoints (percent of responders and change from baseline).  Note that since 
there were two treatment arms, in the first example, each site contains two rows and there are a total of eight rows for the entire 
dataset.  In the second example, each site contains a total of 4 rows, and there are a total of 16 rows for the entire dataset. 
 
Table C: Example for Clinical Site Data Elements Summary Listing with One Endpoint 
UNDER-  SUPP- 
STUDYID  TITLE  SPONCNT  SPONSOR  IND  NDA  BLA  SITEID  ARM  COHORT  SAFPOP  EFFPOP  SCREEN  DISCSTUD  DISCTRT 
IND  NUM 
Double    - 
ABC-123  1  DrugCo, Inc.  000001  Y  200001    001  Active  26  54  61  3  2 
blind...   
Double  Y    - 
ABC-123  1  DrugCo, Inc.  000001  200001    001  Placebo  25  54  61  4  1 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  002  Active  23  44  54  2  1 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  002  Placebo  25  43  54  4  3 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  003  Active  27  55  62  3  0 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  003  Placebo  26  56  62  5  3 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  004  Active  26  49  60  2  2 
blind... 
Double  Y      - 
ABC-123  1  DrugCo, Inc.  000001  200001  004  Placebo  27  50  60  1  0 
blind... 
 
ENDPOINT  ENDPTYPE  TRTEFFR1  TRTEFFR2  CENSOR1  CENSOR2  NSAE  SAE  DEATH  IMPDEV  NOIMPDEV  FINLDISC  LASTNAME  FRSTNAME 
Percent  4 
Binary  0.48  0.64    -  0  2  0  1  < $25,000  Doe  John 
Responders 
Percent  6 
Binary  0.14  0.19    -  2  2  0  1  < $25,000  Doe  John 
Responders 
Percent  9 
Binary  0.48  0.42    -  3  2  1  0  >= $25,000  Washington  George 
Responders 
Percent  11 
Binary  0.14  0.20    -  0  2  0  3  >= $25,000  Washington  George 
Responders 
Percent  4 
Binary  0.54  0.48    -  2  2  0  1  >= $25,000  Jefferson  Thomas 
Responders 
Percent  7 
Binary  0.19  0.32    -  3  6  0  0  >= $25,000  Jefferson  Thomas 
Responders 
Percent  8 
Binary  0.46  0.45    -  4  1  0  0  unknown  Lincoln  Abraham 
Responders 
Percent  13 
Binary  0.12  0.16    -  1  2  0  1  unknown  Lincoln  Abraham 
Responders 
 
MINITIAL  PHONE  FAX  EMAIL  COUNTRY  STATE  CITY  POSTAL  STREET  STREET1 
M  555-123-4567  555-123-4560  John@mail.com  RUS   Moskovska ya  Moscow  103009  Kremlin Road 1   
Oblast
 Moskovskaya   
M  555-123-4567  555-123-4560  John@mail.com  RUS  Moscow  103009  Kremlin Road 1 
Oblast  
  020-3456-7891  020-3456-7890  george@mail.com  GBR  Westminster  London  SW1A 2  10 Downing St   
19 
  Contains Nonbinding Recommendations 
 
 
  020-3456-7891  020-3456-7890  george@mail.com  GBR  Westminster  London  SW1A 2  10 Downing St   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA  Paris  Paris  75002  1, Rue Road   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA   Paris  Paris  75002  1, Rue Road   
10903 New Hampshire Avenue,  Building 4, 
  Office of Medical Products and  Room 1375 
  555-987-6543  555-987-6540  abe@mail.com  USA  Maryland Rockville  20852 
Tobacco, Center for Drug 
Evaluation and Research 
10903 New Hampshire Avenue,  Building 4, 
Office of Medical Products and  Room 1375 
  555-987-6543  555-987-6540  abe@mail.com  USA   Maryland  Rockville  20852 
Tobacco, Center for Drug 
Evaluation and Research 
 
Table D: Example for Clinical Site Data Elements Summary Listing with Multiple Primary Endpoints 
UNDER-  SUPP- 
STUDYID  TITLE  SPONCNT  SPONSOR  IND  NDA  BLA  SITEID  ARM  COHORT  SAFPOP  EFFPOP  SCREEN  DISCSTUD  DISCTRT 
IND  NUM 
Double     
ABC-123  1  DrugCo, Inc.  000001  Y  200001  001  Active  A  26  22  61  3  2 
blind... 
Double     
ABC-123  1  DrugCo, Inc.  000001  Y  200001  001  Active  B  26  22  61  3  2 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  001  Placebo  A  25  23  61  4  1 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  001  Placebo  B  25  23  61  4  1 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  002  Active  A  23  19  54  2  1 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  002  Active  B  23  19  54  2  1 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  002  Placebo  A  25  23  54  4  3 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  002  Placebo  B  25  23  54  4  3 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  003  Active  A  27  26  62  3  0 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  003  Active  B  27  26  62  3  0 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  003  Placebo  A  26  23  62  5  3 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  003  Placebo  B  26  23  62  5  3 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  004  Active  A  26  19  60  2  2 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  004  Active  B  26  19  60  2  2 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  004  Placebo  A  27  20  60  1  0 
blind... 
Double  Y     
ABC-123  1  DrugCo, Inc.  000001  200001  004  Placebo  B  27  20  60  1  0 
blind... 
 
ENDPOINT  ENDPTYPE  TRTEFFR1  TRTEFFR2  CENSOR1  CENSOR2  NSAE  SAE  DEATH  IMPDEV  NOIMPDEV  FINLDISC  LASTNAME  FRSTNAME 
Percent Responders  Binary  0.48  0.58      0  2  0  1  5  < $25,000  Doe  John 
Change from  8 
Continuous  0.74  0.76      0  2  0  1  < $25,000  Doe  John 
Baseline 
Percent Responders  Binary  0.14  0.12      2  2  0  1  5  < $25,000  Doe  John 
Change from  8 
Continuous  0.14  0.16      2  2  0  1  < $25,000  Doe  John 
Baseline 
Percent Responders  Binary  0.48  0.44      3  2  1  0  11  >= $25,0000  Washington  George 
20 
  Contains Nonbinding Recommendations 
 
 
ENDPOINT  ENDPTYPE  TRTEFFR1  TRTEFFR2  CENSOR1  CENSOR2  NSAE  SAE  DEATH  IMPDEV  NOIMPDEV  FINLDISC  LASTNAME  FRSTNAME 
Change from  13 
Continuous  0.67  0.63      3  2  1  0  >= $25,0000  Washington  George 
Baseline 
Percent Responders  Binary  0.14  0.15      0  2  0  3  11  >= $25,0000  Washington  George 
Change from  13 
Continuous  0.14  0.16      0  2  0  3  >= $25,0000  Washington  George 
Baseline 
Percent Responders  Binary  0.54  0.50      2  2  0  1  9  >= $25,0000  Jefferson  Thomas 
Change from  5 
Continuous  0.65  0.61      2  2  0  1  >= $25,0000  Jefferson  Thomas 
Baseline 
Percent Responders  Binary  0.19  0.22      3  6  0  0  9  >= $25,0000  Jefferson  Thomas 
Change from  5 
Continuous  0.19  0.26      3  6  0  0  >= $25,0000  Jefferson  Thomas 
Baseline 
Percent Responders  Binary  0.46  0.51      4  1  0  0  0  unknown  Lincoln  Abraham 
Change from  3 
Continuous  0.71  0.81      4  1  0  0  unknown  Lincoln  Abraham 
Baseline 
0 
Percent Responders  Binary  0.12  0.17      1  2  0  0  unknown  Lincoln  Abraham 
Change from  3 
Continuous  0.15  0.19      1  2  0  1  unknown  Lincoln  Abraham 
Baseline 
 
MINITIAL  PHONE  FAX  EMAIL  COUNTRY  STATE  CITY  POSTAL  STREET  STREET1 
M  555-123-4567  555-123-4560  John@mail.com  RUS  Moskovska ya  Moscow  103009  Kremlin Road 1   
Oblast
  Moskovskaya 
M  555-123-4567  555-123-4560  John@mail.com  RUS  Moscow  103009  Kremlin Road 1   
Oblast  
M  555-123-4567  555-123-4560  John@mail.com  RUS    Moskovsk aya  Moscow  103009  Kremlin Road 1   
Oblast
M  555-123-4567  555-123-4560  John@mail.com  RUS    Moskovsk aya  Moscow  103009  Kremlin Road 1   
Oblast
  020-3456-7891  020-3456-7890  george@mail.com  GBR    Westminster  London  SW1A 2  10 Downing St Suite 2058   
  020-3456-7891  020-3456-7890  george@mail.com  GBR    Westminster  London  SW1A 2  10 Downing St Suite 2058   
  020-3456-7891  020-3456-7890  george@mail.com  GBR  Westminster  London  SW1A 2  10 Downing St Suite 2058   
  020-3456-7891  020-3456-7890  george@mail.com  GBR  Westminster  London  SW1A 2  10 Downing St Suite 2058   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA  Paris   Paris  75002  1, Rue Road   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA  Paris  Paris  75002  1, Rue Road   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA  Paris  Paris  75002  1, Rue Road   
  01-89-12-34-56  01-89-12-34-51  tom@mail.com  FRA  Paris  Paris  75002  1, Rue Road   
  2005 John Fitzgerald Kennedy Boulevard Northwest, 
  International Technology Center, Department of  The Executive 
555-987-6543  555-987-6540  abe@mail.com  USA    Maryland Rockville  20852 
Medicine and Pharmacokinetics, National Institute of  Wing, Suite # 209 
Clinical Research Twin Towers Building, 
  2005 John Fitzgerald Kennedy Boulevard Northwest, 
  International Technology Center, Department of  The Executive 
555-987-6543  555-987-6540  abe@mail.com  USA    Maryland Rockville  20852 
Medicine and Pharmacokinetics, National Institute of  Wing, Suite # 209 
Clinical Research Twin Towers Building, 
  2005 John Fitzgerald Kennedy Boulevard Northwest, 
  International Technology Center, Department of  The Executive 
555-987-6543  555-987-6540  abe@mail.com  USA    Maryland Rockville  20852 
Medicine and Pharmacokinetics, National Institute of  Wing, Suite # 209 
Clinical Research Twin Towers Building, 
  555-987-6543  555-987-6540  abe@mail.com  USA    Maryland  Rockville  20852  2005 John Fitzgerald Kennedy Boulevard Northwest,  The Executive 
21 
  Contains Nonbinding Recommendations 
 
 
MINITIAL  PHONE  FAX  EMAIL  COUNTRY  STATE  CITY  POSTAL  STREET  STREET1 
International Technology Center, Department of  Wing, Suite # 209 
Medicine and Pharmacokinetics, National Institute of 
Clinical Research Twin Towers Building, 
 
22