PhUSE Inspection Site Selection Standard Data Elements WG: CDISC Gap Analysis
Inspection Site Selection Standard
Data Elements:
Gap Analysis of FDA Requirements and
Existing CDISC Standards
Prepared by PhUSE Inspection Site Selection Standard Data Elements
Working Group
26 May 2016
Introduction .................................................................................................................................................. 2
Timing and Use of Dataset ............................................................................................................................ 3
Requested Data Structure, Data Elements, and CDISC Applicability ............................................................ 3
Submission-Level Information ...................................................................................................................... 5
Study-Level Information ............................................................................................................................... 7
Site-Level Information................................................................................................................................... 9
Gap Analysis Summary................................................................................................................................ 16
Working Group Recommendations ............................................................................................................ 18
Next Steps ................................................................................................................................................... 19
Appendices.................................................................................................................................................. 20
Appendix 1: Clinical Site Data Elements Summary Listing from 7 November 12 FDA Draft Technical
Specifications .......................................................................................................................................... 20
Appendix 2: Proposed Revised FDA Draft Technical Specifications....................................................... 25
Appendix 3: Example for Clinical Site Data Elements Summary Listing with Multiple Primary Endpoints
................................................................................................................................................................ 30
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
PhUSE Inspection Site Selection Standard Data Elements WG: CDISC Gap Analysis
Introduction
The past two decades have witnessed a dramatic growth in the size and complexity of
the clinical trials enterprise, posing challenges for FDA in maintaining its traditional
inspection approaches. These challenges include, but are not limited to, an increasing
number of sites per clinical trial, an increasing number of foreign clinical trial sites, finite
resources limiting the number of inspections, PDUFA timelines requiring a high level of
efficiency, and variation in the current site selection methodology. As part of addressing
these challenges, FDA, through the Bioresearch Monitoring Program (BIMO), is working
to modernize and enhance the efficiency and effectiveness of its inspection processes.
FDA’s Center for Drug Evaluation and Research (CDER) has developed a risk-based
Clinical Investigator Site Selection Tool. This tool combines data from sponsor and FDA
databases to quickly analyze and assess clinical site level data contained within an
application to identify clinical sites for inspection early in the review process. This need
has been addressed in the published draft guidance dated December 2012, “Guidance
for Industry: Providing Submissions in Electronic Format — Summary Level Clinical
Site Data for CDER’s Inspection Planning.”
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionR
equirements/UCM332468.pdf. The specific data elements were identified in a
companion technical document dated 7 November 2012 entitled “Specifications for
Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection
Planning”
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionR
equirements/ucm332466.pdf. The comment period for this draft guidance closed on
19 Feb 2013.
While some of the information detailed in the guidance may be available within an NDA
or BLA application, it may not be in a format that allows it to be readily repurposed into a
dataset to be used for analysis in CDER’s inspection site selection tool. A PhUSE
working group was formed in March 2012 that was charged to do a detailed evaluation
of each of the proposed data elements that have been requested by CDER. The group
focused on a couple of key points:


Providing a clear definition of each of the data elements that CDER needs to
complete its site-selection analysis. This will facilitate generation of the
information by enabling sponsors to unambiguously identify the sources of the
information and will support consistent interpretation across sponsor companies.
Providing a preliminary assessment of whether the requested data elements are
consistent with already established clinical data standards CDISC SDTM and
ADaM.
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
PhUSE Inspection Site Selection Standard Data Elements WG: CDISC Gap Analysis
Timing and Use of Dataset
Discussion of development of this dataset can occur at a pre-NDA or pre-BLA meeting
or at a separate sponsor-requested standards meeting if the pre-submission meeting
agenda is full. The FDA may accept this dataset either before or at the time of
application submission, according to the draft guidance referenced in the Introduction.
As mentioned above, the FDA may use the clinical site dataset to assist with selection
of clinical investigator sites for inspection. However, sponsors may also find the
variables contained in the clinsite.xpt dataset of use in risk-based site monitoring
programs and to assist in selection of clinical investigator sites for sponsor audits.
Production of this dataset provides additional benefit in that earlier inspection site
selection by the FDA may lead to a more efficient inspection process, which may permit
sufficient time for resolution of deficiencies identified during the FDA inspections within
the review timeline.
Requested Data Structure, Data Elements, and CDISC Applicability
The proposed data structure and elements are identified in FDA’s “Specifications for
Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection
Planning” referenced in the Introduction section of this document. A copy of the
requested data elements is provided in tabular form in Appendix 1 to this document.
One dataset (named clinsite.xpt) is requested for all major (e.g., pivotal) studies used to
support safety and efficacy claims in the application. This dataset has rows for unique
values of the following fields:



Site
Treatment Arm
Primary Endpoint
All screened/consented patients are incorporated into the dataset. If information on
screen failures is collected, patients who are deemed as such are counted in the
variable SCREEN. All records for a given site within a study have the same value of
SCREEN. Please see below, and also Appendix 3, for examples.
STUDYID
SITEID
ARM
SAFPOP
SCREEN
ABC-123
001
Active
26
61
ABC-123
001
Placebo
25
61
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
PhUSE Inspection Site Selection Standard Data Elements WG: CDISC Gap Analysis
As the above table shows, for Study ABC-123, site 001 screened 61 patients. Of these,
26 were assigned to Active, 25 were assigned to Placebo, and 10 were screen failures.
The requested clinical site dataset elements include the following types of data:



Submission-Level Information (e.g., IND Number, NDA Number)
Study-Level Information (e.g., Study ID, Arm)
Site-Level Information (e.g., Site ID, trial conducted under IND at Site, Number
of Serious Adverse Events, Site-Specific Efficacy and Safety, Principal Clinical
Investigator Contact Information)
The requested information is organized in this document into tables by these above 3
data types. Each table contains the following columns:









Variable Index: Identifies row order in FDA’s “Specifications for Preparing and
Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning”
Variable Name: xpt or other database column name
Variable Label: xpt label or other database column description
Type: Category of data in the column, such as numeric or character
Controlled Terms or Format: Additional description of data in the column, such
as String or ISO 3166-1-alpha-3
Notes or Description: Additional information about how to populate the column
Sample Value: One or more sample values to aid in understanding contents of
the column
Comments: Observations about the column made by PhUSE Working Group
Current Source: Identification of current CDISC source for data point in column
where “S” represents CDISC SDTM, “A” represents CDISC ADaM
Note that for any field, if there is no information available, leave the field blank.
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Submission-Level Information
A total of 6 data elements, shown in Table 1, pertain to the entire submission. Most relate to regulatory status.
Table 1: Submission-Level Information
[NOTE: Yellow highlight indicates a proposed change (new variable, variable name, variable label) from the draft 7 November 2012 structure]
Variable
Index
Variable
Name
Variable
Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
Comments
CDISC Source
(S=SDTM, A=ADaM)
5
IND
IND Number
Num
6 digit
identifier
Investigational New Drug (IND)
010010
application number. If study not
performed under IND, leave blank.
No existing Controlled Terminology for
TSPARM/TSPARMCD.
S/TS new
TSPARM/TSPARMCD
7
NDA
NDA Number Num
6 digit
identifier
FDA new drug application (NDA)
number, if available/applicable. If
not applicable, leave blank.
021212
No existing Controlled Terminology for
TSPARM/TSPARMCD.
S/TS new
TSPARM/TSPARMCD
8
BLA
BLA Number
Num
6 digit
identifier
FDA identification number for
biologics license application, if
available/applicable. If not
applicable, leave blank.
123456
No existing Controlled Terminology for
TSPARM/TSPARMCD.
S/TS new
TSPARM/TSPARMCD
3
SPONCNT
Sponsor
Count
Num
Integer
Total count of sponsors
1
throughout the study. If there was
a change in the sponsor while the
study was ongoing, with sponsors
as defined in 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”.
No existing Controlled Terminology for
TSPARM/TSPARMCD.
S/TS new
TSPARM/TSPARMCD
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Variable
Index
Variable
Name
Variable
Label
4
SPONNAME Sponsor
Name
9
SUPPNUM
Type
Char
Supplemental Num
Number
Controlled
Terms or
Format
Notes or Description
Sample
Value
String
Full name of the sponsor
Drug Co,
organization conducting the study Inc.
at the time of study completion, as
defined in 21CFR 312.3(a). If the
sponsor name exceeds 200
characters, provide the
abbreviated sponsor name from
Clinicaltrials.gov and document
this in the Notes or Description
section in the define file (Clinical
Site Data Elements Summary).
Integer
Serial number for supplemental
application, if applicable. If no
information is available, leave
blank.
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4
Comments
CDISC Source
(S=SDTM, A=ADaM)
S/TSPARM where
TSPARMCD=’SPONSOR’
No existing Controlled Terminology for
TSPARM/TSPARMCD.
S/TS new
TSPARM/TSPARMCD
Study-Level Information
A total of 5 data elements, shown in Table 2, pertain to the study. Variable STUDYID is a potential index variable and key
that allows for integration with other datasets.
Table 2: Study-Level Information
[NOTE: Yellow highlight indicates a proposed change (new variable, variable name, variable label) from the draft 7 November 2012 structure]
Variable
Index
Variable
Name
Variable
Label
Type
Controlled
Terms or
Format
Sample
Value
Notes or Description
Comments
CDISC Source (S=SDTM,
A=ADaM)
1
STUDYID
Study
Identifier
Char
String
Study or trial identification
number.
ABC-123
S/TS.STUDYID
2
STUDYTL
Study Title
Char
String
Title of the study as listed in the
clinical study report (limit 200
characters). If the title exceeds
200 characters, provide
the abbreviated title from
Clinicaltrials.gov and document
this in the Notes or Description
section in the define file (Clinical
Site Data Elements Summary).
Double
blind,
randomized,
placebo
controlled
clinical
study on the
influence of
drug X on
indication Y
S/TS.TSPARMCD=’TITLE’
11
ARM
Description
of Planned
Treatment
Arm
Char
String
Plain text label for the name
given to an Arm or treatment
group as referenced in the
clinical study report (limit 200
characters).
Active name
and dose
(e.g., Active
25mg),
Comparator
product
name (e.g.,
Drug x), or
Placebo
S/TA.ARM
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Variable
Index
Variable
Name
Variable
Label
Type
Controlled
Terms or
Format
Sample
Value
Notes or Description
Comments
CDISC Source (S=SDTM,
A=ADaM)
16
ENDPOINT Primary
Endpoint
Char
String
Plain text label used to describe
the primary endpoint (limit 200
characters). When more than
one primary efficacy endpoint
exists, additional rows should be
added to the dataset to report
additional ENDPOINT,
ENDPTYPE, TRTEFFR,
TRTEFFS, SITEEFFE, and
SITEEFFS values by arm for
each site.
Average
increase in
blood
pressure
S/TS.TSPARM where
S/TS.TSPARMCD=’OUTMSPRI’
17
ENDPTYPE Primary
Endpoint
Type
Char
String
Variable type of the primary
endpoint (i.e., continuous,
discrete, time to event, or other).
Continuous
S/TS new
TSPARM/TSPARMCD
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Site-Level Information
Many of the required data elements (28) involve site level information, some of which is fairly complex (e.g., efficacy
effect, standard deviation) and some of which simply involves contact information for the principal clinical investigator at
the site. Site-level data elements are summarized in Table 3.
Table 3: Site-Level Information
[NOTE: Yellow highlight indicates a proposed change (new variable, variable name, variable label) from the draft 7 November 2012 structure]
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
10
SITEID
Study Site
Identifier
Char
String
Investigator site identifier
assigned by the sponsor.
50
6
UNDERIND Under IND
Char
String
Value should equal "Y" if study
at the site was conducted under
an IND (i.e., a Form FDA 1572
was signed by the investigator)
and "N" if the study was not
conducted under an IND at the
site (i.e., a Form FDA 1572 was
not signed by the investigator).
Y
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Comments
CDISC Source (S=SDTM,
A=ADaM)
DM.SITEID
Applicable to all trials
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
Comments
12
SAFPOP
Number of
Subjects in
Safety
Population
Num
Integer
Total number of subjects in
20
safety population at a given site
by treatment arm. When a
subject has transferred from one
site to another, the applicant
should handle reporting of such
subjects consistently across
sites, should ensure the subject
is counted at only one site, and
should 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 Reviewer’s Guide, if a
guide will be provided.
Pertains only to sites that enrolled
and treated study subjects (safety
population); could capture in
ADaM.ADSL.
13
SCREEN
Number of
Subjects
Screened
Num
Integer
Total number of subjects
100
screened (consented) at a given
site. 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 Reviewer’s
Guide (if provided). The
applicant may opt to further
explain the reasons subjects
transferred between sites in the
BIMO Reviewer’s Guide, if
provided.
“Screened” has the same meaning
as ”Consented”, but often
consented patients who are screen
failures are not in the sponsor’s
database. Note that this is a sitelevel value, not an arm-level value;
please see Appendix 3 for
examples. Could capture in
ADaM.ADSL if data were
collected.
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
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CDISC Source (S=SDTM,
A=ADaM)
Variable
Index
Variable
Name
14
DISCSTUD
Number of
Num
Subject Discons
from Study
Integer
Number of subjects in the safety 5
population who discontinued
from the study.
This pertains to subjects that were
enrolled after informed consent
was obtained; could capture in
ADaM.ADSL.EOSSTT if data were
collected.
15
DISCTRT
Number of
Num
Subject Discons
from Study
Treatment
Integer
Number of subjects in the safety 10
population who discontinued
from the study treatment.
Could capture in ADaM.ADSL if
data were collected.
18
TRTEFFR
Treatment
Efficacy Result
Num
Floating Point
Summary statistic for each
primary efficacy endpoint by
treatment arm at a given site.
0, 0.25, 1, Variable on which treatments are
100
compared according to the SAP;
e.g., change from baseline, time to
event.
19
TRTEFFS
Treatment
Efficacy Result
Standard
Deviation
Num
Floating Point
Standard deviation of the
efficacy result (TRTEFFR) for
each primary endpoint by
treatment arm at a given site. If
N=1, set to 0.
0.065
20
SITEEFFE
Site-Specific
Efficacy Effect
Size
Num
Floating Point
Site effect size with the same
representation as reported for
the primary efficacy analysis.
0, 0.25, 1, The pre-specified primary
100
comparison is the effect size
desired here.
21
SITEEFFS
Site-Specific
Efficacy Effect
Size Standard
Deviation
Num
Floating Point
Standard deviation of the sitespecific efficacy effect size
(SITEEFFE). If N=1, set to 0.
0.065
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
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Sample
Value
Comments
CDISC Source (S=SDTM,
A=ADaM)
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
Comments
22
CENSOR
Number of
Censored
Observations
Num
Integer
Total number of censored
5
observations at a given site by
treatment arm for primary
endpoint (e.g., applicable to
time-to-event). If not applicable,
leave blank.
Primary analysis population as per
SAP. Could capture in ADaM.
23
NSAE
Number of Non- Num
Serious Adverse
Events
Integer
10
Total number of non-serious
adverse events at a given site
by treatment arm for subjects in
the safety population. 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 treatmentemergent).
Could capture in ADaM using
ADAE.AESER.
24
SAE
Number of
Num
Serious Adverse
Events
Integer
Total number of serious adverse 5
events at a given site by
treatment arm, excluding
deaths, for subjects in the safety
population. This value should
include multiple events per
subject.
Could capture in ADaM using
ADaM.ADAE.AESER.
25
DEATH
Number of
Deaths
Integer
Total number of deaths at a
given site by treatment arm for
subjects in the safety
population.
1
Could capture in ADaM using
SDTM.DM.DTHFL.
Num
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CDISC Source (S=SDTM,
A=ADaM)
Variable
Index
Variable
Name
26
PROTVIOL
Number of
Protocol
Violations
Num
Integer
Total number of protocol
violations at a given site by
treatment arm as defined in the
clinical study report. A protocol
violation is an unplanned
excursion from the protocol that
is not implemented or intended
as a systematic change. This
value should include multiple
violations per subject and all
violation types (i.e., not limited
to only significant deviations).
27
FINLDISC
Financial
Disclosure
Amount
Char
String
>=$25,00
Total financial disclosure
amount ($USD) by site
0
calculated as the sum of
disclosures for the principal
clinical investigator and all subinvestigators to include all
required parities under the
applicable regulations (21 CFR
Parts 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.
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
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Sample
Value
20
Comments
Could capture some in ADaM
using SDTM.DV record counts and
other information.
CDISC Source (S=SDTM,
A=ADaM)
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
Comments
28
LASTNAME Investigator Last
Name
Char
String
Doe
Last name of the principal
clinical investigator as it appears
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.
Only the principal clinical
investigator is needed here. May
be able to capture in ADaM by
parsing SDTM DM.INVNAM.
29
FRSTNAME Investigator First Char
Name
String
First name of the principal
John
clinical investigator as it appears
on the Form FDA 1572 or the
signed investigator agreement.
Only the principal clinical
investigator is needed here. May
be able to capture in ADaM by
parsing SDTM DM.INVNAM.
30
MINITIAL
Investigator
Middle Initial
Char
String
Middle initial of the principal
clinical investigator, if any, as it
appears on the Form FDA 1572
or the signed investigator
agreement.
M
Only the principal clinical
investigator is needed here. May
be able to capture in ADaM by
parsing SDTM DM.INVNAM.
31
PHONE
Investigator
Phone Number
Char
String
Phone number of the principal
clinical investigator. Include
country code for non-US
numbers.
44-555555-5555
32
FAX
Investigator Fax
Number
Char
String
Fax number of the principal
clinical investigator. Include
country code for non-US
numbers. If not available, leave
blank.
44-555555-5555
33
EMAIL
Investigator
Email Address
Char
String
Email address of the principal
clinical investigator.
john.doe
@mail.co
m
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CDISC Source (S=SDTM,
A=ADaM)
Variable
Index
Variable
Name
34
COUNTRY
Country
Char
ISO 3166-1alpha-3
3-letter ISO 3166 country code
in which the site is located.
35
STATE
State
Char
String
Unabbreviated state or province Maryland
in which the site is located. If
not applicable, enter NA.
36
CITY
City
Char
String
Unabbreviated city, county, or
village in which the site is
located.
Silver
Spring
37
POSTAL
Postal Code
Char
String
Postal code in which the site is
located. If not applicable, enter
NA.
20850
38
STREET
Street Address
Char
String
Street address and office
number at which the site is
located.
1 Main
St.
39
STREET1
Street Address
Char
String
Street address and office
number at which the site is
located. Use this field when
Variable STREET does not
permit sufficient space to fully
describe street address and
office number at which the site
is located.
Suite 100
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample
Value
USA
Comments
CDISC Source (S=SDTM,
A=ADaM)
S/DM.COUNTRY or
A/ADSL.COUNTRY
Note that our Working Group is proposing that variables DOMAIN and FINLMAX be removed from the FDA’s draft
technical specifications dated 7 November 2012.
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Gap Analysis Summary
In the above site selection standard specifications, there are 39 data elements being
requested. There are some revisions from the FDA’s 7 Nov 2012 draft publication
(please see Appendix 1 for 7 November 2012 specifications): DISCTRT and STREET1
have been added, DOMAIN and FINLMAX have been removed, and recommendations
to modify some variable attributes have been made. These data points are utilized in a
model developed by CDER at the FDA to efficiently identify potential sites for BIMO
inspections. Many of the data points, however, are not routinely produced by sponsor
companies.
Our Working Group confirmed that all the requested data elements in the above tables
are used in the FDA’s model and that the specifications are clear. In addition, we
examined the gap between these specifications and current CDISC standards. This
gap analysis is detailed below.
Of the 39 requested data elements, the following 7 (18%) are explicitly handled by
existing CDISC standards and would typically be included in CRT data sets submitted
with an NDA or BLA:




SPONNAM (Sponsor)
STUDYID (Study Number)
STUDYTL (Study Title)
ARM (Treatment Arm)



ENDPOINT (Primary Endpoint)
SITEID (Study Site Identifier)
COUNTRY (Site Country)
The following 5 data elements (13%) could be incorporated into the SDTM TS (Trial
Summary) domain via new TSPARM and TSPARMCD values. Although current CDISC
Controlled Terminology standards do not exist for these additional parameters, CDISC
Controlled Terminology for these variables is extensible. Note that NDA and BLA
numbers may not be known before submission datasets are finalized, which could
preclude their inclusion by the sponsor in this site dataset:



IND (IND Number)
NDA (NDA Number)
BLA (BLA Number)


SPONCNT (Sponsor Count)
ENDPTYPE (Primary Endpoint Type)
Nine data elements (23%) could be derived from existing CDISC standard variables:



SAFPOP (Safety Population)
SCREEN (Screened Population)
DISCSTUD (Discontinued Study)



DISCTRT (Discontinued Treatment)
CENSOR (Censored)
NSAE (Serious AEs)
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016



SAE (Non-Serious AEs)
DEATH (Deaths)
PROTVIOL (Protocol Violations)
For the other 18 data elements (46%) shown below, such as investigator contact
information, most are included in the eCTD submission but are not in a format
amenable to data analysis. Although technology exists to mine the xml backbone of the
eCTD for information, it is not clear that this would be a more efficient process than
obtaining it by more traditional methods. Issues are that some of the information may
not be known at the time CRT datasets are finalized (e.g., NDA or BLA number), while
other information may be known (e.g., investigator contact information), potentially
resulting in some xml backbone mining being done by the FDA and some by the
sponsor.









UNDERIND (Under IND)
TRTEFFR (Treatment Efficacy Result)
TRTEFFS (Treatment Efficacy Std Dev)
SITEEFFE (Site Efficacy Effect Size)
SITEEFFS (Site Efficacy Effect Size Std
Dev)
FINLDISC (Financial Disclosure Amt.)
LASTNAME (Last Name)
FIRSTNAME (First Name)
MINITIAL (Middle Initial)









PHONE (Phone)
FAX (FAX)
EMAIL (Email Address)
COUNTRY (Country)
STATE (State)
CITY (City)
POSTAL (Postal Code)
STREET (Street Address)
STREET1 (Street Address Cont’d)
A tabular representation of this information is shown below:
CDISC Applicability of Data Elements
Variable Category
Variable Count
Fraction of Total (39)
Explicitly accommodated by CDISC
7
18%
Accommodated by CDISC if extensible Controlled
Terminology used
5
13%
Can easily derive from SDTM/ADaM and capture in
ADaM
9
23%
No existing path
18
46%
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Controlled Terminology for TS.TSPARM and TS.TSPARMCD for the following 7 items
does not currently exist, although Controlled Terminology for these variables is
extensible:




IND Number
NDA Number
BLA Number
Sponsor Count



Sponsor Name
Supplemental Number
Primary Endpoint Type
Working Group Recommendations
CDER’s Clinical Investigator Site Selection Tool increases the likelihood that sites with
unusual data will be identified and increases the efficiency of selecting sites for
inspection. Although the tool is beneficial, there are not sufficient CDISC standards to
support efficient preparation of the information the tool utilizes.
Based on the analysis performed and described above, the PhUSE Working Group on
Inspection Site Selection Standard Data Elements makes the following
recommendations:




New Standard Datasets: We request that CDISC organization evaluate the need
for additional SDTM and/or ADaM datasets and variables to capture information
needed at the submission, study, and site levels, and if a need is determined,
develop appropriate standards.
New Controlled Terminology: We request that CDISC organization evaluate the
need for additional Controlled Terminology values for SDTM.TS.TSPARM and
SDTM.TS.TSPARMCD to capture additional information at the study level, and if
a need is determined, develop appropriate standards.
Semantic Technology: We request that PhUSE consider if semantic technology
could be of benefit in developing the needed data elements for site selection.
HL7 Study Participation Message: There have been suggestions over the years
to evaluate the use of the HL7 Study Participation Message for collecting
information for site selection. Our WG recommends not pursuing this. We have
reviewed this Message and found that the only required data elements in it that
are needed by the site selection tool and that cannot be found in CDISC are
sponsor name, class code (enrolled vs. screening), product, and IND number
(site contact information exists in the Message but it is optional). These data
points are fairly easy for the sponsor to enter on their own, without incurring
problems that could be associated with mining the HL7 Message, such as access
and computer system compatibility.
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Next Steps
The clinical site dataset as specified is quite complex. It is possible that if the CDISC
organization assumes the task of developing structures to support it, those structures
will adhere to normalized database design. FDA may adjust their site selection model
to accommodate new CDISC structures that are developed for this information.
Given that CDISC’s design of site structures would be a time-consuming effort, PhUSE
is considering adding the creation of this dataset to the roster of standard scripts under
development.
Meanwhile, sponsor companies may elect to develop proprietary standards, processes,
and tools for creation of the clinical site dataset. Such efforts could involve specifying
TS.TSPARM and TS.TSPARMCD standard terms and bridging any gap between the
clinical trials management database and the patient database.
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Appendices
Appendix 1: Clinical Site Data Elements Summary Listing from 7 November 12 FDA Draft Technical
Specifications
Variable
Index
Variable
Name
Variable Label Type
Controlled
Terms or
Format
Notes or Description
Sample Value
1
STUDY
Study Number
Char String
Study or trial identification number.
ABC-123
2
STUDYTL
Study Title
Char String
Title of the study as listed in the clinical study report (limit 200 characters)
Double blind, randomized placebo
controlled clinical study on the
influence of drug X on indication Y
3
DOMAIN
Domain
Abbreviation
Char String
Two-character identification for the domain most relevant to the
observation. The Domain abbreviation is also used as a prefix for the
variables to ensure uniqueness when datasets are merged.
DE
4
SPONNO
Sponsor
Number
Num Integer
Total number of sponsors throughout the study. If there was a change in
the sponsor while the study was ongoing, enter an integer indicating the
total number of sponsors. If there was no change in the sponsor while the
study was ongoing, enter “1”.
1
5
SPONNAME Sponsor Name
Char String
Full name of the sponsor organization conducting the study at the time of
study completion, as defined in 21 CFR 312.3(a).
DrugCo, Inc.
6
IND
IND Number
Num 6 digit identifier
Investigational New Drug (IND) application number. If study not performed 010010
under IND, enter -1.
7
UNDERIND
Under IND
Char String
Value should equal "Y" if study at the site was conducted under an IND
and "N" if study was not conducted under an IND (i.e., 21 CFR 312.120
studies).
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 20 of 33
Y
Variable
Index
Variable
Name
Variable Label Type
Controlled
Terms or
Format
Notes or Description
Sample Value
8
NDA
NDA Number
Num 6 digit identifier
FDA new drug application (NDA) number, if available/applicable. If not
applicable, enter -1.
021212
9
BLA
BLA Number
Num 6 digit identifier
FDA identification number for biologics license application, if
available/applicable. If not applicable, enter -1.
123456
10
SUPPNUM
Supplement
Number
Num Integer
Serial number for supplemental application, if applicable. If not applicable, 4
enter -1.
11
SITEID
Site ID
Char String
Investigator site identification number assigned by the sponsor.
50
12
ARM
Treatment Arm
Char String
Plain text label for the treatment arm as referenced in the clinical study
report (limit 200 characters).
Active (e.g., 25mg), Comparator
drug product name (e.g., Drug x), or
Placebo
13
ENROLL
Number of
Subjects
Enrolled
Num Integer
Total number of subjects enrolled at a given site by treatment arm.
20
14
SCREEN
Number of
Subjects
Screened
Num Integer
Total number of subjects screened at a given site.
100
15
DISCONT
Number of
Num Integer
Subject
Discontinuations
Number of subjects discontinuing from the study after being enrolled at a
site by treatment arm as defined in the clinical study report.
5
16
ENDPOINT
Endpoint
Char String
Plain text label used to describe the primary endpoint as described in the
Define file included with each application (limit 200 characters).
Average increase in blood pressure
17
ENDPTYPE
Endpoint Type
Char String
Variable type of the primary endpoint (i.e., continuous, discrete, time to
event, or other).
Continuous
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 21 of 33
Variable
Index
Variable
Name
Variable Label Type
Controlled
Terms or
Format
Notes or Description
Sample Value
18
TRTEFFE
Treatment
Efficacy
Endpoint
Num Floating Point
Summary statistic for each primary endpoint by treatment arm at a given
site.
0, 0.25, 1, 100
19
TRTEFFS
Treatment
Efficacy
Endpoint
Standard
Deviation
Num Floating Point
Standard deviation of the efficacy result (TRTEFFE) for each primary
endpoint by treatment arm at a given site.
0.065
20
SITEEFFE
Site-Specific
Treatment
Effect
Num Floating Point
Site-specific treatment effect reported using the same representation as
reported for the primary efficacy analysis.
0, 0.25, 1, 100
21
SITEEFFS
Site-Specific
Treatment
Effect Standard
Deviation
Num Floating Point
Standard deviation of the site-specific treatment effect (SITEEFFE).
0.065
22
CENSOR
Censored
Observations
Num Integer
Number of censored observations at a given site by treatment arm. If not
applicable, enter -1.
5
23
NSAE
Number of Non- Num Integer
Serious Adverse
Events
Total number of non-serious adverse events at a given site by treatment
arm. 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 treatment emergent events).
10
24
SAE
Number of
Num Integer
Serious Adverse
Events
Total number of serious adverse events excluding deaths at a given site
by treatment arm. This value should include multiple events per subject.
5
25
DEATH
Number of
Deaths
Total number of deaths at a given site by treatment arm.
1
Num Integer
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 22 of 33
Variable
Index
Variable
Name
Variable Label Type
Controlled
Terms or
Format
Notes or Description
Sample Value
26
PROTVIOL
Number of
Protocol
Violations
Num Integer
Number of protocol violations at a given site by treatment arm as defined
in the clinical study report. This value should include multiple violations
per subject and all violation type (i.e., not limited to only significant
deviations).
20
27
FINLMAX
Maximum
Financial
Disclosure
Amount
Num Floating Point
Maximum financial disclosure amount ($USD) by any single investigator
by site. Under the applicable regulations (21 CFR Parts 54, 312, 314,
320, 330, 601, 807, 812, 814, and 860). If unable to obtain the information
required to the corresponding statements, enter -1.
20000.00
28
FINLDISC
Financial
Disclosure
Amount
Num Floating Point
Total financial disclosure amount ($USD) by site calculated as the sum of
disclosures for the principal investigator and all sub-investigators to
include all required parities. Under the applicable regulations (21 CFR
Parts 54, 312, 314, 320, 330, 601, 807, 812, 814, and 860). If unable to
obtain the information required to the corresponding statements, enter -1.
25000.00
29
LASTNAME
Investigator Last Char String
Name
Last name of the investigator as it appears on the FDA 1572.
Doe
30
FRSTNAME Investigator
First Name
Char String
First name of the investigator as it appears on the FDA 1572.
John
31
MINITIAL
Investigator
Middle Initial
Char String
Middle initial of the investigator, if any, as it appears on the FDA 1572.
M
32
PHONE
Investigator
Phone Number
Char String
Phone number of the primary investigator. Include country code for nonUS numbers.
44-555-555-5555
33
FAX
Investigator Fax Char String
Number
Fax number of the primary investigator. Include country code for non-US
numbers.
44-555-555-5555
34
EMAIL
Investigator
Email Address
Email address of the primary investigator.
[email protected]
Char String
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 23 of 33
Variable
Index
Variable
Name
Variable Label Type
Controlled
Terms or
Format
Notes or Description
Sample Value
35
COUNTRY
Country
Char ISO 3166-1alpha-3
3 letter ISO 3166 country code in which the site is located.
USA
36
STATE
State
Char String
Unabbreviated state or province in which the site is located. If not
applicable, enter NA.
Maryland
37
CITY
City
Char String
Unabbreviated city, county, or village in which the site is located.
Silver Spring
38
POSTAL
Postal Code
Char String
Postal code in which site is located. If not applicable, enter NA.
20850
39
STREET
Street Address
Char String
Street address and office number at which the site is located.
1 Main St, Suite 100
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 24 of 33
Appendix 2: Proposed Revised FDA Draft Technical Specifications
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample Value
1
STUDYID
Study Identifier
Char String
Study or trial identification number.
ABC-123
2
STUDYTL
Study Title
Char String
Title of the study as listed in the clinical study report (limit 200 characters). If the title
exceeds 200 characters, provide the abbreviated title from Clinicaltrials.gov and
document this in the Notes or Description section in the define file (Clinical Site Data
Elements Summary).
Double blind,
randomized placebo
controlled clinical
study on the
influence of drug X
on indication Y
3
SPONCNT
Sponsor Count
Num Integer
Total count of sponsors throughout the study. If there was a change in the sponsor while
the study was ongoing, with sponsors as defined in 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”.
1
4
SPONNAME Sponsor Name
Char String
Full name of the sponsor organization conducting the study at the time of study
completion, as defined in 21 CFR 312.3(a). If the sponsor name exceeds 200
characters, provide the abbreviated sponsor name from Clinicaltrials.gov and document
this in the Notes or Description section in the define file (Clinical Site Data Elements
Summary).
Drug Co, Inc.
5
IND
IND Number
Num 6 digit
identifier
Investigational New Drug (IND) application number. If study not performed under IND,
leave blank.
010010
6
UNDERIND
Under IND
Char String
Value should equal “Y” if study at the site was conducted under an IND (i.e., a Form FDA
1572 was signed by the investigator) and “N” if the study was not conducted under an
IND at the site (i.e., a Form FDA 1572 was not signed by the investigator).
Y
7
NDA
NDA Number
Num 6 digit
identifier
FDA new drug application (NDA) number, if available/applicable. If not applicable, leave
blank.
021212
8
BLA
BLA Number
Num 6 digit
identifier
FDA identification number for biologics license application, if available/applicable. If not
applicable, leave blank.
123456
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 25 of 33
Variable
Index
Variable
Name
Variable Label
9
SUPPNUM
Supplement
Number
10
SITEID
11
Type
Controlled
Terms or
Format
Num Integer
Notes or Description
Sample Value
Serial number for supplemental application, if applicable. If no information is available,
leave blank.
4
Study Site Identifier Char String
Investigator site identifier assigned by the sponsor.
50
ARM
Description of
Planned Treatment
Arm
Plain text label for the name given to an Arm or treatment group as referenced in the
clinical study report (limit 200 characters).
Active name and
dose (e.g., Active
25mg), Comparator
product name (e.g.,
Drug x), or Placebo
12
SAFPOP
Number of Subjects Num Integer
in Safety
Population
Total number of subjects in safety population at a given site by treatment arm. When a
subject has transferred from one site to another, the applicant should handle reporting of
such subjects consistently across sites, should ensure the subject is counted at only one
site, and should 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
Reviewer’s Guide, if a guide will be provided.
20
13
SCREEN
Number of Subjects Num Integer
Screened
Total number of subjects screened (consented) at a given site. 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 Reviewer’s Guide (if provided). The applicant may opt to further explain
the reasons subjects transferred between sites in the BIMO Reviewer’s Guide, if
provided.
100
14
DISCSTUD
Number of Subject Num Integer
Discons from Study
Number of subjects in the safety population who discontinued from the study.
5
15
DISCTRT
Number of Subject Num Integer
Discons from Study
Treatment
Number of subjects in the safety population who discontinued from the study treatment.
10
Char String
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 26 of 33
Variable
Index
Controlled
Terms or
Format
Variable
Name
Variable Label
16
ENDPOINT
Primary Endpoint
Char String
Plain text label used to describe the primary endpoint (limit 200 characters). When more Average increase in
than one primary efficacy endpoint exists, additional rows should be added to the dataset blood pressure
to report additional ENDPOINT, ENDPTYPE, TRTEFFR, TRTEFFS, SITEEFFE, and
SITEEFFS values by arm for each site.
17
ENDPTYPE
Primary Endpoint
Type
Char String
Variable type of the primary endpoint (i.e., continuous, discrete, time to event, or other).
18
TRTEFFR
Treatment Efficacy
Result
Num Floating Point Summary statistic for each primary efficacy endpoint by treatment arm at a given site.
0, 0.25, 1, 100
19
TRTEFFS
Treatment Efficacy
Result Standard
Deviation
Num Floating Point Standard deviation of the efficacy result (TRTEFFR) for each primary efficacy endpoint
by treatment arm at a given site. If N=1, set to 0.
0.065
20
SITEEFFE
Site-Specific
Num Floating Point Site effect size with the same representation as reported for the primary efficacy analysis. 0, 0.25, 1, 100
Efficacy Effect Size
21
SITEEFFS
Site-Specific
Efficacy Effect Size
Standard Deviation
Num Floating Point Standard deviation of the site-specific efficacy effect size (SITEEFFE). If N=1, set to 0.
0.065
22
CENSOR
Number of
Censored
Observations
Num Integer
Total number of censored observations at a given site by treatment arm for primary
endpoint (e.g., applicable to time-to-event). If not applicable, leave blank.
5
23
NSAE
Number of NonSerious Adverse
Events
Num Integer
Total number of non-serious adverse events at a given site by treatment arm for subjects
in the safety population. 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).
10
24
SAE
Number of Serious
Adverse Events
Num Integer
Total number of serious adverse events at a given site by treatment arm, excluding
deaths, for subjects in the safety population. This value should include multiple events
per subject.
5
25
DEATH
Number of Deaths
Num Integer
Total number of deaths at a given site by treatment arm for subjects in the safety
population.
1
Type
Notes or Description
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 27 of 33
Sample Value
Continuous
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample Value
26
PROTVIOL
Number of Protocol Num Integer
Violations
Total number of protocol violations at a given site by treatment arm as defined in the
20
clinical study report. A protocol violation is an unplanned excursion from the protocol that
is not implemented or intended as a systematic change. This value should include
multiple violations per subject and all violation types (i.e., not limited to only significant
deviations).
27
FINLDISC
Financial
Disclosure Amount
Char String
Total financial disclosure amount ($USD) by site calculated as the sum of disclosures for
the principal clinical investigator and all sub-investigators to include all required parities
under the applicable regulations (21 CFR Parts 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.
28
LASTNAME
Investigator Last
Name
Char String
Last name of the principal clinical investigator as it appears on the Form FDA 1572 or the Doe
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.
29
FRSTNAME
Investigator First
Name
Char String
First name of the principal clinical investigator as it appears on the Form FDA 1572 or the John
signed investigator agreement.
30
MINITIAL
Investigator Middle
Initial
Char String
Middle initial of the principal clinical investigator, if any, as it appears on the Form FDA
1572 or the signed investigator agreement.
M
31
PHONE
Investigator Phone
Number
Char String
Phone number of the principal clinical investigator. Include country code for non-US
numbers.
44-555-555-5555
32
FAX
Investigator Fax
Number
Char String
Fax number of the principal clinical investigator. Include country code for non-US
numbers. If not available, leave blank.
44-555-555-5555
33
EMAIL
Investigator Email
Address
Char String
Email address of the principal clinical investigator.
[email protected]
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 28 of 33
≥ $25,000
Variable
Index
Variable
Name
Variable Label
Type
Controlled
Terms or
Format
Notes or Description
Sample Value
34
COUNTRY
Country
Char ISO 3166-1alpha-3
3 letter ISO 3166 country code in which the site is located.
USA
35
STATE
State
Char String
Unabbreviated state or province in which the site is located. If not applicable, enter NA.
Maryland
36
CITY
City
Char String
Unabbreviated city, county, or village in which the site is located.
Silver Spring
37
POSTAL
Postal Code
Char String
Postal code in which the site is located. If not applicable, enter NA.
20850
38
STREET
Street Address
Char String
Street address and office number at which the site is located.
2005 John
Fitzgerald Kennedy
Boulevard
Northwest,
International
Technology Center,
Department of
Medicine and
Pharmacokinetics,
National Institute of
Clinical Research
Twin Towers
Building,
39
STREET1
Street Address
Char String
Street address and office number at which the site is located. Use this field when
Variable STREET does not permit sufficient space to fully describe street address and
office number at which the site is located.
The Executive
Wing, Suite # 209
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 29 of 33
Appendix 3: Example for Clinical Site Data Elements Summary Listing with Multiple Primary Endpoints
STUDYID
STUDYTL
SPONNO
SPONNAME
IND
UNDERIND
NDA
BLA
SUPPNUM
SITEID
ARM
SAFPOP
SCREEN
DISCSTUD
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
001
Active
26
61
3
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
001
Active
26
61
3
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
001
Placebo
25
61
4
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
001
Placebo
25
61
4
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
002
Active
23
54
2
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
002
Active
23
54
2
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
002
Placebo
25
54
4
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
002
Placebo
25
54
4
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
003
Active
27
62
3
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
003
Active
27
62
3
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
003
Placebo
26
62
5
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
003
Placebo
26
62
5
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
004
Active
26
60
2
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
004
Active
26
60
2
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
004
Placebo
27
60
1
ABC-123
Double blind…
1
DrugCo, Inc.
000001
Y
200001
∙
∙
004
Placebo
27
60
1
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 30 of 33
DISCTRT
ENDPOINT
ENDTYPE
TRTEFFR
TRTEFFS
SITEEFFE
SITEEFFS
CENSOR
NSAE
SAE
DEATH
PROTVIOL
FINLDISC
LASTNAME
FRSTNAME
3
Percent Responders
Binary
0.48
0.0980
0.34
0.1405
∙
0
2
0
1
< $25,000
Doe
John
2
Change from
Baseline
Continuous
0.74
0.0861
0.60
0.1502
0
2
0
1
< $25,000
Doe
John
3
Percent Responders
Binary
0.14
0.0694
0.34
0.1405
2
2
0
1
< $25,000
Doe
John
4
Change from
Baseline
Continuous
0.14
0.0699
0.60
0.1502
2
2
0
1
< $25,000
Doe
John
0
Percent Responders
Binary
0.48
0.1042
0.33
0.1427
3
2
1
0
≥
$25,0000
Washington
George
1
Change from
Baseline
Continuous
0.67
0.0983
0.52
0.1515
3
2
1
0
≥
$25,0000
Washington
George
4
Percent Responders
Binary
0.14
0.0694
0.33
0.1427
0
2
0
3
≥
$25,0000
Washington
George
3
Change from
Baseline
Continuous
0.14
0.0700
0.52
0.1515
0
2
0
3
≥
$25,0000
Washington
George
2
Percent Responders
Binary
0.54
0.0959
0.35
0.1448
2
2
0
1
≥
$25,0000
Jefferson
Thomas
0
Change from
Baseline
Continuous
0.65
0.0931
0.43
0.1485
2
2
0
1
≥
$25,0000
Jefferson
Thomas
5
Percent Responders
Binary
0.19
0.0769
0.35
0.1448
3
6
0
0
≥
$25,0000
Jefferson
Thomas
6
Change from
Baseline
Continuous
0.19
0.0769
0.43
0.1485
3
6
0
0
≥
$25,0000
Jefferson
Thomas
1
Percent Responders
Binary
0.46
0.0977
0.34
0.1275
4
1
0
0
unknown
Lincoln
Abraham
0
Change from
Baseline
Continuous
0.71
0.0891
0.5545
0.1397
4
1
0
0
unknown
Lincoln
Abraham
2
Percent Responders
Binary
0.12
0.0625
0.34
0.1275
∙
1
2
0
1
unknown
Lincoln
Abraham
Continuous
0.15
0.0694
0.5545
0.1397
∙
1
2
0
1
unknown
Lincoln
Abraham
1
Change from
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 31 of 33
∙
∙
∙
∙
∙
∙
∙
∙
∙
∙
∙
∙
∙
Baseline
MINITIAL
PHONE
FAX
EMAIL
COUNTRY
STATE
CITY
POSTAL
STREET
STREET1
M
555-123-4567
555-123-4560
[email protected]
RUS
Moscow
Moscow
103009
Kremlin Road 1
-
M
555-123-4567
555-123-4560
[email protected]
RUS
Moscow
Moscow
103009
Kremlin Road 1
-
M
555-123-4567
555-123-4560
[email protected]
RUS
Moscow
Moscow
103009
Kremlin Road 1
-
M
555-123-4567
555-123-4560
[email protected]
RUS
Moscow
Moscow
103009
Kremlin Road 1
-
∙
020-3456-7891
020-3456-7890
[email protected]
GBR
Westminster
London
SW1A 2
10 Downing St Suite 2058
-
∙
020-3456-7891
020-3456-7890
[email protected]
GBR
Westminster
London
SW1A 2
10 Downing St Suite 2058
-
∙
020-3456-7891
020-3456-7890
[email protected]
GBR
Westminster
London
SW1A 2
10 Downing St Suite 2058
-
∙
020-3456-7891
020-3456-7890
[email protected]
GBR
Westminster
London
SW1A 2
10 Downing St Suite 2058
-
∙
01-89-12-34-56
01-89-12-3451
[email protected]
FRA
N/A
Paris
75002
1, Rue Road
-
∙
01-89-12-34-56
01-89-12-3451
[email protected]
FRA
N/A
Paris
75002
1, Rue Road
-
∙
01-89-12-34-56
01-89-12-3451
[email protected]
FRA
N/A
Paris
75002
1, Rue Road
-
∙
01-89-12-34-56
01-89-12-3451
[email protected]
FRA
N/A
Paris
75002
1, Rue Road
-
20852
2005 John Fitzgerald Kennedy Boulevard
Northwest, International Technology Center,
Department of Medicine and Pharmacokinetics,
National Institute of Clinical Research Twin Towers
Building,
The
Executive
Wing, Suite
# 209
∙
555-987-6543
555-987-6540
[email protected]
USA
Maryland
Rockville
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 32 of 33
20852
2005 John Fitzgerald Kennedy Boulevard
Northwest, International Technology Center,
Department of Medicine and Pharmacokinetics,
National Institute of Clinical Research Twin Towers
Building,
The
Executive
Wing, Suite
# 209
20852
2005 John Fitzgerald Kennedy Boulevard
Northwest, International Technology Center,
Department of Medicine and Pharmacokinetics,
National Institute of Clinical Research Twin Towers
Building,
The
Executive
Wing, Suite
# 209
20852
2005 John Fitzgerald Kennedy Boulevard
Northwest, International Technology Center,
Department of Medicine and Pharmacokinetics,
National Institute of Clinical Research Twin Towers
Building,
The
Executive
Wing, Suite
# 209
∙
555-987-6543
555-987-6540
[email protected]
USA
Maryland
Rockville
∙
555-987-6543
555-987-6540
[email protected]
USA
Maryland
Rockville
∙
555-987-6543
555-987-6540
[email protected]
USA
Maryland
Rockville
PhUSE Inspection Site Selection Data Elements Reqs-CDISC Gap Analysis, 26 May 2016
Page 33 of 33