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The CTRP system captures the trial data you submit, and from them generates two types of trial documents: a Trial Summary Report (TSR), formatted for user consumption; and an XML file formatted for upload to ClinicalTrials.gov. Both documents contain a subset of trial data elements captured in the CTRP. However, the TSR contains more elements than the XML because ClinicalTrials.gov-required fields are different from those in CTRP. Some data that appear in the TSR do not appear in the XML, and vice versa. The documents are described below.
The following sections compare the TSR data elements with those in the XML. |
TSR-XML Data Element Comparisons
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2013-03...
<verification_date>2013-03</verification_date>...
Trial Category
...
Not included in the XML file
...
Trial Type
...
<study_type>Interventional</study_type>...
NCI Trial Identifier
...
NCI-2011-9999
...
<id_info>
<secondary_id>
<id>NCI-2011-99999</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>CTRP (Clinical Trial Reporting Program)
</id_domain>
</secondary_id>
</id_info>
...
ClinicalTrials.gov Identifier
...
Not included in the XML file
...
Lead Organization Identifier
...
<id_info>
<secondary_id>
<id>CCCCWFU 12345</id>
<id_type>
Other Identifier
</id_type>
<id_domain>Wake Forest University Health Sciences
</id_domain>
</secondary_id>
</id_info>
...
DCP Identifier
...
WFU-01-01-06
...
<secondary_id><id>WFU-01-01-06</id></secondary_id>
<id_info>
<secondary_id>
<id>WFU-01-01-06</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>DCP
</id_domain>
</secondary_id>
</id_info>
...
CTEP Identifier
...
WFU-01-01-06
...
<id_info>
<secondary_id>
<id> WFU-01-01-06</id>
<id_type>
Registry Identifier
</id_type>
<id_domain>CTEP
</id_domain>
</secondary_id>
</id_info>
...
CCR Identifier
...
Type
...
<study_type>Interventional</study_type>...
Official Title
...
<official_title>A Phase II Double-Blind Feasibility Study of Armodafinil....</official_title>...
Brief Title
...
Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
...
<brief_title>Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors</brief_title>...
Not included in the XML file
...
This clinical trial is studying how well Armodafinil works....
...
<brief_summary><textblock>
This clinical trial is studying how well Armodafinil works..../>
<textblock><brief_summary>
...
<detailed_description><textblock>
Detailed Description...
</textblock></detailed_description>
...
I. To estimate....
...
<detailed_description><textblock>
PRIMARY OBJECTIVES: I. To estimate....
<textblock><detailed_description>
...
I. To obtain a preliminary estimate....
...
<detailed_description><textblock>
SECONDARY OBJECTIVES: To obtain a preliminary estimate....
</textblock></detailed_description>
...
OUTLINE: This is a multicenter study....
...
<detailed_description><textblock>
OUTLINE: This is a multicenter study....
</textblock></detailed_description>
...
Keywords
...
<keyword>Feasibility Armodafinil</keyword>
<keyword>narcolepsy</keyword>
...
Reporting Dataset Method
...
Sponsor
...
National Cancer Institute
...
<sponsors>
<lead_sponsor>
<agency>National Cancer Institute</agency>
</lead_sponsor>
</sponsors>
...
Lead Organization
...
Wake Forest University Health Sciences
...
<overall_official>
<first_name>PI First Name</first_name>
<last_name>PI Last Name</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences </affiliation>
</overall_official>
...
Principal Investigator
...
Autissier, Isabelle affiliated with Wake Forest University Health Sciences in the role of Principal Investigator
...
<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>Wake Forest University Health Sciences</affiliation>
</overall_official>
...
Responsible Party
...
Sponsor
...
<resp_party_type>Sponsor</resp_party_type>...
Overall Official
...
Autissier, Isabelle affiliated with Wake Forest University Health Sciences in the role of Principal Investigator
...
<overall_official>
<first_name>Isabelle Name</first_name>
<last_name>Autissier</last_name>
<role>Principal Investigator</role>
<affiliation>National Cancer Institute External</affiliation>
</overall_official>
...
Current Trial Status
...
Closed to Accrual and Intervention as of 08/01/2012
...
<overall_status>Active, not recruiting</overall_status>...
Trial Start Date
...
08/01/2010-Actual
...
<start_date>2010-08</start_date>...
Primary Completion Date
...
01/11/2014-Actual
...
<primary_compl_date>2014-01</primary_compl_date>
<primary_compl_date_type>Actual</primary_compl_date_type>
...
Completion Date
...
02/04/2014-Actual
...
| Info |
|---|
If no data are available, the "<last_follow_up_date>" does not appear in the XML file. |
...
Oversight Authorities
...
United States: Food and Drug Administration
...
<oversight_info>
<regulatory_authority>United States : Food and Drug Administration</regulatory_authority>
</oversight_info>
...
FDA Regulated Intervention?
...
<is_fda_regulated>Yes</is_fda_regulated> ...
Section 801?
...
<is_section_801>Yes</is_section_801> ...
DMC Appointed?
...
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
...
IND/IDE Study?
...
<is_ind_study>Yes</is_ind_study>...
Board Approval Status
...
Submitted, approved
...
<irb_info>
<approval_status>Approved</approval_status>
<irb_info>
...
Board Approval Number
...
IRB00012856
...
<irb_info>
<approval_number>IRB00012856</approval_number>
<irb_info>...
Board
...
Wake Forest University Health Sciences
...
<irb_info>
<name>Wake Forest University Health Sciences</name>
<irb_info>
...
Affiliation
...
<irb_info>
<affiliation>Wake Forest University Health Sciences</affiliation>
<irb_info>
...
<ind_grantor>CBER</ind_grantor>...
<ind_number>119999</ind_number>...
Not included in the XML file
...
<has_expanded_access>Available</has_expanded_access>...
NIH Grants > Funding Mechanism
...
<secondary_id><id>U10CA12345</id><id_type>NIH Grant Number</id_type></secondary_id><secondary_id>
...
NIH Grants > NIH Institution Code
...
<secondary_id>
<id>U10CA 012345</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>
...
<secondary_id>
<id>U10CA8888</id>
<id_type>NIH Grant Number</id_type>
</secondary_id>
...
Not included in the XML file
...
Data Table 4 Information > Funding Category
...
Externally Peer-Reviewed
...
Data Table 4 Information > Funding Sponsor/Source
...
National Cancer Institute
...
Prostate
...
National Cancer Institute
...
<collaborator>
<agency>National Cancer Institute</agency>
</collaborator>
...
Prostate Carcinoma
...
<condition>Prostate Carcinoma</condition>...
Trial Design > Type
...
Interventional
...
<study_type>Interventional</study_type>
and
<study_design>Interventional</study_design>...
Trial Design > Primary Purpose
...
Prevention
...
<study_design>
<interventional_design>
<interventional_subtype>Prevention</interventional_subtype>
</interventional_design>
</study_design>
...
Trial Design > Phase
...
<study_design>
<interventional_design>
<phase>II</phase>
</interventional_design>
</study_design>
...
Trial Design > Intervention Model
...
<study_design>
<interventional_design>
<assignment>Parallel Assignment</assignment>
</interventional_design>
</study_design>
...
Trial Design > Number of Arms
...
<study_design>
<interventional_design>
<number_of_arms>2</number_of_arms>
</interventional_design>
</study_design>
...
Trial Design > Masking
...
<study_design>
<interventional_design>
<masking>Double Blind</masking>
</interventional_design>
</study_design>
...
Trial Design > Allocation
...
Randomized Controlled Trial
...
<study_design>
<interventional_design>
<allocation>Randomized Controlled Trial</allocation>
</interventional_design>
</study_design>
...
Trial Design > Classification
...
<study_design>
<interventional_design>
<endpoint>Safety Efficacy Study</endpoint>
</interventional_design>
</study_design>
...
Trial Design > Target Enrollment
...
Eligibility Criteria > Accepts Healthy Volunteers?
...
No
...
<eligibility criteria >
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
...
Eligibility Criteria > Gender
...
Both
...
<eligibility criteria >
<gender>Both</gender>
</eligibility>
...
Eligibility Criteria > Minimum Age
...
18 Years
...
<eligibility criteria >
<minimum_age>18 years</minimum_age>
...
Eligibility Criteria > Maximum Age
...
N/A
...
<eligibility criteria >
<maximum_age>N/A</maximum_age>
</eligibility>
...
NA...
Eligibility Criteria > Inclusion Criteria
...
Family history of prostate cancer...
...
<eligibility>
<criteria>
<textblock>Inclusion Criteria: Family history of prostate cancer...</textblock>
</criteria>
</eligibility>
...
NA...
Patient must not have had radiation therapy in the pelvic area....
...
<eligibility>
<criteria>
<textblock>Exclusion Criteria: Patient must not have had radiation therapy in the pelvic area....</textblock>
</criteria>
</eligibility>
...
<intervention_type>Drug</intervention_type>...
Armodafinil
...
<intervention_name>Armodafinil</intervention_name>...
2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...
...
<intervention_other_name>2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...</intervention_other_name>...
Given orally
...
<intervention_description><textblock>Given orally</textblock></intervention_description>...
Placebo Comparator
...
<arm_type>Placebo Comparator</arm_type>...
Arm II
...
<arm_group_label>Arm II</arm_group_label>...
Patients receive oral Armodafinil once daily....
...
<arm_group_description>
<textblock>Patients receive oral Armodafinil once daily....</textblock>
</arm_group_description>
...
Accrual rate estimated as the number of patients ....
...
<primary_outcome>
<outcome_measure>Accrual rate estimated as the number of patients ....</outcome_measure>
</primary_outcome>
...
<outcome_description>
<textblock>Estimated using an analysis of covariance (ANCOVA) model which includes....</textblock>
</outcome_description>
...
<outcome_time_frame>Up to 2 years</outcome_time_frame>...
Incidence of toxicity incidents....
...
<secondary_outcome>
<outcome_measure>Incidence of toxicity incidents assessed....</outcome_measure>
<secondary_outcome>
...
<outcome_description>...
<outcome_time_frame>Up to 2 years</outcome_time_frame>...
<outcome_safety_issue>No</outcome_safety_issue>...
Sub-groups Stratification Criteria > Label
...
Not included in the XML file
...
Sub-groups Stratification Criteria > Description
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Marker Name
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Evaluation Type
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Assay Type
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Biomarker Use
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Biomarker Purpose
...
Not included in the TSR
...
Not included in the XML file
...
Markers > Specimen Type
...
Not included in the TSR
...
Not included in the XML file
...
Wake Forest University Health Sciences
Winston-Salem, NC 27106
United States
...
<location>
<facility>
<name> Wake Forest University Health Sciences </name>
<address>
<city>Winston-Salem</city>
<state>NC</state>
<zip>27106</zip>
<country>United States</country>
</address>
</facility>
</location>
...
Autissier, Isabelle, M.
phone:123-123-1234
Email:ia@domain.com
...
<location>
<contact>
<first_name>Isabelle</first_name>.<middle_name>M</middle_name><last_name>Autissier</last_name>
<phone>123-123-1234></phone>
<email>ia@domain.com</email>..
</ contact>
</location>
...
Enrolling by Invitation as of 05/09/2014
...
<location>
<status>Enrolling by Invitation</status>
</location>
...
<investigator>
<first_name>Isabelle</first_name><last_name>Autissier</last_name><role>Principal Investigator</role>
</investigator>
...
Trial Summary Report Data Elements by Section
Each of the following sections contain mapping tables, in the order in which they appear in the TSRs.
Trial Identification Data Elements
| TSR Data Elements | XML Data Elements |
|---|---|
Trial Category | Not included in the XML file |
Trial Type | <study_type> |
NCI Trial ID | <secondary_id><id> |
| Other Trial ID | <id_type> |
| Organization ID | <org_study_id> |
| ClinicalTrials.gov ID | Not included in the XML file |
| Amendment Date | Not included in the XML file |
| Amendment Number | Not included in the XML file |
General Trial Details
| TSR Data Elements | XML Data Elements |
|---|---|
| Study Type | <study_type> |
| Official Title | <official_title> |
| Brief Title | <brief_title> |
Acronym | <acronym> |
| Brief Summary | <brief_summary> |
| Detailed Description | <detailed_description> |
Keywords | <keyword> |
| Reporting Dataset Method | Not included in the XML file |
| Sponsor | <lead_sponsor> |
| Lead Organization | <overall_official> |
| Principle Investigator | <resp_party> |
| Responsible Party | <resp_party_type> |
| Overall Official | <overall_official> |
Status/Dates
...
<overall_status>...
<start_date>...
primary_compl_date>-primary_compl_date_type>...
<last_follow_up_date>Regulatory Information/Oversight Information
| TSR Data Elements | XML Data Elements |
|---|---|
| Oversight Authorities | <oversight_info> |
| FDA Regulated Intervention? | <is_fda_regulated> |
| Delayed Posting Indicator? | <delayed_posting> |
| Section 801? | <is_section_801> |
| DMC Appointed? | <has_dmc> |
| IND/IDE Study? | <is_ind_study> |
Human Subject Safety/Regulatory Authority
| TSR Data Elements | XML Data Elements |
|---|---|
| Board Approval Status | <approval_status> |
| Board Approval Number | <approval_number> |
| Board | <irb_info> |
| Affiliation | <affiliation> |
NIH Grants
| TSR Data Elements | XML Data Elements |
|---|---|
| Funding Mechanism | <secondary_id> |
| NIH Institute Code | <secondary_id> |
| Serial Number | <secondary_id> |
| NCI Division/Program Code | <secondary_id> |
Data Table 4 Information
| TSR Data Elements | XML Data Elements |
|---|---|
| Funding Category | Not included in the XML file |
| Funding Sponsor/Source | Not included in the XML file |
| Program Codes | Not included in the XML file |
| Anatomic Site Code | Not included in the XML file |
Collaborators
| TSR Data Elements | XML Data Elements |
|---|---|
| Collaborator Name | <collaborator>-<agency> |
| Role | Not included in the XML file |
Disease/Condition
| TSR Data Elements | XML Data Elements |
|---|---|
| Disease/Condition Name | <condition> |
Trial Design
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <study_type> |
| Primary Purpose | <interventional_subtype> |
| Phase | <phase> |
| Intervention Model | <assignment> |
| Number of Arms | <number_of_arms> |
| Masking | <masking> |
| Allocation | <allocation> |
| Classification | <endpoint> |
| Target Enrollment | <enrollment> |
Eligibility Criteria
| TSR Data Elements | XML Data Elements |
|---|---|
| Accepts Healthy Volunteers? | <healthy_volunteers> |
| Gender | <gender> |
| Minimum Age | <minimum_age> |
| Maximum Age | <maximum_age> |
| Inclusion Criteria | <criteria> |
| Exclusion Criteria | <criteria> |
Intervention(s)/Intervention(s)
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <intervention_type> |
| Name | <intervention_name> |
| Alternate Name | <intervention_other_name> |
| Description | <intervention_description> |
Arm and Group(s)
| TSR Data Elements | XML Data Elements |
|---|---|
| Number of arms | Not included in the XML file |
Primary and Secondary Outcome Measures
| TSR Data Elements | XML Data Elements |
|---|---|
| Title | <outcome_measure> |
| Description | <outcome_description> |
| Time Frame | <outcome_time_frame> |
| Safety Issue? | <outcome_safety_issue> |
Participating Sites
| TSR Data Elements | XML Data Elements |
|---|---|
| Facility | <facility> |
| Contact | <contact> |
| Recruitment Status and Dates | <status> |
| Target Accrual | Not included in the XML file |
| Investigator(s) | <investigator>-<role> |
Excerpts from Example TSR and Example XML File
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The images below are excerpts from an example XML file. XML files contain all abstracted data in code format that can be submitted to ClinicalTrials.gov for registration.
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