1. CPT and Disclosure: Connecting Critical Processes
November 2018

2. The Information Flow Challenge
The media break that exists between human-readable protocol concepts and the machine-readable (digital) information processed by clinical trial design & execution systems creates the need for frequent human interpretation.
structured information
un/semi-structured information
structured information
Clinical Trial Management
Clinical Trial Supply
Sample Management
Data Capture
Data Management
Disclosure
Report Compilation
Investigator Payments
Therapeutic Area Libraries
Clinical Data Standards
Predictive Analytics
Protocol
Legally approved Nov-2018
inform
inform

3. Protocol Development and Related Processes
Protocol development has become disconnected from critical related processes.
Predictive Analytics
Clinical Trial Registry Data
Clinical Trial Registry
TOC
Registry Results
Study-specific structured data
Protocol
Text
Clinical Study Report
Common Technical Document
Study-specific unstructured data
Tables, Listings, Figures
Legally approved Nov-2018
MDR Metadata Repository
Statistical Analysis Plan
Patient Datasets
Libraries
Objectives/Endpoints
Inclusion/Exclusion
Data Standards
Data Collection

4. Common Protocol Template Enablers
The Technology Enabled Edition of the Common Protocol Template (CPT) avoids media breaks by capturing structured and unstructured information in variables available for export and reuse downstream.
Libraries make model content available
Common layout of content
Legally approved Nov-2018
Information is captured in variables

5. The CDISC Clinical Trial Registry (CTR) Standard
Study Design Model
(SDM)
Operational Data Model (ODM)
Extension of the SDM and ODM standards
Enables the vision of an entirely digital protocol
Creates an aligned set of fields
Placed as structured information into the protocol
Extracted to feed into a clinical trial registry
Legally approved Nov-2018

6. CPT Disclosure Explained
CPT variables capture disclosure data per CDISC Clinical Trial Registry (CTR) Standards
CDISC CTR standards set controlled terminology in a manner that harmonizes across ClinicalTrials.gov, EudraCT, and WHO registries
Common Protocol Template
CPT export generates a CT Registry data file
CT Registry data can be used in other systems
CPT export generates either an Excel file to view the data or an XML file to directly import it into other systems to reuse in automated processes.
CPT Export
Import
Legally approved Nov-2018
In the Dec 2017 release, CPT variables were mapped to CDISC CTR standards where possible with the goal of providing incorporated fields for ClinicalTrials.gov, EudraCT, and WHO registries.

7. CPT and Disclosure to Trial Registries
As of CPT Dec 2017 Release
CPT variables, mapped to CDISC CTR standard, capture protocol registry data required for ClinicalTrials.gov, and enable export to XML and Excel. Instructional text embedded within Basic Word Edition guides authors to create registry-ready content.
Future CPT Development
Expand CPT variables to incorporate fields for EudraCT and WHO registries; Explore further use of CDISC CTR XML schema.
Disclosure is integrated into protocol authoring
Additions have instructional text to harmonize how registry information is captured in the protocol
Next release of CPT Technology Enabled Edition includes variables aligned with required registry terms
Improved quality and consistency
Legally approved Nov-2018

8. CPT Variables for Disclosure Export
CPT Fields (Variables) Available for Export to Facilitate Disclosure to Trial Registries
(options available to export for both clinicaltrials.gov and EudraCT requirements)
Compound Number
Protocol Number
Study phase
Protocol Title
Protocol Short Title
Acronym
Approval Date
Sponsor Name
Sponsor Legal Address
Regulatory Agency ID
Regulatory Agency Number
Intervention Groups and Duration
Data Monitoring Committee
Intervention Model
Primary Purpose
Study Phase
Masking
Participant and Study Completion
Number of Participants
Enrollment Target
Number of Arms
Arm Name
Intervention Name
Intervention Type
IMP and NIMP
Sourcing
Packaging and Labeling
Current Former Names Aliases
Dosage Formulation
Route of Administration
Dosage Level
Unit Dose Strength
Study Rationale
Objectives Primary
Endpoints Primary
Objectives Secondary
Endpoints Secondary
Objectives Tertiary Exploratory
Endpoints Tertiary
Study Design
Overall Design
Inclusion Criteria Age
Inclusion Criteria Informed Consent
Inclusion Criteria Sex
Inclusion Criteria Type of Participant
Inclusion Criteria Weight
Sex of Participants
Planned Minimum Age of Subjects
Planned Maximum Age of Subjects
Exclusion Criteria Medical Conditions
Exclusion Criteria Prior Concomitant Therapy
Exclusion Criteria Prior Concurrent Clinical
Study Experience
Exclusion Criteria Diagnostic Assessment
Exclusion Criteria Other
*Sponsor Status = Commercial
*Trial Type = Interventional
*Responsible Party = Sponsor
*Healthy Volunteer = HLTSUBJ1
Legally approved Nov-2018
*Variables do not appear in Template but are included in export with values populated

9. Benefits to ClinicalTrials.gov Benefits for Investigators & Patients
Benefits for Sponsors
Consistency of the information disclosed (information posted on websites and documents shared)
Effort focused on content review rather than cut & paste
Shorter time and reduced cost to create the disclosure information
Transparency considered during protocol development
Aligns with CDISC CTR
Benefits to ClinicalTrials.gov
Increased quality on information disclosed on ClinicalTrials.gov
Timely information
Benefits for Investigators & Patients
Able to read consistent & better quality information regarding clinical trials
Defines trial information clearly across sponsors
Legally approved Nov-2018

10. Thank you