CPT and Disclosure: Connecting Critical Processes November 2017

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 inform inform

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 MDR Metadata Repository Statistical Analysis Plan Patient Datasets Libraries Objectives/Endpoints Inclusion/Exclusion Data Standards Data Collection

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 Information is captured in variables

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

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 In the Dec 2017 release, CPT variables are mapped to CDISC CTR standards where possible with the goal of providing incorporated fields for ClinicalTrials.gov, EudraCT, and WHO registries.

CPT and Disclosure to Trial Registries 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

CPT Variables Available for Export Compound Number Protocol Number Protocol Title Protocol Short Title Acronym Approval Date Sponsor Name Sponsor Legal Address Agency ID Regulatory Agency Number Data Monitoring Committee Intervention Model Primary Purpose Study Phase Masking Number of Participants Enrollment Target Planned Number of Arms Arm Name Study 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 Primary Objective(s) Primary Endpoint(s) Secondary Objective(s) Secondary Endpoint(s) Tertiary Objective(s) Tertiary Endpoint(s) 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 *These variables do not appear in template text but are included in export with values populated

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 information regarding clinical trials Defines trial information clearly across sponsors

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