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CPT and Disclosure: Connecting Critical Processes

CPT and Disclosure: Connecting Critical Processes. November 2018. The Information Flow Challenge.

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CPT and Disclosure: Connecting Critical Processes

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  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. Disclosure structured information un/semi-structured information structured information Clinical Trial Management Investigator Payments Clinical Data Standards Clinical Trial Supply Protocol Therapeutic Area Libraries Sample Management inform inform Predictive Analytics Data Capture Data Management Report Compilation

  3. Protocol Development and Related Processes Protocol development has become disconnected from critical related processes. PredictiveAnalytics Clinical Trial Registry Data TOC Registry Results Clinical TrialRegistry Study-specific structured data Common Technical Document Clinical Study Report Protocol Text Study-specific unstructured data Tables, Listings, Figures MDR Metadata Repository Statistical Analysis Plan PatientDatasets 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 Information is captured in variables

  5. The CDISC Clinical Trial Registry (CTR) Standard • 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

  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 CT Registry data can be used in other systems CPT export generates a CT Registry data file 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 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

  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 • 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 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 *Variables do not appear in Template but are included in export with values populated

  9. Benefits

  10. Thank you

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