NCI Standards Adoption Briefing

1. NCI Standards Adoption Briefing David Patton and Dianne M. Reeves, RN, MSN Center for Biomedical Informatics and Information Technology Date TBD

2. Agenda • NCI Policy Overview • Benefits for use of NCI Standards • NCI CRF Initiative • caDSR Usage Discussion • NCI Standards Adoption Project Overview • Working Groups • caDSR Training • Next Steps

3. NCI CRF Policy Overview • Provide guidance, optimize utilization, and alleviate the excessive time and resources being invested by the institutions in their use of the NCI standard eCRF modules. • Leverage investment the NCI Cooperative Groups have made in developing NCI standards • Increase potential for investigators to share data for scientific collaborations and perform cross-study analyses   • Reduce time and effort needed to build studies in a CDMS System • Reduce need for curation and form building activity in the caDSR: • Reduce data management burden on participating sites and leading institutions 

4. Standards in Clinical Trials Research Primary Benefits • Support interoperability • Promote common understanding • Support data collection, aggregation and sharing • Create large data sets • Reach trial endpoints more efficiently Secondary Benefits • Improved efficiency of study build and conduct • Improved quality of data collection • Improved clinical trials infrastructure

5. NCI CRF Initiative • Based on 2005 CTWG Report • Develop inventory from existing paper-based case report forms • Match with common data elements • Categorize as mandatory, optional, or conditional • Review with members of cancer community • Finalized after review and approval by representative of each cooperative group, NCI organization, stakeholder and NCI leadership

6. Background CTWG Vision Statement Enhance the best of all the components of the NCI-supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders

7. Background • Establish a Comprehensive Community-Accessible NCI Clinical Trial Database • Promote System Harmonization & Interoperability between NCI’s Clinical Trials systems • Establish Core Library of Standardized Case Report Forms (CRFs) through Stakeholder Consensus • Develop a Credentialing System for Investigators and Sites

8. caDSR Key Terms • Common Data Element (CDE) • Standardized terms for the collection and exchange of data. CDEs are metadata; they describe the type of data being collected, not the data itself. • Question/Answer created from Standard Terminologies • Case Report Form • A data collection form • Case Report Form Module • A collection and sequence of elements grouped to provide context for the information requested by the CRF questions. • Form Builder • A caDSR tool to create forms that replicate the content of Case Report Forms

9. caDSR Key Terms • Curation • The creation and editing of Data Element Concepts, Value Domains, and Data Elements in the caDSR • Carts • CDE cart • Form cart • Collections • Forms (CRFs) • Classification • Model (Domain Analysis Model)

10. caDSR Standards

11. CRF Roadmap

12. Harmonized Data Elements Hypothetical Assembly of a Disease History and Prior Therapies CRF (for electronic) using caBIG® standardized CRF Modules Header module Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. {Study ID}, {PI), {Course#},{Patient ID} , {Institution ID} ~~NOTE: fields may be collected automatically by system ~~ Disease History and Prior Therapies Disease status Stage TNM Primary Site Metastatic Sites Staging/Extent of Disease Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. *Prior Agent Name {*date type}Therapy Start Date {*date type}Therapy Stop Date {*dose type}Total Dose *Unit Agents (Prior/Post Therapies) Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. *Disease response Date of response assessment Outcomes Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Sign Off/Footer Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. ~~NOTE: fields may be collected automatically by system through user login/authentication and e-signatures ~~ Created by Lara Fournier, OHSU, March 2009

13. caBIG®CRF Standardization Process • CRF Question Partition Categories • Mandatory: • A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. • Conditional: • A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. • Optional: • A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study.   • Non-harmonized: • A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module. CRFs

14. Consideration : Partition rules • Mandatory • The element must be included on the CRF. There is an expectation that if the data exists or can be recovered, it will be entered. There may be skip patterns or dependencies that make the completion of an element unnecessary. • Conditional • The element is needed on the form based on certain protocol level rules. These may include: • Disease rules – staging systems for different types of cancer • Phase of study or multi-trial study needs • Requirements like stratification and randomization • Ask yourself ‘When would I not use this variable?’ • When is something NOT conditional – items like Male/Female, or ‘Date of Death’

15. Consideration : Partition rules • Optional • Needed usually for study-specific design requirements. ‘If you need it, this is the best one to use’. • Not Harmonized • Variables that do not fit into the module, or don’t belong in ANY module. • Demography Example

16. caDSR Usage Discussion • How long have you been using Velos / OnCore? • How much do you know about the standards in term of practical use and requirements? • Were you or others at your institution involved in the NCI CRF Standard initiative? • How familiar are you with caDSR and finding/using content? • Does your institution use data elements now? • How compliant are your existing studies with the need to use data elements? • How many trials do you currently have?

17. NCI Standards Adoption Project Overview • Identify and implement a model for Velos to adopt caDSR standards • Identify and implement a model for OnCore to adopt caDSR standards • NCI will provide training and curation support for up to 3 studies per organization • NCI will build the first study • NCI will build the second study along with the organization • NCI will mentor the organization to build the third study • Organization will build the fourth study on their own • Organizations will participate in working groups to develop the models to implement the standards

18. Working Groups • Data Elements • Description • Participate in providing recommendations to facilitate CDMS study startup activities as related to the caDSR • Evaluate the use of the caDSR with the CDMS application including reviewing available forms and CDEs • Goals • Recommendation of a model(s) for the review and/or creation of CRFs and data elements to use within the CDMS application across all groups. • Develop process descriptions • Change management process (including forms and processes) • Process Metrics • Training recommendations/requirements • SOP recommendations

19. Working Groups • Data Quality • Description • Define business rules for use by Cancer Centers in order to evaluate Data Quality and Timelines, for example: • Definition of a complete form • Impact of study build techniques on a data quality algorithm • Goals • Develop business rules and requirements as standards for monitoring site performance standards. • Develop the technical requirements necessary for the CDMS Vendor to program reports detailing site performance metrics to improve data quality and timely data entry. • Develop educational materials to assist with the interpretation and utilization of the CDMS application reports.

20. Working Groups • Study Conduct • Description • Establish work flow and processes for data collection, data management, and data monitoring within the CDMS application • Goals • Identify and document data collection, management, monitoring, and migration processes for standardization that would be of benefit across organizations • Develop work flows for identified processes grouped by data collection, data management, data monitoring, and data migration.

21. Working Groups • Study Build • Description • Define a common workflow for building studies in Velos and OnCore. The working group will also develop a standard approach for configuring studies, forms, edit checks, validations, and data loads. • Goals • Develop a Velos and Oncore study build workflow • Define the roles of study build in relation to the user types • Develop a standard approach to building forms in Velos and Oncore • Define the approach to verify studies built in Velos and Oncore • SOP recommendations

22. Working Groups • Integrations • Description • Determine a list of integration touch points for the CDMS application • Goals • List of integration touch points and processes of how those integrations will work

23. Working Groups • Metrics • Description • Determine operational metrics for study build, study conduct, and study analysis. The eventual goal is to compare current metrics against metrics collected following the use of the caDSR and established standard procedures. • Goals • Gathering baseline data from the current system as well as future metrics for comparison purposes within an organization. • Developing a standard terminology for milestones as well as meaningful units of measurement. • Consistent process and tool set for gathering and mapping metrics using standard milestones.

24. Working Group Logistics • Working groups will meet each week for 1 hour • Each group will include 1 NCI representative • Information will be maintained on the wiki • Link TBD • Neesha Desai and Frank Spina will manage and maintain the wiki site

25. Governance Process • 2 leads per working group • 1 voting participant and 1or more non-voting participantsper working group • Assign 1 ‘active’ (voting) participant and one or more ‘silent’ (non-voting) participants. • The ‘active’ participant must be able to make decisions related to the content of the working group on behalf of their organization. • When critical issues are disseminated to the Cancer Centers for consideration and input, each group will be permitted to provide one final decision regarding their preferences.

26. caDSR Training • Majority of classes are self-paced online • 2 instructor led web based classes after the pre-requisites are completed • Total user time for self-paced classes: 45 min per class for 8 classes • Instructor led classes 60-90 minutes, free of charge (2.5 hours) • Neesha Desai and Frank Spina will set up Doodle Polls for each organization to schedule initial overview training

27. Next Steps • NCI is looking for volunteers to provide overviews of their Velos and OnCore systems • Presentation outline • Building a study in your current CDMS system • Reporting and analyzing data • Describe workflow for getting data out of your systems for analysis • Custom Functionality • Metrics • Gathering metrics during study build • Additional details for presentation will be provided once the volunteers are chosen

28. Reference Material • Contact David Patton, Associate Director, Clinical Research Programs, NCI CBIIT • David.Patton@nih.gov • Contact Dianne Reeves, Associate Director, Biomedical Data Standards, NCI CBIIT • Dianne.Reeves@nih.gov • Contact Neesha Desai, Project Manager, NCI CBIIT • Neesha.Desai@nih.gov • Contact Frank Spina, Project Manager, NCI CBIIT • Frank.Spina@nih.gov • NCI CRF Harmonization and Standardization Wiki • https://wiki.nci.nih.gov/display/CRF/CRF+Harmonization+and+Standardization