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CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch

CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch. Areas of Integration . CTEP Enterprise System is not critical to this phase of Rave deployment but looking ahead integration needs to occur.

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CDMS-CTEP ESYS Integration Overview Steve Friedman, MHSA Chief Operations and Informatics Branch

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  1. CDMS-CTEP ESYS Integration OverviewSteve Friedman, MHSA ChiefOperations and Informatics Branch

  2. Areas of Integration • CTEP Enterprise System is not critical to this phase of Rave deployment but looking ahead integration needs to occur. Possible uses for CDMS in CTEP ESYS environment include: • CDUS reporting for both Abbreviated and Complete including: • Accrual • Demographic • Routine AE • AdEERS reporting for SAEs as well as caAERS based on development activities and migration over from AdEERS • May also include protocol elements abstracted into PATS

  3. Integration Schema – Option 1 Option 1 – • Lead Organization instance of CDMS tool feeds NCI hosted instance • CTEP-ESYS integrates with NCI hosted instance via services How to get there – • NCI hosted instance will need to incorporate CTEP ESYS business rules, provide support and provide validated data for CTEP ESYS consumption • CTEP builds integration/transformation services to retrieve data from NCI hosted instance • Validate LoVs (build services for agents, disease, therapies, etc.) • Extend AdEERS service, build CDUS service

  4. Integration Schema – Option 2 Option 2 – • Lead Organization instance of CDMS invokes CTEP ESYS services directly How to get there – • CTEP ESYS services will include business rules that fire upon submission of data (e.g. CDUS errors) • CTEP ESYS services will need to transform data to conform to standards used by CDMS (e.g. DoB) • Requires Lead Organizations to provide programmatic support in order to invoke CTEP ESYS services • Validate LoVs (build services for agents, disease, therapies, etc.) • Extend AdEERS service, build CDUS service

  5. Additional Integration Touch Points within CTEP Integration with CTMS and CTSU: • CTMS monitored studies reporting to CDUS • Protocols registered in OPEN Requires services and transformation layer CTEP Hosted instance – requires same build out as Option 1 except CDMS hosted instance will be maintained by CTEP

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