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CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes. Prepared by: Ann Setser May 24, 2010. Agenda. Conceptual overview of NCI AE reporting CTEP Adverse Event Reporting Systems Multiple mechanisms for AE data submission Routine via CTMS; CDUS; CDS Expedited via AdEERS

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CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

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  1. CTEP, NCI Adverse Event ReportingProgrammatic & Workflow Processes Prepared by: Ann Setser May 24, 2010

  2. Agenda • Conceptual overview of NCI AE reporting • CTEP Adverse Event Reporting Systems • Multiple mechanisms for AE data submission • Routine via CTMS; CDUS; CDS • Expedited via AdEERS • AE Reporting Workflow • Variable practices • Issues to consider for integration of PRO-CTCAE

  3. NCI AE Reporting Overview • Methodology varies widely among sites, modalities, specialties, practices • There are no guidelines or uniform methods for how to capture, present and interpret AE data  • Within NCI, requirements differ • Paper CRF • Multiple data systems (Groups, Centers, CTEP, contractors, others) • At the patient encounter, most clinician- documented AE / symptom data are not CTCAE terms and often include notes that do not promote straightforward translation to CTCAE Grade (severity indicator)

  4. NCI AE Reporting Overview… • From patient encounter to sponsor analysis and publication, many layers of ‘interpretation and translation’ of AE terms and severity indicators occur. • CTCAE data is a collection of secondary endpoints used to generate an overall picture or general safety profile of a given treatment, to identify gross trends and differences between studies, arms, groups, etc.

  5. CTEP Adverse Event Reporting Systems • Clinical Data Update SystemCDUS • Primary resource of clinical trial data for NCI DCTD and DCP • Types of Data Sets • Abbreviated CDUS (Phase 3 - no AE data) • Complete CDUS (Phase 1, 2 AE data) • Methods of Data Submission • ftp data transfer • web • Contents of data set • Cumulative data per protocol

  6. CTEP Adverse Event Reporting Systems… CDUS Data Submission • Early Phase 1 • via CTMS (Clinical Trials Monitoring System) • File Transfer Protocol (FTP) • Monthly • Other Phase trials: • via CDUS • Lead Group or Lead Institution submits data set • FTP or web • Quarterly

  7. Adverse Events Screen

  8. Steps

  9. CTEP Adverse Event Reporting Systems…AdEERS Adverse Event Expedited Reporting System • Expedited AE reporting tool for CTEP sponsored trials • Expedited reporting (AdEERS) is always in addition to Routine Reporting • All AEs (meeting the CDUS reporting requirements) must be submitted as part of routine reporting • AdEERS does not replace Routine Reporting

  10. CTEP Expedited AE ReportingAdEERS • CTEP-specific rules as a sponsor reporting to FDA • The foundation of AdEERS is CTCAE • Unlike industry (verbatim coded to MedDRA) • AdEERS ‘rules’ based on CTCAE depend on Phase of Trial

  11. Example: CTEP AdEERS ‘Rules’

  12. CTEP Expedited AE ReportingAdEERS • Because of timeline requirements, AdEERS data is usually closer to patient encounter • Requires extensive patient level data entry each time a report is generated • Data reviewed by CTEP almost real-time • 24 hours • 5 days • 10 days • Next slide: Screensnap of AdEERS with Sections of Report

  13. Screensnap of AdEERS with Sections of Report

  14. CDUS-reported and AdEERS-reported AEs • Design and expectations of two systems are very different • CDUS = summary cumulative AE data by quarter • AdEERS = detailed AE data in real-time 2. Initially there was no expectation for comparison of data from the two systems • Programmatic data element requirements differ • Different staff with different AE expertise submit to the different systems 3. AdEERS-CDUS Reconciliation implemented April 1, 2006 • Comparison of the data reported to the 2 systems • All Grade 5 discrepancies must be resolved • All other discrepancies result in a CDUS caution

  15. Workflow Processes for reporting Routine AEs - Paper At the patient encounter clinician documents AEs / symptoms On paper Patient chart / Progress Note Trial-specific ‘cheat sheet’ / AE CRF Electronic Electronic Health Record Remote Data Capture System Nurse, CRA, or Data Manager retrospectively reviews source data Translates symptoms into CTCAE terms and grades and transcribes onto trial-specific AE CRF

  16. Workflow Processes for reporting Routine AEs - Paper… • Site personnel submit paper CRF to Cooperative Group or Lead Organization • Cooperative Group or Lead Organization personnel enter AE data into data system • Technical staff prepare and submit electronic data to CTEP via CDUS ftp

  17. Workflow Processes for reporting Routine AEs - Electronic… • Site access to RDC, CDMS, etc. • Site technical staff program local data file transfer to Group data system • Group technical staff prepare CTEP- required subset of all Group data and reprograms for submission to CTEP CDUS

  18. Going Forward with PRO-CTCAE • Understand strengths and limitations of current AE data systems and processes—from patient encounter to sponsor to regulators to publication • With awareness of the varied processes (paper, electronic), how best might PROs be integrated and help achieve more real-time AE reporting? • How will PRO data be analyzed / utilized relative to clinician-reported AE data? • How can we achieve a common method to summarize and communicate overall AE burden?

  19. Acronyms

  20. Discussion

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