CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

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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 - PowerPoint PPT Presentation

Transcript of CTEP, NCI Adverse Event Reporting Programmatic & Workflow Processes

CTEP, NCI Adverse Event ReportingProgrammatic & Workflow Processes

CTEP, NCI Adverse Event ReportingProgrammatic & Workflow ProcessesPrepared by:Ann SetserMay 24, 2010AgendaConceptual overview of NCI AE reporting CTEP Adverse Event Reporting SystemsMultiple mechanisms for AE data submissionRoutine via CTMS; CDUS; CDS Expedited via AdEERSAE Reporting WorkflowVariable practicesIssues to consider for integration of PRO-CTCAENCI AE Reporting OverviewMethodology 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 differPaper 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)NCI AE Reporting OverviewFrom 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.CTEP Adverse Event Reporting SystemsClinical Data Update SystemCDUSPrimary resource of clinical trial data for NCI DCTD and DCPTypes of Data SetsAbbreviated CDUS (Phase 3 - no AE data)Complete CDUS (Phase 1, 2 AE data)Methods of Data Submissionftp data transferwebContents of data setCumulative data per protocolCTEP Adverse Event Reporting SystemsCDUS Data SubmissionEarly Phase 1 via CTMS (Clinical Trials Monitoring System) File Transfer Protocol (FTP)MonthlyOther Phase trials: via CDUS Lead Group or Lead Institution submits data setFTP or web Quarterly

Adverse Events Screen

StepsCTEP Adverse Event Reporting SystemsAdEERSAdverse Event Expedited Reporting SystemExpedited AE reporting tool for CTEP sponsored trials

Expedited reporting (AdEERS) is always in addition to Routine ReportingAll AEs (meeting the CDUS reporting requirements) must be submitted as part of routine reporting

AdEERS does not replace Routine ReportingCTEP Expedited AE ReportingAdEERSCTEP-specific rules as a sponsor reporting to FDAThe foundation of AdEERS is CTCAEUnlike industry (verbatim coded to MedDRA)AdEERS rules based on CTCAE depend on Phase of TrialExample: CTEP AdEERS Rules

11CTEP AdEERS rules are based strictly on CTCAE components which include Specific AE term (MedDRA LLT)Unique Grade assigned to selected CTCAE term (some terms are not associated with all 5 Grades).Expected defined by CTEP-generated ASAEL (Agent Specific Adverse Event List).Whether or not hospitalization was associated with >/+Grade 3Attribution assigned by site (hopefully clinician / PI).

CTEP Expedited AE ReportingAdEERSBecause of timeline requirements, AdEERS data is usually closer to patient encounterRequires extensive patient level data entry each time a report is generatedData reviewed by CTEP almost real-time24 hours5 days10 daysNext slide: Screensnap of AdEERS with Sections of Report12To make the point that a future system like caAERS or CDMS (?Medidata) would have data entered once and reused for all purposes.Screensnap of AdEERS with Sections of Report

CDUS-reported and AdEERS-reported AEs

Design and expectations of two systems are very differentCDUS = summary cumulative AE data by quarterAdEERS = detailed AE data in real-time2. Initially there was no expectation for comparison of data from the two systemsProgrammatic data element requirements differDifferent staff with different AE expertise submit to the different systems 3. AdEERS-CDUS Reconciliation implemented April 1, 2006Comparison of the data reported to the 2 systemsAll Grade 5 discrepancies must be resolvedAll other discrepancies result in a CDUS cautionWorkflow Processes for reporting Routine AEs - PaperAt the patient encounter clinician documents AEs / symptoms On paperPatient chart / Progress NoteTrial-specific cheat sheet / AE CRFElectronicElectronic Health RecordRemote Data Capture SystemNurse, CRA, or Data Manager retrospectively reviews source dataTranslates symptoms into CTCAE terms and grades and transcribes onto trial-specific AE CRFWorkflow Processes for reporting Routine AEs - PaperSite personnel submit paper CRF to Cooperative Group or Lead OrganizationCooperative Group or Lead Organization personnel enter AE data into data systemTechnical staff prepare and submit electronic data to CTEP via CDUS ftpWorkflow Processes for reporting Routine AEs - ElectronicSite access to RDC, CDMS, etc.Site technical staff program local data file transfer to Group data systemGroup technical staff prepare CTEP- required subset of all Group data and reprograms for submission to CTEP CDUSGoing Forward with PRO-CTCAEUnderstand strengths and limitations of current AE data systems and processesfrom patient encounter to sponsor to regulators to publicationWith 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?AcronymsAdEERSAdverse Event Expedited Reporting SystemCDUSClinical Data Update System (FTP submission)CDS Clinical Data System (Web submission)CDMSClinical Data Management SystemCTCAECommon Terminology Criteria for Adverse EventsCTEPCancer Therapy Evaluation ProgramCRAClinical Research AssociateCRFCase Report FormCTMSClinical Trials Monitoring SystemDCPDivision of Cancer PreventionDCTDDivision of Cancer Treatment and DiagnosisFTPFile Transfer ProtocolRDCRemote data captureDiscussion