Presentation on theme: "Focused on Pulmonology and Hepatology"— Presentation transcript:
1Focused on Pulmonology and Hepatology PSDM 22 May 2008Focused on Pulmonology and HepatologySAE RECONCILIATION: Determining how much to reconcileIntroductionDM CRO working with the CRO DS unitBiotech DM working with internal DS unit; coding personSponsor oversee SAE and coding processNow, Sponsor performing SAE discrepancy identification and resolution; coding lead (sep 2006)Jennifer Juntado, Sr. Manager, Data ManagementConfidential. Property of InterMune, Inc. Any unauthorized review, use, disclosure or distribution is prohibited.
2Typical Data Flow SIMPLE FLOW CHART The CRFs are filled out and monitored then sent to Covance document controlThe data on the CRFs is double data entered, meaning it is keyed in twice by different operators and comparedBefore we can do anything else with the data, the system has to run “BATCH VALIDATION” which includes integrity checks and the edit checks.A lot of different types of cleaning happens to the dataTwo tasks that are important to a study are Coding and SAE Recon
4Typical SAE Collection Period Patient withdraws from study early:SAE collection period ends at earlier of below two time points1) Time of study withdrawal 2) 28 days after last dose of study treatment:ICF Signed:SAEs only reported if related to protocol procedureStudy drug initiated:All AE/SAEs reported per protocolFinal Follow-up Visit:End of SAE collection period
5SAE/AE Collection Period Examples Patient discontinues drug and the next day withdraws from study, but agrees to vital status:Any SAEs occurring after the withdrawal date will not be collectedPatient discontinues drug and 35 days later withdraws from study:Any SAE occurring after the 28th day following study drug discontinuation will not be collectedPatient permanently discontinues drug on 01 August 2007 and experiences an SAE on 12 Sept 2007:SAEs are to be collected until the end of study (Final Follow-up Visit)Patient experiences an SAE of Pneumonia on 01 June 2007 and discontinues study drug the same day. Patient then withdraws from study on 15 June 2007 with the pneumonia still ongoing:Pneumonia will be followed to resolution by DSRM
6Documentation CRFs – Data Management CRF Completion Guidelines – Clinical OperationsSAE Report Form – Drug SafetySAE Reconciliation Plan – Drug SafetyCoding Guidelines – Data ManagementData Handling Report – Data ManagementTo document the evaluation and resulting action of data discrepancies between the Drug Safety serious adverse event (SAE) database and the Clinical adverse event (AE) database between database soft lock and hard lockTo document how “Handling Discrepancies between SAE and AE Databases” deviates from the study’s Serious Adverse Event Reconciliation Plan in the Data Management Plan.
7SAE Reconciliation Flow Chart QuarterlyPrior to milestones: Data Review snapshot; soft lock; hard lock
8SAE Reconciliation Cheat Sheet DM and DSRM takes every opportunity to conduct training at Clinical Operations sponsored events. For example, Study Monitor Training, Study Coordinator Training, and at Investigator Meetings.We make it a point to know what the site is being instructed in completing AE CRFs and SAE Report Forms.Besides querying events that are not in SAE and in AE or vice versa, we provide a SAE RECONCILIATION CHEAT SHEET.Here, I would like to address some fields we are having a lot of queries on.(click) Item 4: The term on the AE CRF has to logically match the Primary Event Term on the SAE REPORT FORM.(click) Item 6: The start date of the event on the AE CRF that is marked SERIOUS must match the DATE BECAME SERIOUS on the SAE REPORT FORM. This can be confusing as there are other dates on the SAE FORM.(click) Item 8: It is very important that the relationship to study drug matches because this may trigger a report to the regulatory agencies.(click)Item 9: Action Taken regarding the study drug and(click) Item 10: Primary Outcome is important because this data needs to be accurate so it can be tabulate what is really going with the patient, the study, etc.
9SAE ReconciliationBecause the terminology on the AE CRF and the SAE Report can be different, the back of the CHEAT SHEET tells you which codes on the AE CRF match up with on the SAE Report.
11Beyond SAEs: Other Data Patient Disposition:Termination of Study TreatmentDate of last study drugTermination due to AEs (or Serious AE) or Reasons where it might be an AEIf an AE or SAE states that treatment was discontinued, then this data must correlate.If early termination of study treatment is due to an AE (or Serious AE, if applicable), then the AE must be captured with consistent information.Study Completion/Early Discontinuation from StudyDate of study discontinuationDiscontinuations due to AE (or Serious AE) or Reasons where it might be and AEMortalityDate of deathPrimary cause of death
12Snapshot of the listing – level 1 In AE not in SAEIn SAE not in AESerious should be marked YESSAEF reported term is not consistent with AE verbatim termCausality does not matchOutcome does not matchAction taken to study treatment is not consistent between SAEF, AE, End of Study TreatmentAction taken to study treatment is not consistent between SAEF and AESAEF dates and AE CRF do not correlate:SAEF date serious < or > Serious AE start date,AE start date is > SAEF date serious and onset of symptoms date;AE start date = onset of symptoms date and not = date became seriousEarly End of Study Treatment CRF was submitted when not applicableISSUES THAT WILL/SHOULD BE CAUGHT DURING ROUTINE DM CLEANING:Serious is marked YES however seriousness criteria is missingSerious is marked NO however seriousness criteria is presentPrimary cause of death missing on mortality CRFAE number needs to be fixedEnd of Treatment CRF missingISSUES THAT WILL/SHOULD BE CAUGHT DURING ROUTINE DSRM REVIEW:SAEF onset of symptoms date blankSAEF date became serious is blank