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PSDM 22 May 2008 Focused on Pulmonology and Hepatology SAE RECONCILIATION: Determining how much to reconcile Jennifer Juntado, Sr. Manager, Data Management Confidential. Property of InterMune, Inc. Any unauthorized review, use, disclosure or distribution is prohibited. Typical Data Flow Data exchange between ITMN and coding vendor CRF Data “paper” Paper is imaged and data is double data entered off the image The system runs checks on the data Monthly data transfers from CRO InterMune ITMN ITMN DSRM provides ITMN DM SAE database extract ITMN DM SAE Recon SAE Collection and Reconciliation 3 Typical SAE Collection Period Patient withdraws from study early: SAE collection period ends at earlier of below two time points 1) Time of study withdrawal 2) 28 days after last dose of study treatment: ICF Signed: SAEs only reported if related to protocol procedure Study drug initiated: Final Followup Visit: All AE/SAEs reported per protocol End of SAE collection period SAE/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 collected » Patient discontinues drug and 35 days later withdraws from study: – Any SAE occurring after the 28th day following study drug discontinuation will not be collected » Patient 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 Documentation » CRFs – Data Management » CRF Completion Guidelines – Clinical Operations » SAE Report Form – Drug Safety » SAE Reconciliation Plan – Drug Safety » Coding Guidelines – Data Management » Data Handling Report – Data Management – To 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 lock – To document how “Handling Discrepancies between SAE and AE Databases” deviates from the study’s Serious Adverse Event Reconciliation Plan in the Data Management Plan. SAE Reconciliation Flow Chart ITMN Drug Safety (ITMN DSRM) provides: 1) SAE extract 2) Query report The Site is responsible for completing the SAE Form and AE CRF in a timely manner. ITMN DM updates the TRACKING spreadsheet (all discrepancies) on the shared drive (within 10 days) ITMN DM identifies discrepancies “IDENTIFICATION” CRO Data Management (CRO DM) provides: 1) raw datasets 2) unresolved DCF text report ITMN DSRM does a full review of all discrepancies and updates the TRACKING spreadsheet on the shared drive with a recommendation “VERIFICATION” (within 10 days) Create a DCF? NO Done for now (DFN) YES ITMN DM updates the TRACKING spreadsheet with suggested DCF Text and sends the proposed DCF Text to Clinical, c.c. DSRM (within one business day) CRO and ITMN Clinical Ops are responsible for DCF resolution from Site CRO DM sends ITMN DM Outstanding DCF Text report within two business days CRO DM creates and sends DCF to the sites within two days. The DCF Text starts with ***SAE RECON*** ITMN DM sends the DCF Text to CRO DM (within two business days) ITMN Clinical (and DSRM) review of DCF Text (within one business day) DFN NO CRO DM: OC DB update? CRO DM evaluates if DCF resolution if an OC DB is necessary CRO DM communicates daily if resolved SAE DCFs have been received. CRO DM sends copy of all resolved DCFs to ITMN DM and ITMN DSRM OR an email stating no resolved SAE DCFs were received by 2 PM local time of day received ITMN DM evaluates DCF resolution YES CRO DM Updates OC database DFN CRO DM sends ITMN DM Outstanding DCF Text report (within two business days) CRO DM creates and sends DCF to the sites. The Re-DCF Text starts with ***RE-QUERY SAE RECON*** ITMN DM sends the DCF Text to CRO DM (within two business days) SAE database update? Re-DCF? ITMN Clinical (and DSRM) review of DCF Text (within one business day) ITMN DM suggests Re-DCF Text YES NO NO YES DFN ITMN DM updates TRACKING Spreadsheet. REDCF goes through resolution loop ITMN DM updates TRACKING spreadsheet ITMN DSRM updates Drug Safety database with DCF resolution or processes the updated SAE Report Form, if applicable. SAE Reconciliation Cheat Sheet SAE Reconciliation Data Management goes beyond typical SAE Reconciliation 10 Beyond SAEs: Other Data » Patient Disposition: – Termination of Study Treatment • Date of last study drug • Termination due to AEs (or Serious AE) or Reasons where it might be an AE • If 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 Study • Date of study discontinuation • Discontinuations due to AE (or Serious AE) or Reasons where it might be and AE – Mortality • Date of death • Primary cause of death Snapshot of the listing – level 1 Snapshot of the listing – level 2 Snapshot of the listing – level 3 Approaching database lock… now what? 15 Prior to database lock What other data points can remain discrepant, yet assuring our regulatory obligations and maximizing subject safety? 17 Questions? 18