Presentation on theme: "Focused on Pulmonology and Hepatology SAE RECONCILIATION: Determining how much to reconcile PSDM 22 May 2008 Confidential. Property of InterMune, Inc."— Presentation transcript:
Focused on Pulmonology and Hepatology SAE RECONCILIATION: Determining how much to reconcile PSDM 22 May 2008 Confidential. Property of InterMune, Inc. Any unauthorized review, use, disclosure or distribution is prohibited. Jennifer Juntado, Sr. Manager, Data Management
Typical Data Flow
3 SAE Collection and Reconciliation
Typical SAE Collection Period ICF Signed: SAEs only reported if related to protocol procedure Study drug initiated: All AE/SAEs reported per protocol Final Follow- up Visit: End of 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:
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 28 th 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
SAE Reconciliation Cheat Sheet
10 Data Management goes beyond typical SAE Reconciliation
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
15 Approaching database lock… now what?
Prior to database lock
17 What other data points can remain discrepant, yet assuring our regulatory obligations and maximizing subject safety?