InterMune, Inc'

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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.
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Typical Data Flow
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SAE Collection and Reconciliation
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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
Final Follow-up Visit End of SAE collection
period
ICF Signed SAEs only reported if related to
protocol procedure
Study drug initiated All AE/SAEs reported per
protocol
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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

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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 studys
  Serious Adverse Event Reconciliation Plan in the
  Data Management Plan.

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SAE Reconciliation Flow Chart
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SAE Reconciliation Cheat Sheet
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SAE Reconciliation
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Data Management goes beyond typical SAE
Reconciliation
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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

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Snapshot of the listing level 1
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Snapshot of the listing level 2
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Snapshot of the listing level 3
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Approaching database lock now what?
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Prior to database lock
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What other data points can remain discrepant, yet
assuring our regulatory obligations and
maximizing subject safety?
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Questions?