focused on pulmonology and hepatology sae reconciliation: determining how much to reconcile psdm 22...
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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
CRF Data“paper”
Data exchange between ITMN
and coding vendor
Paper is imaged and data is double
data entered off the image
The system runs checks on the data
ITMN DM SAE Recon
Monthly data
transfers from CRO
ITMN DSRM provides
ITMN DM SAE database extract
InterMuneITMN
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 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
The Site is responsible
for completing the SAE Form and AE CRF in a timely manner.
ITMN Drug Safety (ITMN DSRM)
provides:1) SAE extract2) Query report
CRO Data Management (CRO
DM) provides:1) raw datasets
2) unresolved DCF text report
ITMN DM identifies discrepancies
“IDENTIFICATION”
CRO DM creates and sends DCF to the sites within two days. The DCF Text starts with***SAE RECON***
Create a DCF?Done for now
(DFN)NO
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)
YES
ITMN DSRM updates Drug Safety database with DCF resolution or processes the
updated SAE Report Form, if applicable.
DFN
ITMN Clinical (and DSRM) review of DCF Text (within
one business day)
CRO DM:OC DB update?
YES
CRO DMUpdates OC
database
DFN
NO
DFN
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
CRO DM communicates daily if resolved SAE DCFs
have been received.
ITMN DM updates theTRACKINGspreadsheet
(all discrepancies) on the shared drive
(within 10 days)
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)
ITMN DM sends the DCF Text to
CRO DM (within two
business days)
CRO DM sends ITMN DM Outstanding DCF Text report within two
business days
CRO DM evaluates if DCF resolution if an
OC DB is necessary
ITMN DM suggests Re-DCF
TextNO
ITMN Clinical (and DSRM) review of
DCF Text (within one business day)
ITMN DM sends the DCF Text to CRO
DM (within two business days)
CRO DM sends ITMN DM
Outstanding DCF Text report (within
two business days)
ITMN DM updatesTRACKINGspreadsheet
CRO DM creates and sends DCF to the sites.
The Re-DCF Text starts with
***RE-QUERY SAE RECON***
CRO and ITMN Clinical Ops are responsible for DCF
resolution from Site
ITMN DM updatesTRACKING
Spreadsheet. RE-DCF goes through
resolution loop
ITMN DM evaluates
DCF resolution
SAE database update?
Re-DCF?
YES
YES
NO
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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What other data points can remain discrepant, yet assuring our regulatory obligations and maximizing subject safety?