Methods for Deploying Methods for Deploying eSignatureseSignatures in in Methods for Deploying Methods for Deploying eSignatureseSignatures in in Trip Reporting and Clinical Supply Trip Reporting and Clinical Supply Management for CTMSManagement for CTMS
Alex Platkin, Jason Essig, Ahila SelvarajAlex Platkin, Jason Essig, Ahila SelvarajDBMS Consulting
OCUG 2009 — New OrleansOCUG 2009 — New Orleans06 October 2009
CTMS Focus Group
1
CTMS Focus GroupSession 08
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements
� Thanks to OCUG for this opportunity to present � Thanks to OCUG for this opportunity to present
for the CTMS focus group
� Thanks to the OCUG Planning and Review � Thanks to the OCUG Planning and Review
Committee and Siebel Clinical CTMS Focus Group
Chairs for their patience in receiving and Chairs for their patience in receiving and
reviewing this presentation
2©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Business Case for EBusiness Case for E--SignaturesSignaturesBusiness Case for EBusiness Case for E--SignaturesSignatures
� CTMS is first and foremost a management and � CTMS is first and foremost a management and
tracking tool
� Identify data and processes with regulatory � Identify data and processes with regulatory
impact
� Is CTMS the “System of Record” ?
3©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
The Moment of TruthThe Moment of TruthThe Moment of TruthThe Moment of Truth
� Select business process� Select business process
� Trip Reports
Decision Points (e.g. Remove Subject)� Decision Points (e.g. Remove Subject)
� Site Communication Package
� Select an approach
� Typewriter Rule vs.
Electronic Record / Electronic Signature
4©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Scenario for EScenario for E--SignaturesSignaturesScenario for EScenario for E--SignaturesSignatures
� Trip Report Approval Workflow:� Trip Report Approval Workflow:
� CRA to sign on submitting
� Study Manager to sign on approval
5©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
6©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
AuthenticationAuthenticationAuthenticationAuthentication
� Components of e-signature per 21 CFR Part 11� Components of e-signature per 21 CFR Part 11
� Authenticate user
� Siebel authentication context
7©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
8©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
9©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
10©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
11©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Audit TrailAudit TrailAudit TrailAudit Trail
� What data is audit trailed� What data is audit trailed
� Components of audit trail per 21 CFR Part 11
12©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Signature LogSignature LogSignature LogSignature Log
� Record all signature events, name, date, values� Record all signature events, name, date, values
� Audit Trail for signature data (metadata)
13©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Part II: Supply ManagementPart II: Supply ManagementPart II: Supply ManagementPart II: Supply Management
14©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Supply Management ScenariosSupply Management ScenariosSupply Management ScenariosSupply Management Scenarios
� Business processes incorporated into CTMS� Business processes incorporated into CTMS
� IP distribution and tracking
� Managing product availability (warehouse inventory)
� Managing site inventory
IVRS/IWRS interface� IVRS/IWRS interface
15©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Serialized Asset ModelSerialized Asset ModelSerialized Asset ModelSerialized Asset Model
� Use Product–Asset hierarchy already in Siebel� Use Product–Asset hierarchy already in Siebel
� Kit-level control at depot and site
� Evaluate ROI (Return on Investment)
� Next steps (progress towards tracking solution?)
16©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Serialized Asset ModelSerialized Asset ModelSerialized Asset ModelSerialized Asset Model
� Leverage Product>Asset Hierarchy� Leverage Product>Asset Hierarchy
17©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Transaction RecordsTransaction RecordsTransaction RecordsTransaction Records
18©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Transaction DetailTransaction DetailTransaction DetailTransaction Detail
19©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Batch AccountingBatch Accounting
� No serializing: keep track of batch -> product
Batch AccountingBatch Accounting
� No serializing: keep track of batch -> product
� Manage available inventory for each protocol
� Replenish, ship, and re-allocate transactions
Ship to site
Internal
Bottles
PR001
Bottles
PR002
Brochures
PR001
Brochures
PR002
Internal
Replenish: pour into bucket
Batch expiry: spill bucket
20©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
Batch expiry: spill bucket
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Managing Inventory at SiteManaging Inventory at SiteManaging Inventory at SiteManaging Inventory at Site
� Example: When to deliver CRFs to sites, and how � Example: When to deliver CRFs to sites, and how
much
� Objective: send small amount each time, in
keeping with newly enrolled subjects
21©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Depletion and ReplenishmentDepletion and ReplenishmentDepletion and ReplenishmentDepletion and Replenishment
� Also: model ancillary products consumption
Formula:
100
120
140
Formula:
Inventory (N+1) =
Inventory(N) +
40
60
80
100Inventory(N) +
Supply(N) –
SubjectsActive(N) x PerSubjectRate
0
20
40
1 2 3 4 5 6 7 8 9 10
Replenish at pre-defined amount
Replenishment Alert
22©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Case StudyCase StudyCase StudyCase Study
� Batch Accounting Scenario� Batch Accounting Scenario
� Shipment Authorization to trigger shipment by
third party
� Shipment Authorization to trigger update of � Shipment Authorization to trigger update of
inventory per protocol
� E-Signature for the Shipment Authorization
23©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Shipment Authorization RecordShipment Authorization RecordShipment Authorization RecordShipment Authorization Record
� System record to issue report (authorization)
� Note the “Approved” status
Subtract shipped amount from relevant Protocol-� Subtract shipped amount from relevant Protocol-
Product-Batch combo bucket
24©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Shipment Authorization RecordShipment Authorization RecordShipment Authorization RecordShipment Authorization Record
25©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
Question and Answers Question and Answers Question and Answers Question and Answers
� Alex Platkin
+1-416-225-8115
� Jason Essig
[email protected]@clinicalserver.com
+1-917-846-7683
26©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting
OCUG 2009 New Orleans: Methods for Deploying eSignatures in CTMS October 2009
BiographyBiographyBiographyBiography
Alex Platkin, Senior OLS/RDC/CTMS Global Deployment Alex Platkin, Senior OLS/RDC/CTMS Global Deployment Specialist, DBMS Consulting, Inc.
� Alex is a Senior OLS/RDC/CTMS Global Deployment Specialist DBMS Consulting, with several years of Siebel Specialist DBMS Consulting, with several years of Siebel business analysis and deployment experience.
Jason Essig, Senior Siebel Architect Expert, DBMS Jason Essig, Senior Siebel Architect Expert, DBMS Consulting, Inc.
� Jason is a Senior Siebel Architect Expert for DBMS Consulting, with 10+ years of Siebel configuration and Consulting, with 10+ years of Siebel configuration and architecture experience.
27©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Presented by: DBMS Consulting