Planning/Monitoring Special Interest Group

1
Planning/MonitoringSpecial Interest Group

• John Speakman
• Associate Director, Clinical Trials Products and
  Programs
• NCI Center for Biomedical Informatics and
  Information Technology
• john.speakman_at_nih.gov

caBIG Clinical Trials Management Systems
Workspace Face-to-Face Meeting May 30 31,
2007 Portland, Oregon
2
Agenda

• Overview of Planning/Monitoring SIG Activities
• Scope, Validation and Feedback
• Study Initiation Tool (SIT)
• DCP Enterprise System Knowledgebase (DESK)
• Investigator and Site Credential Repository (ISC)
• Federal Investigator Registry of Biomedical
  Informatics Research Data (FIREBIRD)
• Protocol Lifecycle Tracking (PLT)
• Requirements Gathering for Data Sharing (after
  the break)

3
What is the Clinical Trials Management Systems
Workspace Trying to Achieve?

• Facilitate the planning and instantiation of
  clinical trials, (and their monitoring of trials
  once they are instantiated)
• Facilitate the conduct of clinical trials
• Facilitate the reporting and sharing of clinical
  trial data to existing/new destinations,
• Achieve interoperability
• Increase the ability of systems to access and use
  the data and functionality of other systems
• Facilitate the integration of new sources and
  destinations of data

4
Special Interest Groups and Projects

• Reporting/
• Sharing
• Clinical Trials Database
• Routine Data Exchange
• Clinical Trials Object Model
• Janus (FDA Repository)
• Adverse Event Reporting and Collection

• Planning/
• Monitoring
• Investigator and Site Credential Repository
• Study Initiation Tool
• Protocol Lifecycle Tracking
• FIREBIRD
• DCP/DESK

• Conduct
• Standardized Case Report Forms
• Cancer Central Clinical Database (C3D)
• Participant Registry
• Laboratory Interface
• Financial/Billing
• Study Calendar
• Subject Prescreening
• Vendor Systems

• Interoperability
• System Interoperability and Harmonization
• Structured Protocol Representation (BRIDG)
• Clinical Trials Interoperability Project

5
Study Initiation Tool (SIT)
6
DCP Enterprise System Knowledgebase (DESK)
7
Investigator and Site Credential Repository (ISC)
8
Federal Investigator Registry of Biomedical
Informatics Research Data (FIREBIRD)
9
Protocol Lifecycle Tracking (PLT)
10
Clinical Trial Process Map (Dilts et al.)
11
Protocol Lifecycle Tracking Draft Storyboards

• Enable non-technical domain people to model
  workflows
• Standard building blocks of "IRB", "Contracts and
  Grants", etc.
• Enable different groups of non-domain people to
• enter data about studies
• move them along the workflows as milestones
  happen, e.g., when they receive the list of
  studies that got approved at IRB
• Produce a dashboard that will answer questions
  like
• How many studies are likely to start accruing
  patients in the next month (i.e., how many have
  passed the first n steps)
• Is the IRB a bottleneck?" (i.e., how many
  studies have passed the step before the IRB and
  are waiting, how many have been in this state for
  (e.g., )over two months?)
• Do we have any trials that are stuck in the
  system?" (i.e., are there any trials that have
  not changed state for (e.g.,) more than four
  months)?
• Other questions?
• Existing data sources exist (e.g., IRB database
  systems)
• Ability to interoperate with these systems is
  desirable

12
Requirements Gathering for Clinical Trial Data
Sharing

• Data Sharing in the Planning/Monitoring SIG
• Data Sharing Opportunities and Potential
  Obstacles, other DSIC Considerations
• Study Initiation Tool (SIT)
• DCP Enterprise System Knowledgebase (DESK)
• Investigator and Site Credential Repository (ISC)
• Federal Investigator Registry of Biomedical
  Informatics Research Data (FIREBIRD)
• Protocol Lifecycle Tracking (PLT)

13
Privacy/Intellectual Capital Terms Conditions
Decision Tree DSIC WS
14
Study Initiation Tool (SIT)
15
DCP Enterprise System Knowledgebase (DESK)
16
Investigator and Site Credential Repository (ISC)
17
Federal Investigator Registry of Biomedical
Informatics Research Data (FIREBIRD)
18
Protocol Lifecycle Tracking (PLT)
19
Requirements Gathering for Clinical Trial Data
Sharing
20
Next Steps

• Summary of discussion points
• Review of Action Items

21
Q A