The caBIG Strategic Plan caBIG NIH by alicejenny

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									           Planning/Monitoring
           Special Interest Group
           Meeting

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

           caBIG™ Clinical Trials Management Systems
           Workspace
           August 21, 2007

May 2007
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 2                                           2
Meeting Objectives


 • Introduction of Planning / Monitoring Task Force
    • Role of SIG and Task Force
 • Recap / Overview of Planning / Monitoring SIG
    • CTMS Workspace Structure
    • SIG Relationship to Workspace, Task Force, Steering
      Committee
    • Overview of SIG Projects and Activities
 • Project Focus: Protocol Lifecycle Tracking
    • Project Rationale
    • Overview of Inception Phase
    • Elaboration Phase: Potential Scenarios
  3 • Proposed Process for Elaboration and Construction     3
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 4                                           4
Introductions



•       SIG Lead:          John Speakman
                           NCI Center for Biomedical Informatics and Information
                           Technology (NCI CBIIT)
                           john.speakman@nih.gov
•       SIG Facilitator:   Lisa Schick
                           Booz Allen Hamilton (BAH)
                           schick_lisa-marie@bah.com
•       SIG Support:       Liz Rios
                           Booz Allen Hamilton
                           rios_liz@bah.com



    5                                                                          5
Meeting Schedule for SIG



• All SIG calls are open to the community
• Listserv: CABIG_CTMS_PLAN_SIG@LIST.NIH.GOV
• Join the listserv at http://list.nih.gov, browse lists alphabetically

         Meeting                            Call Schedule
Planning/Monitoring SIG        3rd Tuesday each month; 2:00-4:00pm ET




6                                                                         6
SIG Meetings


• All SIG meetings are open to the community
• Information on the SIG meetings are posted to the Listserv
  (https://list.nih.gov/archives/cabig_ctms_plan_sig.html)
• SIG Members are encouraged to provide input and feedback on the
  projects via the following mechanisms:
    • Participate in SIG calls, Workspace calls and face-to-face
      meetings
    • Participate in community demonstrations of applications that are
      under development (announced via the CTMS and SIG Listserv)
    • Contact a Task Force member
    • Contact a Steering Committee member
    • Contact SIG Lead or Facilitator
                                                                         7
7   • Contact CTMS Workspace Lead
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 8                                           8
Role of Special Interest Groups (SIGs) in
caBIG™ Governance



 •   Common Foundation
 •   Coordinated development
 •   Active management
 •   Community directed
     • Through Workspace SIGs
 • Four caBIG™ principles:
     •   Open source
     •   Open access
     •   Open development
     •   Federation


 9                                          9
Clinical Trials Working Group



  • National Cancer Advisory Board Group
  • Report “Re-engineering the Cancer Clinical Research
    Enterprise” (June 2005)
  • http://integratedtrials.nci.nih.gov
  • Remit: advise on “whether, and
    in what ways, the NCI-supported
    national clinical trials enterprise
    should be restructured to realize
    the promise of molecular
    medicine for advancing
    oncologic clinical practice in the
    21st Century”
  10                                                      10
Clinical Trials Working Group (CTWG)


       CTWG Goals               CTWG Informatics Initiatives

                         Establish a comprehensive database
 Enhanced Coordination   containing regularly-updated information on
                         all NCI-funded clinical trials
                         Achieve industry and FDA concurrence on
                         standard Case Report Forms incorporating
                         Common Data Elements
 Enterprise-wide         Promote establishment of national clinical
 Standardization         trial information technology infrastructures
                         that are fully interoperable with NCI’s cancer
                         Biomedical Informatics Grid (caBIG™)
                         Develop a credentialing system for
                         investigators and sites that is recognized and
                         accepted by NCI, industry sponsors, clinical
                         investigators, and clinical trial sites
  11                                                                 11
CTMS Workspace Goals


 • Facilitate the planning and instantiation of clinical trials,
     (and 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
     • Facilitate the integration of new sources and destinations
        of data
     • Increase the ability of systems to access and use the
        data and functionality of other systems

12                                                                  12
caBIG™’s Special Sauce: Modularity Implies
Interoperability

• Building for the next ten years: Need to interface
  rapidly with new data sources and destinations
• Only a set of interoperable modules is agile enough to
  handle the speed of science
• Anyone can build a
  module that plugs in – if
  they build to published
  caBIG™ standards
• Modularity implies
  interoperability


13                                                    13
CTMS Workspace Organization


     Planning/                Study Conduct                    Reporting/
     Monitoring                                                 Sharing
                             • Standardized Case
                               Report Forms
• Investigator and Site                                  • Clinical Trials Database
                             • Cancer Central
  Credential Repository                                  • Routine Data Exchange
                               Clinical Database
• Study Initiation Tool                                  • Clinical Trials Object
                               (C3D)
• Protocol Lifecycle                                       Model
                             • Participant Registry
  Tracking                                               • Janus (FDA Repository)
                             • Laboratory Interface
• FIREBIRD                                               • Adverse Event
                             • Financial/Billing
• DCP/DESK                                                 Reporting and
                             • Study Calendar
                                                           Collection (caAERS)
                             • Subject Prescreening
                             • Vendor Systems

                              Interoperability
                  • System Interoperability and Harmonization
                  • Biomedical Research Integrated Domain Group (BRIDG) model
                  • caBIG™ Clinical Trials Suite (Clinical Trials Interoperability
                    Project)
14                                                                              14
CTMS SIGs: Telcon Schedule and Listservs


       SIG           Teleconference           Listserv (http://list.nih.gov)


Planning /         3rd Tuesdays
                                        CABIG_CTMS_PLAN_SIG@LIST.NIH.GOV
Monitoring         2:00 – 4:00 PM EDT

                   3rd Wednesdays
Study Conduct                           CABIG_CTMS_COND_SIG@LIST.NIH.GOV
                   3:00 – 5:00 PM EDT

Reporting /        4th Wednesdays
Sharing                                 CABIG_CTMS_REPT_SIG@LIST.NIH.GOV
                   3:00 – 5:00 PM EDT

                   4th Tuesdays
Interoperability                        CABIG_CTMS_INTR_SIG@LIST.NIH.GOV
                   2:00 – 4:00 PM EDT




15                                                                             15
CTMS SIG Listservs: How To Subscribe


• Browse lists at NIH Listserv List page
   https://list.nih.gov/cgi-bin/show_list_archives).
• Select Listserv of choice
• Click on “Join or leave the list, or update options”
• Enter Email address and full name and click on “Join the List.”
• Upon receipt of confirmation Email, click on link provided within the
  Email to finalize subscription.
• To unsubscribe from any list, please visit the NIH Listserv List page and
  click on the specific listserv link. Click on “Leave the List”, enter email
  address and full name, and click on “Leave the List.”


 16                                                                       16
CTMS Workspace Management

       NCI Initiative
     Management Team                General Contractor                         Steering
     (Center for Biomedical         (Booz Allen Hamilton)                     Committee
       Informatics and IT,
     Coordinating Center for
         Clinical Trials)


                  Special Interest Group                    Task Force(s)
                                                   (Tactical view, focused primarily on
                                                      CTWG Informatics Initiatives)




                                             Project Execution Teams

                                              Developers         Adopters




                                                                                          Relationship Legend


                                                                                               Tasking

                                                                                               Reporting

                                                                                             Informational
17                                                                                                       17
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 18                                          18
Planning / Monitoring Task Force Members
(as of today)

Sarah Blendermann   Pfizer, Inc.

Susie Bullock       University of Texas MD Anderson Cancer Center

Jack London         Thomas Jefferson University / Kimmel Cancer Center
                    University of California at Irvine / Chao Family Cancer
Christine McLaren
                    Center
Sorena Nadaf        Vanderbilt-Ingram Cancer Center
                    Consumer Advocates in Research and Related
Diane Paul
                    Activites
George Redmond      NCI Cancer Therapy Evaluation Program

Ann Setser          NCI Cancer Therapy Evaluation Program

Donna Shriner       NCI Cancer Therapy Evaluation Program

Judy Smith          NCI Division of Cancer Prevention                   19
 19
Investigator and Site Credential Repository
(ISC)


 Clinical Trials Working Group Informatics Initiative

 A credentialing system for clinical trial investigators and sites that is
 recognized and accepted by NCI, industry sponsors, clinical
 investigators, and clinical trial sites.

 Note that the goal of this initiative is not any kind of new credential or
 credentialing authority, but a repository for existing recognized
 credentials.

 Existing systems to be considered
 for the basis of such a system include
 FIREBIRD and the Clinical Trial Support
 Unit’s Regulatory Support System (RSS)

20                                                                            20
Study Initiation Tool (SIT)



  A web-based trial initiation portal to
  facilitate phase III treatment and complex
  phase II protocol activation at sites. The
  functionality will be similar to the trial
  initiation materials provided to sites by
  industry sponsors and will include a
  checklist that reminds sites of staff and
  services that must be in place to
  successfully implement a trial (e.g.,
  personnel requirements, necessary
  infrastructure, IRB submission
  requirements, data management needs,
  procedure instructions, etc.).


21                                             21
Protocol Lifecycle Tracking (PLT)


The Protocol Lifecycle Tracking Tool will assist overall protocol
management by documenting the lifecycle of a protocol over the course of
a given clinical trial, starting at Concept Development and continuing
through to Submissions and Publications.




 22                                                                    22
Federal Investigator Registry of Biomedical
Informatics Research Data (FIREBIRD)

FIREBIRD automates the Form 1572 registration process, a key activity in
the regulatory data submission process and compliance requirement for
investigators participating in clinical trials. The current paper-based
process results in significant cost, overhead and delays both for the
investigators and the sponsors. FIREBIRD enables investigators
to register on-line
With NCI and other
sponsors, including
pharmaceutical
companies, and
allows investigators
to centrally maintain
and manage all 1572
registrations.


23                                                                         23
DCP Enterprise System Knowledgebase
(DESK)


 A set of web-enabled systems to support the scientific and administrative
 work of the NCI Division of Cancer Prevention (DCP). DESK is also a way
 to standardize data across clinical trials and distribute information to DCP
 and its contractors.




24                                                                        24
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 25                                          25
Protocol Lifecycle Tracking


• Will enable clinical trial sites to streamline and
  expedite the administration of trials by:
      • Documenting the lifecycle of each protocol over its course
          • starting at concept development
          • continuing through to submission and publication
      • Interrogating the system for real-time information about the status
        of trials
      • Visualizing their own clinical trials process map
      • Optimizing the process by which they conduct clinical trials by
        identifying
          •   Sub-optimal process flow
          •   Potential for deadlock / mutual waiting
          •   Bottlenecks
          •   Redundant / valueless / limited-value steps in the process

 26
      • Comparing and standardizing this process with other sites          26
 Protocol Lifecycle Tracking System –
 Potential Sample Building Blocks

                                                                               Pharmacy / Drug
 LOI Writing / Approval        Identify Staff              Accruals
                                                                                   Supply


    Protocol Writing       IRB Review / Approval           Waivers                   Audits


   Grant Submission /
                           CRB Review / Approval          Deviations          Protocol Suspension
       Approval


   Scientific Review /      Contract Creation /
                                                     Amendment Process         Financial Closeout
       Approval                 Execution

                             Budget Creation /
Informed Consent Writing                              IRB Annual Review            Follow-Up
                                Approval


                             Creation of Case
Regulatory Documentation                            Adverse Event Reporting     IRB Notifications
                              Report Forms


  Investigator Brochure     Open Trial to Accrual           Billing               Publications
    27                                                                                       27
Clinical Trial Process Map (Dilts et al.)




28                                          28
Clinical Trial Process Map – detail portion




29                                            29
Clinical Trial Process Map – detail portion




30                                            30
Protocol Lifecycle Tracking – Vision

• 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 over
     n 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?
• Data sources exist (e.g., IRB systems, other caBIG™ modules)
31 •                                                                         31
       Goal: Ability to interoperate with these systems
Protocol Lifecycle Tracking – Inception Phase


• Purpose: assess and define a complete set of
  requirements for a system which will be the basis of
  subsequent parts of the project.
• Objectives: create an understanding of the
  stakeholders, their business requirements
• Key activities:
     • Identify Stakeholders
     • Identify Key Stakeholder Requirements
     • Develop and Deliver Requirement Use Cases
     • Prioritize Requirements based on stakeholder input and overall
       need and feasibility
     • Identify Key Success Factors for the successful Implementation of
       this Module
32                                                                    32
Questionnaire – Inception Phase


• Out of 20 original stakeholders, 13 responses were
  received
   • Included 3 SIG Leads and 5 adopters of CTMS applications
• 17 other respondents
   • Cancer Centers, NCI, Cooperative Group and Pharmaceutical
     Companies

Number of responses by organization type
 Cancer Center                                            21
 NCI                                                      2
 Cooperative Group                                        3
 Pharmaceutical Company                                   2
 Other                                                    2
 Total
 33                                                       30     33
Requirements – prioritized via questionnaire


• Priority 1 Requirements
     •   Provide Identifying Protocol Information
     •   Provide Contract Approval Information
     •   Provide Protocol Suspension/Activation
     •   Provide Protocol Process Information
     •   Provide Annual IRB Approval date
     •   Provide Grant/Contract Approval date
     •   Provide amendment approval date and date of most recent
         informed consent
     •   Provide date informed consent submitted and approved to IRB
     •   Provide local accrual information
     •   Provide protocol creation information – sponsor approval and date
     •   Provide SRB information - date sent, informed consent date, and
         date approved

34                                                                      34
Requirements – prioritized via questionnaire



• Priority 2 Requirements
     • Provide Adverse Event information
     • Provide Regulatory Information
     • Provide national accrual information
     • Provide LOI information: Date LOI was submitted, status of LOI
       and the reason for approval or rejection of LOI
     • Provide annual IRB information – informed consent date




35                                                                      35
Requirements – prioritized via questionnaire



• Priority 3 Requirements
     • Ability to drill down from high-level summary to details
     • Provide information LOI for protocol
     • Provide protocol budget information
     • Provide access to patient information
     • Provide access to patient followup
     • Provide Investigator Brochure (IB) information
     • Provide IB Approval/Rejection information
     • Provide LOI Approval Date and status information
     • Provide more detailed information around Contracts, Grants, SRB,
       IRB, and protocol creation
     • Provide annual IRB information: Human Subjects Training for all
       investigators

36                                                                   36
PLT - Categories of data

Data Categories                           Potential Sources       Access Privileges
Concept Development and Creation of       Local Existing System   System Administrator, Clinical Trials Administrator, PI,
Protocol Status and Dates                                         Research Team
Letter of Intent or Concept Submission    Local Existing System   System Administrator, Clinical Trials Administrator, PI,
Date                                                              Research Team
Letter of Intent or Concept Approval by   Local Existing System   System Administrator, Clinical Trials Administrator, PI,
Sponsor date and status                                           Research Team
Approval of Protocol status and dates     Local Existing System   System Administrator, Clinical Trials Administrator, PI,
                                                                  Research Team, Contract/Grants Administrator,
                                                                  Financial Team
Grant/Contract Review Dates and           Local Existing System   System Administrator, Clinical Trials Administrator, PI,
statuses                                                          Research Team, Contracts/Grants Administrator,
                                                                  Financial Team
Grant/Contract Negotiation Dates and      Local Existing System   System Administrator, Clinical Trials Administrator, PI,
Statuses                                                          Research Team, Contracts/Grants Administrator,
                                                                  Financial Team
Grant/Contract Approval Date              Local Existing System   System Administrator, Clinical Trials Administrator, PI,
                                                                  Research Team, Contracts/Grants Administrator,
                                                                  Financial Team
Budget Development Dates and              Financial Billing       System Administrator, Clinical Trials Administrator, PI,
Statuses                                                          Research Team, Financial Team
Budget Review Dates and statuses          Financial Billing       System Administrator, Clinical Trials Administrator, PI,
                                                                  Research Team, Financial Team
 37                                                                                                                  37
Budget Negotiation                        Financial Billing       System Administrator, Clinical Trials Administrator, PI,
                                                                  Research Team, Financial Team
PLT - Categories of data #2


Data Categories               Potential Sources          Access Privileges
Budget Approval               Financial Billing          System Administrator, Clinical Trials Administrator, PI,
                                                         Research Team, Contracts/Grants Administrator, Financial
                                                         Team
Scientific Review Board       Local Existing System      System Administrator, Clinical Trials Administrator, PI,
Application Date and status                              Research Team
SRB Informed Consent          Local Existing System      System Administrator, Clinical Trials Administrator, PI,
Status and Date                                          Research Team
IRB Application Dates and     Local Existing System      System Administrator, Clinical Trials Administrator, PI,
Statuses                                                 Research Team, Financial Team, DSMC
IRB Informed Consent Dates    Local Existing System      System Administrator, Clinical Trials Administrator, PI,
and Statuses                                             Research Team
Regulatory Document           Credentialing Repository   System Administrator, Clinical Trials Administrator, PI,
Completion Dates and Status   or Local Existing System   Research Team
Regulatory Document           Credentialing Repository   System Administrator, Clinical Trials Administrator, PI,
Submission Status             or Local Existing System   Research Team
SRB Review Meeting Dates      Local Existing System      System Administrator, Clinical Trials Administrator, PI,
                                                         Research Team, Financial Team, DSMC
SRB Approval Date             Local Existing System      System Administrator, Clinical Trials Administrator, PI,
                                                         Research Team, Financial Team, DSMC
IRB Review Meeting Date       Local Existing System      System Administrator, Clinical Trials Administrator, PI,
                                                         Research Team, Financial Team, DSMC
 38                                                                                                                 38
PLT - Categories of data #3

Data Categories                    Potential        Access Privileges
                                   Sources
IRB Review Status and Date         Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
                                   System           Team, Financial Team, DSMC
IRB Initial Approval Date          Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
                                   System           Team, Financial Team, Contracts/Grants Administrator
IRB annual Approval status and     Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
dates                              System           Team
IRB Amendment status and           Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
dates                              System           Team
IRB Informed Consent status        Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
and dates                          System           Team
IRB Investigator Brochure status   Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
and dates                          System           Team
Data Safety Monitoring Board       Local Existing   DSMC, PI, Research Team, System administrator, Clinical Trials
status and dates                   System           Administrator
Case Report Form Development       Local Existing   System Administrator, Clinical Trials Administrator, PI, Research
status and dates                   System           Team, Case Report Form Developer
Patient Screening dates,           C3PR             System Administrator, Clinical Trials Administrator, PI, Research
numbers of patients screened                        Team, Financial Team
Randomization – Number of          C3PR             System Administrator, Clinical Trials Administrator, PI, Research
patients randomized to each Arm                     Team, Financial Team
Patient Follow Up
 39                                EDC System                                                                     39
                                                    System Administrator, Clinical Trials Administrator, PI, Research
                                                    Team, Financial team
PLT - Categories of data #4

Data Categories                Potential Sources          Access Privileges
Drug Ordering and Inventory    Local Existing System      System Administrator, Clinical Trials Administrator, PI,
Status                                                    Research Team
IRB Adverse Events             Local Existing System      DSMC, PI, Research Team, System administrator, Clinical
Approval status and dates                                 Trials Administrator
Invoice Status and Dates       Financial Billing System   Financial Team, Clinical Trials Administrator, PI and System
                               or Local Existing System   Administrator
Payment Status and Dates       Financial Billing System   Financial Team, Clinical Trials Administrator, PI and System
                               or Local Existing System   Administrator
Accrual statuses and Dates     C3PR                       DSMC, PI, Research Team, Financial Team, System
(Closed, Suspended,                                       Administrator, Clinical Trials Administrator
reactivated, Terminated)
Clinical Abstract status and                              All Users
dates
Clinical Publication                                      All Users
Bibliography
Clinical Presentation date                                All Users
(future or past).
Local Protocol Accruals        C3PR                       System Administrator, Clinical Trials Administrator, PI,
                                                          Research Team, Financial Team, DSMC
National Protocol Accruals     C3PR                       System Administrator, Clinical Trials Administrator, PI,
                                                          Research Team, DSMC
Local Protocol Targets
 40                                                       System Administrator, Clinical Trials Administrator, PI,   40
                                                          Research Team, Financial Team, DSMC
    PLT – Categories of data #5

Data Categories              Potential Sources          Access Privileges
National Protocol Targets                               System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        DSMC
IRB Comments                 Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team
Scientific Review            Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team
Comments
Audit Type (FDA, IRB)        Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        DSMC
Audit Dates                  Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team
Audit Statuses               Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        DSMC
Audit Comments               Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        DSMC
Dates Adverse Events         Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team,
were reported to the IRB                                DSMC
Adverse Events Metrics       caAERs                     System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        DSMC
Amendment Number             Local Existing System      System Administrator, Clinical Trials Administrator, PI, Research Team,
                                                        Financial Team, DSMC
Investigator Certification   Local Existing System or   System Administrator, Clinical Trials Administrator, Principal Investigator
Statuses                     Credentialing Repository   and Co-Investigator for which the certification status applies.
Investigator Certification   Local Existing System or   System Administrator, Clinical Trials Administrator, Principal Investigator
                                                                                                                            41
Dates41                      Credentialing Repository   and Co-Investigator for which the certification date applies.
Use Cases – Defined during Inception


• General functionality
     • Manage users
     • Login
• Common Functions
     •   Select Protocol
     •   Assign Tasks
     •   Update Tasks
     •   Manage Notifications and Alerts
     •   Generate Reports
• Application and Role-specific Use cases
     •   Monitor Protocol Summary
     •   Monitor Concept/Protocol Development
     •   Monitor Trial Startup Activities
     •   Monitor Trial Conduct Activities
     •   Monitor Trial Closeout Activities      42
42
Protocol Lifecycle Tracking – Example
Scenarios (‘pre-storyboards’)

  • Monitor Trial Startup: allows users to track the protocol
      contract, budget, case report development, informed consent,
      investigator certification, regulatory documents, scientific review and
      institutional review board statuses, dates and assignments.
  • Monitor Concept/Protocol Development: allows users
      to track protocol creation by allowing users view specified
      assignments and statuses about the letter of intent submission, the
      writing of the protocol and the protocol submission.
  • Monitor Trial Conduct: allows users to track the protocol
      while the protocol is active. This includes the following information:
      waivers, deviations, accruals, amendments, audits, billing, protocol
      suspension and reactivation, pharmacy and drug supply, adverse
      events and Institutional review board statuses, dates and
      assignments.


 43                                                                         43
Protocol Lifecycle Tracking – Example
Scenarios (‘pre-storyboards’)

• Monitor Trial Closeout Activities: allows users to track the
     protocol wrap up. This includes the following information: follow up,
     financial close out, accrual close out, protocol termination statuses and
     dates and Publications and Presentations
• Manage Notifications and Alerts: To allow the user to add,
     edit, or delete rule-based notifications and/or alerts for a protocol or a
     group of protocols via portal component.
• Generate Reports: To allow the user to generate reports from the
     PLT Portal information.




44                                                                                44
Assumptions – Inception Phase and Now


• Then: The PLT architectural approach assumed that most information
  will be pulled from other CTMS workspace applications. Minimal
  protocol information would be entered by the user. The system would
  only provide the ability to assign tasks, enter dates tasks due, and
  write comments related to tasks.
• Then: It was further assumed that a computable protocol
  representation would be at the core of the PLT System.

• Now: we will eliminate dependencies on other projects and support
  data entry within PLT directly (APIs will still be required)
• Now: See if we can identify an open source commercial workflow tool
  that is easily customizable, see if we can build workflows as
  macros/programs for this tool


45                                                                  45
Protocol Lifecycle Tracking - Elaboration


• In Scope
   • Exchange protocol summary data with limited number
     of systems
   • Customizable, ability to add new lifecycle statuses and
     workflows for monitoring and management
   • Dashboard presentation of lifecycle stages of individual
     protocol (e.g. development, planning, execution, etc.)
• Out of Scope
   • Computable representation of a protocol (planned for
     later based on BRIDG model and CDISC’s Trial Design
     Model)

 46                                                         46
Protocol Lifecycle Tracking Elaboration – plan
forward

  • Identify list of potential PLT Scenarios/Storyboards
    to define the use of Version 1 of PLT
  • Document storyboards using formal tools (e.g. UML
    Activity Diagrams) to establish clarity/eliminate
    ambiguity
     • Storyboards will involve workflows and lifecycle
       documentation
     • Translation/transformation will be done using domain
       analysts working with Subject Matter Experts from
       SIG
  • Identify top 6-8 scenarios for initial testing and
    validation
     • Subject Matter Experts from SIG as usability testers
 47                                                       47
Sample Scenario From CTMS interoperability
(CTMSi) project

• Sample Scenarios developed by Subject Matter
  Experts to drive CTMSi demo for caBIG™ Annual
  Meeting (Feb 2007)

• Sample Storyboard: Enroll Subjects
   • CRA verifies that the patient meets eligibility criteria and
     if so, registers the patient (C3PR) to the study. Once
     they are registered/enrolled to a study, notification
     needs to go out to multiple systems (SC, CDMS). The
     message needs to indicate that the registration date
     needs to be the first date of the treatment epoch. CRA
     will review the Study Calendar and schedule the next
     visit and associated activities for that patient.         48
 48
Agenda


 • Meeting Objectives

 • Introductions

 • SIG Meeting Schedule

 • Overview of CTMS Workspace

 • Overview of Planning and Monitoring SIG

 • Protocol Lifecycle Tracking

 • Comment, Feedback, Questions

 • Review of Action Items
 49                                          49
Thank you! Q & A




50                 50

								
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