CTMS Best Practices SIG

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CTMS Best Practices SIG
Quarterly CTMS Face-to-Face Duke
University January 30-31, 2006

• Jieping Li Andrea Hwang
• Georgetown Lombardi UCI Chao

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Agenda

• CTMS Best Practices SIG Update
• SOP Working Group Progress
• Domains of Interest Questionnaire Results
• FAQ/QA

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BP SIG Update

• The BP SIG kick-off meeting was held on Sep. 13,
  2005
• The BP SIG Charter was approved on Nov. 8, 2005
• The SOP WG kick-off meeting was held on Sep. 27,
  2005
• The SOP WG Charter was approved on Oct. 25, 2005
• The SIG continues to promote participation and
  identify domains of interest

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BP SIG Charter - Purpose

• The Clinical Trial Management System (CTMS) Best
  Practices Special Interest Group (BP SIG) will
  focus on establishing and fostering relevant
  clinical trial management best practices for the
  caBIG community. Best practices will support
  clinical research activities, such as
• Protocol administration
• Participants registry
• Technology neutral best practices and protocol
  life-cycle processes for the conduct of a
  clinical research trials
• Data migration (for legacy clinical trial data)
• The CTMS BP SIG will complement, but not overlap,
  with best practice groups in other caBIG
  Workspaces. The CTMS BP SIG will aim to harmonize
  best practices within the area of cancer clinical
  trial management.
• For the purpose of this Special Interest Group, a
  Best Practice is defined as a technique or
  methodology that, through experience and
  research, has proven to be reliable in leading to
  a desired result. The identification and
  possible adoption of Best Practices can be
  presented to the SIG from member experiences or
  developed as a combination of proven techniques
  or processes.

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BP SIG Charter - Objective

• Solicit active membership in the CTMS BP SIG
  from
• All areas within the caBIG community
• Expand participation to include pharma, biotech,
  vendors, and government partners
• Participants who are domain experts in the area
  of clinical research trials
• Participants who are interested in contributing
  to the success of this new SIG
• Offer guidance and disseminate best practices for
  implementing CTMS workspace tools to
• Facilitate standardization of best practices
• Assure the veracity and authenticity of data
  collected in clinical research trials
• Continue to develop SOPs for clinical research
  trials through the SOP Working Group.
• Provide a forum for identifying additional areas
  of interest and sharing solutions that are
  relevant to all CTMS Workspace participants. As
  the SIG identifies new areas of interest, other
  Working Groups will be established under this
  SIG.

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BP SIG Charter Scope and Applicability

• All Best Practices, once approved by the BP SIG,
  will be made available to all of the caBIG
  community and the general public.
• The best practices developed and recommended by
  this SIG will not be mandatory for acceptance by
  the caBIG participant sites. However, as a
  representation of a collective domain expertise,
  it is recommended that the best practices and
  accompanying supporting documentation (i.e.,
  SOPs) be considered for adoption by all caBIG
  participant sites as a way to ensure
  standardization and authenticate results of
  cancer research trials.

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SOP WG Charter Objectives

• Review/discuss recommended SOP list and
  prioritization
• Reach consensus on new SOPs to enable efficient
  use of clinical data management applications or
  activities
• Share best practice knowledge for the conduct of
  clinical trials, according to ICH Guidelines,
  Title 21 Regulations (including 21 CFR Part 11)
  and regulations concerning the requirements and
  controls around patient confidentiality, the
  Health Insurance Portability and Accountability
  Act (HIPAA)
• Facilitate the exchange of useful information on
  clinical research trials, enabling the sites to
  remediate risk.

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SOP WG Charter Authority

• The SOP Working Group is authorized to make
  decisions aiding the process of defining and
  developing business processes and SOPs. The SOP
  Working Group will ensure that the business
  processes and SOPs are relevant and acceptable
  for the needs of caBIGTM and the individual
  member sites.
• SOPs will be developed and approved by the SOP
  Working Group. The approved SOPs will be posted
  for review and confirmation by the CTMS Best
  Practices SIG.
• Any deviations or revisions to existing SOPs and
  Attachments will also be presented to the SOP
  Working Group.
• For SOPs, the Working Group will follow the SOP
  approval procedures outlined in this charter.
• For Attachments, the Working Group will review
  the proposed changes to ensure no conflict with
  existing SOPs and note the revision in the
  meeting minutes.

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SOP WG Charter Membership and Responsibilities

• Membership shall be open to all caBIGTM
  participants, however only the cancer sites may
  have voting privileges.
• When there is more than one representative from a
  particular site, the organization identifies one
  individual as its primary representative and the
  other individual as the alternate representative.
  While everyone will have the opportunity to
  discuss and review items put before the Working
  Group, only the primary representative, or their
  designated alternate, may vote on initiatives put
  before the Working Group.

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SOP Review Procedure
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Agenda

• CTMS Best Practices SIG Update
• SOP Working Group Progress
• Domains of Interest Questionnaire Results
• FAQ/QA

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SOP WG The SOPs became effective on October 31,
2005
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SOP Working Group Progress Priority

• The SOP WG prioritized the list of upcoming SOPs
  to review
• Study Close SOP
• Clinical Data Management Plan Guideline
• Data Safety Monitoring Board Review (DSMB) SOP 
• Breaking the Statistical Blind SOP
• Study Reports (ISS ISE formats) SOP
• Training Process (on implementing SOPs training
  using CBT) SOPs
• Statistical Analysis Plan  SOP
• Patient Registration (C3PR) SOPs
• Dictionary Maintenance SOP
• Data Export/Import SOP
• Protocol Administration (C3PA) SOP
• Change Control (systems) SOP
• Computer Systems Validation SOP

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SOP Working Group Progress Approved SOPs

• All the Effective SOPs can be found at
  https//cabig.nci.nih.gov/workspaces/CTMS/Meetings
  /SIGs/Best_Practices/SOPs/SOPs
• Since September 2005, the following SOPs were
  approved by the BP SIG
• CR-008 Study Close and Lock
• CR-010 Data Operations for the DSMB
• CR-011 Breaking the Statistical Blind
• CR-013 Statistical Analysis Plan
• The following SOP have been approved by the SOP
  WG and are ready for BP SIG review and approval
• AD-007 Training on SOPs
• CR-009 Guideline for Clinical Data Management Plan

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SOP Working Group Progress SOP Walk-through
SOP drafted and distributed to SOP WG
SOP presented and discussed at November SOP WG
SOP WG determined that Closing a Study
temporarily was significantly different than the
Final Lock
SOP WG determined that separate PDs are required
for Study Close and Study Lock
SOP CR008 Study Close
PD CR008 Study Close
Discussion Record for CR008
SOP CR008 Study Close
PD CR008 Study Close
Discussion Record for CR008
SOP and PD modified to create separate PDs for
Study Close and Study Lock
SOP and modified PDs presented and discussed and
approved at December SOP WG
SOP and modified PDs presented and approved at
January BP SIG
Distribute to SOP WG
Distribute to BP SIG
SOP CR008 Study Close Lock
PD CR008 Study Close
PD CR008 Study Lock
Discussion Record for CR008
SOP CR008 Study Close Lock
PD CR008 Study Close
PD CR008 Study Lock
Discussion Record for CR008
SOP CR008 Study Close Lock
PD CR008 Study Close
PD CR008 Study Lock
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Computer Based Training (CBT)

• It is available online. https//cabig.nci.nih.gov/
  workspaces/CTMS/Meetings/SIGs/Best_Practices/SOP_C
  omputer_Based_Training
• The CBT will support training for those sites
  that are adopting the SOPs.
• The CBT will capture and report out on the status
  of training by user
• The user will receive an email when they have
  completed the training modules
• The user is responsible for updating their local
  site training coordinator on their training
  activities
• Managing end-user training records remains the
  responsibility of the participating site
• NCICB will maintain the CBT that will support
  training for all SOPs delivered by the CTMS BP SIG

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Agenda

• CTMS Best Practices SIG Update
• SOP Working Group Progress
• Domains of Interest Questionnaire Results
• FAQ/QA

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Domains Of Interest Questionnaire Goal

• To assist the CTMS Best Practice SIG to identify
  domains of interest in the clinical trial data
  management area.
• To help to brain storm, discuss and develop best
  practices for conducting clinical trials under
  the caBIGTM umbrella.

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Domains Of Interest Questionnaire
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Domains Of Interest Questionnaire Results

• 14 completed questionnaires have been received.
• The most interest centered around
• CRF Management
• Participant Registry
• Informed Consent Workflow
• Assuring Compliance with Protocols
• Defining Metrics for Clinical Research Trial
  Management

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Domains Of Interest Questionnaire Results

• Additional areas were also noted
• Electronic Data Capture of Laboratory Results
• Interactive Research Data Exploration Tools
• Testing and Evaluation of SOP Implementation
• Templates for User Acceptance Testing
• Templates for Training Plan/Schedule for C3D
  implementation
• Financials Budget Preparation and Management
• Adverse Event Handling
• Study Calendar
• Requirements (resources, level of effort, etc.)
  for adoption of the different caBIG tools

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Agenda

• CTMS Best Practices SIG Update
• SOP Working Group Progress
• Domains of Interest Questionnaire Results
• FAQ/QA

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BP SIG FAQ

• We are in the process of putting together a FAQ
• How would a center go about implementing these
  SOPs describe the process?
• How do I suggest changes to SOPs?
• Which documents are modifiable, locally - and do
  we have to have these reviewed and approved also?
• What if we dont have roles defined exactly as
  they are on the SOPs in our centers, many of
  these roles may be done by the same person
  with a job title different than whats labeled on
  the SOP?
• How do I determine which people need to be
  trained on which SOPs?
• Etc..

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Acknowledgment

• Following are people who contributed with great
  devotion to the BP SIG.
• Brenda Duggan, NCICB
• Christo Andonyadis, NCICB
• Michele Pontinen, Booz Allen
• Patrice Clark, Booz Allen
• David Geismar, Booz Allen
• Hadley White, Booz Allen
• Lara Fournier, Oregon Health Science University
  
• Bob Annechiarico Duke Univesity

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CTMS BP SIG Logistics

• The SIG meets once a month on 2nd Tuesday from
  300-400pm (EDT).
• The SOP Working Group meets once a month on the
  4th Tuesday from 300 to 500pm (EDT)
• The CTMS Best Practices SIG website is
  https//cabig.nci.nih.gov/workspaces/CTMS/Meetings
  /SIGs/Best_Practices/Best_Practices_SIG
• The CTMS Best Practices SIG listserv is
  http//list.nih.gov/archives/cabig_ctms_bpsig-l.ht
  ml