CTMS Best Practices SIG

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CTMS Best Practices SIG
Quarterly CTMS Face-to-Face UCSF August 29-30,
2005

• Andrea Hwang and Jieping Li

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Agenda

• CTMS Best Practices SIG Launch
• SOP Working Group
• QA

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Background The Best Practices SIG was
established in response to multiple requests from
our last caBIG Annual Meeting. In response

• This SIG will focus on best practices for
  clinical research trials activities to support
• Protocol Administration
• Patient and investigator registry
• Technology neutral best practices and life-cycle
  processes for the conduct of a clinical research
  trials using a clinical data management
  application
• Data migration (for legacy clinical trial data)
• This SIG will compliment and not overlap with
  best practices groups in other workspaces

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The CTMS Best Practices (BP) SIG was established
to meet the need for the expanded forum to
address best practices important to the CTMS
workspace participants.

• The SIG will piggy-back on the accomplishments of
  the C3DS User Group in supporting the
  bench-to-bedside goals of caBIG
• The priorities, structure and charter of the new
  SIG will be defined by its membership
• New SIG is open to all CTMS Workspace
  participants
• The Co-Leads for this new SIG are Andrea Hwang
  and Jieping Li

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The CTMS BP SIG will focus on establishing and
fostering relevant clinical trial management best
practices across caBIG community.

• Leverage working groups to focus on defining best
  practices for key priorities related clinical
  research trials in the caBIG environment
• Continue developing SOPs to support
  standardization of the clinical research trial
  process . The SOP Working Group will be the first
  WG under this new SIG
• Reach out to the wider community (e.g., pharma,
  biotech, SPORES, FDA) to collaborate on
  developing standard CRF modules
• As the SIG identifies new areas of interest,
  other WG will be established
• Provide guidance and support for implementing
  CTMS workspace tools
• Provide a forum for identifying areas of interest
  and sharing solutions that are relevant to all
  CTMS Workspace participants

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The key objectives for the CTMS BP SIG for Year 1
includes the following

• 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
• Who are domain experts in the area of clinical
  research trials
• 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
• Facilitate information sharing among CTMS
  Workspace participants

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Agenda

• CTMS Best Practices SIG Launch
• SOP Working Group
• QA

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The SOP Working Group will be the first WG formed
under the new SIG.

• This WG will build on the success of the C3DS
  User Group in support of clinical research trials
  under the caBIG umbrella
• The WG will review SOPs and accompanying
  documentation to assure the work products are
  standard, meet regulatory requirements, and are
  flexible to adopt to local site requirements
• Members of this working group will be expected to
  rapidly develop and review SOPs
• Maximum of two members per organization (one
  primary, one alternate)
• Expected that the working group will develop,
  review and submit a minimum of two SOPs per month
  during Year 2
• Report out to the CTMS BP SIG work products for
  final review and approval

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As background, the C3DS User Group was formed to
review, advise and deliver SOPs and best
practices for clinical research trials conducted
under the caBIG umbrella.

• 43 work products (18 SOPs, Procedures, workflows,
  guidelines templates) to support clinical
  research trials were approved by the group during
  Year 1
• The SOPs and accompanying documentation were
  designed and authored to be technology neutral
  and to assure the authenticity and veracity of
  data collected during clinical research trials
• The SOPs are not modifiable by the local site,
  however, the accompanying procedures can be
  modified to support local activities
• Approval of SOP procedure modifications will
  remain the sole responsibility of the SOP Working
  Group moving forward

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The C3DS User Group represented both the intra-
and extramural cancer research community.

• Members
• Sue Dubman, NCICB, Chair
• Brenda Duggan, NCICB, Vice-Chair
• Christo Andonyadis, NCICB
• Lara Fournier, Oregon Health Science University
  
• Andrea Hwang, University of California, Irvine
• Jieping Li, Georgetown University
• Beverly Meadows, DCP
• Diane Reeves, NCICB
• Vicki Sallée, The University of Pennsylvania
• Allison Wise, CCR

• Contributors
• Anita Tierney, NYU School of Medicine
• Anne Martocci, NYU School of Medicine
• Ann Setser, CTEP
• Erin Iturriaga, DCP
• Dr. Xin Zheng, Albert Einstein
• Lisa Escobar, Albert Einstein
• Dan Sands, NCI ISSO
• Kim Diercksen, Terrapin Systems
• Michele Pontinen, Booz Allen
• Patrice Clark, Booz Allen
• David Geismar, Booz Allen
• Dan Steinberg, Booz Allen

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Standard templates were developed, approved and
adopted by the participants. The rationale for
this action included

• Easy to modify
• Written at high level, therefore reduced the risk
  of non-compliance
• Facilitates easier collaboration with the
  biopharmaceutical industry
• One document linking all information together
• Easily adapted for multiple sites to use
• Easier to use and follow as provides visual and
  text descriptions at the right level user
  friendly
• Less governance required for SOP maintenance

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Purpose Describe what the SOPs are broadly
required for (their rationale), as described in
ICH E6 Good Clinical Practice A Consolidated
Guideline as well as in other regulatory or
cancer site documentation requirements.
Scope Describe the scope of this SOP (e.g. it is
applicable to all SOPs prepared for clinical
trials for which XXXXX is the sponsor).
Requirements Describe responsibilities of
individuals and details of certain processes,
inherent to the SOP.
References / Regulations / Guidelines List any
references, which have been used for this SOP
(e.g. ICH E6 Good Clinical Practice, etc.),
updates of which may impact this SOP
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Attachments The attachment section will include a
list and description of process flows, activity
steps and other relevant documents for the SOP.
The actual documents will not be included in the
SOP.
TITLE DESCRIPTION
1) Glossary of Terms Acronyms Provides a list of general research terms and acronyms.
2) Principles for Writing SOPs Outline of best practices for developing SOPs
3) Process Flows for SOP Provides a visual reference guide for the steps in this procedure Provides a high-level process flow that breaks down the individual steps required for the preparation of SOPs.
4) Procedure for Developing and Maintaining SOPs Provides the details outlining the individual steps needed to develop and maintain a new SOP This document provides instructions for the preparation of SOPs and it establishes procedures and responsibilities to ensure that all SOPs are prepared, retained and deleted in a consistent manner. The content of this procedure should be followed strictly any departure from this procedure should be documented and brought to the attention of senior clinical staff at the site.
5) Approval Process Flow for SOP (TBD) This Process Flow outlines the individual steps that need to be completed as part of the SOP approval process. (Note This process flow will be completed on approval of this SOP.)
6) Process Flow for Deviations from SOP (TBD) This Process Flow outlines the individual steps that need to be completed as part of the SOP Deviations process. (Note This process flow will be completed on approval of this SOP.)
7) NCICB Guidelines for Document Management This document provides guidelines for the management and control of documents.
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The following SOPs are being issued in September,
2005. The SOPs become effective on October 31,
2005
SOP Name Number Attachments
SOP for SOPs AD-001 Principles for Writing SOPs Procedure Description for Developing and Maintaining SOPs Workflow
SOP for Revisions and Deviations of SOPs AD-002 Procedure Description for Documenting SOP Deviations Revisions Workflow
SOP for Release and Distribution of SOPs AD-003 Procedure Description for Release and Distribution of SOPs Procedure Description for Numbering and Versioning of SOPs Workflows
SOP for Security Compliance (HIPAA) AD-004 Procedure Description for Security Compliance Workflow
SOP for Patient Privacy (HIPAA) AD-005 Procedure Description for Patient Privacy Workflow
SOP for Study Setup CR-001 Procedure Description for Study Setup Workflow
SOP for Study Conduct CR-002 Procedure Description for Study Conduct Workflow
SOP for CRF CR-003 Procedure Description for developing CRF Workflow CRF Questionnaire Template
SOP for CDE Curation CR-004 Procedure Description for CDE Curation Workflow
SOP for Application Standards Library Maintenance CR-005 Procedure Description for Application Standard Library Workflow
SOP for Coding of Data CR-006 Procedure Description for Coding Data Workflow
SOP for Reconciliation of Serious Adverse Event Database CR-007 Procedure Description for Reconciliation of SAEs Workflow Sample SAE Data Reconciliation Form
SOP for 21 CFR Part 11 Compliance CV-001 Procedure Description for 21 CRF Part 11 Compliance Workflow Regulatory Impact Questionnaire Detailed ERES and Risk Tool Assessment
SOP for Establishing and Maintaining User Accounts IT-001 Procedure Description for Establishing and Maintaining User Accounts Workflow
SOP for Retiring User Accounts IT-002 Procedure Description for Retiring User Accounts Workflow
SOP for Electronic Loading of Lab Data IT-003 Procedure Description for Electronic Loading of Lab Data Workflow
SOP for Electronic Loading of CDEs IT-004 Procedure Description for Electronic Loading of CDEs Workflow CDE Load Checklist
SOP for Standard Programming IT-005 Procedure Description for Standard Programming Workflow
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A CBT application will be made available to all
sites for training on the SOPs

• NCICB will maintain the CBT that will support
  training for all SOPs delivered by the CTMS BP
  SIG
• The CBT will be updated with new SOPs according
  to a pre-defined release schedule
• 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
• Working lunches Preview the CBT

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Year 2 SOPs for consideration include

• Study Close
• Revoking of Patient consent under HIPAA
• Breaking the Statistical Blind
• Clinical Data Management Plan Template
• Study Reports (ISS ISE formats)
• Data Safety Monitoring Board Review (DSMB)
• Training (SOPs personnel/qualification)

• Patient Registration (C3PR)
• Change Control (systems)
• Computer Systems Validation
• Dictionary Maintenance
• Data Export/Import
• Statistical Analysis Plan
• Protocol Administration (C3PA)

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The logistics for the CTMS BP SIG are as follows

• The SIG will meet once a month on 2nd Tuesday
  from 300-400pm (EDT).
• First meeting scheduled for Sept. 13th
• Focus on defining the SIGs charter
• The SOP Working Group will meet once a month on
  the 4th Tuesday from 300 to 400pm (EDT)
• First meeting scheduled for Sept. 27th
• Focus prioritizing and scheduling next set of
  SOPs
• The CTMS Best Practices SIG listserv is
  http//list.nih.gov/archives/cabig_ctms_bpsig-l.ht
  ml

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Agenda

• CTMS Best Practices (BP) SIG Launch
• SOP Working Group
• QA