1. Orientation (On-Boarding Process) for the CTMS Best Practices SIG

2. 11 Agenda  Introduction to the CTMS Best Practices SIG –Background –Charter  SOP Working Group –Charter –SOP Progress  Logistics

3. 22 Agenda  Introduction to the CTMS Best Practices SIG –Background –BP SIG Charter  SOP Working Group –Charter –SOP Progress  Logistics

4. 33 Background – Year 1  Initial work on developing SOPs and Best Practices to support clinical research trials began under the auspices of NCICB and was intended to specifically support the implementation of C3D at adopter cancer sites –SOPs, guidelines and procedures based on industry ‘best practices’ –Technology neutral in order to support any/all clinical data management applications –Developed & maintained by NCICB to relieve the administration burden on the adopting Cancer Sites for developing/maintaining required regulatory documentation ( i.e., SOPs, Guidelines, Best Practices) –Addressed good records management to assure the authenticity, veracity and non- repudiation of clinical research data (records) –Based on Title 21 Regulations & ICH Guidelines for Clinical Research Trials  SOP WG was formed and officially chartered to review and approve SOPs and best practice documents (C3D SOP WG)  Documentation initially authored by Booz Allen subject-matter-experts and vetted with the SOP WG members  During Year 1 of the SOP WG activities, 18 SOPs, Procedures, Guidelines & Best Practices were approved and rolled-out for implementation  CBT module was designed and rolled out to support training on all approved SOPs

5. 44 During Year 1, standard templates were developed, approved and adopted by the C3D SOP WG These templates reflect the framework for best, standard practices that:  Are easy to modify –Written at high level, therefore reducing the regulatory risk of non-compliance  Facilitate standardization and easier collaboration with the biopharmaceutical industry  Link all required, regulatory information to one SOP document  Are technology neutral, hence are easily adaptable for multiple-site use regardless of the clinical data management application implemented by the site(s)  Are easy to follow, as visual and text descriptions are constructed for the right level, making them user friendly  Eliminate overhead at the adopter site, as ownership and administrative responsibilities remains with the NCICB (ownership & quality assurance)

6. 55 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

7. 66 TITLEDESCRIPTION 1) Glossary of Terms & AcronymsProvides a list of general research terms and acronyms. 2) Principles for Writing SOPsOutline 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. 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.

8. 77 Background – Year 2  The Best Practices SIG was chartered to continue the SOP work and to address best practices for other functional activities within the CTMS WS  The new BP SIG was launched on September 13, 2005  The SOP Working Group was formed to continue the SOP authoring process, under the direction of the BP SIG, and was launched on September 27, 2005  Overall, the BP SIG continues to promote participation within the WS and to identify “domains of interest” –Other WGs may be formed as domains of interest are identified by the SIG membership  Ownership and administrative support of all SOPs remains the sole responsibility of NCICB During the Second Annual caBIG™ Meeting, it was suggested by members of the caBIG™ community that a new CTMS SIG be created to address “Best Practices” across the entire WS and to complete the authoring and approval of SOPs to support clinical data management activities

9. 88 BP SIG Charter (1)  The CTMS Best Practices SIG focuses on establishing and fostering relevant clinical trial management best practices for the caBIG™ community. Best practices support clinical research activities, including: –Protocol administration –Participants registry –Technology neutral best practices and protocol life-cycle processes for the conduct of clinical research trials –Data migration (for legacy clinical trial data)  The BP SIG will complement, but not overlap, with best practice groups in other caBIG™ Workspaces. The BP SIG will aim to harmonize best practices within the area of clinical research trial management within the CTMS WS  For the purpose of this SIG, 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 group from member experiences or developed as a combination of proven techniques or processes

10. 99 BP SIG Charter (2)  Solicits active membership in the CTMS BP SIG from: –All areas within the caBIG™ community –Expands participation to include pharma, biotech, vendors, and government partners –Participants are recruited who are ‘domain experts’ in the area of clinical research trials –Participants are recruited who are interested in contributing to the success of this new SIG  Offers guidance and disseminate best practices for implementing CTMS workspace tools to: –Facilitate standardization of best practices –Assure the veracity, authenticity and non-repudiation of clinical research data (records) collected in clinical research trials  Continues to develop SOPs for clinical research trials through the SOP Working Group  Provides a forum for identifying additional areas of interest and sharing solutions that are relevant to all CTMS WS participants

11. 10 BP SIG Charter (3) Roles & Responsibilities: MemberRole & Responsibilities SIG Lead & Co-Lead  Provides strategic direction to the CTMS BP SIG  Ensures the CTMS BP SIG adheres to NIH and NCI Policies and guidelines  Approves agenda items (including meeting minutes)  Schedules meetings & assigns tasks to the BP SIG Membership  Brings the body to vote once the appropriate level of discussion on particular issues have been reached Best Practices SIG members (Representatives from NCI organizations and sites conducting clinical trials)  Reviews and provides input on the WG SOPs and processes developed to support clinical research trial Working Group operations by the agreed upon time frame  Approves SOPs for implementation by the adopting cancer sites  Responsible for achieving SIG objectives  Support WGs created under the SIG  Takes and approves CTMS BP SIG decisions  Actively participates and contributes to the SIG activities and WGs  Provides feedback and makes recommendations for addressing gaps and/or issues identified by the group SIG Scribe  Takes SIG meeting notes and disseminates drafts to the SIG membership  Seeks concurrence on meeting notes, issues final draft for approval by the SIG membership  Captures and reports out to the SIG Lead issues and/or gaps

12. 11 BP SIG Focus Areas  CRF Management  Mentoring caBIG™ technology adopters  Participant Registry  Informed Consent Workflows  Assuring Compliance with Protocols  Defining Metrics for Clinical Research Trial Management  Computational Models for SOPs (BRIDG Model)  Providing regulatory documents (SOPs, Guidelines, Procedures) to supporting the entire protocol lifecycle

13. 12 Agenda  Introduction to the CTMS Best Practices SIG –Background –Charter  SOP Working Group –Charter –SOP Progress  Logistics

14. 13 SOP WG Charter (1)  The SOP WG was created under the auspices of the BP SIG to review, discuss and recommend SOPs to support clinical research trials and to prioritize the authoring of SOPs and documentation moving forward  WG participants must reach consensus on new SOPs and new business processes to enable efficient use of clinical data management applications or activities - eliminating or substantially reducing any SOP or business process revision at their individual sites  WG participants must 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)  WG members are required to facilitate the exchange of useful information on clinical research trials, enabling the sites to remediate risk  WG members serve as a source to define requirements for enhancements, implementation, ongoing support and maintenance of the SOPs, and training requirements moving forward for SOPs

15. 14 SOP WG Charter (2)  The SOP Working Group is authorized to take decisions that aid the process of defining and developing business processes and SOPs. The WG is charged to assure that the business processes and SOPs are relevant, acceptable and meet the needs of caBIG TM community and the adopter member sites  SOPs are developed and approved by the WG. WG approved draft SOPs will be posted for review and confirmation by the CTMS Best Practices SIG membership  Any deviations or revisions to existing SOPs and their attachments, proposed by the adopting cancer sites, are required to be presented to the WG for review and approval –For revised SOPs, the WG will follow the SOP approval procedure outlined in the charter –For revised Attachments, the WG will review the proposed changes to assure the revised attachments do not conflict with existing SOPs –If revised SOPs and/or Attachments are approved by the SOP WG and the BP SIG, then ownership of that revised SOP and all attachments is transferred entirely (ownership and administrative overhead) to the ‘proposing’ cancer site

16. 15 SOP WG Charter (3) Roles & Responsibilities: The SOP WG Membership is open to all caBIG TM participants. However, only cancer site adopters have voting privileges ( i.e., vendors, biopharmaceutical representatives, and/or consultants do not have voting privileges on work products but are strongly encouraged to contribute during the authoring, review and approval process). MemberRole & Responsibilities SOP WG Lead & Co-Lead  Provides strategic direction to the WG  Ensures the WG deliverables adhere to NIH and NCI Policies and guidelines as well as Title 21 Regulations and ICH Guidelines for Clinical Research Trials  Approves agenda items (including meeting minutes)  Schedules meetings & assigns WG tasks  Brings the WG membership to vote once the appropriate level of discussion on SOPs and attachments has been reached SOP WG members (Representatives from NCI organizations and sites conducting clinical trials, including biopharmaceutical representatives, vendors and consultants)  Reviews and provides input on the draft SOPs and processes developed to support clinical research trials  Reports out SOPs for review and approval to the BP SIG  Responsible for achieving WG objectives  Takes decisions and approves CTMS BP SIG decisions  Actively participates and contributes to all WG activities  Provides feedback and makes recommendations for addressing gaps and or issues identified by the group WG Scribe  Takes WG meeting notes and disseminates drafts to the WG membership  Seeks concurrence on meeting notes, issues final draft for approval by the WG membership  Captures and records out to the SOP WG Lead risks, gaps

17. 16 SOPSOP TitleSOPSOP Title AD001Develop and Maintain SOPsCR008Study Close SOP AD002Managing Deviations and Revisions to SOPsCR009Clinical Data Management Plan Guideline AD003Release and Distribution of SOPsCR010Data Safety Monitoring Board Review (DSMB) SOP AD004Information Security ComplianceCR011Breaking the Statistical Blind SOP AD005Protecting Patient Privacy (HIPAA)CR012Study Reports (ISS & ISE formats) SOP AD006Revoking of Patient consent under HIPAA SOPCR013Statistical Analysis Plan SOP AD007Training Process (on implementing SOPs training using CBT) SOPs CR014Patient Registration (C3PR) SOPs AD008Change Control (systems) SOPCV001Requirements for Complying with 21 CFR Part 11 CR001Study SetupCV002Computer Systems Validation SOP CR002Study ConductCV003Vendor Audit Guideline CR003Develop and Manage CRFsIT001Establishing and Maintaining User Accounts CR004CDE CurationIT002Retiring User Accounts CR005Application’s Standards Library MaintenanceIT003Electronic Loading of Laboratory Data CR006Coding of Clinical Research DataIT004Electronic Loading of CDEs CR007Reconciliation of SAE EventsIT005Standard Programming SOP Working Group Progress to Date Effective – Available for Use Approved by BP SIG – Not Available for Use Under review - Not Available for Use

18. 17 SOP Review Procedure

19. 18 Example: SOP walk through by the SOP WG SOP drafted and distributed to SOP WG SOP CR008 Study Close PD CR008 Study Close SOP presented and discussed at November SOP WG SOP WG determined that Closing a Study temporarily was significantly different than the Final Lock Discussion Record for CR008 SOP CR008 Study Close PD CR008 Study Close SOP WG determined that separate PDs are required for Study Close and Study Lock SOP and PD modified to create separate PDs for Study Close and Study Lock Discussion Record for CR008 SOP CR008 Study Close & Lock PD CR008 Study Close PD CR008 Study Lock SOP and modified to PDs presented and discussed at December SOP WG Discussion Record for CR008 SOP CR008 Study Close & Lock PD CR008 Study Close PD CR008 Study Lock SOP and modified to PDs presented and approved at January BP SIG Discussion Record for CR008 SOP CR008 Study Close & Lock PD CR008 Study Close PD CR008 Study Lock Distribute to SOP WG Distribute to BP SIG

20. 19 Computer Based Training (CBT)  It is available online for all ‘released’ and ‘effective’ SOPs and accompanying documentation –https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOP_ Computer_Based_Traininghttps://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOP_ Computer_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 supports training for all SOPs delivered by the BP SIG and the SOP WG

21. 20 SOP Working Group: Priorities Going Forward  The SOP WG priorities for Year 3 planned activities include: –Review all Year 1 SOPs –Review Role Titles for all SOPs –Complete CBT for Year 2 SOPs –Complete BRIDG Modeling activities for Year 2 SOPs –Complete BRIDG Modeling activities for Year 1 SOPs

22. 21 Agenda  Introduction to the CTMS Best Practices SIG –Background –Charter  SOP Working Group –Charter –SOP Progress  Logistics

23. 22 CTMS BP SIG Meeting Logistics  The BP SIG meets once a month on the 2 nd Tuesday from 3:00-4:00pm (EDT)  The SOP Working Group meets once a month on the 4 th Tuesday from 3:00 to 5:00pm (EDT)

24. 23 CTMS BP SIG Website Info  The CTMS Best Practices SIG website is: –https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/Best_ Practices_SIGhttps://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/Best_ Practices_SIG  The CTMS Best Practices SIG gForge site (for task tracking, document storage, etc.) is: –http://gforge.nci.nih.gov/projects/ctms-bpsig/http://gforge.nci.nih.gov/projects/ctms-bpsig/  The CTMS Best Practices SIG gForge site that lists SOPs is: –http://gforge.nci.nih.gov/docman/?group_id=91http://gforge.nci.nih.gov/docman/?group_id=91  The CTMS Best Practices SIG listserv is: – http://list.nih.gov/archives/cabig_ctms_bpsig-l.htmlhttp://list.nih.gov/archives/cabig_ctms_bpsig-l.html  The CTMS SOP Working Group listserv is: –https://list.nih.gov/archives/cabig_ctms_bpwg-l.htmlhttps://list.nih.gov/archives/cabig_ctms_bpwg-l.html

25. 24 BP SIG Members and Contributors Members  Brenda Duggan, Clinical Informatics Program Director, NCICB, dugganb@mail.nih.gov  Christo Andonyadis, Clinical Trials Application Engineering, NCICB, christo.andonyadis@nih.gov  Andrea Hwang, Co-SIG Lead, University of California, Irvine, ychwang@uci.edu  Jieping Li, Co-SIG Lead, Georgetown University, lj38@georgetown.edu  Lara Fournier, SIG & SOP WG Scribe, Project Manager, Oregon Health & Science University, fourniel@ohsu.edu fourniel@ohsu.edu  Bob Annechiarico, Director of Cancer Center Information Systems, Duke University, bob.annechiarico@duke.edu  Robert Lanese, Case Comprehensive Cancer Center, robert.m.lanese@case.edu robert.m.lanese@case.edu  Robert Morrell, Wake Forrest University Baptist Medical Center, bmorrell@wfubmc.edubmorrell@wfubmc.edu Booz Allen Support Staff  Michele Pontinen, pontinen_michele@bah.com  David Geismar, geismar_david@bah.com  Hadley White, white_hadley@bah.com  Farhia Mussa, mussa_farhia@bah.com