CTMS Best Practices SIG

1. Andrea Hwang and Jieping Li CTMS Best Practices SIG Quarterly CTMS Face-to-Face UCSF August 29-30, 2005

2. CTMS Best Practices SIG Launch SOP Working Group Q&A Agenda

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

4. 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 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.

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

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

7. CTMS Best Practices SIG Launch SOP Working Group Q&A Agenda

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

9. 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 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.

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

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

12. 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

13. 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.

14. The following SOPs are being issued in September, 2005. The SOPs become effective on October 31, 2005

15. 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 A CBT application will be made available to all sites for training on the SOPs

16. 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) Year 2 SOPs for consideration include:

17. The SIG will meet once a month on 2nd Tuesday from 3:00-4:00pm (EDT). First meeting scheduled for Sept. 13th Focus on defining the SIG’s charter The SOP Working Group will meet once a month on the 4th Tuesday from 3:00 to 4:00pm (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.html The logistics for the CTMS BP SIG are as follows:

18. CTMS Best Practices (BP) SIG Launch SOP Working Group Q&A Agenda