Group 3 – Design Change Management Process (Armando)

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Group 3 – Design Change Management Process (Armando) When: Monday, March 19th
Place: Silver Spring Civic Center | Sliver Spring, Maryland, USA
Facilitator: Armando Oliva
Attendance:

Name Organization
Armando Oliva FDA (FDA Co-Lead)
Hany Aboutaleb Biogen Idec (Industry Co-lead)
Max Kanevsky OpenCDISC (Industry Co-lead)
Adrienne Bonwick Eisai Ltd
Beate Hientzsch Accovion
Bill Gibson SAS
Brooke Hinkson Genzyme
Frank Newby CDSIC
Kieu Pham FDA
Melissa Binz Novartis Pharma
Thomas Haag Novartis

General discussion

Group 3 – Design Change Management Process (Armando)

  • Propose and discuss Change Management Process
o What are the possible approaches to change management?
o What is the role of workgroup members?
o What is the role of CBER/CDER CCG?
o What should be the makeup of the Change Management Board?
o How do we evaluate and propose changes to existing rules or new rules?
o What is are the details of the approval process (review periods, voting, etc.)?
o What is a reasonable release schedule?

Summarize group findings

  • Change Control Board Charter
1. CCB Membership
a. Voting and non-voting members
b. Voting members - CDISC, FDA, Industry (needs definition)
c. Non-voting member - Vendors
d. How many (one each for voting member)
e. Elections
f. 3 year Terms – rotate one member per year after 3 years for continuity
Rotating chair per year to arrange, every member has to attend the meeting – if can’t attend then reschedule.
o Voting members:
FDA - internal processes to appoint
CDISC - CDISC to appoint
Industry - CRO or Sponsor
• Request for volunteers on WIKI
• Nominations to include relevant experience
• Initial Appointment by members of the group, subsequent appointment by other members of the board
2. Decision Making Process


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3. Purpose
To establish a working process and governing body to manage changes to study data conformance and quality checks that support the end goal
of data standardization to enable standard analysis and pooling techniques.
4. Scope
This group will manage a minimum set of checks to support study data submissions (and related data collection checks).
The checks include conformance checks to existing standards and checks to support the usability/analysis of the data.
5. Inputs
Change request form for an individual change that describes
• Type of change (new/modify/delete)
• Rationale for change
• Description / definition (pseudo code?)
• Requestor
• Standard / Version / Domain / Rule identifier (for existing rules)
• Rule categorization (business vs. technical)
• Date of request
• Urgency
6. Deliverables
Assessment of request that includes
• Tracking number
• Decision
Publication schedule
• Urgent change: as required
• Non urgent changes: release every 6 months
i. Alongside the CDISC version release
7. Success criteria
• Transparency
• Documentation of information and processes in one view
a. Metrics
8. Definitions & acronyms
• Versioning: major vs. minor releases (discuss)
• Meetings: monthly teleconferences

Group Agenda




Group Discussion




Group Findings




Group Follow up






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Last revision by Hany.aboutaleb,04/11/2012