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Last Updated: 11/04/14

Table of Key Recommendations & Products

Goal Deliverable Appointed SG Key Recommendations/
Products
Define WG(s) Mission and Operating Framework Define working group (WG) reporting structure — what, frequency, mechanism for issue resolution AWG  
Document that describes the mission and goals of the AWG, communications plan, the frequency of meetings, and desired products and timeline. AWG
Description of what other small groups or SGGs will be needed and their purpose, reporting structure to AWG, and timeline for specifics and deliverables AWG
Agendas and action items from each SG teleconference and face-to-face AWG
SG status reports AWG
Define caHUB Mission, Objectives, Scope of Operations Develop the mission statement for caHUB: Vision, Mission, & Value Proposition SPOS Strategic Plan Document
Develop list of key objectives, distinguishing between short term and longer term SPOS
Define caHUB scope for Phase 1 and 2 (Profile of clients; gap analysis for client’s needs; biospecimen accrual plan (sample types, volumes, sourcing objectives) based on clients' needs; budget/personnel/facilities requirements; ARRA reporting requirements SPOS
Develop the strategic plan document SPOS
Propose and define research and consulting services SPOS
Define caHUB Organizational Structure Develop overall organizational plan:
Org Structure
Management Structure
Governance and oversight committee recommendations
Reporting structures
Proposal on need, organization, and charter for advisory committee(s)
Charters for expert groups
SPOS
Define caHUB Business and Operating Plans Develop tissue collection standard operating procedures Biospecimen Biospecimen Subgroup Key Recommendations
Develop biospecimen qualification criteria:
snap frozen & formalin-fixed, paraffin embedded
Biospecimen
Tissue collection prioritization strategy Biospecimen
Develop quality assurance/quality control process metrics Biospecimen
Bridge requirements/ needs of processes with repository facility attributes. (Review and refine facility plans and metrics/measurements. Building of facility will occur in Phase 2) Facilities Key Recommendation Document
Establish architectural framework that comprehensively illustrates interoperable components of caHUB Facilities
Establish use cases that illustrate the informatics vision for caHUB (high level) Informatics Notional Informatics Architecture (NIA) Document
Provide operational informatics input into activities of other caHUB subgroups Informatics
Address and compile subject matter vocabularies Informatics
Define Ethical, Legal, and Social Issues (ELSI) Preliminary considerations document: Analysis of the ethical, legal, and policy issues surrounding informed consent, privacy, ownership, intellectual property, etc. ELSI Preliminary Considerations Document
Draft informed consent documents (cancer and normal tissues) ELSI
Define Partnering Objectives and Potential Targets.
- Biobanks
- CAP
- FDA
- Pharma
Report on caHUB partnering Objectives customers, needs, cost-recovery potential and ideas, proposed timeline Partnerships Key Recommendation Document
List/profiles of potential partners, list of key assumptions, risks, opportunities for each:
Assess relationship between industry and caHUB
Partnerships
Define Communications Strategies Develop a communications strategy for all stakeholders including description of key stakeholders (intramural, extramural, other government agencies, patients and patient advocacy, private foundations, Congress) and their role in design and implementation of the caHUB Communications Preliminary Communications Plan
Define "Rapid Autopsy" Parameters and the Range of Normal ("Non-diseased") Sample and Data Requirements to Meet Genotype-Tissue Expression Project and Other Identified Market needs Best Practices Document for Rapid Autopsy/Post Mortem Recovery of Normal Tissues (Includes: 1. operational and technical overview of common types of recovery programs, 2. unique ethical and legal considerations, 3. donor family and community considerations, 4. common normal tissue sampling schema, 5. example next of kin informed consent, 6. example materials transfer agreement, 7. common data elements for post mortem recovery) ANT Key Recommendations for Rapid Autopsy/Post Mortem Recovery of Normal Tissues
Manuscript Featuring Recommendations for Rapid Autopsy/Post Mortem Recovery of Normal Tissues ANT Manuscript Featuring Recommendations for Rapid Autopsy/Post Mortem Recovery of Normal Tissues (pending publication)