Table 1.

PORTAL Process Model: Governance Components, Guiding Principles, and Effects on PORTAL

GUIDING PRINCIPLES ADDRESSED	DESCRIPTION	PURPOSE	EFFECT ON PORTAL
GOVERNANCE COMPONENT: DECISION-MAKING PROCESSES
I A, II A, IV A	Included site PIs and other stakeholders from the steering committee in decision-making in all areas of governance and guideline setting	Facilitated collaboration and preemptively avoided conflicts that could slow progress	Helped PORTAL to establish a governance structure by Month 6 of an 18-month project
IV D			Allowed time to apply guidelines and adjust when necessary or desired
GOVERNANCE COMPONENT: PROJECT GOVERNANCE
II B–D	IRB structure (lead and cede)	All sites agreed on a lead IRB (usually lead PI’s site), and other sites cede study oversight	IRB approvals and ceding for the CDM across all took a mean of 25.9 days and a median of 18.5 days to complete; about 150 days for CER cohort approvals
II B, IV C	Subcontracting by using prenegotiated templates	Lead site assumes responsibility for sending subcontracts using prenegotiated language; this expedites participating site execution	Subcontracts executed for all but one participating site in just over 2 months
I A, IV A–C	PI selection for new scientific opportunities	Ensured consistent, transparent, and rapid response to new scientific opportunities	Investigators used the process for PI selection; lead PIs for obesity studies identified in 4 days
I C, II C, III B, IV A and B	Authorship and co-authorship for manuscript	Set expectations for lead authors, co-authors, and use of sites’ data in publications	Investigators submitted manuscript proposals; once approved, all site investigators were invited to be co-authors fostering scientific collaboration and maintaining a culture of sharing scientific credit
GOVERNANCE COMPONENT: DATA GOVERNANCE (is part of governance structure but not the only part)
II B–D, III A	Reciprocal Data Use Agreement (DUA)	Create and execute a single data sharing agreement that covered all study activities at all sites	Draft circulated to all sites for comment, incorporated comments into a final draft that was executed by all sites in 12 weeks; by this time sites were poised to begin data sharing
I B, IV B	Analytic Plan Procedures (APP)	Standardizes SAS code development, distribution, and testing, and specifies how participating sites execute, review and return results	Through standardizing the process of writing, testing, and executing distributed code, cohort teams could plan for this process; in addition review procedures enhanced safeguards to protect PHI
I A–B, II B–D	Other data governance tools and processes ○ Standards for Data Exchange and Quality Assurance ○ Data Sharing Matrix ○ PopMedNet Security Specifications ○ Data Incident Response Plan	Created shared expectations for lead and participating sites regarding data sharing, data quality, and response times Specifies what data can be shared with whom, when, and under what circumstances Outlines security measures at the FISMA-compliant hosting site for PopMedNet Outlined a process for notification “cascade” should a data incident (data released or shared outside of the scope of data agreements) occur	Collaboration is made easier through ensuring predictability in data sharing and management processes
GOVERNANCE COMPONENT: ENGAGING STAKEHOLDERS (NONRESEARCHERS) IN GOVERNANCE
III C, IV E	Role of patients, advisory council members in governance	Foster stakeholder support in research activities Contribute to Network sustainability	Increasing over time Difficult to find those with expertise and willingness to contribute in this area Patient stakeholders included in Steering Committee in Phase II