The PCORI Board of Governors approved this addition to the Methodology Standards for a public comment period in October 2017. The public comment period took place between October 30 and December 29, 2017, and the final standard was approved by the Board in April 2018.

View the Final Standards

View the Draft Proposed Standards for the Public Comment Period

 

Submitted Public Comments

Submitted Time

11/20/17 9:47

IR-7: In the study protocol, specify a data management plan that addresses, at a minimum, the following elements: collecting data, organizing data, handling data, describing data, preserving data, and sharing data.

This seems like standard Data Safety and Monitoring Plan, often overseen by a DSMB.

Name and Organization

Bill Riley

Community

Stakeholder

Stakeholder Community

Policymaker

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Submitted Time

12/29/17 15:40

General feedback on the Standards for Data Integrity and Rigorous Analyses

Overall, the standards are quite useful and appear consistent with extant high quality data management approaches. However, for many implementation studies, it often is extremely difficult to conform to the high standards of a DMP as described. Therefore, the data collection and quality plan needs to be tested in the real setting in which it will be deployed. This should be done in advance so that problems can be foreseen and mitigated. Nowhere is this more important than in community based participatory research and other types of field research in low resource settings. Additionally, funders should acknowledge that adhering to these standards often requires substantial resources of time and money that should be allowed for in proposals.

Name and Organization

Lisa Simpson, MB, BCh, MPH, President & CEO, AcademyHealth

Community

Stakeholder

Stakeholder Community

Health Researcher

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