Collaboration Details

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Title of Collaborative Activity:

Trial Transparency via Registration and Results Reporting at NIH ClinicalTrials.gov

Description of Collaborative Activity:

The purpose of this trans-NIH, inter-agency collaboration is to implement legal and policy requirements related to disseminating clinical trial information and promote understanding of these requirements through engagement with and the development of resources for stakeholders. NLM collaborates with FDA, OD/OSP, OGC, and other parts of NIH to improve transparency of clinical trials via registration and results reporting at NLM's ClinicalTrials.gov through implementing regulatory requirements and NIH trial transparency policies, including the 2016 NIH Policy on the Dissemination of NIH-funded Clinical Trial Information. NLM has also collaborated with OD/OBSSR to develop resources for the behavioral and social science community to support submitting study information to ClinicalTrials.gov and with OD/OBSSR, OD/OSP, OER, OLPA, and OCPL to engage the basic science community and understand their concerns about reporting NIH-funded basic experimental studies with humans to ClinicalTrials.gov.

Type of Collaborative Activity:

Resource Development

Year the Collaborative Activity Originated:

2000

NIH Participating Institutes/Centers/Office of the Director:

CC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, OD/DPCPSI/OBSSR, OD/OER, OD/OLPA, OD/OSP

HHS Agency Collaborators on this Activity:

FDA