Title of Collaborative Activity: |
Clinical and Translational Science Awards (CTSA) Regulatory Knowledge Key Function Committee |
Description of Collaborative Activity: |
The CTSA Regulatory Knowledge Key Function Committee will promote the protection of human subjects and facilitate communicating shared regulatory compliance issues and improvements. Clinical research regulation issues addressed may include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, safety and regulatory management and compliance, etc. CTSAs can disseminate best practices that reduce or remove institutional impediments to clinical and translational research which would enhance inter-institutional collaborations. Regulatory support provided through a CTSA should assist investigators in their regulatory process and documentation requirements. The CTSA Regulatory Knowledge Key Function Committee will also ensure that collaborative clinical and translational research activities are facilitated, whether by procedures or best practices, in developing the Regulatory Support interactions with the IRB and compliance office without loss of participant protections. |
Type of Collaborative Activity: |
Select Type of Collaborative Activity
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Year the Collaborative Activity Originated: |
2008 |
NIH Participating Institutes/Centers/Office of the Director: |
CC, NCI, NCATS, NHGRI, NIAID, NIBIB, NICHD, NIDDK, NLM, OD |
HHS Agency Collaborators on this Activity: |
FDA |
