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Category: Regulatory
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Managing Review & Quality Assurance of NCATS Prior Approval Packages A presentation discussing the activation of the new NIH eRA Human Subjects System (HSS). The activation presents an opportunity to consolidate and simplify the submission, review, and approval of Prior Approval requests that involve human subjects research conducted through NCATS UL1 pilot projects and KL2 scholar projects.
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Data and Safety Monitoring Plans and Monitoring Groups/Board All clinical trials supported by NIH should have some form of monitoring based on a Data and Safety Monitoring plan (DSMP). Look here for examples of monitoring plans based on level of risk .
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Standard Operating Procedure – NCATS Prior Approval for Human Subjects Research Process This SOP was implemented as of 5/1/16 and applies to:
-TraCS pilot grantees whose grants were awarded after 5/1/16 and whose project involves human subjects; and
-KL2 and TL1 scholars appointed after 5/1/16 whose primary research project involves human subjects.
-TraCS pilot grantees whose grants were awarded after 5/1/16 and whose project involves human subjects; and
-KL2 and TL1 scholars appointed after 5/1/16 whose primary research project involves human subjects.
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Standard Operating Procedure - NCATS Prior Approval for Vertebrate Animal Research This SOP was implemented as of 7/3/18 and applies to:
-TraCS pilot grantees whose grants were awarded after 5/1/16 and whose project involves vertebrate animals; and
-KL2 and TL1 scholars appointed after 5/1/16 whose primary research project involves vertebrate animals.
-TraCS pilot grantees whose grants were awarded after 5/1/16 and whose project involves vertebrate animals; and
-KL2 and TL1 scholars appointed after 5/1/16 whose primary research project involves vertebrate animals.
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