Effective Date: March 28, 2003
Expiration Date: September 07, 2013
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17.1.1 Number of research proposals reviewed by the IRB.
17.1.2 The number of proposals approved and disapproved by the IRB.
17.1.3 Number of research proposal renewals.
17.1.4 Number of adverse reactions or equipment failures or modifications reported to the IRB by the PI, the IRB Compliance Officer (if mandated), crew surgeon, or other responsible monitors or officials.
17.1.5 Tracking of action item responses from PI's.
17.1.6 Number of IRB letters of reprimand or more serious sanctions imposed.
17.1.7 Number of audits and follow up corrective actions adopted as a result of complaints to the IRB.
17.1.8 Number of official mishap investigations instituted or completed and corrective action taken to avoid repetitions.
17.1.9 Number of cases of research misconduct occurring in IRB-approved protocols.
17.1.10 Number of investigators taking the NASA Bioethics training. Number of first-time training certifications versus number of recertifications.
17.1.11 Number of DSMB reviews, corrective actions, and lessons learned.
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