![]() ![]() Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.There is a new form for consolidated human subjects, inclusion enrollment report, and clinical trial information.PHS Inclusion Enrollment Report: Discontinued use (data collection moved to new PHS Human Subjects and Clinical Trials Information form).Updated biosketch instructions so that scholastic performance requires only scientific/professional graduate courses to be listed.Added new "Is this an applicable clinical trial under FDAAA?" field.Included instructions specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring Plan.".Included instructions specific for AHRQ applicants. Updated instructions to Section 3.2 "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" and the single IRB plan attachment. ![]()
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