Study Title Exempt question answered Exemption # if yes – Clinical Trial Questionnaire completed – ClinicalTrials.gov Identifier provided, if applicable Section 2* Conditions or Focus of Study Eligibility Criteria Age Limits N/A if no – Inclusion of Women, Minorities, and Children Recruitment and Retention Plan** Recruitment Status** Study Timeline** Enrollment of First Subject** Inclusion Enrollment Report Section 3 Protection of Human Subjects Multi-site study question answered IRB plan if – “Yes” Clinical Trials Only Data and Safety Monitoring Plan and Safety Monitoring Board” question answered “Data Overall Structure of the Study Team Section 4 (Clinical Trials Only) Brief Summary Study Design all answered – Outcome Measures one for each measure – Statistical Design and Power Subject Participation Duration intervention” question answered “FDA-regulated – attachment provided if “Yes” Dissemination Plan * Skip this section if only Exemption 4 selected for Exemption Number (1.3) ** Skip if selected for the study involve human “No” “Does participants?” (1.4.a.)
Study Title Exempt question answered – Exemption # if yes Clinical Trial Questionnaire completed – ClinicalTrials.gov Identifier provided, if applicable Section 2* Conditions or Focus of Study Eligibility Criteria Age Limits – N/A if no Inclusion of Women, Minorities, and Children Recruitment and Retention Plan** Recruitment Status** Study Timeline** Enrollment of First Subject** Inclusion Enrollment Report Section 3 Protection of Human Subjects Multi-site study question answered – IRB plan if “Yes” Clinical Trials Only Data and Safety Monitoring Plan “Data and Safety Monitoring Board” question answered Overall Structure of the Study Team Section 4 (Clinical Trials Only) Brief Summary Study Design – all answered Outcome Measures – one for each measure Statistical Design and Power Subject Participation Duration “FDA-regulated intervention” question answered – attachment provided if “Yes” Dissemination Plan * Skip this section if only Exemption 4 selected for Exemption Number (1.3) ** Skip if “No” selected for “Does the study involve human participants?” (1.4.a.)
NIH_Review_Checklist_2%20%283%29.docx