Protomechanics. Guide for preparing and conducting clinical research study.
PROTOCOL CHECKLIST FOR INITIAL REVIEWS
This checklist serves as a guide to investigators to assist in the submission of items necessary for IRB review. Please consult your IRB office for requirements that may be specific to your Institute.
NIH-1195 – CLINICAL RESEARCH PROTOCOL: INITIAL REVIEW APPLICATION | |||||
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________ |
Completed NIH-1195: "Clinical Research Protocol: Initial Review Application" | ||||
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________ |
Abbreviated Title (30 characters or less, including spaces) | ||||
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________ |
Precis (Attach a summary of the study objectives, study design, and outcome measures of the protocol in 400 words or less) | ||||
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________ |
Physician Referral Required | Yes _____ | No _____ | ||
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________ |
Associate Investigator and Institute Clinical Director Approval Initials (NIH-1195 must be initialed by all AI’s; AI’s from Institutes other than that of the Principal Investigator must have their Clinical Director initial the NIH-1195) | ||||
CLINICAL RESEARCH TYPE (CHECK ONE) | |||||
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________ |
Screening | ||||
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________ |
Training | ||||
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________ |
Natural History | ||||
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________ |
Clinical Trial: | phase I ___ | phase II ___ | phase III ___ | phase IV ___ |
PROTOCOL SECTION HEADINGS | |||||
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________ |
Precis | ||||
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________ |
Table of Contents/Outline | ||||
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________ |
Background/Introduction | ||||
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________ |
Objectives | ||||
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________ |
Study Design and Methods | ||||
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________ |
Study Design (initial evaluation procedures and screening tests, phases, procedures and sequence of study) | ||||
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________ |
Details of Experimental Treatment | ||||
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________ |
Participant Inclusion and Exclusion Criteria | ||||
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________ |
Monitoring Subjects and Criteria for Withdrawal of Subjects from the Study | ||||
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________ |
Analysis of Study | ||||
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________ |
Human-Subject Protections | ||||
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________ |
Rationale for Subject Selection (prevalence/population data/statistical considerations, justification for exclusions, and recruitment strategies) | ||||
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________ |
Evaluation of Benefits and Risks/Discomforts | ||||
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________ |
Consent and Assent Processes and Documents | ||||
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________ |
Appendices (if applicable) | ||||
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________ |
References | ||||
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________ |
Pages Numbered Consecutively | ||||
OTHER ADMINISTRATIVE OR COMMITTEE REVIEWS | |||||
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________ |
Radiation Safety Committee (RSC) | Yes _____ | No _____ | ||
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________ |
Radioactive Drug Research Committee (RDRC) | Yes _____ | No _____ | ||
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________ |
Institutional Biosafety Committee (IBC) | Yes _____ | No _____ | ||
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________ |
Recombinant-DNA Advisory Committee (RAC) | Yes _____ | No _____ | ||
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________ |
Food and Drug Administration (FDA) | Yes _____ | No _____ | ||
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