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