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-1195-1 CLINICAL RESEARCH PROTOCOL: CONTINUING
REVIEW APPLICATION
|
________ |
Completed NIH-1195-1: "Clinical
Research Protocol: Continuing Review Application" |
________ |
Current Précis
(Attach a summary of the study objectives, study design, and
outcome measures of the protocol in 400 words or less.) |
CONTINUING REVIEW PROGRESS MEMO
|
The continuing review progress memo
should include the following elements: |
________ |
Description of protocol progress |
________ |
Subject accrual demographics for
past year and previous years |
________ |
List of amendments made to the protocol
over the previous year |
________ |
Explanation of any "yes"
responses on the NIH-1195-1 form |
________ |
Discussion of any new information
obtained from this or related protocols or from literature review
that may affect risk or benefits to subjects |
________ |
Additions or removal of Principal
Investigator, Medical Advisory Investigator, and/or Associate
Investigators from the protocol |
________ |
Justification for continuation of
protocol based on the results of treatment thus far, including
specific end points of the protocol |
________ |
List of relevant publications or
abstracts |
BODY OF PROTOCOL
|
________ |
Current Précis |
________ |
Current protocol consolidates
multiple amendments made to the protocol over previous year |
PROTOCOL CONSENT AND ASSENT DOCUMENT
|
________ |
Current consent and assent documents
printed from the World Wide Web at URL http://www.cc.nih.gov/protocolconsents/ |