PROTOCOL CHECKLIST FOR CONTINUING REVIEWS
NIH-1195-1 – CLINICAL RESEARCH PROTOCOL: CONTINUING REVIEW APPLICATION | |
|
________ |
Completed NIH-1195-1: "Clinical Research Protocol: Continuing Review Application" |
|
________ |
Current Prйcis (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 |
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________ |
Subject accrual demographics for past year and previous years |
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________ |
List of amendments made to the protocol over the previous year |
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________ |
Explanation of any "yes" responses on the NIH-1195-1 form |
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________ |
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 |
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________ |
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 Prйcis |
|
________ |
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/ |
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