June 15, 2009: Revisions to the “CHECKLIST FOR NEW PROJECT INVOLVING HUMAN SUBJECTS (N)”
Wednesday, June 24, 2009 (586 reads)
The following administrative revisions have been made to the New Protocol Checklist (N): - Question 28b has been revised to request additional information about whether the research will involve the National Institutes of Health (NIH) Genome Wide Association Studies (GWAS) Program.
- Questions 29 regarding use of investigational drug has been revised to confirm if UHCMC Investigational Drug Services (IDS) is to be utilized as part of the study and to request a copy of the IDS Exemption Request Form.
- Question 29 has also been revised to request a copy of the IND/IDE correspondence affirming IND/IDE status from either the FDA or the Study Sponsor.
- Question 35 has been revised to correct the name of the Dahms Clinical research Unit (DCRU).
Please utilize the most current version of the New Protocol Checklist when submitting a new protocol. Failure to utilize the most current version will result in delays in approval process.
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