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New Submissions (Protocol and Site) |
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| Protocol Initial Submission Form |
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| PI & Site Initial Submission Form |
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| Protocol and Site Submission Checklist - Biomedical Studies |
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| Protocol and Site Submission Checklist - Non Biomedical Studies |
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| Investigative Location Form (Site & Study Staff Information) |
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Informed Consent (ICF) Template |
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| Informed Consent / Authorization Agreement Template |
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CR, Site Status and Termination Reporting |
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| Continuing Review / Termination Guidelines for Completion |
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| Continuing Review / Submission Checklist |
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| Continuing Review / Termination Submission Form |
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| Site Status Report |
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Modifications and Recruitment Submissions |
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| Recruitment Material - Submission Form |
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| Modifications & Revisions Submission Form |
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SAE, UAP, Prompt Reporting Events |
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| SAE & Protocol Deviations Submission Form |
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| Unanticipated Problems (UAP) Submission Form |
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CRRI Investigator Handbook and Sponsor Instructions |
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| Investigator's Handbook (Contact CRRI for password) |
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| Terms of IRB Oversight (for Sponsors) |
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Schedules and Fees |
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| IRB Meeting Schedule 2008 |
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| Fee Schedule 2008 |
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Other Forms or Documents |
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| IRB Statement of Compliance Memo |
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| IRB Oversight Waiver (Appendix 2) |
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| Indemnification Agreement Template |
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