Biomedical Files
Files for biomedical submissions
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Biomedical Application
- Application for biomedical submissions to the IRB
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Biomedical Application Submission Checklist
- Items needed to be included with the submission to the IRB
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Biomedical Application Instructions
- Instructions on how to submit a biomedical application to the IRB
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Biomedical Assent Template
- Assent template to be used for all biomedical studies with children over age 7
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Biomedical ICF Template for Biorepositories
- Consent Template to follow for all biorepositories
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Biomedical ICF Checklist
- Checklist to follow when creating the biomedical consent
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Biomedical Drug Rechallenge ICF Template
- Use to determine if event caused by study drug
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ICF template log
- Log for changes to the ICF template
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Biomedical Preamble Template
- To be used for waiver of signed informed consent
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Biomedical Pregnancy ICF Template
- To be used if a subject becomes pregnant and follow up is needed
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Biomedical Specimen ICF Template Checklist
- Checklist to follow when creating the specimen consent
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Biomedical Specimen ICF Template
- Checklist to follow when creating the specimen consent
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Case Report ICF Template
- Consent Template to follow when creating a case report
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Case Report Application
- Application for case report submission
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Additional Co-Investigators and Research Staff page
- If you need to add additional personnel, please use this page and attach it to the application
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Appendix B
- Research Involving Pregnant Women/Fetuses/IVF
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Appendix C
- Prisoners As Subjects
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Appendix D
- Children as Subjects
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Appendix E
- Drugs and/or Biological Products
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Appendix F
- Use of Devices in Research
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Appendix G
- Conflict of Interest
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Appendix H
- Tissue and/or Specimen Banking
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Appendix I
- Use of Protected Health Information (HIPAA)
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Appendix J
- Informed Consent Waivers
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Appendix K
- Request for Exemption
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Appendix L
- Request for Expedited Review
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Appendix M
- Off Site Recruitment of Research Subjects
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Appendix N
- IRB Authorization Agreements
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Appendix O
- Sponsored Study Billing Information
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Review Certification Form
- Human Studies Review Certification Form
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Biomedical Assent Template
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Biomedical ICF Template
