Forms and Documents

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Investigator Guidance

• HRP-910 INVESTIGATOR MANUAL
• HRP-800 INVESTIGATOR GUIDANCE - Investigator Obligations
• HRP-802 INVESTIGATOR GUIDANCE - Informed Consent
• HRP-803 INVESTIGATOR GUIDANCE - Documentation of Informed Consent
• HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations
• HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations
• HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations
• HRP-813 INVESTIGATOR GUIDANCE - Additional ED Obligations
• HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations
• HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations
• HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations
• HRP-817 INVESTIGATOR GUIDANCE - Additional ISO 14155 Obligations
• HRP-818 INVESTIGATOR GUIDANCE - Additional HHS Obligations
• HRP-820 INVESTIGATOR GUIDANCE -  Quality Improvement Activities in Health Care
• HRP-821 INVESTIGATOR GUIDANCE - Is it Human Subject Research?
• HRP-822 INVESTIGATOR GUIDANCE: IND Applicability Checklist

 

General Guidance, Tools & Definitions

• Definitions
• External IRB Reliance
• HRP-900 – BROCHURE:  Should I take Part in Research
• Public Data Sets
• Data Use Agreement Toolkit
• Deception in Research
• FERPA and Research with Student Records
• Investigator Requirements for Retaining Research Data
• Is it Human Subject Research
• Research as class requirements
• Types of Consent

 

Templates

• TEMPLATE Exempt Information Sheet
• HRP-500 CONSENT TEMPLATE
• HRP-501 CONSENT TEMPLATE: MINIMAL RISK
• HRP-502 - TEMPLATE Consent for Emergency Use
• HRP-503 - TEMPLATE Consent Short Form
• HRP-504 - TEMPLATE Protocol
• HRP-570-TEMPLATE Data Use Agreement
• Patient Consent for Publication - Generic