HRPP Toolkit Crosswalk

SOPs/Policies

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Worksheets/Checklists *

• HRP-310 - Human Research Determination

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-311 - Engagement Determination

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-312 - Exemption Determination

Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-001 - Definitions

Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Introduction to IRB
• Video - Navigate the Study Workspace

SOPs/Policies

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Worksheets/Checklists *

• HRP-309 - Ancillary Review Matrix

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

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Templates

• HRP-503 - Protocol Template

Job Aids/Demo Videos

• Video - Developing Research Protocol
• Job Aid - Protocol Documents Overview

SOPs/Policies

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Worksheets/Checklists *

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Templates

• HRP-503a - SBS Protocol Template

Job Aids/Demo Videos

• Video - Developing Research Protocol
• Job Aid - Protocol Documents Overview

SOPs/Policies

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Worksheets/Checklists *

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Templates

• HRP-503b - NHSR Protocol Template

Job Aids/Demo Videos

• Video - Developing Research Protocol
• Job Aid - Protocol Documents Overview

SOPs/Policies

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Worksheets/Checklists *

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Templates

• HRP-508 – Site Supplement to Sponsor Protocol Template

Job Aids/Demo Videos

• Video - Developing Research Protocol
• Job Aid - Protocol Documents Overview

SOPs/Policies

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Worksheets/Checklists *

• HRP-315 - Advertisements

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-316 - Payments

Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-090 - Informed Consent Process

Worksheets/Checklists *

• HRP-314a - Criteria for Consent

Templates

• HRP-502 - Consent Document Template

Job Aids/Demo Videos

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SOPs/Policies

• HRP-091 - Written Documentation of Consent

Worksheets/Checklists *

• HRP-317 - Short Form Consent Documentation

Templates

• HRP-507 - Short Form Consent Template

Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Job Aid - Assign an Ancillary Reviewer (IRB)

SOPs/Policies

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Worksheets/Checklists *

• HRP-410 - Waiver or Alteration of Consent Process

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-411 - Waiver of Written Documentation

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-329 - HIPAA Applicability
• HRP-330 - HIPAA Authorization
• HRP-441 - HIPAA Waiver

Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-013 - LARs, Children and Guardians

Worksheets/Checklists *

• HRP-416 - Children

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-415 - Prisoners

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-412 - Pregnant Women

Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-013 - LARs, Children and Guardians

Worksheets/Checklists *

• HRP-417 - Adults with Impaired Decision-Making Capacity

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-333 - Certificate of Confidentiality

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-334 - AI

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Create and Submit a Single Site Study
• Job Aid - Create and Submit a Single Site Study

SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Create and Submit a Multi-site Study
• Job Aid - Create and Submit a Multi-site Study

SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Respond to a Clarification Request
• Job Aid - Respond to a Clarification Request

SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Create and Submit a Modification
• Job Aid - Create and Submit a Modification
• Job Aid - Modify a Study Site
• Video - Respond to Modifications Required
• Job Aid - Respond to Modifications Required

SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Create and Submit a Continuing Review
• Job Aid - Create and Submit a Continuing Review

SOPs/Policies

• HRP-024 – New Information

Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Video - Create and Submit RNI
• Job Aid - Create and Submit RNI

SOPs/Policies

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Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-801 - Establishing Reliance Agreements
• HRP-806 – Review Request to Rely on External IRB

Worksheets/Checklists *

• HRP-832 - Considerations for Relying on an External IRB

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-830 - Communication and Responsibilities

Templates

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Job Aids/Demo Videos

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SOPs/Policies

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Worksheets/Checklists *

• HRP-833 - Considerations for Serving as the sIRB

Templates

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Job Aids/Demo Videos

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SOPs/Policies

• HRP-804 - External IRB Post-Review
• HRP-805 - External IRB Updates

Worksheets/Checklists *

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Templates

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Job Aids/Demo Videos

• Job Aid - Submit an Invitation to a pSite