Quick Reference Guides & Downloads

Browse our library of reference guides and downloads to quickly answer your on-the-job questions. You'll find information categorized by the key stages of a research study in alignment with Good Clinical Practice (GCP).

Recruitment & Consent

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Recruitment & Consent

Considerations, Community Engagement, & Informed Consent

Approval & Compliance

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Approval & Compliance

Initial Approvals, Continuing Reviews, & Maintaining Regulatory Binders

Subject Visits & Operations

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Subject Visits & Operations

Data Entry, AE/SAE Reporting, & Subject Interaction Best-Practices

Study Design & Funding

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Study Design & Funding

Study Design, Background Research, & Funding/Reporting Requirements

Monitoring & Management

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Monitoring & Management

Monitoring Best-Practices, Corrective Action Plans, & Personnel Transitions

Ethics & Misconduct

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Ethics & Misconduct

Historical Events, Current Principles, & Regulatory Best-Practices

Study Initiation & Closeout

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Study Initiation & Closeout

Study Agreements, SIV's & Study Closure Procedures

Regulatory Templates

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Regulatory Templates

Standardized Templates for Common Regulatory Forms & Study Logs