HRPP
Huron’s HRPP SOPs represent a complete set of tools (Standard Operating Procedures, templates, worksheets, checklists, and databases) designed with the goal of meeting regulatory and accreditation requirements, including:
- Food and Drug Administration (FDA)
- Department of Health and Human Services (DHHS)
- AAHRPP®
- Department of Energy
- Department of Education
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- Department of Defense
- Department of Justice
- Environmental Protection Agency
- Veterans Administration
- International Council on Harmonisation – Good Clinical Practice (ICH-GCP) E6 standard
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This HRPP toolkit incorporates maximum regulatory flexibility consistent with good compliance practice.
These SOPs are comprehensive, brief (<60 pages), easy to follow, completely non-redundant, easy to update and maintain, and readily adaptable to electronic IRB systems. Importantly:
- These documents have been used successfully by organizations applying for AAHRPP accreditation;
- They have successfully been incorporated into electronic IRB systems;
- Unlike most SOPs, these documents are written around business processes (e.g., pre-review, review, post-review) rather than topics (e.g., continuing review, drugs, and protocol deviations), and;
- They reference checklists and worksheets, allowing users to efficiently and effectively make and document regulatory determinations.
Please contact us at hrppsops@huronconsultinggroup.com for additional information.