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PLANREFERENCE OUTLINE
GLP Study Plan
Nonclinical GLP study plan defining objective, test system, test/reference items, Study Director and QA responsibilities, procedures, and archiving. Maps to OECD GLP and 21 CFR Part 58.
REGULATIONS MAPPED
OECD Principles of GLP21 CFR Part 58
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A GLP study plan (protocol) that defines a nonclinical safety study’s design, conduct, and responsibilities before work begins — the controlling document for a compliant study.
What's Inside
✓Study objective and design
✓Test system and test/reference items
✓Roles — Study Director, QA, personnel
✓Experimental procedures and schedule
✓Records, data capture, and archiving
How to Use It
1Define the objective, design, and endpoints
2Specify the test system and item characterisation
3Assign the Study Director and QA oversight
4Detail procedures, sequence, and records
5Approve before the experimental start date
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Study Identification and Objective
2Test System and Test / Reference Items
3Study Director and Personnel Responsibilities
4QA Program and Inspections
5Experimental Design and Procedures
6Schedule and Key Dates
7Records, Data, and Archiving
8Approvals
REGULATORY CONTEXT
The OECD Principles of GLP and 21 CFR Part 58 require an approved study plan with a named Study Director and QA oversight. This template captures the controlling elements those principles demand.