21 CFR Part 58 - Good Laboratory Practice (GLP)
Test Articles and Protocol (Subparts F & G)

21 CFR Part 58 - Good Laboratory Practice (GLP) 58.120: Protocol

Each study must have an approved written protocol that clearly indicates objectives and all methods for conduct. The protocol must contain specified elements and be signed by the Study Director.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 211.100 Written Procedures for Production and Process Control

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Test Articles and Protocol (Subparts F & G)

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.