Regulatory Requirements

The FDA GLP regulations are a Quality Standard for the conduct of regulated studies specifically delineated in the Scope (§58.1) of Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). The FDA expects the GLP regulations to be followed to the extent practicable for Animal Rule studies, to include the model defining natural history studies. There are several partnering Guidance for Industry documents that provide FDA’s current thinking on best approaches and expectations for the conduct and oversight of regulated studies. The ORNcS (both the Regulatory Science and the Regulatory Operations branch) can help navigate compliance requirements for study design, conduct, and oversight.  

Below is a summary table of the types of documents required to satisfy overarching requirements. Study records should be transparent and allow for reconstruction of all study-related activities.

Studies Conducted Under a Quality System Using GLP as a Reference Standard

Requirement

Accomplished via:

Planned

Study plan (protocol*) signed by Sponsor and Study Director*

Performed

Performed by trained personnel according to written procedures (referred to as Standard Operating Procedures or SOPs)

Monitored

Inspected by independent Quality Assurance Unit (QAU)

Documented

All raw data and observations recorded and retained

Reported

Results summarized in a final report

Archived

Protocol, SOPs, training records, raw data, observations, deviations, final report are securely stored

*Definitions (per GLP regulations):
Protocol = Approved document that clearly indicates the objectives and all methods for the conduct of the study. [Subpart G, Section 58.120 (a) ]
Study Director = Individual responsible for the overall conduct of a nonclinical laboratory study. [Subpart A, Section 58.3 (m) ]

Quality Agreement

ORNcS Regulatory Operations can help with the development of Quality Agreements for industry- or government-funded contracts that may not have a strict regulatory compliance requirement but require a formal quality system infrastructure.  A Quality Agreement may be included as part of the Sponsored Research Agreement to ensure clear definition of deliverables related to study planning, record keeping, data handling, data review and/or verification, and reporting of findings.