Protocol nonclinical laboratory study

Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study Sec. 58.120 Protocol. 

Nonclinical laboratory studies must be conducted in accordance with the protocols. 

Maintain copies of all protocols pertaining to all (nonclinical laboratory) studies for which the unit is responsible. 

List of Required Items for a Protocol of a (Nonclinical Laboratory) Study (From... 

SUBPART G PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDY... 

A protocol is required for each nonclinical laboratory study. Usually a single protocol will cover only one experiment with a single test article in a single type of test system. It is permissible, however, to conduct several experiments using the same test article under a single comprehensive protocol. It is also permissible to study several test articles concurrently using a single common procedure under one protocol. 

In nonclinical research, attention to detail is every bit as important as in clinical development. As Gad (2006) observed, the importance of nonclinical laboratory studies demands that they be conducted according to scientifically sound protocols and with meticulous attention to quality. ... 

Protocol for conduct of a nonclinical laboratory study (subpart G)... 

Every person who is responsible for any part of any GLP study must have the appropriate education, training, and experience, or combination thereof, to enable that person to perform the assigned functions. Each testing facility shall maintain up-to-date records of training, experience and job description for everyone involved in the conduct of a nonclinical laboratory study. There shall be adequate personnel to conduct the study according to the protocol who shall take appropriate precautions to avoid contamination of the test and control articles and the test systems. 

The final report and any amendments, all raw data, documentation, protocols and any amendments, and specimens (with the exception of specimens subject to degradation) generated as a result of a nonclinical laboratory study shall be retained in an archive. The archive facility needs to be set up for orderly storage and expedient retrieval. Conditions of storage shall minimize deterioration of the documents or specimens. The archives do not necessarily have to be an in-house facility the laboratory may contract with commercial archives to store materials in a GLP fashion. 

Any laboratory that conducts nonclinical laboratory studies must provide dedicated space for the storage of raw data, documentation, protocols, specimens, and interim and final reports from completed studies. The laboratory must have an orderly system for storing such material, and that system must provide an expedient method for retrieving of archived materials (e.g., on the request of an the FDA inspector). 

Are all raw data, documentation, protocols, specimens, and final reports generated as a result of a nonclinical laboratory study retained ... 

Parts 58.120 and 58.130 address the protocol and conduct of the nonclinical laboratory study. The FDA judges whether or not the facility s protocol is generated, approved, changed, or revised in conformance with the GLPs. The overall test system monitoring, specimen labeling, and data collection procedures must be described for the EIR. 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

It is very likely that incomplete or missing records would prevent the verification of data integrity. Source records should be complete to facilitate an understanding of actual study conduct for critical phases of method development, method validation, and subject sample analysis. The records should confirm whether the testing was conducted in an appropriate manner, with well-designed and optimally controlled experiments. The documentation of actual laboratory events should demonstrate that the quantitative measures are suitable to achieve the objectives of the clinical or nonclinical protocol. The records should confirm that the reported results accurately reflect the actual concentration of the analyte in the biological matrix. It should be noted that the failure to adequately document critical details of study conduct has resulted in rejection of bioanalytical data for regulatory purposes. 

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