Nonclinical specimens

Records, raw data, and specimens from a nonclinical laboratory study must be retained for whichever of the three time periods indicated above is shortest. An exception is made for those nonclinical laboratory studies that support an application for an IND or an IDE, for which records must be retained for a minimum of 5 years after the results of those studies are submitted to FDA. 

The function of clinical chemistry in toxicology (as well as in human and veterinary medicine) is to provide, via laboratory analysis, evaluations of the qualitative and quantitative characteristics of specific endogenous chemical components present in samples of blood, urine, feces, spinal fluid, and tissues. The purpose is to help identify abnormal or pathological changes in organ system functions. The most common specimens used in clinical chemistry are blood and urine, and many different tests exist to test for almost any type of chemical component in blood or urine for example, blood glucose, electrolytes, enzymes, hormones, lipids (fats), other metabolic substances, and proteins. The tests used were all initially applied to human clinical medicine, and may not possess the same utility when performed as part of nonclinical toxicity studies in a wide variety of other species. 

Details of the GLPs and GLP inspections may be found on government-specific websites. Many are listed in the references below. Briefly, the FDA GLPs, define the scope of the regulation and have a detailed listing of definitions. If the FDA is to consider a nonclinical laboratory study in support of an application for a research or marketing permit, the testing facility, records and specimens must be available for inspection by an authorized employee of the FDA. 

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 off-site data storage locations need to be indexed and documented so that this information is easily obtainable. In either case, the FDA requires that documentation records, raw data, and specimens pertaining to a nonclinical laboratory study shall be retained in the archive(s) for a period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted in support of an application for a research or marketing permit. With the exception of investigational new drug applications or applications for investigational... 

A laboratory that conducts nonclinical laboratory studies must provide space for the storage of raw data and specimens from such studies. Access to the archives must be controlled. This is best accomplished by providing a lockable area and by defining in the laboratory s SOPs who has access to archive materials and under what conditions (e.g., use only within the archives or check-out rights). 

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. 

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