Laboratory safety data

Laboratory safety data When the CRFs arrive at the data manager s office, questions will arise relating to laboratory safety data. Queries may occur at the investigator site and advice can be requested from the pharmaceutical physician associated with the clinical trial in the sponsor company. 

There are several different kinds of laboratory safety data that require interpretation. These include routine screening for study subject selection, diagnostic evaluation of the subject, identification of risk factors, monitoring the progress of the disease or treatment, detection of adverse reactions, determination of appropriate dosages for certain at-risk subject groups (e.g. those with renal impairment). 

In general, the interpretation of laboratory safety data is undertaken for the following... 

Laboratory safety data can be erroneous, and this must always be considered when abnormalities are reported. There are numerous sources of error, which may be related to the study subject (e.g. self-medication, certain foods, undue exercise), sample collection technique, storage and transport, the analytical technique used... 

Individual study subjects may have to be withdrawn from the trial if abnormalities in laboratory safety data are confirmed and considered... 

Laboratory safety data can be erroneous, and this must always be considered when abnormalities are reported. There are numerous sources of error, which may be related to the study subject (for example, self-medication, certain foods, undue exercise), sample collection technique, storage and transport, the analytical technique used (for example, high variability, inappropriate reference ranges, interfering substance in the sample), or to the report (for example, transcription errors). Some of the sources of error are listed in Table 6.4. When there is doubt about the validity of the test, it should be repeated and, if necessary, at a different laboratory. 

Another important issue one should keep in mind that the safety data provided by manufacturers for their devices, with due validation by a third certifying authority are laboratory results. Laboratory safety data, provided by manufacturers may be useful predictor safety data pertinent to control system but real world installed safety is... 

Besides lead, there may be a variety of other substances that a worker may be exposed to. Earlier in this chapter we mentioned the possibility of mobile laboratories. If your site does have a mobile lab, there are a variety of other regulations that should be considered. Of course, hazard communication comes into play. A typical laboratory can have volumes of material safety data sheets in its libraries. Besides hazard communication, you should determine whether a chemical hygiene plan is a requirement. In addition, we need to consider how the laboratory might affect the site emergency plan. 

Cleaning for fluorine service. It is important that materials that may contact elemental fluorine be thoroughly cleaned to remove any traces of grease or other substance that may ignite on contact with fluorine. Furthermore, it is important to passivate all surfaces that may contact fluorine. Refer to the manufacture s fluorine material safety data sheet for more information. The assembled anodes used in the laboratory were degreased by refluxing overnight with trichlorotrifluoroethane in an oversized Soxhlet extractor. 

Additional information may be had on storage of chemicals from several sources. Material Safety Data Sheets, for example, have specific instructions with regard to storage. The local fire inspector will have good suggestions, and much can be found in reference books. Above all, the laboratory operator should throughly familiarize himself with all chemicals to be used in order to develop a safe storage system. 

At the laboratory stage, data on substances involved and their mixtures must be gathered material properties, physicochemical data, ecological and toxicological data, costs of raw materials and intermediates, an estimate of product price, energy and equipment costs, etc. These data are needed in simulation programs and to determine toxicity, safety, and impact on the environment. The data on toxicity, degradability, and safety are required by the authorities to execute an approval procedure for the plant. 

Health and Safety Manual, Lawrence Livermore National Laboratory, 1991-1996 Lange s Handbook of Chemistry, JA Dean, J Dean, McGraw Hill, 13th edition, 1985 Loss Prevention in the Process Industries, FP Leed, Butterworth-Heinemann, 1992 Material Safety Data Sheets (MSDS) CD-ROM, Sigma-Aldrich-Fluka, 1995 (subscription)... 

H. Safety considerations. The Occupational Safety and Health Administration (OSHA), US Department of Labor, standard entitled Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450) makes it necessary to address safety issues in the SOP. The standard requires laboratories that use hazardous chemicals to maintain employee exposures at or below the permissible exposure limits specified for these chemicals in 29 CFR Part 1910, Subpart Z. Hazards associated with any specific chemicals used in a method must be addressed so that the user has the information needed to follow the Chemical Hygiene Plan for their laboratory. The method developer should limit the use of hazardous chemicals where feasible. The use of toxic and/or carcinogenic reagents should be avoided or eliminated as much as possible. Additionally, the cost of disposal is increasing and could impact the practicality of a method. Material Safety Data Sheets for the analyte(s) and any unusual or hazardous reagents should be provided for the user. 

Canada Minister of National Health and Welfare, Laboratory Centre for Disease Control, Office of Biosafety. Material Safety Data Sheet-Infectious Substances Clostridium botulinum. January 23, 2001. 

List Biological Laboratories, Inc. Material Safety Data Sheets (MSDSs) for Bacterial Toxins. http //www.listlabs.com. 2006. 

ADEs and medication errors can be extracted from practice data, incidents reports from health professionals, and patient surveys. Practice data include charts, laboratory, prescription data, and administrative databases, and can be reviewed manually or screened by computer systems to identify signals. A method of ADE and medication error detection and classification has been presented that is feasible and has good reliability (Marimoto et al. 2004). It can be used in various clinical settings to measure and improve medication safety. 

Drug Levels in Plasma. Drug levels may also be measured in a clinical trial. Such levels are usually part of a pharmacokinetic analysis but also provide important safety data. This information would be particularly relevant in cases of suspected or actual drug overdosage, drug interactions, to correlate medicine levels with toxic events, or in other situations. It must be clarified whether free levels of the drug and/or the protein bound will be measured by the laboratory. 

Comparison of laboratory test data with results of open air long-term experiments. Ecotoxicol Environ Safety 7(4) 390-399. 

Every activity in the laboratory should be assessed for the potential hazards involved and all the relevant information should be presented in a standard format known variously as procedure hazard forms or material safety data... 

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