Safety Study Reports

Rasmussen, N. (1975). Project leader. Reactor Safety Study. Report WASH-1400 NUREG 75/014. US Nuclear Regulatory Commission, Washington, DC. 

From a health and safety study report in the United Kingdom, it has been found that, of the total number of accidents involving control systems, 44% resulted from specification-related issues, 15% from design and implementation issues, 6% from installation and commissioning, 15% from O M issues, and 20% from changes after commissioning (indicated anticlockwise in the figure). 

Reactor Safety Study An Assessment of Accident Risks in U.S. Commercial Nuclear Power Plants, Report WASH-1400 (NUREG-75/014), U.S. Nuclear Regulatory Commission, Washington, D.C., Oct. 1975. 

Reports of safety studies must be provided to the regulatory authorities on completion. 12.6.7... 

Surveillance requests are usually targeted at particular concerns, vhich the FDA vill specify as part of the scope of the surveillance order. The manufacturer must submit a plan to the FDA outlining ho v the surveillance vill be conducted. Once approved, the surveillance plan must be put into effect, usually for not more than 3 years, and any reports agreed as part of the plan must be submitted to the FDA. Surveillance plans are quite similar in concept to the safety studies that may be agreed vith regulatory authorities for drugs. 

The study termination form data may be used for efficacy or safety analysis purposes. With regard to safety, if patients discontinue a study medication earlier than patients on standard therapy or placebo, then that is important to know. For efficacy analyses, patients who withdraw due to a lack of efficacy or adverse event may be precluded from being considered a treatment responder or success. Also, often the study termination date is used as a censor date in time-to-event analyses for therapy efficacy. Study termination forms play a key role in patient disposition summaries found at the start of a clinical study report. From a CDISC perspective, the study termination form is a finding. 

In the 12-month safety study (N = 805, 2 1 (alvimopan placebo) randomization) 3 at 0.5 mg twice daily was well tolerated and showed evidence of sustained efficacy when taken continuously for 12 months by patients with nonmalignant pain requiring sustained treatment with opioids. However, unexpectedly, there were more reports of myocardial infarctions in patients treated with 3 at 0.5 mg twice daily compared with placebo-treated patients. The majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of 3, including studies in patients undergoing bowel resection surgery who received 3 at 12 mg twice daily for up to 7 days. A causal relationship with 3 has not been established [29]. 

HSE, Application of QRA in Operational Safety Studies, Health and Safety Executive report 025, 2002, p. 19. 

HSE, Explosion Hazard Assessment A Study of the Feasibility and Benefits of Extending Current HSE Methodology to Take Account of Blast Sheltering, Health and Safety Executive report HSL/2001/04, Sheffield, 2001. 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

Island/Thurrock Area, HMSO, London, 1978. Rasmussen, Reactor Safety Study An Assessment of Accident Risk in U. S. Commercial Nuclear Power Plants, WASH-1400 NUREG 75/014, Washington, D.C., 1975. Rijnmond Public Authority, A Risk Analysis of 6 Potentially Hazardous Industrial Objects in the Rijnmond Area—A Pilot Study, D. Reidel, Boston, 1982. Considine, The Assessment of Individual and Societal Risks, SRD Report R-310, Safety and Reliability Directorate, UKAEA, Warrington, 1984. Baybutt, Uncertainty in Risk Analysis, Conference on Mathematics in Major Accident Risk Assessment, University of Oxford, U.K., 1986. 

A study of the perceived trustworthiness of different sources of information about food safety was reported in the Eurobarometer (1998). It indicated the trust in consumer associations was the highest, followed by national authorities. Overall, sources of information about food safety were least trusted from producers, companies, and market venders. Following is the percentage of respondents perceiving each of the information sources as completely trustworthy ... 

Emmen, H.H., and E.M.G.Hoogendijk. 1998. Report on an ascending dose safety study comparing HFA-134a with CFC-12 and air, administered by whole-body exposure to healthy volunteers. MA-250B-82-306, TNO Report V98.754, The Netherlands Organization Nutrition and Food Research Institute, Zeist, The Netherlands. 

Monsanto s experience with information-gathering and reporting under section 8(d) - Health and Safety Studies - has not been as rewarding as the inventory activity. On July 8, 1978 EPA issued a Final Rule requiring submission of lists and copies of... 

Technical. Additional technical support in companies other than testing personnel will arise from the need for additional recordkeeping, such as the annual reports and TSCA inventory ( 8(a) and (b)), records of significant adverse reactions to health or environment ( 8(c)), records of applicable health and safety studies ( 8(d)), and notices of substantial risk to health or environment ( 8(e)). In larger... 

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