Good Clinical Practice , Code

Today, clinical trials must adhere to nationally and internationally agreed codes of good clinical practice, which define ethical and scientific standards. Good clinical trial design and conduct should apply scientific methods. Skilful analysis can never correct for poor design. The purpose of the trial should be defined and specific hypotheses stated in the written study protocol, which will also include details of how the trial will be conducted. Errors in the data have two components, purely random errors and systemic errors or bias, which are not a consequence of chance alone. Randomisation of subjects is important both to avoid observer bias and to prevent or minimise the influence of unknown factors that might influence the results. 

Good Clinical Practice A Question and Answer Reference Guide. Waltham, MA PAREXEL International, 2005. This 420-page spiral hoimd guide provides answers to more than 400 GCP-related questions. Additional reference material in the volmne includes relevant portions of Title 21, Code of Federal Regulations, selected ICH guidehnes, and the European Chnical Trials Directive. 

The code of Good Clinical Practice was established to ensure subject safety and arose because of biases inherent in clinical research (e.g. pressures to recruit subjects for payment, publication, etc.), which needed some counterbalance. It is hoped the reader... 

U.S. Code of Eederal Regulations Title 21 Part 58, Good Laboratory Practice for Non-Clinical Studies. 

The system must provide the ability to print various inventory, sample, and pre- and post-dispensing labels. All labels should include a bar code and printed text with the pertinent batch and/or lot information. Labels must comply with GMP-GLP (good laboratory practices) requirements to meet the needs of both laboratories and clinical manufacturing. Labels should be available in multiple sizes to accommodate laboratory sample containers as well as production drums. 

Such support can involve responding to complaints about promotional activities, which may come from other companies or external agencies such as, in the UK, the Prescription Medicines Code of Practice Authority. A medically qualified person should certainly have overall responsibility for clinical drug safety issues (see Section 9.3.6). Pharmaceutical physicians are usually involved in the training of sales representatives. In addition, a good pharmaceutical physician can be a credible ambassador for the company when lecturing to external audiences or dealing with the communication media. 

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