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Clinical safety officer

In anticipation of the introduction of risk management requirements under 1EC80001 (or in case of expansion of the scope of the Medical Devices Directive), the NHS Connecting for Health (CfH) Chnical Safety Group commenced creating and training a network of Trust based Clinical Safety Officers to assist in the safety management tasks associated with new systems deployment. [Pg.163]

These CSOs are to be supported in 2010 by the formation of IT Clinical Safety Officers within each Strategic Health Authority (SHA). [Pg.163]

The CfH Chnical Safety Group has in place a team of safety engineers and Regional (Northern and Southern) Clinical Safety Officers who will provide a centre of excellent for IT safety engineering in support of Trusts and SHAs. This national infrastracture will be available to health organisations to assist with compliance planning for 1EC80001. [Pg.163]

This rule varies from state to state. Some materials are exempt from Nuclear Regulatory Commission or State licensing requirements. Most institutions already have an institutional license which would specify the safety officer. It would be well for the clinical chemistry laboratory to check with this individual before beginning to use radioactive materials. If there is no license, many manufacturers of isotope materials will assist the laboratory in obtaining the proper license. [Pg.67]

FDA investigators compare information that clinical investigators provided to sponsors on case report forms with information in source documents such as medical records and lab results, says Carolyn Hommel, a consumer safety officer in DSI. [Pg.249]

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... [Pg.346]

Study coordinator. See also CCRC, CRC. Supervisory Consumer Safety Officer Society for Clinical Trials Standard deviation... [Pg.542]

Reporting has been revised, such that incorrect narcotic counts are now dealt with directly by Pharmacy. Infectious disease reports and Occupational Health and Safety (OH and S) problems are tracked through Pubhc Health and OH and S, respectively. Performance management issues are the domain of Human Resources ami not the Office of Clinical Safety Evaluatiou... [Pg.68]

First aid clinic location is important and can usually be accommodated by the gatehouse together with the safety officer s office, both being prominently labelled to enable all personnel to note their location immediately they start work. [Pg.72]

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. [Pg.263]

Many state and federal clinical laboratory (CLIA) programs have included worker safety criteria, and the Canadian Office of Laboratory Security—strengthened in response to the possibility of bioterrorism—has added a laboratory safety division. Based upon these models it seems a reasonable prediction that OSHA will soon launch the process of coordinating and consohdating worker safety laboratory standards into a new and comprehensive code. [Pg.230]


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See also in sourсe #XX -- [ Pg.50 , Pg.150 ]




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Safety officers

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