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The regulations were originally introduced in 1994 in compliance with European Directive 92/57/EEC and were previously revised in the CDM Regulations 2007. [citation needed] CDM Regulations 2015 define responsibilities according to particular roles from client, designer and contractor. The main changes from the CDM Regulations 2007 are: [4]
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial.The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.
Under the CDM regulation, the client appoints a competent Principal Contractor and CDM coordinator, who notifies the Health and Safety Executive (HSE) by using Form 10 (F10). [9] [10] Failure to do so means the client must take the duties of Principal Contractor and CDM coordinator assigned to the parties under CDM 2007.
Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration. To ensure quality control, these queries are usually addressed and resolved before the CRF data is included by the sponsor in the final clinical study report. Depending on variables relating to ...
Stairway, treads, and walkways must be free of dangerous objects, debris and materials. A registered professional engineer should design a protective system for trenches 20 feet deep or greater for safety reasons. To prevent injury with cranes, they should be inspected for any damage. The operator should know the maximum weight of the load that ...
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