Steering committee implementation responsibilities

The current structure of MedDRA is defined in Table 21.6. There will be a central maintenance organization responsible for development, user support, implementation and communication as well as an international user group. A management board will oversee the activities of the central maintenance organization with direction provided by the ICH Steering Committee. A standard medical dictionary will facilitate electronic data exchange between industry and regulatory authorities worldwide, as recommended by the ICH. 

These specificities and many others are changing with the implementation ICH guidelines, for example, the enforcement of the new GCP abolishes the traditional Steering Committee of Investigators, the controller is only responsible to warrant the blindness of the trial. However, it generally takes a long time in Japan to modify such strong traditions, and they will probably still be in practice for some years more. 

The steering committee provides overall direction to the risk management and PSM programs. The committee should be chaired by the facility manager and is responsible for the overall implementation of risk management at the site. Typically, the steering committee will be composed of the following persons ... 

Reporting to the steering committee are subcommittees, one for each of the major elements of the program. Each of these subcommittees will be responsible for the development of a detailed policy for their particular element of the standard within the overall company guidelines, and will also be responsible for ensuring that its element is properly implemented and maintained. 

The implementation of a behavioral safety process usually will be the responsibility of your steering committee. The implementation process outlined in Table 14.1 provides the team with the opportunity to change the checklist to meet particular needs of each area or site. Such additional input will not be necessary if your design team and safety team are the same group. 

Your design team planned the behavioral safety process and will become the steering committee and take responsibility for implementation. 

Continue with this chapter to clarify the responsibilities of steering committees and management for implementing the behavioral safety process within the pilot... 

The steering committee has the primary responsibility for implementing the design team s plans (see Table 14.2). 

Management has several responsibilities for supporting the implementation efforts of the steering committee ... 

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