GB/T 22275.2-2008Requirements of conduct for Good Laboratory Practice (GLP) -- Part 2: The role and responsibilities of the study director in GLP studies (English PDF)

4.1 Project Leader tasks

4.1.1 The project leader is the sole controller of research and, ultimately responsible for the overall, the implementation of scientific research. This is the project leader Main task. Obligations and responsibilities of GLP principles are derived from the provisions of this major task. Experience has shown that only the correct research the delegate responsibility to a specific person responsible, because in order to avoid the researchers received conflicting instructions which led to poor research program carried out. At any given time there may be only a project leader for the study. Some responsibilities project leader may be appointed Pies, such as in sub-contract the study, but the project as a single person in charge of the final control center's research responsibilities can not be delegated.

4.1.2 In this regard, the project leader should ensure that science, management, regulatory and other aspects of the study are controlled, through the coordination of the project leader tube Managers, research and (or) technical personnel and quality assurance programs to control research.

In the multi-site study involved more than one test site, the person in charge of the control if the project can not be implemented under the direct supervision, of the research process 4.1.3 You can give a trained, qualified and experienced personnel, is the project representative. Project on behalf of the person in charge of the project in accordance with the applicable GLP principles to study the implementation of a specific phase.

4.1.4 From a scientific point of view, the project leader is usually responsible for the design and approval of research plans, supervise data collection, analysis and reporting Technical experts. According to the project leader in charge of the final total draw conclusions. As the chief technical specialist, project leader should cooperate with other Technical experts and (or) project coordinated by the representative, they found that in order to understand the research process, receiving and evaluating their respective reports and studies Include in its final study report.

4.1.5 From a management perspective, the project manager should be responsible for the application of resources (such as personnel, equipment and facilities) and coordination to ensure Expected research process can be carried out properly.

4.1.6 ensure the implementation of regulations and consistent research is the project leader responsibilities. In this role was project leader responsible for ensuring RESEARCH