Читать книгу Risk Assessment - Marvin Rausand - Страница 141

Most study objects have to comply with a number of laws and regulations. Many of these give requirements related to health and safety, and some of them require that risk assessments be performed. It is important that the study team is familiar with these laws and regulations, such that the requirements are taken into account in the risk assessment.

Risk assessment standards and/or guidelines have been developed for many types of study objects and application areas (see Chapter 20). Internal requirements and guidelines given by the organization that performs the risk assessment may also need to be adhered to. The study team must be familiar with these standards and guidelines.

The number of documents required to support a risk assessment may be substantial. A document control system should therefore be established to manage the various documents and other information sources. This system must control the updating, revision, issue, or removal of reports in accordance with the quality assurance program to ensure that the information remains up to date.