5.2.01 Evaluation programme Estimated reading: 1 minute 173 views Authors Download the VA as PDF Download Goal and purpose Develop, implement and maintain an evaluation programme (development process) to demonstrate the quality of the services provided on an ongoing basis. The scope, organisation, range, control and documented information are defined. Definition of the development phases, risk assessment, evaluation procedures (validation, verification), responsibilities and authorisations for development, management of the departments involved in development. Determination and recording of development inputs, development evaluation, release Area of application Integration of new and existing processes into an established quality management system, Application of new procedures/methods in established clinical processes, e.g. the introduction of robotics in surgery and telemedicine, Reorganisation of clinical processes as a result of demand-driven performance, e.g. vaccination during pandemics, Reorganisation of processes due to unsatisfactory results, e.g. high rate of post-operative infections, Reorganisation of clinical processes as a result of serious adverse events, e.g. increase in drug-related side effects, Design of clinical trials (according to 7.3.1 note 2 of DIN EN 15224) Description of the Resources Risks Documentation Responsibility and qualification Notes and comments Applicable documents Literature Terms Attachments Annual development planDevelopment teamsConflicts of interest 5.2 Analysis and validation - Previous Clinical Trial Manual Next - 5.2 Analysis and validation 5.2.02 Design planning (development inputs)
