5.2.04 Clinical-experimental research program Estimated reading: 1 minute 38 views Authors Aim and purpose If a new product (treatment method) is developed by the organization or if it participates in a new development, an appropriate study program is drawn up. Clinical studies should be conducted in accordance with the applicable rules of clinical research. A research department is commissioned to carry out the study in accordance with the rules of "Good Clinical Practice (GCP)" Application Description of the procedure Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2 Analysis and validation - Previous 5.2.03 Verification from the literature Next - 5.2 Analysis and validation 5.2.05 Ethics Committee
