The objective of monitoring clinical research is to ensure that:
- the rights and well-being of the subjects are protected
- the data from the research that is reported are accurate and verifiable in source documents
- the execution of the study is in accordance with the applicable protocol, Standard Operating Procedures (SOPs), ICH-GCP, ICH-GCP R 2.0, ISO14155 and with the relevant legal requirements
starts supervising the research with the submission and selection of sites. This is followed by monitoring visits and the associated reporting until closure of the study.
New European ethical considerations for research with minors.