Clinical Research Institute HUCH offers monitoring services, or regular quality monitoring, for investigator-initiated clinical studies.
Clinical Research Institute HUCH offers monitoring services, or regular quality monitoring, for investigator-initiated clinical studies. Monitoring is performed in accordance with currently valid rules and regulations, Good Clinical Practice (ICH-GCP), and the standardized instructions of Clinical Research Institute HUCH.
The aim of monitoring is to ensure:
- Subjects’ rights, safety, and well-being
- Research yields reliable and high-quality scientific data
- Research is conducted in accordance with the research plan, Good Clinical Practice, and official regulations
- Monitoring is an integral part of quality assurance in clinical research, and when it is done well, monitoring supports researchers in their efforts to conduct high-quality clinical studies. The lead researcher is responsible for arranging monitoring of researcher-initiated studies, and it is recommended to contact a study monitor early on in the planning process.
A monitoring agreement is drafted. It includes a monitoring plan and cost estimate. The monitoring plan defines the scope and nature of monitoring in cooperation with the researcher, based on a research risk assessment.
The first monitoring visit is done before the research subjects are recruited. This ensures that the essential permits, resources and researcher file are in good shape when the research center is ready to start the study.
During the study, monitoring visits are made as agreed in the monitoring plan. The number of visits depends on factors such as number of study subjects, recruitment rate, risks involved in the study, and the amount of data to be collected. The first proper monitoring visit to a research center is made soon after the first subject has entered the study to ensure smooth start of the research.
At the end of the study, a closing visit is carried out to ensure the completion of data collection, finalize issues and review the archiving plan.
Study Monitor Leena Partanen, tel. 040 669 2853, ext-leena.partanen (at) hus.fi