Clinical Research Institute HUCH Ltd. offers monitoring services, or regular quality monitoring, for researcher-initiated clinical studies.
Clinical Research Institute HUCH Ltd. offers monitoring services, or regular quality monitoring, for researcher-initiated clinical studies. Monitoring is performed in accordance with currently valid official rules and regulations, Good Clinical Practice (ICH-GCP), and the standardized instructions of Clinical Research Institute HUCH.
Monitoring aims to ensure
- the subjects’ rights, safety and wellbeing
- the reliability and high quality of research findings
- that research is conducted in compliance with the research protocol, good clinical practice, and official regulations
Monitoring is an important part of quality assurance in research. When done well, monitoring supports researchers in performing high-quality clinical research. The principal investigator is responsible for arranging the monitoring of researcher-initiated studies, and the recommendation is to contact the Clinical 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 already before the research subjects are recruited. This ensures that the essential permits, resources and Investigator 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. In order to ensure a smooth start for the research, the first proper monitoring visit to a research center is made soon after the first subject has entered the study.
At the end of the study, a closing visit is carried out to ensure the completion of data collection, finalize any unresolved issues, and review the archiving plan.
The Investigator File contains the key documents concerning the research. The purpose of the documents is to demonstrate that the research has complied with the standards of good clinical practice and current regulations.
Forms in accordance with a suggestive table of contents and good clinical practice (GCP) in your Investigator File can be downloaded here:
Investigator File Index
Signature and Delegation log
Subject identification and enrolment log
Drug accountability log
Protocol deviation tracking log
Record of Retained body fluids
Monitoring visit log
Origin of source data