Monitoring

The purpose of monitoring is to ensure that:

• The rights and well being of subjects participating in the study are protected
• The conduct of the study is in compliance with the current approved protocol/protocol amendments, with Good Clinical Practice (GCP) and with the appropriate regulatory requirements.

Studies will be assessed for monitoring once approval has been given by the Research & Development Dept. Studies that meet any or all of the following criteria may be selected for monitoring:

• Projects for which University is the sponsor
• Clinical Trials using Investigational Medicinal Products (IMPs)
• Randomised studies
• High risk studies, e.g. studies where there is a high risk of Serious Adverse Events (SAEs)
• Suspected Unexpected Serious Adverse Reactions (SUSARs) or studies where the occurrence of SAEs/SUSARs/toxicity measurements is being used as an endpoint
• Large intake studies
• Blinded studies
• Research involving children

These criteria will not, however, be considered exhaustive and studies may be selected for monitoring on the basis of individual circumstances alone. Whilst the criteria above may be used to identify studies, the individual reason for the research department selecting a study for monitoring will not be disclosed.

Staff concerned about study conduct or compliance of a study with GCP/Regulatory requirements may request that a study is monitored by emailing the Research & Development Dept. You can also request a monitoring visit of your own study.

What happens after my study has been identified by the Reserach Management Office (RMO) to be monitored?

Staff from the office will visit the study site at a pre-arranged time to perform the monitoring visit. It is important that during the visit at least one member of the research staff is present at the site. The staff member will not be required to accompany the monitor(s) throughout the duration of the entire visit (unless they wish to) but will need to be available during some parts of the monitoring process to answer questions and in case RMO staff require any assistance. Monitoring will cover all aspects of the study conduct, although particular emphasis will be paid to essential documentation, the Investigator Site File (ISF) or equivalent and consent documents.

The findings of each site visit will be collated and a visit report produced; this report will be sent to the site within 28 days of the visit. The Chief/Principal Investigator (CI/PI) will be required to provide the Research Management Office with a response within 28 days of receiving the report detailing the actions taken/actions to be taken to remedy the findings.

What is an Investigator Site File?

In order for clinical trials to be run in accordance with ICH-GCP (ICH Harmonised Tripartite Guideline for Good Clinical Practice) there are certain essential documents that must be compiled and retained at each study site. These documents serve to demonstrate the compliance of the Sponsor, Investigator and Monitor with the standards of ICH-GCP and applicable regulatory requirements.

To encourage compliance with ICH-GCP and promote successful management of clinical trials within UH Bristol, the Research Management Office has developed a template for an Investigator Site File (ISF). This template is designed to assist Chief/Principal Investigators (CI/PI) in compiling those essential documents required at research sites and creating a central document store and information source in which to file them.

I would like some help in setting up my site file, who should I contact?

We have introduced a new training resource and can offer you or one of your research team practical advice and assistance in setting up your site file in preparation for the start of your study. A mutually convenient time could be arranged in which to do this on site. If you would be interested in this service please contact the Research Governance Officers in the Research Management Office.