Governance and Good Clinical Practice
Governance - Roles and Responsibilities
When doing research in Leeds on LTHT patients we (research teams, the sponsor, LTHT) have an obligation to ensure patients are treated ethically and safely at all times. R&I have a responsibility to make sure all the legal hurdles have been jumped before you start then researchers and sponsors have an obligation to follow the agreed protocol and collect the agreed data. The outcome should then ideally be a robust data set answering a relevant medical question.
No-one person can do everything in a trial. To be successful specific tasks within a trial – from set up through to archiving, need to be delegated appropriately from the sponsor all the way through the trial team. Initially a contract between the sponsor and the host organisation will delegate who does what at a high level as well as describe the costs. A series of template agreements exist for use in the NHS and are available from the UK Clinical Research Collaboration website.
Please contact R&I for information on contracts as early as possible in your study approval process. Identifying the correct template will speed up any negotiations. Please note in LTHT we prefer to use unmodified template agreements.
Once the contract is agreed – locally the Principal (lead) Investigator should delegate trial specific task to his team – this must be documented in a delegation log. See the key support documents page for a template you can adopt for your own use.
Risk and Mitigation
All trials carry some risk to the researchers, the patients, the sponsors and the hosting organisation. Protocols are designed to minimise these risks, which is why sponsors often wish to check via monitoring that the protocol is being followed. If you are leading your own trial we will ask you to complete a risk assessment before we accept sponsorship, which can be accessed here in the support documents.
Monitoring and Inspection
If you are working on a drug trial you may be monitored by the R&I team or by the sponsor and you may even be inspected by the MHRA. They will be checking to ensure you have followed the protocol and the terms of the contract have been adhered to.
Here are just some of the sorts of findings you will want to avoid if monitored or inspected!
- Filing of trial paperwork incomplete, inappropriate or non-exisitent!
- No record of sponsor amendment approval.
- No entries in the patient notes matching date of consent/visit schedule.
- No evidence of timely review of medical results.
- Safety reporting not in line with protocol.
- Can't match the data in the database to the source/patient notes.
- No clinical confirmation of eligibility in the data set or the notes or both.
- No description of how samples are collected, stored, transported or processed.
- No contract in place with 3rd parties contributing to the study.
If these findings are present you are potentially putting patient safety at risk and are unlike to be generating reliable data. Please see our key support documents page for guidance on how to manage you trial before and after approval.
Good Clinical Practice (GCP)
Any one working on a research trial in LTHT should be working to the standards of Good Clinical Practice described in the Research Governance Framework (2005) and if you are working on a drug trial as described in UK law in the Medicines for Human Use (Clinical Trials) Regulation SI:1031 2004 and subsequent amendments.
The standards of GCP described in these two documents are the same but when working on a drug trial they are legally binding and are what you will be inspected against.
GCP training is available through several sources that are recognised by the LTHT R&I as equivalent and can be accessed via the R&I training page.
GCP ensures patient safety and supports high quality data collection – if you are doing one of these well then the other will follow.