Any medicinal products used in your research study must be manufactured, packaged and labelled according to good manufacturing practice (PDF) (even though your study is not CTIMP governed by the regulations).
Most studies will need a full review by a REC. However, studies with 'no material ethical issues' may apply for proportionate review which is usually complete within two weeks of submission. Further information, a toolkit to check eligibility and submission details are available on the HRA website.
Although REC review is not required for research limited to use of previously collected, non-identifiable information, even from NHS patients, CTRG do need to be aware of the research and review the documents on behalf of the University.
Please note that if the research is being conducted within the NHS in England permission through HRA is needed. If however it is conducted in Scotland or Wales (or Health and Social Care (HSC) in Northern Ireland) NHS or HSC management permission for each NHS/HSC research site is needed.
Guidelines from the International Committee of Medical Journal Editors (ICMJE) require most clinical research studies to be listed on a public register before they can be considered for publication.
This applies to 'any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcome'. Interventions include drugs, surgical procedures, devices, behavioural treatments, dietary interventions and process-of-care changes. Health outcomes include any biomedical or health-related outcomes including pharmacokinetics and adverse events.
If you are unsure whether your study needs registration, contact CTRG for advice.
The University has an account with the clinicaltrials.gov registry, which provides online, searchable access to the public. Registration cannot be created until all regulatory approvals are in place. Please email email@example.com if you would like an individual user account, including the CI’s full name, title, work phone and email address.
A research master file (RMF) should be compiled as soon as possible. We recommend that all study documents be filed together, in a coherent format, in order to enable ease of access. Our research master file index template can be adopted for your study:
Design of a clear case report form (CRF) and a system for recording and storing data electronically are essential aids to GCP compliance.
The CRF should include all the fields of data that are covered in the protocol.
Use of software specially designed for constructing databases is not essential. The SOP template includes guidelines on the construction of a spreadsheet:
A database should:
- have a written specification (what it is intended to do)
- be secure but accessible by those authorised to do so
- have a clear audit trail (what data additions and amendments have been made, when and by whom)
- be validated (tested) as 'fit for purpose'
Each individual involved in conducting a study should be qualified by education, training and experience to perform his or her respective task. This applies to the chief/principal investigator, and to any staff to whom accountability is delegated. The chief investigator is responsible for ensuring all staff are appropriately trained for their role.
Training includes the protocol, relevant SOPs and GCP training. All training must be recorded and records accessible for monitoring, inspection and auditing.