Clinical research studies
Study preparation requirements for clinical research studies
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.
REC review is not required for research limited to use of previously collected, non-identifiable information
In cases of that data being obtained from the NHS/HSC, however, the data is still governed by the UK Policy Framework for Health and Social Care Research. This means that the research must have University sponsorship (via the Research Governance, Ethics & Assurance Team) and NHS/HSC permission.
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 the Research Governance, Ethics & Assurance Team 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 RGEA.Sponsor@admin.ox.ac.uk if you would like an individual user account, including the CI’s full name, title, work phone and email address.
If there is involvement of any third party, then you may require contracts and agreements to be in place. The Research Governance, Ethics & Assurance Team, together with the Research Funding & Contracts Team, can help identify what agreements (if any) are required.
Trial master file (TMF) 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 trial master file contents 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.
