Clinical research planning
Sponsorship and ethics applications
Sponsorship is required for all Clinical Research under the Research Governance Framework(s), including trials that fall within the scope of the Clinical Trial or Medical Device Regulations. Identification of the Sponsor must be considered early in the planning process. Where the Chief Investigator is employed by OUH, the Trust will usually act as Sponsor.
All research involving human participants, human tissue or human data (unless the data is previously collected, fully anonymised and cannot be traced back to an individual) requires approval from a Research Ethics Committee (REC) prior to any study procedures taking place.
Medicinal products
Any medicinal products used in your research study must be manufactured, packaged and labelled according to Good Manufacturing Practice (even if your study is not CTIMP governed by the Regulations).
Good Manufacturing Practice (pdf) - http://ec.europa.eu
Proportionate review
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 2 weeks of submission. Further information, a tool kit to check eligibility and submission details are available on the HRA website.
NHS Research Ethics Committee (REC) Proportionate Review Service - www.hra.nhs.uk
Research using anonymised data
Although REC review is not required for research limited to use of previously collected, non-identifiable information, even from NHS patients, OUH R&D do need to be aware of the research and review the documents on behalf of the Trust.
Please note: if the research is being conducted within the NHS, you will still need to gain NHS permission.
Protocol registration
Most journals require many studies to have been listed on an independent, free to access, validated public register.
These include:
- trials whose primary purpose is to affect clinical practice
- trials providing evidence of clinical effectiveness or adverse effects
- investigations of the biology of disease
- collection of preliminary data that may lead to larger clinical trials
- device trials.
The trial must be registered before the first patient is recruited.
Acceptable registries include:
Agreements
If any third party (including commercial involvement, facilities or services from an NHS trust or other university) is involved, then contracts and agreements need to be in place prior to trial start.
These include:
- supply of the Medical device
- funding / educational grant
- laboratory and/or pharmacy services
- out-of-hours code breaking services
- emergency medical cover
- participation of other sites (in multicentre studies).
OUH R&D can help identify what agreements are required. The OUH contract team will help put these in place.
OUH R&D Department - Contact us
Research Master File
A Research Master File 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.
OUH R&D has produced a Research Master File Index that can be adopted for your study.
Data management and Case Report Form design
Design of a clear Case Report Form (CRF) and a system for recording and storing data electronically are essential aids to GCP compliance. Whilst many researchers have access to software specially designed for the construction of databases, this is not essential for producing a compliant database.
A database should:
- have a written specification (what it is intended to do) - to be filed in the TMF
- be secure but accessible to authorised users
- have a clear audit trail (what data additions and amendments have been made, when and by whom)
- be validated (tested) as 'fit for purpose'.
Training
Each individual involved in conducting a trial 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.
OUH R&D and the Clinical Trials and Research Governance (CTRG) Team jointly organise GCP training days on a regular basis. Contact the CTRG administrator for details.
Clinical Trials and Research Governance (CTRG) Team - researchsupport.admin.ox.ac.uk
In addition, an online GCP course is available free to employees of OUH and the University of Oxford, or anyone working on a study sponsored or hosted by either organisation.
OUH requires that staff refresh their GCP training every three years.