Clinical Research: essential information

Please note that the CTRG pages are currently under development.
If you have any questions please contact elaine.chick@admin.ox.ac.uk

Legislation and Guidance Documents

Clinical researchers must comply with an extensive range of legislation and guidance, including:

Guidelines for Good Clinical Practice (GCP) (380kb)
Department of Health Research Governance Framework for Health and Social Care 2005
Data Protection Act 1998
Mental Capacity Act 2005
Human Tissue Act 2004

In addition, for Clinical Trials of Medicinal Products:

Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments 2006a, 2006b, 2008 and 2009

And, for Clinical Trials of Medical Devices:

The Medical Devices Regulations 2002
CTRG facilitates compliance through advice, support, guidance and training to researchers on activities such as
  • writing  protocols, information sheets and consent forms
  • ethics, Medicines and Healthcare products Regulatory Agency (MHRA) and NHS approval submissions
  • clinical trial planning
  • safety reporting

Please contact CTRG as early as possible when you are planning your study.

Throughout your study CTRG will need copies of relevant study documentation and updates including  amendments and progress reports to ethics or the MHRA. We will extract the information we need and thus avoid regular requests for information the University is obliged to collect as Sponsor.

How to classify your study

The Medicines and Healthcare products Regulatory Agency (MHRA) have an algorithm [PDF document] to help you decide whether your study is a Clinical Trial of a medicinal product and governed by statute. If you remain unsure about your trial, CTRG staff will be happy to advise you.

What is Good Clinical Practice (GCP)?

GCP is an international ethical and scientific quality standard for designing, conducting and reporting trials that involves the participation of human subjects. Compliance provides public assurance that the rights, safety and well being of trial subjects are protected, and that the Clinical Trial data are credible. GCP is consistent with the principles of the Declaration of Helsinki.

Costing your research

For information on costing your research, including advice on Full Economic Costing (FEC) considerations, please see  How to cost a research project. Clinical Researchers should contact the Medical Research Services team for assistance.

Grant applications

For information on the grant application procedure, including a step-by-step guide, and instructions on how to use the online submission systems of the major funders, please see Applying for funding. Clinical Researchers should contact the Medical Research Services team for assistance.

Sponsorship

The Sponsor

  • takes legal responsibility for initiation and management of the study
  • provides insurance for the study
  • is required for all clinical studies not just trials
  • is not necessarily the funder. Many funding bodies are unable to provide sponsorship

The University usually assumes Sponsorship when a University employee has designed the study and is acting as the Chief Investigator. The University must actively consent in writing if it is to act as Sponsor.

If you would like the University to sponsor your study, please contact CTRG as early as possible. As a minimum:

  • at the time of funding application for Clinical Trials of an Investigational Medicinal Product.
  • at least 5 working days before submission of an ethics application for all other clinical research.

CTRG will need the following documents:

IRAS full dataset and site-specific information forms, see https://www.myresearchproject.org.uk/Signin.aspxdownload instructions (628kb)
Detailed Protocol
Participant Information Leaflet
Informed Consent Form
Principal/Chief Investigator CV (NRES format)
GP Letter (if applicable)
Advertisement(s) including texts of email or radio adverts (if applicable)
Confirmation of Funding
Independent peer review, if applicable (i.e. if you do not already have an independent review as part of your funding application or project development. A template is available.)

CTRG will review documentation prior to ethics submission and ensure that any insurance issues are addressed.

Ongoing sponsorship is subject to the following:

  • All substantial amendments are approved by CTRG before submission to a REC or the MHRA
  • Non substantial amendments including changes in end date, recruitment numbers and sites are notified to CTRG
  • All Annual Progress Reports, Development Safety Update Reports (Trials only) and End of Trial/Study notifications must be copied to CTRG

Hosted studies

For studies sponsored by other organisations which will be carried out on University premises, a non NHS SSI form  must be submitted to the local Research Ethics committee. CTRG require the above documents for review before authorising your SSI form.

CTRG will advise on indemnity statements required on the ethics application form and the Participant Information Leaflet.

The study will be entered on the CTRG database which is used for generating Annual Returns for the insurance company.

Insurance and Indemnity

For most studies, CTRG can confirm indemnity within the letter of Sponsorship. However, certain categories of trials and studies must be referred to the University insurance office for individual consideration. CTRG can do this for you. These are any research involving:

Children under 5 years old
Investigation of processes of conception/contraception
Participants who are pregnant
Participants from outside the UK
Administration of drug/device/vaccine which has been designed, developed or manufactured by the University
Any genetically engineered product
CTRG will liaise with the Insurance Office to determine whether cover can be arranged and, if so, any potential cost.

Unless your study is on the CTRG database, indemnity is not assured. It is important that both the ethics application form and the Participant Information Leaflet include the correct indemnity statements. This is assessed individually on review of the study or trial. CTRG will advise on the appropriate wording.

Confidentiality

Most Clinical Research Studies require the processing and/or storage of personal and sensitive information. The Data Protection Act 1998 legislates for the control and protection of personal information relating to living individuals including both facts and opinions about the individual. It is important that you comply with the Act and process/store all personal information in accordance with it.

The Information Commissioner's Office provide guidance on determining what is personal data.

If your research involves the use of patient-identifiable information without consent, you will need to apply to the National Information Governance Board for Health and Social Care (NIGB). Applications can be made via the Integrated Research Application System (IRAS) application process.

Oxford University Hospitals pathology access and approvals for research

Research studies that will be using the OUH NHS Trust Pathology & Laboratories services must go through the following process (58kb).

Oxford Laboratory Medicine has been set up to facilitate access to pathology services, expertise and bioresources and ensure that research use of pathology resources are costed and charged appropriately. This applies to all studies using this service, commercial and non-commercial. For all OUH and University sponsored studies this should be addressed at the protocol development stage.

Central University Research Ethics Committee (CUREC)

CUREC is concerned with policy decisions relating to practice, procedures and guidelines for the approval and monitoring of projects involving human participants which are undertaken by members of staff and/or student members of the University.

Beneath CUREC are two Inter-Divisional Research Ethics Committees (IDRECs):

  • Social Sciences Division IDREC, broadly covering research in that division, and the Humanities and Mathematical, Physical and Life Sciences Divisions
  • Medical Sciences Division IDREC, broadly covering research in that division.

Between them those committees scrutinise research projects involving human participants which fall outside of the scope of the NHS ethics approvals system, e.g. student questionnaire or observation studies in a non-NHS setting and from September 2011 studies only involving NHS staff as participants.

The Committee does not review studies which involve human participants recruited within an NHS environment or using NHS resources or if the study falls under the remit of the NHS research ethics committees.

Oxford Tropical Research Ethics Committee (OxTREC)

The Oxford Tropical Research Ethics Committee (OxTREC) is composed of lay and expert persons concerned with the ethical review of the University's research projects conducted overseas. The committee was set up to provide ethical review for research studies conducted outside of the European Union by University employees. If your study falls into this category please contact Jacqueline Gerencser (OxTREC Administrator) for further information.