• About research support
• Contacts
• News
• Consultations
• Training and professional development
• Find funding
• Major sponsors
• Applying for funding
• Costing and pricing
• Research Facilities and Equipment
• Research contracts
• Consulting activity
• Intellectual Property
• Impact and Knowledge Exchange
• Managing awards, reporting outcomes and Open Access
• Clinical Trials and Research Governance
  • Clinical Research: essential information
  • Clinical Trials
  • Clinical Research Studies
  • Downloads
  • Face-to-Face Good Clinical Practice (GCP) training at Oxford
  • GCP online training course
• Research integrity and ethics
• Research Income and Activity Reports

Clinical Research Studies

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

The University of Oxford as Sponsor requires that all Clinical Research Studies adhere to the Department of Health Research Governance Framework for Health and Social Care 2005. It provides a core standard of quality for research. It includes clinical or non-clinical research undertaken by universities within the health and social care systems that might have an impact on the quality of those services.

• Sponsorship
• Protocol Development
• Participant Information Leaflets and consent forms
• Insurance and Indemnity
• Medicinal Products
• Ethics Application
• Proportionate Review
• NHS Permissions
• Protocol Registration
• Research Master File
• Standard Operating Procedures (SOPs)
• Data Management and Case Report Form Design
• Training
• Written Informed Consent
• Mental Capacity Act 2005
• Substantial Amendments
• Non-substantial Amendments
• Progress Reports - REC and R&D
• Early End/Temporary Halt to Study
• Study Completion
• Archiving
• Publication and Final Report

Sponsorship

Protocol Development

A protocol is one of the essential documents required for a research study and must be drafted early on in study development. It describes in detail the objectives, design, methodology, statistical consideration and organisation of the  study and will act as a 'manual' for the research team to ensure adherence to the planned methods. As the study gets underway, it can then be used to monitor progress and evaluate study outcomes.

As a minimum the Protocol should include the following:

Title

Abstract/summary

Background or rationale of the project

Aims / objectives

Information on participants

Experimental design and methods (including statistical analysis)

Ethical considerations

Resources and costs

The protocol should go into as much detail about the research project as possible, to enable CTRG and the ethics committee to understand your study. CTRG have produced a Clinical Research Study Protocol Template (113kb) that meets governance requirements.

Peer review

If the research study has not been reviewed by the funder via a competitive process to ensure quality then you must provide an independent peer review: Independent peer review template (110kb)

Statistical review

The Centre for Statistics in Medicine may be willing to give you support if you do not have a statistician within your department.

Pharmacy Review

If you are using a medicine in your study, and are planning to use an NHS pharmacy, then they should be included in the protocol review.

Document Control

You will need to ensure document control throughout the review procedure. CTRG have an SOP Template for Document Control (56kb), which can be adapted to suit your study or department.

Participant Information Leaflets and consent forms

It is important that the information given to participants, before obtaining their written informed consent to take part, is clear and concise. NRES (National Research Ethics Service) provides detailed guidelines, use of which will avoid unnecessary delay at sponsor and ethics review. The guidelines are updated from time to time so it is important to use the current version.

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.

Medicinal Products

Any medicinal products used in your research study should be manufactured, packaged and labelled according to Good Manufacturing Practice (even if your study is not a Clinical Trial governed by the Regulations).

Ethics Application

The Integrated Research Application System (IRAS) is used for all new ethics applications.

Clear guidelines are provided by NRES (National Research Ethics Service) on how to complete the form. CTRG staff will be happy to give you advice. Question-specific guidance is available on the IRAS website.

IRAS is a single form-filling system for applying for the relevant approvals from the following review bodies:

Administration of Radioactive Substances Advisory Committee (ARSAC)

Gene Therapy Advisory Committee (GTAC)

Medicines and Healthcare products Regulatory Agency (MHRA)

Ministry of Justice

National Offender Management Service (NOMS)

NHS / HSC research offices

NRES/ NHS / HSC Research Ethics Committees

National Information Governance Board (NIGB)

The forms are web-based and can be worked on repeatedly prior to submission. Documents to submit are itemised on a checklist provided on IRAS. These include:

The protocol

Participant Information Sheet

Informed Consent Form

GP Letter (if any)

Advertisement (if any)

Sponsorship Letter (which includes a statement on indemnity)

Peer review

Study type specific documents such as questionnaires

Once CTRG have approved your application you will need to book a slot for review by an ethics committee. You will be given an REC reference to add to your forms. CTRG will need this reference to issue a letter of Sponsorship and Indemnity approval and the signature page from your ethics application form. Please note that the final forms (without the DRAFT watermark) are generated on the IRAS site via a 'Submission' tab.

CTRG have produced an SOP Template for Ethics Committee Applications V3.1 (51kb) that can be adapted to suit your particular study.

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 NRES website.

NHS Permissions

If your study involves recruitment of staff or patients from an NHS Trust, or uses Trust facilities, you will need to get approval from the relevant R&D Department. A Site Specific Information (SSI) Form must be generated on IRAS and sent  to the NHS Trust R&D office.

Co-ordinated System for NHS Permissions (CSP)

You can use CSP to gain NHS permission if your study

• is eligible for the NIHR CRN Portfolio. You need to complete a short Portfolio Adoption Form (PAF) via IRAS, for which you should receive a response within two working days; or
• is adopted by the Comprehensive Clinical Research Network, the Primary Care Research Network or one of the six Topic-specific Clinical Research Networks;or
• is NIHR-funded through Biomedical Research Centres (BRCs), Biomedical Research Units (BRUs) or Collaborations for Leadership in Applied Health Research and Care (CLAHRCs)

Further information about eligibility and the application process can be found on the NIHR CSP website.

Protocol Registration

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.

Purely observational studies do not require registration. If you are unsure whether your study needs registration, err on the side of caution and seek registration if you might want to publish in an ICMJE journal.

The University has an account with the clinicaltrials.gov registry, which provides online, searchable access to the public. Contact the CTRG Administrator if you would like an individual user account created for you.

Research Master File

A Research Master File (RMF) should be compiled as soon as possible. We recommend that these documents be filed together, in a coherent format, in order to enable ease of access. CRTG have produced a Research Master File Index (59kb) template that can be adopted for your study.

Standard Operating Procedures (SOPs)

It is good practice to have Standard Operating Procedures (SOPs), or equivalent documentation in place for your study and CTRG have a range of templates, including an SOP Template (49kb) that can be adapted by your department.

They cover a range of activities involved in the study conduct and are designed to ensure that practice is standard, regardless of who is carrying out the activity. Staff involved in the study must be trained in the activities for which they are responsible and a clear concise SOP will give guidance on how to perform an activity to anyone unused to that particular procedure.

Data Management and Case Report Form Design

The design of a clear Case Report Form (CRF) and the system for recording and storing data electronically will help researchers comply with the protocol. Early consideration should be given to this. Your 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. You may wish to use Excel. A template SOP Database Design (2,843kb) is available with guidelines on the construction of a spreadsheet. A database should:

• Have a written specification (what it is intended to do)
• Be secure
• Have a clear audit trail (what data additions and amendments have been made, when and by whom)
• Be validated (tested) as 'fit for purpose'

If you need help or advice with the construction of your spreadsheet, please contact CTRG.

Training

The Research Governance Framework (RGF) requires that each member of the research team, including those at collaborating sites, is qualified by education, training and experience to discharge his/her role in the study, and that their qualifications are documented. This applies to the Chief/Principal investigator, and to any staff to whom responsibilities are delegated. The Chief Investigator is responsible for making sure all staff are appropriately trained for their role. Training can range from formal training days, through training provided to individual investigator teams, to independent study.

CTRG organise Good Clinical Practice (GCP) training days on a regular basis. (Please also see the 'What is Good Clinical Practice?' section on our Essential Information page.) Contact the CTRG administrator for bookings and details.

An online GCP course is available free to employees of the University or the Oxford University Hospitals NHS Trust or anyone working on a study sponsored or hosted by either organisation. There are five modules:

• Protocol and Associated Documents
• Applications, Agreements and Approval
• Trial Master Files
• Conducting the Trial
• Safety Reporting

Register via https://secure.admin.ox.ac.uk/rso/gcp/.

If you do not have a system for recording training given, please see our SOP Template for Qualification, Experience & Training of Clin. Res. Personnel (51kb) and a Training Form (20kb) that can be adopted by your team should you wish to do so.

Written Informed Consent

Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to their decision to participate. Written and verbal versions of the information should be presented to the subject detailing no less than: the exact nature of the study; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that they are free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.

The subject should be allowed as much time as wished to consider the information, and the opportunity to question the investigator, their GP or other independent parties to decide whether they will take part.

Written informed consent will then be obtained by means of a dated subject signature and dated signature of the person who presented informed consent. A copy of the signed informed consent form will be given to the subject.

Persons taking informed consent must be appropriately trained and be authorised by the Chief/ Principal Investigator. The participant information sheet should, at all times, reflect the full information available for the study. Any new information should be promptly addressed in an amendment. Following approval by CTRG the amendment must be submitted to the REC and Trust R&D. An SOP Template for Informed Consent (58kb) is available and can be amended for your own use.

Mental Capacity Act 2005

Research Studies involving adults (aged 16 or over) who lack capacity must comply with the Mental Capacity Act 2005. This includes persons with dementia, learning disabilities, mental health problems, stroke or head injuries who may lack capacity to make certain decisions, including consenting to participate in a research study. (Note: the Act does not apply to studies which fall under the Clinical Trials Regulations).

Any research involving a person lacking capacity that would otherwise have required consent from participants may only be lawfully carried out if an NHS research ethics committee (REC) in England or Wales has given a favourable opinion. This includes research that would otherwise fall outside the remit of an NHS REC. The REC can only approve the research if it meets the following criteria:

• the research must relate to the condition causing the mind or brain impairment, or to a condition resulting from or attributed to the mind or brain impairment;
• the research cannot be done as effectively using people who have mental capacity; and
• the research must produce results relevant to the condition (or a similar condition) affecting the person and have small risks or low adverse impact on the person, or it must have potential benefits to the person without disproportionate risk.

The researcher must stop the research if at any time they think that one of the above criteria is not met, unless withdrawal of any treatment as part of the research would impose a significant health risk.

Substantial Amendments

A protocol amendment is required if it is necessary to make changes post approval. A substantial amendment is defined as an amendment to the terms of the protocol or any other supporting documentation that is likely to affect to a significant degree:

1. the safety or physical or mental integrity of the subjects of the study
2. the scientific value of the study
3. the conduct or management of the study

If the amendment is due to safety concerns it may be implemented immediately and an amendment form submitted as soon as possible. In all other cases the sponsor REC and relevant R&D departments must approve substantial amendments before implementation.

Non-substantial Amendments

CTRG must review these amendments in order that they can ensure that indemnity is not affected by the change, for example change of end date or additional sites. However, they do not require REC or R&D approval. CTRG has an SOP Template for Preparation and Approval of Protocol Amendments (59kb) that you can adopt/adapt for this purpose.

Progress Reports - REC and R&D

Annual Progress Reports

A progress report should be submitted to the main REC each year on the anniversary of the date on which the favourable opinion was given as described on the NRES (National Research Ethics Service) website. A copy of each report must be emailed to the CTRG administrator and the relevant R&D Trust (if applicable).

Early End/Temporary Halt to Study

If the study is terminated prematurely or temporarily, it is the responsibility of the Chief Investigator (on behalf of the Sponsor) to notify the REC within 15 days explaining the reasons for this. Please inform CTRG of any such suspension or early end.

Study Completion

Study completion or end of a study is normally considered as the date when the last participant has their last visit (of all sites, if a multi-site study). The definition of end of a study must be clearly described in the protocol. The Chief Investigator must notify the REC, CTRG and relevant R&D (if applicable).

Archiving

The University of Oxford requires that all essential documents be retained for at least 5 years after the completion of a Clinical Research Study or for a longer period if there are other applicable requirements e.g. genetic studies. If the Study involves minors under 18 years old, essential documents should be archived until 3 years after the youngest subject reaches 18 years old, or 5 years after the conclusion of the study, whichever is longer. Please see our SOP Template for Archiving of Essential Documents (55kb).

Publication and Final Report

The Chief Investigator should also provide a summary of the clinical study within one year of the end of the trial to the REC. CTRG have a Final Report Template (42kb) that is available for use. The University is called upon occasionally to provide references to recent publications. Please inform CTRG of the reference when your paper is accepted for publication.

• Back to top
• Recommend this page