Protocol

How to prepare a protocol for a clinical trial (CTIMP) or clinical research study

A protocol is one of the essential documents (PDF) required for a clinical trial (CTIMP) or clinical research study and must be drafted early in the design process.

The protocol describes in detail the objectives, design, methodology, statistical considerations and organisation of the research and will act as a ‘manual’ for the research team to ensure adherence to planned methods. As the research gets underway, it can be used to monitor progress and evaluate study outcomes.

The protocol should go into as much detail about the research project as possible, to enable the Research Governance, Ethics & Assurance Team and all bodies to which you are submitting for approval to understand what you intend to do. It is also essential in order for the Research Governance, Ethics & Assurance Team to check that appropriate insurance cover can be provided.

Although you may have a protocol prepared for a funding application, there are additional aspects that you need to consider before submission to an ethics committee and to regulatory bodies. You should follow the University Core SOP 2 (see our Resources page ) and use the GCP-compliant protocol templates for clinical trials and clinical research studies. 

If you are submitting your research proposal to CUREC for ethical approval please see the MS IDREC application process page for protocol information.

For a full list of protocol templates see our Resources page.

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A clinical trial (CTIMP) protocol must comply with the requirements of the Medicines for Human Use (Clinical Trials) Regulations.

Using the GCP-compliant protocol templates (below) will ensure that all aspects of the research procedures have been considered, including the requirements for protocols from the Declaration of Helsinki (2013, clause 22). The Research Governance, Ethics & Assurance Team can review your protocol for compliance.

Alternatively, you can refer to Section 6 of the ICH Guidelines for Good Clinical Practice (GCP) (PDF) for an outline of the requirements.
 

Data privacy

If you handle personal information about individuals, you have legal obligations to protect that information under the General Data Protection Regulation (GDPR).

Please refer to the University's guidelines on data protection and research, and the University policy on data protection.

Information governance

The Information Governance Office provides guidance on information security. For more information on how this applies to medical research please see the Medical Sciences Division's website.

 

If the research has not been reviewed by the funder via a competitive process to ensure quality then an independent peer review should be submitted.

 

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

 

You will need to ensure document control throughout the review procedure.

The SOP template can be adapted to suit your study or department:

 

This is one of the most important aspects of a clinical trial protocol, and is also required for interventional clinical research studies.

It is possible to adopt risk-adapted approaches to safety reporting. Consider whether the burden of reporting can be reduced without compromising safety:

  • If your research uses a licensed medicine, do you need to gather data on non-serious adverse events?
  • If there are foreseeable serious adverse events (eg due to disease progression) can these be documented in the protocol to avoid the need for immediate reporting?

In both cases they must be clearly stated in the protocol approved by the MHRA (clinical trials only) and REC.

The safety section in protocol templates provide guidance on this, and the Research Governance, Ethics & Assurance Team will advise in the course of the sponsorship review process.

The regulations require that all serious adverse events (SAEs), unless excluded in the protocol, are reviewed by an appropriate safety monitoring committee.

If there is no trial-specific or department-specific safety monitoring committee, the Research Governance, Ethics & Assurance Team may be able to make arrangements for your SAEs to be reviewed by the Oxford University Hospitals NHS Trust/University Trial Safety Group.

Contacts

RGEA TEAM  

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