Writing your protocol and supporting documents

You will need to ensure that all your documentation is ready before you apply for your approvals. This may include preparation of the following:

Protocol
Information for Participants including (but not limited to):

• Participant Information Sheet
• Participant Consent Form
• Participant Invitation Letters / Reminder Letters
• Other recruitment materials such as posters, adverts, flyers etc
• Questionnaires
• Clinician information sheets
• Interview Topic Guides
• Data Collection Sheets

All supporting documents must be labelled with a date and version number. These enable tracking of changes. Any changes to these documents after your study approvals have been obtained must be accompanied by a change in version number and date and will need to be approved by or notified to the bodies that originally approved your study. Please see page on amendments for more detail.

You will already have thought carefully about your recruitment strategies when you designed the study, so you will need to ensure that all recruitment materials are designed at this stage. It will save you time later on if you have all recruitment materials ready at the start, and get them approved by the REC and R&D even if you don’t expect to use these until later down the line. Further information on recruitment of patients can be found here.

Protocol

A document that describes the objectives, design, methodology, statistical considerations, and organisation of a trial.
The Medicines for Human Use (Clinical Trials) Regulations 2004

The research protocol forms an essential part of a research project. As your research ideas develop into a workable study a written protocol will help to formalise your ideas and gain feedback from others through peer review. A well written protocol is also necessary for your applications to funding bodies and ethics and research governance committees. The protocol can also act as a manual for members of the research team to ensure they adhere to the methods outlined.

Guidance on writing a research protocols is available on the Research Design Service. It can also be helpful to look at the REC and R&D application forms which you will need to submit as these can help to focus your thinking on particular areas such as ethical issues and recruitment of your patients.

Designing Information for Participants for Use in Research

Documents which will be used by research participants (including information sheets (see below), invitation letters, questionnaires, recruitment posters etc) need to be written in simple, non-technical terms and be easily understood by a lay person. The text should be clear, in an appropriate font style and size, and manageable, with large sections of unbroken text being avoided.

Involving the public in the design of your materials will help to assess understanding and readability.

It can also be helpful to test your text using one or more readability tools such as the Gunning Fog Index (see Box below)

Participant Information Sheets

Participant information sheets are key to ensuring your potential participants are fully informed about your research and will influence whether a participant wishes to take part in your study, particularly if you are relying on postal recruitment when this may be the first approach a participant has had about your study.

The participant information sheet needs to clearly set out why the research is being carried out, what will be involved for the participant and what the potential risks and benefits are to taking part, and must be tailored to the population you are studying. You may need multiple information sheets for different groups such as participants / carers; cases / controls; parents / children.

The National Research Ethics Service provide a comprehensive guide to participant information sheets and what should be included.

Contact for Complaints

Researchers should be aware that all complaints related to the study need to be reported through the Trust / PCT complaints systems, this is in addition to any study specific requirements. Participants should be informed of this via the participant information sheet.