Supporting documentation for studies

Before submitting your study for all necessary approvals you will need to prepare your supporting documentation.  This includes preparation of a full protocol, information sheets for all participants, consent forms and other necessary information (such as invitation letters, questionnaires etc).

In addition, the following documentation is required for submission for HRA approval to enable participating NHS organisations in England to assess and confirm their capacity and capability to deliver the research:

  • completed HRA Schedule of Events (SoE) and Statement of Activities (SoA) templates for non-commercial studies; templates  and guidance on their completion can be found here.
  • for commercially sponsored studies, completed   NIHR Industry Costing Template and the commercial template agreement(s) must be submitted. 

Protocol

The research protocol forms an essential part of a research project. It is a document that describes, in detail, the plan for conducting the study. The study protocol explains the purpose and function of the study as well as how to carry it out and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes. 

The HRA is in the process of developing a suite of protocol guidance and templates for different study types.  Currently a draft template is available for qualitative studies only.  Further detail can be found on the HRA website.

 

Participant Information Sheets and Consent Forms

The Participant Information Sheet and Consent Form are key documents and a major consideration during ethical review.  These are the documents that will explain your study to potential participants and help them to make an informed decision as to whether to participate.  The preparation of you Patient Information Sheets and Consent Forms will be dictated by the design of your study and the participants involved, as it may be necessary to prepare multiple types of information sheet (e.g. for patients, for carers, for children of different age groups).  Guidance on the content and considerations for preparing participant information sheets and consent form can be found on the HRA website.

 

If you are inviting participants to participate in your study by post, you might also consider preparing a summary information sheet (1-2 page) to accompany your invitation letter.

 

Participant Invitation Letters

Depending on the design of your study it is common for participants, particularly in primary care, to be invited to take part in the study by post.  You will therefore need to prepare appropriate invitation letters which can be put on appropriate headed paper and sent out by the participants clinician to allow patients to express an interest in the study.  You should consider:

  • What are you telling them about why they have been approached? (as searches on practice systems may be broad – are you inviting patients who “might” have the condition being studied rather than those who have a confirmed diagnosis?). 

  • Is it clear where study visits are being held? (if they have to attend the hospital, this should be made clear)

  • How participants reply – who will they contact?  How will responses be collated?

  • Will you need to follow-up on any invitation letters and how will you do this?

 

You may want to consider PPI input into design of any patient facing material and the overall approach to participants.

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