3. Creating study documents

What documents are needed?

The research application website provides a full list of documents you may need to submit with your research application. See our IRAS top tips page for guidance on how to access this list.

There are some important points to remember about the list:

• Many of the listed documents may not be required for your study.
• Our research and development team can create or assist with several documents. For instance, the Organisation Information Document.
• There are some other documents you will need once your study is open. Our research and development team can help with this. See the study delivery page for more information.

Study Protocol – overview

Every research study must have a protocol.

The protocol document explains the full details of the study. This includes its rationale, objectives and population/data to be included.

It will also include planned activities (such as questionnaires or assessments) and a data collection and analysis plan.

We have created separate guides on our website about data collection and data analysis.

There are some other safety and administrative aspects to include in the protocol as well. For instance:

• safety checks
• confidentiality arrangements
• plan for archiving study documents.

Our research and development team can support you, if it is helpful.

Protocol templates

The HRA (Health Research Authority) provides different protocol templates.

Our research and development team have also developed a more streamlined protocol template that is designed for non-interventional studies. The templates are not mandatory and are provided as useful examples.  For further advice, email tewv.researchanddevelopment@nhs.net

Documents for recruiting participants

If you plan to recruit people to participate in your study, you need to explain this in the protocol. It is important to fully describe:

• The eligibility criteria for who can take part.
• The best way to find people who may be eligible to take part. For instance, you may ask service colleagues to refer people attending appointments and/or use clinic lists and databases. This is where there is appropriate permission in place.
• The best way to approach people who may be eligible to take part. For instance, whether you will approach people when they attend for a routine NHS visit and/or use another approach. This might be sending a study invite letter.

You will also usually need to create a Participant Information Sheet (PIS) and consent form:

• The PIS helps explain the study to people considering if they wish to take part.
• The consent form is used to document the person’s agreement to participate.

There is extensive guidance on developing a PIS and a consent form template on the NHS HRA website. The website also provides quality standards and ethical considerations for participant information. It can also be useful to see if there are good practice tips for these documents from other similar studies.

Your study may potentially need extra arrangements to best support the persons you would approach.  For instance, the involvement of consultees or alternative consent methods. If so, then please review the HRA guidance and speak to research and development for advice.

As well as helping with your study design, Patient and Public Involvement (PPI) can provide invaluable feedback. Such as developing the PIS and identifying how best to support the persons you wish to approach.

The standard arrangement for NHS research is that if a person consents to take part in a study they can still choose later to withdraw if they wish. This ability to withdraw should be clear in the PIS.

We also have the following templates:

• Study invite letter
• GP notification letter (if there is a care-related reason to inform GPs and the person has given their consent for this)

These are generic templates and should be updated to work best for your study.

Peer support

It is good practice to arrange for suitable independent contacts, based outside of our trust, to review your study before you submit your formal research application.

Our research and development team has a peer review template.

The team can advise on potential contacts to approach if you are unsure. All templates can be provided upon request by email to TEWV.researchanddevelopment@nhs.net.

Interview guides and questionnaires

If you plan to use a interviews or questionnaires as part of your study, you should provide copies of the documents you will be using. For instance, your interview schedule guide and/or a copy of the questionnaire.

When you upload each questionnaire to the research application website you will need to confirm if it is a pre-existing, validated questionnaire or a new template you have created.

Documents provided by our research and development team

If your study is sponsored by Tees, Esk and Wear Valleys NHS Foundation Trust then:

• The Organisation Information Document (OID) and Schedule of Event (SoE) documents are only needed if your study involves a research site other than our trust.
• If these OID and SoE documents are required, our research and development team will help create these.
• The other documents listed that relate to sponsorship, contracting and finances in most cases will not be required.
• If your study did have a contracting requirement – for instance a collaboration agreement with another organisation supporting the study – then our research and development team can arrange this for you.

If in doubt about document requirements, please liaise with our research and development team for advice.