Recruitment and general progress
It is important to have a solid plan for recruiting participants for your study. This will help you achieve your sample size within the agreed timescale.
As part of your recruitment strategy, it is important to consider:
- What type of communications you will need with colleagues, if you need their help.
- Whether you will need access to any internal or external systems, such as a database.
- What you can do to recruit across a wide range of areas and populations. It is important to have an inclusive approach and to give more people the chance to take part.
Our research staff can support recruitment if your project is adopted onto the NIHR portfolio. The NIHR Study Support Service can also potentially provide support.
If you are leading a study that involves external research sites, you should track their progress. This means making sure all recruitment is recorded and they are reaching their targets. We recommend booking catch up meetings with each site and regular communication to offer support.
Data collection
It is important to collect data in line with the requirements of the study protocol. This includes collecting the correct data items securely and to the study timescales. See creating study documents for more information on data security.
If you are collecting data from other sites, we recommend you regularly check for data quality and completeness during the study. You should not leave this until the end of the study when it may be more difficult to resolve any missing data.
Adverse events, reactions or deviations
- It is important to record any adverse events (AEs), adverse reactions (ARs) and protocol deviations that occur during your study. A definition of AEs, ARs and protocol deviations, and how quickly each one must be reported, is in our SOP (Standard Operating Procedures).
- If you contact tewv.researchanddevelopment@nhs.net our team can provide a template form for AEs, ARs and protocol deviations.
- With AEs and ARs it is important to promptly record the details. This includes recording whether participant safety or data quality has been affected, and if the AE or AR is thought to be related to the study.
Monitoring visits
All studies sponsored by our trust are monitored, usually by a member of the research and development team. This is described in our Standard Operating Procedures (SOPs).
Monitoring helps ensure research is conducted as per the protocol, SOPs and the principles of Good Clinical Practice. It also provides useful learning points.
If the sponsor or an auditor arranges a monitoring visit of your study, you may be asked beforehand to help prepare. For instance, you may need to arrange access to the study records where appropriate, or to find some desk space for the Monitor. You must be available for at least part of the day during the monitoring visit. This is so you can help with any queries and discuss any immediate feedback.
After the visit, the Monitor will prepare a report for discussion with the local research team. They may book a meeting to discuss the findings with you.
Finances
Some studies may need payments, such as grant-funded research studies. If you need to arrange a purchase order for a payment or order, contact tewv.researchgrantscontracts@nhs.net to confirm the details. You will be given a cost code to reference.
Please do not hesitate to contact us if you want to check the status of the study finances.
