RESEARCH ROADMAP
Managing your project
Staying on top of your research project.
Once your study has received all the necessary approvals, there are a few things you will need to be keeping up with while you are recruiting your participants and collecting your data.
Being a Principal investigator
The Principal Investigator (PI) is the clinician responsible for the leadership and conduct of the study at Solent NHS Trust. The PI ensures that the study is conducted in accordance with the study protocol, protects the integrity of the data collected and, most importantly, upholds the safety, wellbeing and rights of all participants.
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The PI can delegate responsibilities to others in their team once they have ensured that staff are appropriately qualified through training and experience to undertake the role they have been delegated. Although the PI may not be working on the study every day, they must remain actively involved in its management through ensuring there is an up-to-date log of staff involved in the study, meeting regularly with the study team, reviewing participant eligibility and reviewing adverse events. Evidence of PI involvement in the management of the study will be requested by study sponsors.
Changes to your study
It is possible to make a change to your study after you have received approval, if you find that things aren’t going to your original plan. Changes to research projects are called amendments. Amendments are processed according to what is being changed, the type of study you are conducting and the organisation(s) that reviewed your original application.
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If Solent NHS Trust is the sponsor of the study, you will need to get in touch as soon as you know you would like to make a change.
More information on types of amendments and the process to follow is available on the HRA website.
Keeping organised: Investigator Site File (ISF)
For all studies, it is good scientific practice to ensure that documentation relating to the conduct of the research at your site is kept in an organised way. This enables reconstruction of the study at any time. Documentation can be kept electronically or on paper, however it should be complete, logically organised and easily accessible to sponsors and regulatory bodies on request. If you keep a paper ISF, it should be kept locked in a filing cabinet (for fire-proofing) within a locked room in accordance with applicable data protection requirements. Please let us know the location of your ISF if you are holding it within your clinical area, rather than within one of our research offices.
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ISFs are commonly audited for their completeness by study sponsors, usually following the recruitment of the first study participant and towards the end of the study. If your study is sponsored by Solent, a member of our team will visit at agreed intervals to audit your ISF and other documentation throughout your study.
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Solent NHS Trust has a Standard Operating Procedure (SOP) for creating and maintaining an ISF, which includes a suggested contents list. This is available on EDGE, and will soon be published on our website.
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For information and support with setting up and maintaining your ISF, get in touch.
Keeping organised: Case Report Forms (CRFs)
Each participant recruited into a study will have a series of questionnaires and data collection forms in addition to a signed informed consent form to document their participation in the study. This collection of documents is known as a case report form (CRF). It’s very important that all questionnaires and data collection forms are filled in according to the protocol. The data collected using these forms IS the research.
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Solent NHS Trust has an SOP relating to data management for research coming soon. In the meantime, for information and support with data collection, get in touch.
Recording your recruitment: Using EDGE
We use EDGE to keep up to date with how every research project in Solent is going. EDGE is a really useful tool to assist with project management – it shows recruitment against your study target, acts as a repository for study documents and supports invoicing for research costs. At Solent, it is mandatory for recruitment into every research study to be recorded on EDGE. EDGE can be accessed here.
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When you begin to set up your study, an EDGE account will be automatically created for you by our research governance team. You will need to follow the links in the introductory email, set up a password and then you’re good to go. Full training will be given to first time users of EDGE and this can be done face-to-face at your base, or virtually. Get in touch to learn more.
Confirming or uploading recruitment for NIHR Portfolio studies
For studies that have been adopted onto the National Institute of Health Research (NIHR) Portfolio, it is mandatory that all recruitment is recorded on the Central Portfolio Management System (CPMS) as well as onto EDGE. Portfolio studies are managed for their performance by the NIHR and the data recorded on CPMS has implications for the activity-based and capacity building funding awarded to Solent by the NIHR each year.
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When you find out that your study is eligible to be adopted onto the Portfolio, the NIHR Portfolio Team will send you an email asking to confirm who will be the Research Activity Coordinator (RAC) for the study, and providing guidance on how to record recruitment on CPMS.
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For most studies, recruitment which is recorded on EDGE for Solent NHS Trust will automatically appear on CPMS. The study team simply needs to confirm that recruitment. Training on how to do this is available via NIHR Learn.
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Some studies are designated ‘anomaly’ or ‘manual upload’ studies. In this situation, CPMS will not read recruitment directly from EDGE. Instead the RAC for the study team will have to upload the recruitment to the CPMS manually. In those instances, it is important the RAC knows which Solent site code to allocate the recruitment to. Solent’s research governance team will be able to tell the RAC which site code to use.
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For assistance on uploading to the CPMS, get in touch with us via email. We can support you at your base or virtually.
Documenting in the clinical record: SystmOne for research
The care provided to research participants as part of your study should be documented in the clinical record via the Research Unit on SystmOne (S1). The unit was designed following consultation with patients and clinicians to ensure that it was clear to all that patients were taking part in research.
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Each research study is set up as an individual caseload on S1. The caseload for your study will be created when the study opens at Solent.
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Get in touch to find out more about documentation of research activity in the clinical record. If you require access to the unit, email us with your NHS Smartcard number and we will organise access and training for you. Training is available via the Solent Patient Systems team, or we can provide training at your base or virtually.
Participant safety: Reporting adverse events and adverse incidents
Adverse events in research that are graded as serious or above must be reported to us as soon as you become aware of the event, after you have ensured that the participant is safe and receiving appropriate treatment for the event. The event does not have to be related to the research for it to require reporting.
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Serious adverse events are defined within Good Clinical Practice (GCP) principles, but you should check your study protocol or SOPs for safety reporting to determine which events would require reporting.
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If Solent is the sponsor of your study, you may need to expedite reporting of the event to the statutory or regulatory bodies, dependent on the type of research you are conducting.
It is possible that an adverse event may also be a Trust adverse incident that needs to be reported on Ulysses.
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Get in touch for guidance on adverse events and incidents, but please first ensure that the participant is safe and receiving appropriate treatment for the event. Contact us by email or call on 0300 123 3994.
Progress reports, end of study declaration and dissemination plan
The Health Research Authority (HRA) and the Research Ethics Committees (REC) require researchers to submit an annual report to update them on the progress of the research. The process for submitting the progress report depends on the approvals required for your research. More information and forms to complete are available on the HRA website.
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If you are funded by an NIHR award, you will need to submit an annual progress report online through Researchfish to demonstrate the value and impact of your research. If this applies to you, you will get an email from the NIHR when it’s time to submit your report. Further information can be found on the NIHR website.
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When your last participant has made their last visit as part of the research, you will need to submit an end of study declaration to the HRA and/or REC within 90 days. The process for declaring the end of study varies according to the approvals required for your research. More information and the forms you need to complete can be found on the HRA website.
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You will also need to send a final report on your research, which includes whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants, to the HRA and/or REC within 12 months of the end of the study. More information can be found on the HRA website.
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If Solent NHS Trust sponsors your study, copies of progress reports, end of study declarations, dissemination plans (particularly how you plan to tell your participants and patients about your findings) and final reports must be sent to the research governance office. If your research is published, a copy of the article must be sent to us too. Please email them stating your study IRAS number.
Archiving your data
For most studies, research documentation is held for a maximum of 5 years, but there are some exceptions to this for studies involving investigational medicinal products (IMPs), non-CE marked devices and studies which recruited children. The study IRAS form will indicate how long research records should be held for.
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For guidance on how long to store your data, support with archiving documentation and information on the rules for destruction of research records, please contact us.