Delivered through Birmingham Health Partners (BHP) and the Institute of Translational Medicine (ITM), Research FIRST provides a flexible and innovate approach to supporting non-CTIMP research and other projects (for example, Clinical Audits, Service Evaluations and Management Databases).
The service is delivered by the core team based at the ITM, with direct access to clinical, academic and professional support services support from across the BHP ecosystem, and is designed to be flexible and tailored to the requirements of individual teams and/or projects.
The service complements the existing research infrastructure across BHP and ensures that all projects are delivered to a high standard in a timely manner whilst complying with all relevant regulations and guidelines (including GCP, GDPR and individual sponsor’s Quality Management Systems).
Primarily we work with teams across BHP, but also support projects from outside the Partners, including other NHS Trusts and commercial companies. We welcome approaches from any interested parties to explore what support we may be able to provide.
We can support any project that is not a Clinical Trials of Investigational Medicinal Products (CTIMP) or any other study operating under the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA); requests for support for this type of project should be redirected to the relevant Clinical Trials Unit (BCTU or CRCTU).
We can support a wide range of research methodologies, from observational studies to surveys and screening studies. In some instances, we can also provide support for qualitative projects.
We also provide support for non-research projects, including audits, service evaluations and operational and/or management processes – for example, the UoB COVID Test and Trace system.
Where we are unable to help, we can signpost you to the appropriate team that may be in a position to provide the expertise that you require.
We aim to be as flexible as possible and work with you to identify what level of support is most appropriate for your needs. We can do as little as provide your team with access to REDCap, or as much as full management and delivery of your project. We are able to provide support in any of the following areas:
- Full project set up, management and close down
- Project development
- Development of the project documentation
- Submission of relevant permission requests (for example IRAS, R&D approvals)
- Site set up, support and closedown
- Ensuring compliance with all applicable regulation and guidelines at all stages
- Identification and obtaining of relevant required legal contracts and agreements
- Access to REDCap
- Development of REDCap project databases
- Data management, data cleaning and data archiving
- Project administration
- Statistical analysis
- Support and/or training for your existing team, particularly with regard to REDCap database building
Our services are costed in a number of ways. Where we are fully managing a project and are included in the initial funding bid, costs are calculated in the usual way based on the estimate of staff and consumables required.
Where you require access to REDCap only, there are minimal annual charges for provision of access to the system which contribute to the costs of the servers and the IT support required to maintain them.
Where we provide expertise and support for any element of a project, we meet with you to discuss your requirements in detail and provide you with a quote based on the estimated number of hours and grade of staff required to deliver. For example, if you need a REDCap database built, we can estimate the number of hours we expect it to take and provide the cost accordingly.
Finally, we are able to operate on a consultancy basis. Where you have a fixed amount of funding to purchase support, we can translate that into a number of hours available to you which can be used to ‘buy’ the expertise you require. For example, we could use the hours to provide the expertise to support or train a member of your team to build your own database.
We use REDCap to build databases for the projects we support; BHP/ITM have a REDCap system that is installed and maintained by the University of Birmingham IT department.
REDCap is an online database system developed by Vanderbilt University that is specifically designed for clinical trials, but can be also be built to accommodate different methodologies. It is a user friendly and intuitive and works for a range of options. REDCap complies with the relevant regulation, although teams need to consider their process around their data access and management policies to ensure continued compliance. Research FIRST is able to support you with this.
If you prefer to develop your database using a different platform, please contact us and we will endeavour to identify another party to support you with this.
Please email email@example.com providing some detail about the support you would be interested in, and a member of the Research FIRST team will be in contact with you to arrange further discussions.
“Research FIRST is the most effective and delivery focussed organisation that I have worked with. They have helped set up the new digital data infrastructure for the UK Coronavirus Cancer Monitoring Project within a period of weeks, and were pivotal to provide the evidence globally that cancer treatments could continue during the COVID-19 pandemic.
“They are characterised by a team of individuals who are focussed on the research and the questions that need answering, while still maintaining the highest level of service. My experience is that the team is very efficient, knowledgeable and responsive. Working with Research FIRST has been an extremely positive experience.”
Lennard Lee, UK Coronavirus Cancer Monitoring Project
“I cannot speak highly enough of the Research FIRST team – without them, the COV-AD study, a multi-site, national study into how immunodeficient patients respond to COVID-19 vaccines, simply would not have happened. Their expertise in the end-to-end management of a large clinical study, including navigating REC approval, facilitating data management, study finance and the understanding logistics and practicalities of moving large numbers of clinical samples between NHS and academic institutions ensured a complex study ran smoothly and greatly improved the quality of the data we have collected. Furthermore, they have been an absolute pleasure to work. I can not recommend their service highly enough.”
Dr Adrian Shields, Clinical Lecturer – Clinical Immunology Service
Hosted by the ITM and UoB IT services, BHP is pleased to offer interested individuals access to The BHP REDCap Community. This community provides a forum for interaction and dialogue about REDCap-related topics and will be of relevance to anyone with an interest in this software. The group is open to registered members and consists of people who have a wide range of REDCap experience, including those who do not yet use it but are interested in gaining a greater understanding. Participation is optional, but is highly recommended.
Who can register?
Anyone who works with one of the BHP member organisations, and has an interest in REDCap can register to join the community. Experience of REDCap is not necessary as the focus of the group is to share knowledge.
How does the community work?
Although hosted by the ITM/IT, the forum is community led; members can suggest specific topics to be covered at meetings, can take a lead on discussions in areas they have specific expertise or support the delivery of larger seminar sessions. A collaborative, interactive approach for mutual support is encouraged. Once registered you will gain access to the BHP REDCap Community ‘Teams’ site, a shared online resource which provides support for REDCap. This includes documentation, helpful links and a chat area where people can post advice or ask questions within the group. The community also meet regularly to discuss different topics, provide small group training and periodically deliver larger lecture style discussions around REDCap.
How do I register?
If you wish to register with the community, oe would like further information, please email firstname.lastname@example.org . Once your membership is confirmed, you will be given access to the community resources.
Dr Kate Fletcher – Head of Operations (ITM) and Head of Research FIRST
As the founder of Research FIRST, Kate has always been passionate about the need for a high quality, adaptive, customer led service that provides support and expertise for the delivery of research. Having worked in a health services research environment at the University for over 20 years, she has extensive experience in the delivery of studies using a range of different methodologies. In 2012 she obtained a PhD examining the role of GPs in the recruitment of patients to primary care based randomised controlled trials, an understanding of which facilitated the delivery of studies in a manner which maximises participant recruitment rates.
In 2016 she became the Head of Operations at the Institute of Translational Medicine and introduced the Research FIRST service. Under Kate’s guidance, Research FIRST has expanded rapidly and now supports a wide range of projects from across Birmingham Health Partners and beyond.
Gail Heritage – Research Practitioner and Research FIRST Contracts Lead
Gail graduated with a degree in Forensic Science and has worked in various roles over the years. She worked as an MLSA in microbiology before taking up a role as Senior Assistant Technical officer for anticoagulation services. Gail has worked at the University of Birmingham as a Clinical Trails Practitioner for over 10 years gaining extensive experience in both study coordination and study management support. She is also a trained phlebotomist and works directly with study participants in the clinic setting; in her current role she provides support for the follow up of participants enrolled in the SIREN study.
In 2019 Gail joined Research FIRST and has played a key role in the development and delivery of the service. She is the Research FIRST Contracts Lead, helping projects to obtain the necessary contracts in a timely manner; she also works across a range of studies, supporting with the development and delivery of the projects in a variety of ways.
Hollie Wagg – Clinical Research & Database Manager
Hollie joined the University of Birmingham in 2009 as the Data Manager for Professor Jonathan Mant’s Stroke Programme, which incorporated a range of projects using varied methodologies. She developed a particular skill in running data searches on a variety of GP surgery computer systems, becoming the department lead in this area, and supporting the CRN with this expertise. Hollie then expanded her knowledge and become a Trial coordinator working on Primary Care Studies, more latterly as part of the Birmingham Clinical Trials Unit where she also supported the development and implementation of the Quality Management System. In 2017, Hollie became a Research Co-ordinator in the Gastroenterology team, gaining experience in the delivery of research in a secondary care setting whilst managing a small team and developing skills in the development of REDCap databases.
In 2020, Hollie joined the Research First team as a Senior Research Co-ordinator and the Quality Assurance and Compliance Lead, with responsibility for developing and maintaining all relevant documentation. She supports a range of studies, including COV-AD (Study launches to investigate immune response to SARS-CoV-2 infection in patients with antibody deficiencies (birmingham.ac.uk)), and also developed the UoB COVID Test and Trace database.
Dr Naomi Campton – Clinical Research & Database Manager and Research FIRST REDCap Lead
Naomi has over 20 years of research experience and has a varied background within the research pipeline from Bench to Clinic. She obtained her PhD and first postdoctoral post in the field of diabetes and Obesity research at Aston University under Prof. Cliff Bailey. She joined the University of Birmingham in December 2012 as part of the Dentistry team. Over the years she has had may roles including Senior Laboratory Technician, Research Clinical Support, and Clinical Trials Coordinator. In 2016, working with Prof. Iain Chapple in the School of Dentistry, she took over the management of Dentistry’s audit and research projects. Naomi’s experience has a wide span from lab to clinic, through governance approval and database development using the REDCap Platform, to project delivery.
Naomi moved to Research FIRST in 2019 to take up the post of Clinical Research and Database Manager. She is the Research FIRST Lead for REDCap, and is responsible for the management of the ITM’s REDCap instalment, along with supporting the delivery of projects requiring a database component.
Emily Heritage – Senior Data Manager
Emily has 7 years of administrative experience in various sectors. She joined the University of Birmingham as a Data Manager in 2019 and has worked on a variety of projects, including large scale international research studies. She has 3 years experience in using REDCap to build databases and monitor study data quality.
Emily joined Research FIRST as a Senior Data Manager in 2020, working predominately on a large COVID research project. She also supports a range of other projects with the development and maintenance of their REDCap databases.
Joe Humphreys – Senior Data Manager
Joe graduated from University with a degree in Psychology and accepted a role in a clinical research organisation where he supported a variety of research projects. He gained a range of experience, from processing of blood samples to recruiting participants into trials.
Joe came to the University in 2019, working as a Data Manager on vascular trials at the Birmingham Clinical Trials Unit. He joined the Research FIRST team in 2021 as a Senior Data Manager where he is responsible for the data management on a number of studies. He also supports a range of other projects with the development and maintenance of their REDCap databases.