CRF Manager's Group
Work Group Deputy: Tinashe Samakomva
Group Purpose:
The CRF Managers Group provides a collaborative forum for CRF Operational Managers/Leads to share and address operational and strategic challenges, exchange best practice, and support continuous improvement across CRFs. The group promotes peer support, shared learning, and the exchange of tools, resources, and plans developed across CRFs.
Membership Criteria:
- Membership is open to individuals from UKCRF Network member CRFs who have operational responsibility for the CRF.
- Where there is no dedicated CRF Manager, a Lead Nurse or equivalent role with operational responsibility may join and represent their CRF.
- CRFs operating across multiple sites may nominate a representative from each facility.
Laboratory Work Group
Work Group Deputy: Andrew Bennie
Group Purpose:
The Laboratory Managers Work Group was established and continues to support the UKCRF Network in achieving its objectives related to providing standard laboratory practice for commercial and non-commercial trials across the UKCRF Network.
The primary purpose of the group is to standardise best practice throughout UK and Ireland CRF laboratories via training and educating staff, management of quality issues, set-up and costing of trials, and equipment management and usage. Each work group sets annual objectives, which are accessible to members via the Group’s MS Team channel.
The Laboratory Managers Work Group is part of the UKCRF Network’s Work Package for Operational Excellence (WP1).
Membership Criteria:
- The Laboratory Managers Work Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in laboratory practices, training, quality assurance and regulations.
- Members must either be the designated Lab Manager or the individual responsible for laboratory operations within their CRF. In cases where a CRF does not have dedicated laboratory staff, another member of staff, such as a Clinical Research Nurse who oversees laboratory-related activities may join to represent their CRF.
- This group is open to one representative per CRF Laboratory.
Study Intensity Group
Work Group Deputy: Alex Radford
Group Purpose:
The Study Intensity Work Group was established and continues to support the UKCRF Network in achieving its objectives and lead on the ongoing development, implementation, and validation of the Study Intensity Tool.
The primary purpose of the group to support the implementation and use of the Study Intensity Tool at CRFs and other NHS/HSE clinical research departments across the UK and Ireland.
The tool assists research teams in assessing workload and informs workforce planning decisions, providing a validated and standardised approach across the Network. The tool accurately predicts the Whole Time Equivalent (WTE) staffing numbers required for the efficient delivery of a specific clinical study.
The Study Intensity Work Group is part of the UKCRF Network’s Work Package for Operational Excellence (WP1).
Membership Criteria:
- The Study Intensity Work Group consists of representatives from various CRFs across the UK and Ireland with expertise in study set-up and delivery, particularly in paediatric, adult, or disease-specific studies, as well as experience using the Study Intensity Tool or with advanced Excel skills.
- Group members should have relevant experience in one or more of these areas: study set-up and delivery, tool usage, or advanced Excel.
- Membership is capped at 15 to ensure that members are given support to develop their expertise in use of the tool.
Information Management and Technology Work Group
Group Purpose:
The Information Management and Technology work group was established and continues to support the UKCRF Network in achieving its objectives to facilitate the sharing of ideas and expertise related to information systems developments; emerging software technology; data and information management and a common UKCRF Network approach to completing the NIHR CRF Annual Reports.
The primary purpose of the group is to support NIHR annual reporting processes and data management, while facilitating expert knowledge sharing and collaboration across a range of topics such as electronic data capture systems, inspection findings and data integration. Each work group sets annual objectives, which are accessible to members via the Group’s MS Team channel.
The Information Management and Technology Group is part of the UKCRF Network’s Work Package for Strategic Leadership (WP2).
Membership Criteria:
- The Information Management and Technology Work Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in the management of both clinical and performance data relating to a CRF or similar research infrastructure.
- Group Members should be staff involved in the ongoing management of CRF portfolio data and the preparation of NIHR or other funding organisation reports.
- Membership should in principle be made up of only one representative per CRF however multiple members from a single CRF can join in the case of multiple sites within an organisation or roles within a single CRF contributing different elements to the overall data management process.
Industry Liaison Work Group
Group Purpose:
The Industry Liaison Group was established to support the UKCRF Network in achieving its objectives related to industry activities associated with early phase commercial trial delivery and experimental medicine research, and the strategic programmes of Work Package 2.
The primary purpose of the group is to:
Bring together a group of peers and industry liaison experts from across the UKCRFNetwork.
Cultivate a collaborative approach across CRFs with regards to industry liaison and commercial partnerships, sharing resources and overcoming challenges.
Support our relationships with industry partners, promoting UK and Ireland CRFs as a preferred destination for early-phase studies.
Drive forward initiatives to enhance CRF multi-site studies and provide support for related topics such as costs and infrastructure needs.
The Industry Liaison Work Group is part of the UKCRF Network’s Work Package for Strategic Leadership (WP2).
Membership Criteria:
- The Industry Liaison Work Group consists of representatives from various CRFs/and or host organisations across the UK and Ireland who have expertise and experience in industry liaison, business development and/or commercial partnership management.
- This is an open group, but single representation from each organisation is encouraged.
Education Work Group
Work Group Deputy: Rachael Phillips
Group Purpose:
The Education and Training Work Group was established and continues to support the UKCRF Network in achieving its objectives related to workforce training and development. The primary purpose of the group is to develop, maintain and promote national training documents and tools available for local adaptation and implementation.
The Education and Training Work Group is part of the UKCRF Network’s Work Package for Workforce Development (WP3).
Membership Criteria:
- The Education and Training Work Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in education and training.
- Group Members should have an education/training brief within their role and multiple members can join per CRF, however, there is the expectation that all members have the capacity to fulfil the responsibilities outlined above.
Clinical Research Delivery Work Group
Work Group Deputy: Jacqueline Bramley
Group Purpose:
The Clinical Research Delivery Work Group (formerly Research Nurses and Practitioners Group) was established and continues to support the UKCRF Network in achieving its objectives related to the research delivery workforce, encompassing all health and care professionals within patient / participant facing roles working in Clinical Research Facilities (CRFs).
The primary purpose of the group is to provide a community of practice for clinical staff across the CRFs, and to undertake collaborations to identify and develop packages of work. Each work group sets annual objectives, which are accessible to members via the Group’s MS Team channel.
The Clinical Research Delivery Work Group is part of the UKCRF Network’s Work Package for Workforce Development (WP3).
Membership Criteria:
The Clinical Research Delivery Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in clinical research delivery and workforce development, including early phase and advanced therapies and associated professional issues
One representative per profession per CRF, a combination of the following may join:
- Adult Lead/Senior Research Nurse/Matron (B7+)
- Paediatric Lead/Senior Research Nurse/Matron (B7+)
- Adult Clinical Research Nurses (band 5/6)
- Paediatric Clinical Research Nurse (band 5/6)
- Advanced Clinical Practitioner
- Clinical Research Practitioner
- Midwife,
- AHP.
Quality Assurance Work Group
Deputy Chairs: Kim Lee and Sarah Ruiz
Group Purpose:
The Quality Assurance Work Group was established and continues to support the UKCRF Network in achieving its objectives related to workforce development and the promotion of a culture of regulatory compliance and continual quality improvement.
The primary purpose of the group is to support collaborative working and sharing of good practice through networking and the development of tools and guidance documents that promote high quality, safe and compliant research practices across the UKCRF Network.
Membership Criteria:
- The Quality Assurance Work Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in regulatory compliance and managing quality systems.
- Group Members should be in a lead QA role or have a remit for quality management as part of their role.
- Multiple members can join from a single CRF, but a maximum of two members per CRF can attend Quality Assurance Work Group business meetings.
- The Quality Assurance Work Group is an open group with no cap on membership, however, all members are expected to be active contributors to group objectives.
Involvement Work Group
Group Purpose:
The Involvement Work Group was established and continues to support the UKCRF Network in achieving and build on our successful track record of supporting CRFs in collaboration and coordination of patient and public involvement, engagement (PPIE) and participation activities.
The primary purpose of the group is to share best PPIE practice, providing peer support and support the learning needs of CRF PPIE Leads. Each work group sets annual objectives, which are accessible to members via the Group’s MS Team channel.
The Involvement Work Group is part of the UKCRF Network’s Work Package (WP) for Involvement and Inclusion (WP4).
Membership Criteria:
- The Involvement Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in PPIE. Group Members should have PPIE in their role.
- There is no restriction on the total number of members. Staff members who meet the above criteria are welcome to join.
Inclusion Work Group
Group Purpose:
The Inclusion Work Group was established and continues to support the UKCRF Network indeveloping and strengthening the equality, diversity and inclusion (EDI) culture across the UKCRF Network.
The primary purpose of the group is to share best Equality, Diversity and Inclusion practices, provide peer support and support the learning needs of CRF EDI Leads. Each Work Group sets annual objectives, which are accessible to members via the Group’s MS Team channel.
The Inclusion Work Group is part of the UKCRF Network’s Work Package (WP) for Involvement and Inclusion (WP4).
Membership Criteria:
- The Inclusion Work Group consists of representatives from various CRFs across the UK and Ireland who have expertise and experience in EDI. Group members should have a responsibility for EDI within their role.
- There is no restriction on the total number of members. Staff members who meet the above criteria are welcome to join.
