CTAP Research Scientific and Oversight Board
The Clinical Trials Accelerator Platform (CTAP) programme is governed by the Research Scientific & Oversight Board (RSOB). The RSOB also oversees a number of different types of review services, including CTAP badging for CF clinical research studies.
Find out what the RSOB does and how they can support you.
What is the CTAP RSOB?
The CTAP Research Scientific & Oversight Board (RSOB) brings together various CF experts to provide leadership and strategic oversight of the Clinical Trials Accelerator Platform (CTAP) programme.
The RSOB is made up of CF clinical experts, CF representatives (people with CF and parents of people with CF), a senior statistician, and CTAP trial coordinators.
The RSOB review services for sponsors include:
- review of funding applications
- assessing and awarding CF studies with CTAP badging status*
- protocol review*
*Only for studies not suitable for European Cystic Fibrosis Society Clinical Trials Network (ECFS-CTN) review
Criteria for review services
For studies to be eligible for the above review services, they must fulfil CTAP’s remit by being one of the following:
- Interventional clinical trial (medicinal and non-medicinal interventions) – commercial and academically sponsored studies
- Real-World Evidence (RWE) studies
- Non-interventional academic studies which are multi-centred and competitively funded
Out of remit studies
For studies which don’t fulfil the CTAP remit, there is an opportunity for an ‘out of remit’ review if the study is classified as a national priority.
How to apply
To apply for any of the RSOB review services offered, please complete the CTAP RSOB application form and return to us at [email protected].
You’ll need to submit the following documentation with your application:
- protocol (if available)
- study synopsis
- evidence of independent protocol review (if appropriate)
- patient information sheet
More information on each of the review services can be found below, or in the attached application form. Please contact the CTAP team with any questions.
-
Funding Application Review
The RSOB can provide feedback on applications for studies that are applying for NIHR funding or other competitively available funding. Applicants will be provided with high-level feedback on the study design and if appropriate, a letter of support may be provided to submit with the funding application(upon request).
To apply, studies must fulfil CTAP’s remit.
-
CTAP Study Badging
The RSOB awards CF clinical research studies with CTAP badging status. Studies that are awarded CTAP badging status can benefit from a range of support from CTAP. For example, CTAP badged studies are eligible for direct support from CTAP’s national team of funded trial coordinators.
The RSOB awards studies with CTAP badging status based on their impact and scientific quality. It prioritises studies that address top research priorities.
Only studies not appropriate for review by the ECFS-CTN will be considered for CTAP badging.
-
Protocol Review
The RSOB can provide detailed feedback for commercial or academic studies that have not yet submitted for regulatory approval.
To apply, studies must fulfil CTAP remit and not be eligible for ECFS-CTN protocol review.
Note: this is a paid service for commercial sponsors.
-
Out of remit study support
The RSOB considers applications to support studies that are outside of this remit but are considered to be of national priority or urgency. This may include clinical research studies answering an important question that could benefit from short-term CTAP network support. Applications for this support will be considered by the CTAP RSOB on a case-by-case basis.
Patient and public engagement and involvement
We provide trial sponsors with PPIE support at every stage of the clinical trial process
Trials Tracker
The Trials Tracker lists CF clinical trials recruiting in the UK.
How we support clinical trials
Our Clinical Trials Accelerator Platform (CTAP) supports CF clinical trials in the UK.