Running a study through the HRB Primary Care Clinical Trials Network Ireland (CTNI)
Step 1: Expression of Interest
Initiate contact with the HRB Primary Care CTNI by emailing a brief outline of the study to firstname.lastname@example.org
If required, the study PI and other team members schedule a meeting or telecon with the Development Manager and the Network Director to discuss the study
We can advise you on
- Feasibility of proposed practice and patient recruitment, screening and consent protocols
- Incentives to practices and practice staff
- Including patients/public voice in designing your study protocol, including recruitment processes, identifying patient-important outcomes, reviewing patient information materials, and dissemination
- Completion of ethics applications
- General trial methodology issues, as relevant to primary care
Step 2: HRB Primary Care CTNI study adoption process
The study team completes a Study Adoption Request Form and emails it to email@example.com
The Study Adoption Panel meets ad hoc to review adoption requests and either accept/reject/look for more information.
When a study is conducted through the Network, the Network agrees an appropriate fee with the study team to cover Network support – the fee varies with the level of support that will be involved.
Network branding and acknowledgement will be discussed.
When a study is accepted by the Study Adoption Panel, the PI/study team are asked to keep the Network informed of key progress milestones of the grant application process/study schedule, to help the Network manage future communication with and recruitment of practices into different studies.
Criteria for study adoption
The Study Adoption Panel will consider the following questions when assessing a request:
- Does the study involve recruitment and/or advertising through general practice or primary care centres?
- Is the study a pilot or a trial, or is it gathering data that may be used/useful when designing a trial in the future?
- Does the study investigator and team have an acceptable track-record?
- Is there a confirmed funding source and does the sponsor have an acceptable track-record?
- Does the study have ethical approval granted and is the study GDPR-compliant (with supporting documentation)?
- Are there potential risks to the Network?
- Does the protocol include any procedures that the adoption panel believe will jeopardise the study?
- Does the study improve patient care or have the potential to improve patient care in the future?
- Is the study compatible with primary care practice in Ireland; is the prevalence of the target patient population sufficient for recruitment?
- Does the HRB Primary Care CTNI have the capacity to provide requested resources?
- Are there conflicting trials ongoing within the Network or higher priority studies pending?
Phase IV studies are usually, but not invariably, considered ineligible.
The Network Development Manager will inform the applicant of the decision within three days of the Study Adoption Panel review.
Once the study is adopted, the Network will continue to work in partnership to:
- Keep the Network up to date with screening and recruitment numbers
- Acknowledge Network support
- Inform Network about study results
Initial contact with Network practices to invite them to take part in a study is made via an email sent by Network staff, which includes, as an attachment, a brief overview of the study prepared by the research team. This one-page, email-friendly advertisement is prepared by the study team and reviewed by the Network.
Practices indicate an initial expression of interest to the Network, at which stage the Network connect the study team with the practice.
Ongoing Network involvement
The nature of the ongoing involvement of the Network in a study will be agreed once a study is accepted by the Study Adoption Panel and will vary from study to
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