Frequently Asked Questions
RECOMMENDED ANSWERS FOR YOUR FREQUENTLY ASKED QUESTIONS
If you have a frequently asked CRP-related question that you would like answered, please let us know using this form.
CRPs and MEDICINES MANAGEMENT
o Are CRPs able to collect IMPs (and other medications), and provide them to patients for self-administration?
o Are CRPs able to be involved in administration of medications?
o Will there be standard guidance issued surrounding this in addition to the statement in the scope of practice?
For reference, the Academy for Healthcare Science Accredited Register Clinical Research Practitioner (CRP) Scope of Practice states that :
‘Clinical Research Practitioners with adequate training and clinical supervision in place may be expected to collect an IMP from pharmacy, ensure its safe storage and/or supply the IMP to the study participant. Referral to supporting clinical services sits outside the Clinical Research Practitioner's Scope of Practice.’
Hence, administering an IMP is outside the Clinical Research Practitioner's Scope of Practice. To avoid doubt, the supply of the IMP does not extend to administering the IMP to the study participant.
This guidance is there to protect all CRPs and maintain participant safety.
The following discussion points may be helpful in conversations with your employer.
The scope of practice will undergo a three-year review shortly (2024) to align with the regulatory bodies' policies. However, we do not envisage this particular point changing imminently.
Your unique selling point in the delivery of studies is recognised as a specialist in the project management of studies for successful and timely delivery in health and care environments that is proactive, adaptive and based on an in-depth understanding of studies and their delivery context requirements. In the future, as CRPs become established as a professional body, the scope of extended clinical skills may be something your education programmes choose to address. But for now, a CRP is not permitted by law to administer medicines.
In the new NIHR Vaccine Learning Framework, which is about to be released (July 2024) you will see that under the Public Health England module - Vaccine Administration Training for the CRP role, we have put ‘For Information only ‘, so this is clear. Please note: We know that in COVID-19, people outside of healthcare professionals were trained to administer vaccines, but please remember that these were not CTIMPS and that it was a national emergency.
REGISTERED CRPs vs UNREGISTERED
o Is there a distinction between what registered CRPs and non-registered CRPs should be allowed to do?
This distinction will be decided by the team lead, and will be guided by Trust policy. Registered CRPs will have demonstrated to the AHCS a level of competency, accountability and experience provided within their portfolio of evidence, including documented assurance of this from their employer, and as such may be expected to hold a higher level of responsibility and be involved in more complex studies.
o What is the value in registering as a CRP when I'm already working in the role? What difference will it make?
CRPs registered with a professional regulator lends credibility and assurance that their practice includes an accountable commitment to patient safety, and it signals to our colleagues, patients, industry, and all the stakeholders that you adhere to high standards of quality, ethics, and professionalism. This in turn enhances trust and confidence in the service provided by CRPs, making CRPs visible and giving a voice at the table. This is already happening in various ways, eg. a survey conducted by Cancer Research UK (2024) about the Clinical Research Workforce identifed CRPs as a group of responsents in their own right for the first time. Registered CRPs are becoming increasingly recognised as eligible for funded training opportunities, as well as positions of leadership and management.
CRPs and INFORMED CONSENT
o Can CRPs be involved in CTIMP consenting?
This question is similar to medicines management, in that only a clinician can receive consent when the study involves a CTIMP. CRPs can receive consent for a variety of other studies where the protocol permits and the PI is content to delegate this study activity. This would generally often be the case for observational studies, large scale genomic studies, and Quality of Life questionnaire studies, for example.
Access to joining the CRP Register without a degree
o What's happening with the Experienced Practitioner Gateway? I've heard that this will be closing soon, is this right?
Joining the the AHCS Accredited Register for CRPs is open to eligible practitioners now. Find out more here: https://www.ahcs.ac.uk/registration/psa-accredited-register/clinical-research-practitioners/
The Experienced Practitioner Gateway access route to joining the register was introduced in January 2023, with a closure date of January 2025 set and kept under review while standardised education and training routes remain in development. As defined education routes remain pending, AHCS are intending to extend operation of this exceptional access route to January 2026.
More info will be posted on the AHCS website in due course: https://www.ahcs.ac.uk/registration/psa-accredited-register/clinical-research-practitioners/about-the-gateway/
If you don't have a degree but do have the required amount of practitioner level experience and wish to become registered, it is advisable that you begin your Experienced Practitioner Gateway eligibility application without delay. AHCS have indicated that every application going through this route will be assessed and supported to enable attainment of registration.
CRP APPRENCTICESHIP - joining the CRP Register in the future through a defined education route
o Who will this be for, and which HEIs are running the programme?
To grow the registered CRP workforce of the future, CRP Apprenticeship programmes are currently in development . These programmes will form the basis of standardised education and training that will underpin a pathway leading to AHCS Accredited Registration. Entry requirements for Level 5 and Level 6 programmes are being designed, working with HEI providers and employers. Updates will be provided on this site.
Employing a CRP vs a Research Nurse
o As a manager, why would I employ a CRP, when I could have a nurse?
CRPs thrive in multi-professional teams where their role complements research nurses and others, and a general rule of thumb would be to employ the best person for a particular job. CRPs have basic clinical skills within their scope of practice that contribute capacity to conducting clinical trials to ensure the timely delivery of studies. A CRP is a specialist in clinical trial delivery, and a registered CRP will be experienced in working on a number of different studies at the same time. CRPs often work across different clinical specialities and will have a wide and extensive knowledge of research project management. CRPs generally have advanced database skills, and often will have diverse data software knowledge used by many Pharma and CROs to keep track of commercial studies. The CRP contribution to multi-professional teams strongly enables capacity and capability to deliver.
CRP Directory and the wider Community of Practice
o How does the CRP Directory differ from the Register, and why do we need a Directory?
The CRP Directory was launched in 2018 as a community-building platform bringing together early adopters with intent to join the AHCS accredited register. Joining the CRP Directory is the first step taken when applying to join the Register. Those listed on the CRP Directory includes a broad representation of the CRP community of practice who are a first point of contact in relation to progressing development of the profession. Benefits of joining the Directory include signalling intent to join the Register, as well as staying directly informed on developments for CRPs, proactively remaining engaged in surveys and consulations, and becoming directly involved in development of the CRP profession through activities that may be led locally, regionally or nationally.
Maintaining registration with AHCS
o What is the revalidation process for CRPs?
To maintain their AHCS registration, registered CRPs are required to confirm on a annual basis its validity through self-declaration that (i) their practice continues to meet the Standards of Proficiency for CRPs, and (ii) they remain committed to ongoing CPD annually, evidencing this if requested to do so as part of the CPD Audit process conducted by AHCS. A revalidation process for CRPs may be introduced in the future, and this is being considered at present by AHCS.