Useful Links
If you are aware of something useful to share with members please contact css@nihr.ac.uk
Introduction to GCP - IMP management module
This specialised Good Clinical Practice (GCP) module explores Investigational Medicinal Product (IMP) management within the context of clinical trials conducted in the NHS.
It is a specialist module for the Introduction to Good Clinical Practice (GCP) for those who have delegated responsibility (freedom to act) for IMP management for a clinical trial. It meets a training need for GCP IMP management outside of a pharmacy setting and by non pharmacy professionals while continuing to ensure Pharmacy staff receive the relevant training they need to be GCP compliant.
This specialist module must be completed in addition to Introduction to GCP training or GCP Refresher training.
Fundamentals of Clinical Research for IMP Management training
This module is aimed at staff involved in the delivery of clinical trials of Investigational Medicinal Products (IMPs) that are working under the guidance of written SOP, for example; study specific instruction, pharmacy / IMP manual, or study protocol.
This learning is suitable for pharmacy staff and for non pharmacy staff.
COVID-19 Vaccine Trials Training
The NIHR has endeavoured to provide the relevant general training resources for staff to undertake delivery of COVID 19 vaccine trials. In addition, it is expected that these will be supplemented by trial specific training as detailed in each study protocol, in addition to any training required by local trust policy.
EC guidelines on good manufacturing practice for investigational medicinal products for human use
Please find above a link to the consultation document concerning GMP for IMPs (issued Dec 2017). The new guidelines will become active when the new EU CT Regulation comes into force although this date has not yet been announced.
The web-based interactive Costing Tool (iCT) provides a framework for transparent cost display and calculation to support swift local site budget negotiations when planning commercial trials in the NHS.
HRA Approval including work on single technical reviews (pharmacy)
Health Research Authority (HRA) Approval provides a single approval for research in the NHS.
The NHS Specialist Pharmacy Service supports medicines optimisation across the NHS. High-cost, complex and innovative medicines and medicines-related services are key areas for us. Our main purpose is simple: To help to improve the use of medicines so people live longer, fuller lives.
NPCTAG hope that the position statement provides a useful guidance note for pharmacy staff in what can be a contentious area of discussion with trial sponsors.
The Pharmaceutical Journal, the official monthly journal of the Royal Pharmaceutical Society, provides information and analysis on the latest advances in any branch of pharmacy practice and pharmaceutical science throughout the world.
With the pressures of the pandemic beginning to ease and COVID-19 caseloads falling, work is underway to support the recovery of research into other conditions, and to increase the strength of the UK’s research base and life sciences sector. This supports the vision set out by the Department of Health and Social Care in the document Saving and Improving Lives: the future of UK clinical research delivery.
The Royal Pharmaceutical Society is the dedicated professional body for pharmacists in England, Scotland and Wales.
National Institute for Health and Research
The NIHR Clinical Research Network Coordinating Centre manages the Clinical Research Network (CRN) on behalf of the Department of Health. The CRN makes it possible for patients and health professionals across England to participate in clinical research studies within the NHS.
Pharmacy Research UK is the principal funder of pharmacy research in the UK. The organisation is well respected, a member of the Association of Medical Research Charities and is hosted by the Royal Pharmaceutical Society.
The Association of the British Pharmaceutical Industry
The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of bioscience in the UK.
The ABPI is the UK trade body that represents the research-based bio-pharmaceutical industry in the UK.
MHRA Good Clinical Practice (GCP) forum
The GCP forum is a tool to help those involved in clinical trials of Investigational Medicinal Products to comply with the clinical trials legislation and GCP requirements.
The HRA is an executive non-departmental public body of the Department of Health in the U K. The HRA exists to provide a unified national system for the governance of health research.
British Oncology Pharmacy Association
Promoting the role of specialist oncology and haematology pharmacists and technicians.
The Center for Pharmacy Postgraduate Education (CPPE)
CPPE: provider of educational solutions for the NHS pharmacy workforce across England to maximise its contribution to improving patient care.
United Kingdom Clinical Pharmacy Association provides opportunities for networking, collaborations, sharing best practice and inspiring innovation. Their community is both supportive and stimulating, offering our members and event delegates the opportunity to explore, learn, innovate and flourish.
The Association of Pharmacy Technicians United Kingdom (APTUK) is the national professional leadership body for pharmacy technicians working in all pharmacy sectors across all countries in the UK: England, Northern Ireland, Scotland and Wales.