Quality Statement

Gareth Hayes Associates deliver facilitated training that is designed to provide an essential background to clinical research activities undertaken according to current Good Clinical (Research) Practice guidelines and regulations for studies across the United Kingdom and Europe. It references the applicable EU Directives, UK regulations (Statutory Instruments) and the Research Governance Framework in the first instance and also takes into consideration the broader scope of multi- national work including the FDA CFR. The various training curricula are aimed at roles specific to both sponsor and site, either together or specifically targeted. Such roles include monitors, study and project managers, CTAs, data managers, document associates, PIs, CIs and Sub-Is, research nurse, pharmacy staff, laboratory staff, and trial-related staff who, for example, have direct patient contact and/or who are handling data and documents. The curricula are also appropriate for staff belonging to non-commercial sponsors, e.g. R&D staff, CTU teams, university personnel, as well as those specialise in areas not always associated with CT-IMPs, e.g. psychiatry, emergency research, surgery, medical devices.

Every session takes into account different learning styles and encourages a mix of lecture, seminar and interactive workshops to build on the clinical research skills already evidenced by training records and to offer opportunities for new competencies to be enhanced. The integrity and safety of trial subjects, alongside the scientific principles of quality management of systems, reproducibility of data, and transparency of conduct are reinforced at all times.

To fulfil a right and proper training cycle where training is considered to be a process not an event, delegate expectations will be addressed as part of their learning experience and the size and location of the learning group will be pre-determined for optimal exposure to the full scope of material. All delegates will be followed-up, as required, to complete the facilitation of the desired learning outcomes. It will provide all the latest information on the legal framework governing performance and conduct of clinical trials, particularly regarding Statutory Instruments, and build on findings from recent MHRA Inspections.

Training will usually incorporate a number of practical exercises focusing on delegates' own experiences and from case studies brought by the trainer. Exercises can include intimate sessions on consent, pharmacovigilance, documentation, product accountability, and quality management systems. Evaluation of training effectiveness will be measured throughout the session, at the end in the form of a short assessment and objectives-met report. Where possible, and to satisfy the best available level of Kirkpatrick, communication will continue with delegates until such a time that a suitable competency is achieved and agreed. Trainers and facilitators will utilize Bloom's Taxonomy as a structure for assessing delegate's learning.