Operational skills

Details

Title

Operational skills

Type

Stage One

Module code

HLS001

Requirement

Compulsory

Module objective

By the end of the training period trainees will, in respect to operational skills be able to:

• Analyse, synthesise, evaluate and apply knowledge
• Perform a range of technical and clinical skills and procedures
• Demonstrate the attitudes and behaviours necessary for professional practice as a consultant clinical scientist dealing with the complexities, uncertainties and tensions of professional practice at this level.

Knowledge and understanding

By the end of the training period the trainee will be able to demonstrate the ability to analyse, evaluate and synthesise relevant knowledge and its application to their professional practice in relation to:

• study design and interpretation; the importance of controls, including historical controls; minimum acceptable sample sizes for different types of study
• legislation covering the development, transport, use, and disposal of therapeutic entities/novel chemicals/chemical consumer products/agrochemicals/food additives and other dietary components
• conduct of safety studies and the methods by which existing guidelines are revised, i.e. OECD, WHO, ICH
• assessment of drug efficacy, clinical pharmacology and clinical trials (Phase I-IV studies)
• safety pharmacology
• bioinformatics
• principles of quality control, quality assurance, audit, archiving
• SI and associated units
• harmonisation in reporting of analytical results
• chemical and pharmaceutical nomenclature; drug classification (UK and abroad);
• Medicines Act; controlled drugs and licensing arrangements/ laboratory requirements
• statistical analyses and specific procedures to control variation, experimental populations and their differences, epidemiology, parametric and non-parametric analytical techniques, associations, regression and correlation
• Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Clinical Pathology Accreditation (CPA), United Kingdom Accreditation Service (UKAS)
• REACH and the Cosmetic Directive
• Health and Safety at Work, COSHH, radioactive handling, genetic manipulation regulations
• animal welfare and experimentation. Home Office legislation and requirements (‘reduction, refinement, replacement’)
• medical research ethics committees
• ethics of professional practicemedical research ethics committees
• staff training and development processes. EUROTOX, HCPC registration.