About Us
The project to develop a web based educational resource commenced in March 2006 following identification of the need aftre the implementation of new legislation relating to research and in particular research that involved investigational medicinal products.
Aims of the project
- to develop a web based educational resource for pharmacy staff involved in the provision of research/ clinical trials that involve investigational medicinal products
- to encourage the sharing of best practice throughout Scotland through the sharing of information, experiences and ultimately documentation developed as part of this project
- to facilitate the development of pharmacy staff by the completion of competency based educational frameworks depending on their educational requirement
Research Methodology
A multidisiplinary Reference Group was convened which met on approximately 3 occasions with further comments as to the progress of the work being shared 'virtually'.
The objectives of the Reference Group were to ensure that ;
- the project progressed
- timelines were adhered to
- a multidisciplinaryapproach was considered
A Working Group, comprising of several members (5) of the Pharmacy Specialist Interest Group for Clinical Trials (Scotland) was also convened.
The objectives of the Working Group were to ;
- faciltate the scoping of the work
- develop material for the educational framework
- facilitate the editing of the web based resource
- facilitate piloting of the resources including the various competency frameworks
A variety of literature was reviewed and a variety of websites were accessed during the 'scoping ' part of the project. General underpinning knowledge in the form of a 'website' with links was developed. From this more specialist underpinning knowledge, competency frameworks and methods of assessment were developed.
Competency Frameworks
The various competency frameworks were developed by reviewing a variety of frameworks
that were already available (e.g. Stage 11 (SHPVTS), SVQs, The NHS Knowledge
and Skills Framework (NHS KSF) and the Development Review Process (Oct 2004),
and the job descriptions (submitted as part of the project by members of CTSIG).
Learning outcomes and competencies relating to the various process required to be undertaken by pharmacy staff when managing a clinical trial, within the NHS, in Scotland were developed. Particular reference was given to the requirements as dictated by the new legislation (EU Directive Clnical Trials 2001/20) introduced in 2001.
Performance Indicators were subsequently developed from the competencies and were 'mapped' into a specific competency framework depending on the level of education required.
Assessment and Evaluation
Methods of assessment for the various levels of education were agreed and multiple choice questions and checklists developed.An e portfolio was developed to encourage the recording of CPD (it is anticipated that the e portfolio will link with the RPSGB CPD records in 2008)
The project is now in the pilot phase. The impact of the educational resource will be evaluated in the near future.
Grateful thanks is extended to Yousaf Ahmend a 3rd year pharmacy student (2006) who facilitated the initial scoping exercise of this project, as part of a vacational placement during his 3rd Year at Strathclyde University.