Process modelling
Process Mapping: An Updated Approach to Quality System Management
Steve Nicholas
This article describes the role that process maps can play in updating an organisation’s approach to managing and documenting their quality system. It proposes the use of process mapping as part of a multimedia-based approach to communicating work-based activities. The article provides examples of how the adoption of process maps can encourage a process-based approach to managing quality, which the author considers fundamental to the development of modern and robust quality management systems.
Challenging the Traditional SOP with Process Modelling
Steve Burman & Suzanne O’Connor
Following a series of re-organisations, mergers and acquisitions, Pfizer was faced with a myriad of duplicative Standard Operating Procedures (SOPs), varying widely in size, structure, level of detail and scope. This challenge also furnished an opportunity to re-think the nature of an SOP, address some of the accessibility issues and potentially increase their value and utility in day-to-day operations.
Feature
Nancy Milligan & Andrew Smith
February 27th 2008 saw the first joint symposium held by the European Medical Writers Association (EMWA) and the Institute of Clinical Research (ICR). Nearly 100 members of the two professional organisations gathered in London to discuss the ethics and best practice of publishing clinical trials. Nancy and Andrew were there…
Paul Chester MICR & Tania Worth RICR
With so many technological and regulatory changes in recent years, it is easy to overlook the importance of individual and team performance in timely delivery of clinical trials. Paul and Tania present a short survey of the perceptions of individual team members to assess the importance of non-technical aspects of performance in both successful and unsuccessful trials.
National update
Knowledge & Skills at the Study Site: Requirements for Clinical Research Professionals in India: A Survey
Samyuktha Ajay & Dr Arun Bhatt
India is a relatively new destination for clinical research, with a several-fold increase in India’s participation in global clinical trials in recent years. However, the demand for trained personnel, both in the industry and at hospital sites, far exceeds the available pool of trained personnel. The authors present a survey of knowledge and skills requirements of different clinical research professionals in industry and at hospital sites.
People
Louise Wood
Dr Louise Wood is Head of Innovation and Industry R&D Relations in the Research and Development Directorate of the Department of Health for England. She talks to us about the recent developments in the UK clinical research environment, driving transformational change across a diverse set of organisations and bringing together the “two cultures” of industry and the NHS for successful collaboration. An audio version of the complete interview is also available.
Professional development
Ali Orr & Sue Fitzpatrick HonFICR CSci
ICR was elected a licensed body of the Science Council in October 2007, making it the only organisation permitted to award Chartered Scientist (CSci) status to clinical research professionals. Half-way through the first year of this new way to recognise the expertise of members, the authors reflect on the benefits of CSci designation.
Helena Korjonen
There are many valuable research tools all ICR members can access through our website, and this piece is intended to help you use them more effectively. Helena walks through an example of reporting on all new drugs undergoing development in type II diabetes, using information tools available free to members through the ICR website.
Training Needs of Research Nurses: A Survey
Arun Acharjya MICR
As part of its strategy and vision for the year, the ICR Research Nurse Special Interest Group discussed the training needs of Research Nurses, conducting a survey in March 2008. As Vice-Chair of the SIG, Arun Acharjya presents the results, and reflects on how they will inform future activities.
Viewpoint
Andrew Smith
Andrew is cautious of being too critical of the recent announcement of a deal on the voluntary scheme to replace the Pharmaceutical Pricing Regulation Scheme (PPRS). However, it is certainly not the value-based pricing system many had hoped for. He ponders whether it could be a stop-gap while a more sophisticated system is developed, or a simple price cut, squandering the opportunity to improve on the current ‘blunt instrument’.
Conference reports
Most of the session reports from ICR’s Annual Conference were published in June’s CRfocus. The remaining few will be available online shortly.
Clinical Trial Insurance in Europe: Current Issues & Avoiding Pitfalls [coming soon]
James Bird
Adrian Bootes
Andrew Booth
Allergic Reactions to Food in Children: What Are the Risks? [coming soon]
Allan Colver
Presenting Science: A Trial by Media [coming soon]
Suzanne Elvidge
Listening to our Patients: Who Will Pay My Parking? [coming soon]
John Needham
Regular update
Susan Ollier MICR
This month saw the graduation of the first group of ICR/Cranfield Health students on the Clinical Research MSc course. On June 6th, Susan Ollier was a guest at a packed graduation ceremony at Cranfield University in Bedfordshire, UK. Her congratulations (and ours) go to all our graduates and especially to prize-winners Bridget Juniper and Javier Moreno Farre.
