In 2007, a Quality Assurance (QA) management system was introduced within HSRU (including CHaRT) to ensure adherence to the NHS Research Governance Framework and EU Clinical Trials Directive thus meeting the wide range of legal, ethical, regulatory and governance requirements.
The objective of which is to develop and promote robust quality assurance systems integrating them into HSRU's (CHaRT) best working practices. These systems include:
- Standard Operating Procedures (SOPs) and best practice guidelines.
- Standardisation of processes and study documentation to provide templates, forms and checklists.
- Ensuring staff are: adequately trained for their tasks; familiar with HSRU's remit for staff training; education and development (including GCP); and for those in CHaRT working to CHaRT's Standard Operating Procedures (SOPs).
- Conducting assessments of quality within HSRU's projects and overseeing HSRU's co-operation with external auditors.
Please note, all training is held in Room 115, Health Sciences Building, Foresterhill (unless otherwise stated).
NIH releases best practices for combining qualitative and quantitative research
The National Institute of Health (NIH) recently published guidance for the best practice in mixed methods research in health sciences (see: http://obssr.od.nih.gov/scientific_areas/methodology/mixed_methods_research/index.aspx). Mixed methods research combines the strengths of quantitative research and qualitative research. Despite the increased interest in mixed methods research in health fields and at NIH, prior to this report, there was limited guidance to help scientists developing applications for NIH funding that featured mixed methods designs, nor was there guidance for the reviewers at NIH who assess the quality of these applications.
Academy of Medical Sciences report: a summary
The charity 'Myeloma UK' has recently prepared a summary of the Academy of Medical Sciences report 'A new pathway for the regulation and governance of health research', highlighting its major points. The main report can be downloaded here.
Revised process for handling requirements
The process for handling amendments for studies that have gained approval through the National Institute for Health Research Coordinated System for Gaining NHS Permission (NIHR CSP) in England has been revised. The revised process, which came into effect on 4 January 2011, sets out a clear timeline and consistent approach for handling amendments and will improve the facilitation and tracking of the process for the Chief Investigator (CI) and Sponsor. The full process can be downloaded from the NIHR CSP publications section of the NIHR CRN CC website, a one page summary for researchers is also available at the same location.
For more QA news, see the April 2012 newsletter.