Quality in clinical research starts with a systems approach. The “systems” include training programs, role definition, organizational structure, responsibilities and accountability, Standard Operating Procedures (SOPs) and processes, documentation, and metrics.
All stakeholders in clinical research, pharmaceutical, biologic, and device companies, Investigators, CROs, IRBs etc., should have quality systems to ensure that their output from clinical research is of the highest quality and in compliance with GCP, protocols, and other requirements. High quality research results in faster product approvals at lower cost! So, all stakeholders should be interested in quality and saving money.
So how do you start building quality systems? Most of these actions are also required by GCP requirements (e.g., qualified staff, training programs, documentation, etc.)
- Hire the right people who have the skills/expertise (qualifications) for the procedures.
- Develop standards for processes, procedures and outcomes/results
- Ensure adequate and complete documentation for all procedures and results (e.g. written SOPs)
- Provide training programs on GCP, Clinical Research Methods, SOPs, and skills/expertise for the specific role the person performs in clinical research
- Collect, track and measure metrics on the results/outcomes of the procedures.
- Perform periodic Quality Assurance Measurements to ensure conformance to procedures
- Implement CAPA actions to improve quality and performance
A key part of quality is consistent performance of procedures producing a consistent result. A critical part of these quality actions is developing standard procedures and processes (SOPs) so anyone performing the procedure will complete it in the same way and produce the same result. In addition to providing a standard for procedures, Standard Operating Procedures also provide training information for new hires on how things are done at their new workplace. SOPS set the measure for quality results so staff performance can be measured to the standard required.
Writing SOPs is only one of the steps toward quality results. Everyone must be trained on the SOPs and performance must be measured against the standard to ensure the correct results. Metrics must be collected on a regular basis to ensure staff is following the SOPs. If metrics and performance measurement are not done, compliance to the SOPs decreases since “no one is interested if we follow procedures” or even worse, “I can do it MY way because no one follows-up on compliance”. In these cases the good effort of designing and writing standard procedures is wasted, as no one is performing in that way.
When I have been auditing to measure compliance to SOPs, I have noted that many employees are unable to describe the standard procedure for an activity. If they can’t describe it, they can’t perform the procedure correctly. Then, standardization and quality decreases. In order for standard processes leading to quality to be effective, there must be written SOPs, training on the SOPs, and metrics and measurement on the compliance to the SOPS. Like a 3 legged chair, all three items must be present for the quality system to work well.
Measurement to the standard procedures includes QA audits and metrics. For example, it’s difficult to know exactly what your driving speed is until you look at the speedometer. Regular metrics of key procedures will give you that “dashboard reading” of whether your staff are on track or designing their own way of doing things.
Some Key Measurements and Metrics are:
- Documentation audits for complete and accurate regulatory documents
- Number of data queries
- Enrollment tracking
- Number of protocol violations
- Training records
- Adverse event reporting timing
- Proper informed consent.
- I’m sure you can list others
Write or review your SOPs to ensure you have consistent procedures and a quality system at your site or company. It’s is the foundation of quality clinical research. If you don’t set the standard, how will anyone be able to perform to levels of high quality clinical research?
Today’s article was written by Lorraine Ellis, CEO and Founder of Research Dynamics, a Rochester, NY based contract research organization (CRO). Lorraine is an expert in GCP and FDA regulations. The original article, as well as many other interesting topics can be found on the Research Dynamics Blog.