What is the role of quality in clinical trials?
Clinical trials provide information on the safety and efficacy of drugs under study. Sponsors of the clinical trial ensure that the investigators are following the compliant protocol and collecting and reporting quality data. Quality, one of the core modules of the trial, can be defined as a set of characteristics that a product or service must possess in order to meet the requirements of the customer. Quality management system in clinical research aims at establishing and consistently achieving compliance with ethical, regulatory and GXP standards and maintaining authenticity of the clinical data. Quality control and quality assurance are the standard components of the quality management system in clinical research.
What is quality control?
In clinical research, quality control process assures internal consistency by conducting periodic operational checks at every stage of the trial process and data handling to verify the compliance of the trial process and reliability of the data. The steps involved in the quality control process include developing the trial protocol, data collection and pooling the data in the database, analysis of the data and preparing the trial report.
Facilities of the institution and proficiency of investigators are expected to be of high quality and act as deciding factors for developing a trial protocol. It is developed by thoroughly reviewing and analysing previous data related to trials. The data managers are continually trained to keep themselves up-to-date on maintenance of quality in the data collected and assure consistency and accuracy. Quality evaluation of the research is needed for proper analysis of the data. Monitoring and audit play a key role in assuring quality throughout the trial.
What is quality assurance?
Quality assurance refers to systemic and independent audit of all activities and documents related to a clinical trial. This is performed by quality assurance personnel who are not involved in the research to determine whether the trial was conducted and that the collection, analysis and reporting of data were in accordance with the protocol, standard operating procedures (SOPs) and Good Clinical Practices (GCP). In short, this process assesses the efficiency of quality control processes carried out by the sponsors.
The trial specific quality assurance audits include audits of the trial protocol, case report form (CRF), trial sites, trial database, graphs, tables and statistics and trial report. Whereas quality assurance system audits include audits of central lab and service providers, computerised data collection system, monitoring system, IP management and distribution system, document management and archiving and sponsor’s pharmacovigilance system.
One important aspect of quality assurance in clinical trials is good clinical practice (GCP) which can be defined as a set of ethical and scientific quality guidelines that must be observed globally for planning, conducting, recording and reporting clinical trials which involve the participation of human subjects.
What is the quality plan?
The quality plan defines how the quality control and quality assurance processes are abided by throughout the clinical trial and describes various quality related tasks in the study. It documents quality practices, resources and activities that are specific to a project.
In a nutshell
Quality control and quality assurance activities in a clinical trial:
- Ensures that the trial is in compliance with protocols, Standard Operating Procedures and Good Clinical Practices
- Resolves systemic problems before the end of the trial
- Helps minimize data queries
- Come up with ways to minimize cycle times for various processes
- Assure the credibility and reliability of the data
- Make sure that the data entered at all stages of the trial is consistent and accurate
- Play an important role in dealing with cases of nonconformity during the trial
James Lind Institute (JLI) offers many online courses in clinical research quality assurance. For more information please go through the links below: