Clinical trials follow certain ethical standards adhering to Good Clinical Practice (GCP) ensured by quality assurance team members without compromising the quality of the trial results which is critical for clinical research. Education of quality assurance in clinical trials is offered at national and international professional and scientific settings.
Quality Assurance (QA)
Quality Assurance in clinical trials allows conducting planned and systematic activities that ensure a trial is performed to document and report generated data in compliance with Good Clinical Practice (GCP) guidelines and other applicable regulator. Quality Assurance in clinical trials is a set of internationally recognised scientifically ethical quality requirements observed and used in designing, conducting, recording, documenting and reporting clinical trials that involve the participation of human subjects. Pharmaceutical companies recognize the benefits of carefully managed quality data for drug development and clinical trials.
Continuous monitoring of data, collection of procedures, managing the quality of clinical data and data management practices are the ongoing challenges at every level of the clinical study. Continual dynamic process of quality assurance throughout a clinical study requires maintaining accuracy and quality, systematic and independent examination of all trial-related documents and activities. Accuracy and integrity is ensured in clinical data by thoroughly reviewing data, validating outlying data points and carefully documenting query identification and resolution throughout a study. Expectations and requirements can change during a study, even though the study requirements are carefully set forth initially in detailed documents of approved clinical protocol, data management and project plans. Audits evaluate conducted activities and determine appropriately generated, recorded, analyzed and accurately reported data according to good clinical practices (GCPs) and standard operating procedures (SOPs).
Importance of Quality in Clinical Trials
Clinical trials are powerful tools for demonstrating effectiveness of a novel intervention or treatment to potentially demonstrate the ability of the community at large to reap the benefits of effectively delivered intervention. These trials suffer from quality variations among the participating treatment institutions and documenting the frequency of such variations is important. Quality assurance in a clinical trial can minimize the possibility of discrepancies and allow systematic treatment management among participating institutions. The quality assurance professionals in clinical trials also take up the responsibility to incorporate protocol compliant subjects for the project. The quality assurance audit team in clinical research performs audits from the initial data collection to the final trial report stage. These audits help the team members to review the entire clinical trial process; identify and rectify issues; modify and improvise the processes for future trials.
A comprehensive quality assurance (QA) program can define acceptable and unacceptable variations followed by detecting and correcting the causes of the variations. The ability of a program to improve the quality of clinical trials by reducing variations in treatment delivery has been demonstrated. Effective programs improve cooperation among groups involved in clinical trials as well as the participating institutions. The program should allow conducting procedures readily, identify and quantify variations in relevant parameters, detect and correct significant variations and demonstrate the outcome of the trial. The program meets national and international standards and identifies various aspects of the treatment delivery chain. These programs require adequately experienced and appropriately qualified personnel to set tolerance limits for the accuracy required within the specific trial. Such programs are designed to confirm all the aspects of the protocol and frequency of monitoring the protocol compliance varies between trials. All treatment plans for trials are reviewed and approved by experts before treating patients.
Online Course at JLI
James Lind Institute (JLI) provides an online program – Advanced PG Diploma in Clinical Research & Quality Assurance to help train professionals for maintaining quality of clinical trials.
For more information please visit: www.jli.edu.in