Clinical trials assess the efficacy and safety of pharmaceutical products, medical devices, and procedures. These trials provide critical data that support the approval and use of medical products. Since clinical trials have a significant impact on public health, pharmaceutical companies need quality assurance. Understand basic procedures with this brief overview of quality control in clinical trials.
Protocol Development and Review
The first step in ensuring quality control is to develop a protocol that defines the study objectives, endpoints, design, methodology, inclusion and exclusion criteria, and other important aspects of the trial.
The protocol development process involves input from a variety of stakeholders, including the study sponsor, investigators, and regulatory authorities. The protocol goes through a review process to ensure that it meets regulatory requirements and is scientifically sound.
Training and Site Management
Quality control also involves training of investigators and site staff. Training ensures uniform conduct of trial procedures across all study sites and generation of high-quality data. Site management activities include monitoring conduct, compliance with the protocol, and adherence to regulatory requirements.
Staff perform this through monitoring data collection, data entry, source document verification, and adverse event reporting.
Data Quality Assurance
Data quality assurance activities ensure that the data from the clinical trial are accurate, complete, and reliable. This involves several activities such as data cleaning, data validation, and data management.
Data cleaning identifies and corrects errors in the data, while data validation involves checking the accuracy and completeness of the information. Data management includes maintaining the audit trail, saving study documentation, and ensuring data security.
Monitoring and Auditing
Monitoring and auditing are critical for quality control in clinical trials. Monitoring is an ongoing oversight of the trial conduct and data generation. Typically, study teams or independent clinical research organizations (CRO) examine information.
Auditing involves a systematic review of the clinical trial to ensure that everything meets protocol and regulatory requirements. Regulatory authorities perform audits.
Reporting and Analysis
Reporting and analyzing the data is the final step in quality control. Researchers perform data analysis using statistical techniques to determine conclusions about products or procedures under study. They report the results in a clinical study report (CSR) and submit them to regulatory authorities for review.
Quality control involves several steps to ensure the safety of new medicines. This supports public health and advances scientific studies. Clinical trials pave the road to successful, safe medicines. Moravek offers carbon-13 labeled compounds that support research and experimentation. Work with us today!