U.S. FDA regulations require that a clinical trial Sponsor monitor the progress of a clinical investigation to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted to the FDA.
Similarly, the International Conference on Harmonization (ICH), which was organized to develop tripartite harmonization initiatives with input from the European Union, Japan, and the United States, states that the purposes of clinical trial monitoring are to verify that the rights and well-being of human subjects are protected, to verify that the reported clinical trial data are accurate, complete, and verifiable from source documents, and to verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practices (GCP), and with the applicable regulatory requirement(s).
Aptiv Solutions regularly monitors pharmaceutical and medical device clinical trials around the globe. Our clinical research associates (CRAs) ensure that studies are performed in accordance with FDA regulations and GCP/ICH guidelines and:
- Ensure investigator compliance with the protocol and regulations and identify any deviations to the clinical study plan
- Verify subject eligibility and informed consent
- Ensure reporting of adverse events
- Review and verify study data
- Identify and resolve any problems at the study sites during the course of the clinical trial
- Prepare study sites and sponsors for FDA inspections that may occur during the course of the clinical study or after the study is closed