Investigator Obligations in FDA Regulated Research

The investigator plays a crucial role in ensuring the success of a clinical trial. As part of their obligations, they are responsible for conducting the study in compliance with the protocol, Good Clinical Practice (GCP), and all applicable regulations. This includes ensuring the safety and well-being of trial participants, maintaining accurate and complete records, and submitting reports to the Institutional Review Board (IRB) and the FDA as required.

In addition to these obligations, investigators must also ensure that the trial is conducted in accordance with the principles of GCP, which provides a framework for conducting clinical trials that ensures the rights, safety, and well-being of trial participants are protected. The investigator must also maintain confidentiality and not disclose any confidential information related to the trial. By fulfilling these obligations, investigators can help ensure the integrity and validity of the trial data and contribute to the advancement of medical knowledge.

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