What is the first action a company should take if it finds that one site in a clinical study has not properly consented all subjects?

The first action a company should take when it discovers that one site in a clinical study has not properly consented all subjects is to re-consent all improperly consented subjects. This course of action is crucial because informed consent is a fundamental ethical and regulatory requirement in clinical research. Ensuring that all subjects clearly understand the study, its purpose, risks, and benefits is vital for maintaining the integrity of the research and protecting the participants' rights.

By re-consenting the affected subjects, the company is actively working to rectify the situation and ensure that all participants are properly informed. This action demonstrates a commitment to ethical standards and compliance with Good Clinical Practice (GCP) guidelines. After addressing the consent issues with the affected subjects, further steps, such as re-training study staff or informing regulatory bodies, may follow to prevent similar occurrences in the future. However, the immediate priority is to ensure that all subjects are adequately informed before continuing any study-related activities.