What can be a consequence of failing to adhere to GCP and regulatory requirements in trials?

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The consequence of failing to adhere to Good Clinical Practice (GCP) and regulatory requirements can lead to potential harm to participant rights and safety. GCP is designed to ensure that clinical trials are conducted ethically and scientifically, with the ultimate goal of protecting the rights, safety, and well-being of the participants. When these principles are disregarded, it can result in inadequate informed consent processes, insufficient monitoring of adverse events, or non-compliance with protocols, all of which can jeopardize the health and rights of participants. This not only poses ethical concerns but can also lead to legal repercussions for the researchers and the institutions involved in the trial.

In contrast, the other options suggest outcomes that benefit the trial, which are unrealistic under the premise of non-compliance to GCP. Increased participant recruitment speed, enhanced data credibility, and improved trial publicity are all positive outcomes that might occasionally be sought in clinical trials, but they cannot be achieved responsibly or ethically if GCP and regulatory requirements are not followed.

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