Certified Clinical Research Associate (CCRA) Practice Exam

The circumstance that could lead to termination of a subject's participation in a trial is based on the investigator's discretion under specific conditions. In clinical trials, investigators hold a significant responsibility for ensuring the safety and well-being of the subjects involved. This includes monitoring their health and reactions to the study intervention throughout the trial. If an investigator determines that a subject is experiencing adverse effects, is not following the protocol, or if the subject's medical condition changes in a way that compromises their eligibility or safety, the investigator has the authority and ethical obligation to terminate their participation. This decision is made in light of the overarching goal of protecting subjects and maintaining the integrity of the trial. Other options do not directly align with circumstances typically warranting a subject's termination. For instance, a lack of previous medical history may require further assessment but does not inherently lead to termination. Delays in obtaining consent focus more on procedural issues rather than a direct cause for termination. Lastly, a subject's age demographic might influence eligibility criteria for enrollment but is not a reason that would lead to termination during the trial once they are participating.