Common Mistakes Sites Make When Conducting Clinical Trials
Clinical trials come with great responsibility for the Principal Investigator. These trials need to be conducted with rigorous supervision and adherence to regulations.
To help you avoid some basic errors, here are some of the common mistakes people make when conducting clinical trials:
1. Initiating study procedures before obtaining signed informed consent from the participant
The informed consent of the participant must be obtained before any research procedures start. This could cause the study site to be found in breach of the study protocol and Good Clinical Practice.
2. Not following the protocol on restricted concomitant medicine
The Principal Investigator overseeing the participant may sometimes prescribe medicine that deviates from the protocol. Despite wanting to treat a patient’s adverse reaction, this is a mistake because it could breach data integrity, interfere with the study medication’s efficacy and be a possible hazard to the study patient.
3. Failing to maintain essential documents
These documents generated during a clinical trial should outline the trial conduct and its integrity. For example, is each protocol amendment approved by an independent ethics committee at the site? Did the sponsor update their investigator brochure at least annually? Were serious adverse events reported within the required timelines to the regulatory bodies?
To avoid these and other mistakes, reach out to the experts at CRT Solution. We offer courses for research coordinators, research nurses, and research professionals (clerks, administrators, and assistants). We offer in-person training across the province of Quebec and virtually across the rest of Canada and North America.
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To learn about the training we offer, please click here. If you have any questions about research, we’d love to hear from you. For more information, please call us at (514) 532-1335 or email us at firstname.lastname@example.org.