Basics of ICH-GCP Guidelines
At JBR Clinical Research, we’re a longtime partner of clinical trials and sponsors. Our goal is to ensure accurate clinical research approaches in a variety of fields, from pain and vaccines to imaging and dermatology, among many others.
A big part of the oversight for these kinds of studies relates to the rights of test subjects, governed in a broad sense by Good Clinical Practice guidelines that we discussed in a recent blog. In particular, researchers must always note the tenets of ICH-GCP, or the International Conference on Harmonization-Good Clinical Practices guidelines. What are these, and how might they impact your research project? Let’s take a look.
The ICH-GCP is a harmonized standard that’s designed to protect the rights, safety and welfare of human subjects. It’s also meant to minimize human exposure to investigational products, improve the quality of data, speed up the marketing of new drugs and decrease the cost to sponsors and the public.
Compliance with this standard is consistent with the Declaration of Helsinki, and ensures that data is reliable. In our next section, we’ll go into the 13 core principles of ICH-GCP.
Here are the 13 core principles of the ICH-GCP:
- Trials should be conducted in accordance with the Declaration of Helsinki and applicable regulatory requirements.
- Before trials begin, risks and inconveniences should be weighted against benefits for the trial subjects and society at large. A trial should only proceed if benefits outweigh risks.
- Rights, safety and well-being of subjects are the most important considerations and should hold the most weight.
- All available information should be adequate to support the proposed trial.
- Trials should be scientifically sound and described in clear, detailed protocol.
- Trials should be conducted in compliance with protocols from a prior institutional review board or independent ethics committee.
- Any medical care or decisions for trial subjects should be carried out by qualified physicians.
- Every individual conducting the trial should be qualified in education, training and experience.
- Freely given informed consent must be collected form all subjects prior to participation.
- All trial information should be recorded, handled and stored in proper ways that ensure accuracy.
- Confidentiality of records should be protected.
- Any investigational products should be manufactured, handled and stored in compliance with Good Manufacturing Practice (GMP).
- Systems with procedures that assure that quality of every aspect of the trial should be implemented.
Want to learn more about ICH-GCP guidelines, or interested in finding out how to participate in pink eye clinical studies, hernia surgery studies, a bunion removal study or any of our other clinical trials? Speak to the pros at JBR Clinical Research today.