Eurofins CRL offers GCP (Good Clinical Practice) compliant testing to support the needs of your project.

GCPs, which are US government standards that must be met by laboratories generating data for FDA, are frequently misunderstood. The goal of this page is to provide a framework for understanding the "basics" of GCP regulations.

                                         

Good Clinical Practices are a set of standards that are pertinent to clinical testing data submissions to the FDA. GCPs are designed to protect the rights, safety, and well-being of study subjects during their partipation in clinical trials and the following elements are some of the essential foundations of GCP standards:

IRB Submission

For any given GCP clinical trial, an Institutional Review Board (IRB) reviews the trial-related documents prepared by Eurofins CRL to ensure that the rights and safety of study subjects are maintained throughout the course of their particpation in testing. The IRB reviews study protocols, protocol amendments, written informed consent forms, subject recruitment advertisements, available safety information or nonclinical data, and the qualifications of the Principal Investigator prior to approving of the study design. Clinical studies are approved by the IRB prior to subject recruitment.

Informed Consent

Before being enrolled in a clinical study, participants must review an informed consent document that notifies them of the purpose of the trial, their responsibilites as a subject (should they choose to participate), the reasonably foreseeable risks and benefits to the subject, etc. Signed written informed consent is obtained from each study subject for each clinical study they choose to participate in.

Safety Reporting

In the interest of monitoring and maintaining the safety of clinical trials, Eurofins CRL documents each adverse event reported by study subjects throughout the course of clinical studies and appropriately reports serious adverse events to Study Sponsors and the overseeing IRB.

Medical Care of Study Subjects

During and following a subject's participation in a clinical trial, ECRL ensures that adequate medical care is provided to study subjects for any adverse event related to their participation in the trial.

 

 

Eurofins CRL Is:

An FDA GLP and GCP-compliant testing organization staffed by skilled, experienced microbiologists and subject recruiters.  ECRL can help speed your project to completion.