Here are the top 10 functions that need FDA GCP training:
1. The Clinical Trial Sponsor
A clinical trial sponsor is the individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
According to GCP guidelines, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and regulatory requirements.
2. Clinical Trial Investigators
A clinical trial investigator is the person responsible for the conduct of the clinical trial at a trial site. If the clinical trial is conducted by team of individuals at the trial site, then the investigator is the responsible leader of the team and is known as the Principal Investigator.
Some highlights from FDA guidance:
3. The Person or Group that Performs Clinical Trial Monitoring
Clinical trial monitoring is an integral part of Good Clinical Practices.
The purposes of clinical trial monitoring are to verify that:
4. Whoever Performs the Clinical Trial Audits
A sponsor’s audit of a clinical trial is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
The auditor chosen by the sponsor to audit a clinical trial should be:
5. The Institutional Review Boards (IRBs), Independent Ethics Committees (IEC)
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is an independent body comprising medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.
An IRB/IEC should carry out the following activities to guarantee the rights and safety of trial subjects:
6. The Party Responsible for Informed Consent
Informed consent is a cornerstone and key ethical consideration in clinical trials. It is a critical component of any GCP guideline. Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate.
Informed consent is not a one-time event – it a continuing process throughout the study, providing information for participants.
7. Clinical Trial Documentation Department Personnel
Proper clinical trial documentation is important in ensuring GCP compliance. Documentation is defined by GCP guidelines as all records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
8. Writers of Clinical Trial Protocols
A clinical trial protocol is an essential element in GCP guidelines and compliance. At its most basic, a clinical trial protocol is a study plan on which all clinical trials are based. A protocol or plan has to be properly designed in order to protect the welfare and health of trial subjects as well as properly answer clinical research questions.
9. The Group that Compiles the Clinical Trial Investigator’s Brochure
The Investigator’s Brochure or IB is a compilation of the clinical and nonclinical data on the investigational product that is relevant to the study of the product in human subjects. GCP guidelines state that the purpose of the IB is to provide the investigators and others involved in the trial with the information to improve their understanding and compliance with of the protocol.
10. Clinical Trial Safety Reporting Group
Clinical trial safety reporting is an integral part of the clinical study process. GCP guidelines give clear requirements regarding the reporting of serious adverse events (SAEs) and abnormalities. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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