Question: Is GCP Training Mandatory?

How long is GCP valid for?

3 yearsSince GCP certificates expire after 3 years, the current certificate remains accessible when all quizzes have a passing score (greater than or equal to 80%) and until the expiry date has passed..

Why is GCP training important?

GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global.

What does GCP consist of?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

What is GCP certification?

GCP Professional Certifications are role-based and are used to prove you have advanced design and implementation skills. The exams expect you to have practical, hands-on knowledge related to your particular job.

Is GCP training required by the FDA?

Yes, the Food and Drug Administration (FDA) conducts GCP training.

How often do you need to do GCP training?

GCP training is required every 3 years.

How long is GCP training?

As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around three to six hours to complete a GCP course.

Who is responsible for GCP compliance?

Compliance with the Protocol (ICH GCP 4.5) The PI is responsible for ensuring that the study is conducted in compliance with the research protocol. He or she should ensure that all protocol violations are identified, documented, and reported in accordance with sponsor and IRB requirements.

What are the principles of GCP?

Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles. Research involving humans should be scientifically justified and described in a clear, detailed protocol.

Is GCP training required?

The policy does not require a particular GCP course or program. Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization.

Who needs good clinical practice training?

All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) .

What are the 3 main GCP principles?

Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.