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What is the purpose of GCP?

What is the purpose of GCP?

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 are GCP regulations?

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial.

What is a GCP certificate?

The Good Clinical Practice Certification is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational (not approved by FDA) drugs or devices.

What is the difference between ICH and GCP?

ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.

What does GCP mean?

Good Clinical Practice
● Define Good Clinical Practice (GCP)

Who needs to be GCP trained?

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials can learn about the requirement to be trained in Good Clinical Practice (GCP).

Who needs a GCP certificate?

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) .

How long is GCP training?

All GCP training can be accessed through the NIHR. Individuals must register with NIHR Learn prior to accessing the training. Please be aware that the certificate is valid for 3 years from the date of certification.

What are the main GCP principles?

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

How do I practice GCP?

Here are a few tips to help you start learning Google Cloud Platform on your own:

  1. Start With Cloud Basics. Before you can get comfortable with Google Cloud Platform, you need to understand the basics of the cloud.
  2. Explore Free Google Cloud Resources.
  3. Sign Up for GCP Training Courses.
  4. Get Google Cloud Certified.

How long is GCP valid?

3 years
Since GCP certificates expire after 3 years, the current certificate remains accessible when all quizzes have a passing score (greater than or equal to 80%, or 100% if required by your IRB) and until the expiry date has passed.

What are the principles of good clinical practice?

There are 13 key principles of Good Clinical Practice (GCP). The first seven are: Adherence to ethical principles. Risk minimization. Subject’s rights, safety, and well-being. Adequate drug information.

What is a good clinical practice course?

Good Clinical Practice (GCP) GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics , and devices, as well as those involved in behavioral intervention and social science research studies.

What are the requirements for clinical research?

To get an entry-level job in clinical research, you are required to be an undergraduate degree in life sciences, nursing, biotech or medical sciences and a diploma or certification in clinical research from a reputed institute.

What is a global clinical trial?

Global Clinical Trials ( GCT ) is a premium contract-research organization (CRO) that offers support for the preclinical and clinical Phase I-IV studies as well as post-marketing activities to Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions.