Good Clinical Practice (GCP) is a crucial training certification for anyone involved in clinical research. The GCP framework sets the foundation for the ethical, practical, and scientific standards of any research initiative.
Full Answer
What is the definition of good clinical practice?
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
What are good clinical practice guidelines?
Good clinical guidelines should be based on up-to-date scientific knowledge, and it should be possible to follow the recommendations in daily medical practice. International uniform standards are now used worldwide for the assessment of clinical guidelines.
What is good clinical practice (GCP) training?
What is Good Clinical Practice training? Monash Partners ‘Introduction to Good Clinical Practice (GCP) Training’ involves a six-hour face-to-face interactive workshop and is fully accredited. The training is suitable for staff with and without previous International Council on Harmonisation (ICH) GCP training, and is designed for all those involved in pharma or interventional clinical research.
How long is GCP Training Certification valid for?
The GCP certification stays valid for 1 year from the day of passing the GCP certification examination. Recertification can be achieved through a re-examination that can be scheduled through the Training Portal when it is due after paying the Certification fee.
Who needs GCP certification?
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 do I get good clinical practice certification?
Good Clinical Practice (GCP) CertificationComplete a CITI GCP course online.Complete an NIH GCP course online.Attend a WUSTL-sponsored instructor-led course.
How long does it take to get good clinical practice certification?
Learners may complete the modules at their own pace. 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.
What is good clinical practice?
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.
Is GCP training free?
Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. NIH also offers GCP training that is free of charge, including options from NIAID, NIDA, and NCATS.
How long is a GCP valid for?
2 yearsIt is highly recommended that GRP/GCP training is updated with a Refresher every 2 years.
What are the 3 main GCP principles?
Subject's Rights, Safety, and Bell-Being. ICH GCP Principle 3 states that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
Does GCP certification expire?
All Associate and Professional Google Cloud certifications are valid for two years from the date an individual certifies.
What is GCP and why is it important?
Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.
How long is good clinical practice valid for?
What is the expiry date for the ICH GCP course? How long is it valid for? We recommend retaking the course every 2 years. However, you can retake it to refresh your memory or if there is an update before this time.
Why GCP training is required?
GCP training aims to ensure that: the rights, safety, and well-being of human subjects are protected. clinical trials are conducted in accordance with approved plans with rigor and integrity. data derived from clinical trials are reliable.
How is GCP enforced?
This is achieved through audits of clinical data contained in PMA's prior to approval, data audits of IDE and 510(k) submissions, inspections of Institutional Review Boards and nonclinical laboratories, and enforcement of the prohibition against promotion, marketing, or commercialization of investigational devices.
What are the 3 main GCP principles?
Subject's Rights, Safety, and Bell-Being. ICH GCP Principle 3 states that the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
What is HSP certification?
Highly Sensitive Person (HSP) Certification Training Program This course is for professionals working with Highly Sensitive People. It covers various assessments, mistaken conditions, health-related issues, and challenges with identity, relationships, boundaries, as well as traditional/alternative therapies.
Does GCP certification expire?
All Associate and Professional Google Cloud certifications are valid for two years from the date an individual certifies.
How long is Citi GCP training good for?
3 yearsGCP training must be renewed every 3 years through one of the following: Completing the CITI GCP “refresher module” that is available for those who have completed the initial CITI GCP training.
Who developed the GCP - Social and Behavioral Research Best Practices for Clinical Research course?
The development of the GCP - Social and Behavioral Research Best Practices for Clinical Research course was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program, grant number 3UL1TR000433.
How does the GCP - Social and Behavioral Research Best Practices for Clinical Research course differ from other GCP courses?
The GCP - Social and Behavioral Research Best Practices for Clinical Research course applies GCP principles to behavioral intervention and social science research studies. Other GCP courses cover drug, device, and biologic-related studies.
Is GCP training the same as human subjects protection training?
No. GCP training is a separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.
Does CITI Program offer GCP training that is compliant with the NIH policy?
The National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP.
Who should take GCP training?
GCP content is suitable 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.
How do I know which GCP course I should take?
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
How long does it take to complete a GCP course?
Learners may complete the modules at their own pace. 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.
What is GCP training?
GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to ensure that: the rights, safety, and well-being of human subjects are protected. clinical trials are conducted in accordance with approved plans with rigor and integrity.
What is the purpose of GCP?
The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.
Does the NIH require a GCP?
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. NIH also offers GCP training that is free of charge, including:
What is clinical research training?
Clinical research training is a course developed by the National Institutes of Health to train its investigators. It is available for others to enhance their knowledge of clinical research.
Does the FDA offer training?
The FDA offers training related to our good clinical practice (GCP) regulations and partners with other federal agencies and organizations across the United States to conduct additional training.
Who is it for?
GCP training is required for anyone involved in conducting clinical research. The GCP certification is a requirement of the 2005 Research Governance guidelines for Health and Social Care covering all research connected to the NHS in England, and those working in clinical trials.
Why Whitehall Training?
Whitehall Training goes above and beyond to deliver the most reliable, fully compliant training opportunities in an online, interactive environment. We’ve helped over 10,000 organisations to ensure they’re compliant with the highest legal and ethical standards. Our portfolio is populated by courses written by leading experts in the field.
What is a GCP?
Good Clinical Practice (GCP) is a crucial training certification for anyone involved in clinical research. The GCP framework sets the foundation for the ethical, practical, and scientific standards of any research initiative. Compliance with the GCP provides public assurance that the safety, wellbeing, and rights of each research participant is being protected.
What is GCP training?
GCP training ensures anyone involved in research knows how to perform specific tasks according to the highest scientific, practical, and ethical standards. GCP courses will empower learners to be more competent in their roles while preserving the rights, wellbeing, and safety of anyone involved in studies or research.
Do clinical trials require training?
For clinical trials, the Medicines for Human Use regulations require all staff to be trained according to the GCP guidelines to carry out their projects. With our training solution, you can adapt your course experience to suit your needs, making learning easier for people with limited time and schedule opportunities. Our courses also come in a variety of languages for global support.
What is a GCP course?
GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. Acceptable GCP courses include: National Institute of Allergy and Infectious Diseases (NIAID): GCP Learning Center.
What is the GCP?
The principles of Good Clinical Practice (GCP) training, consistent with the International Conference on Harmonisation (ICH) Efficacy Document E6#N#(link is external)#N#, help to ensure the safety, integrity, and quality of clinical trials.
What is GCP?
Good Clinical Practice (GCP) is an international quality standard for conducting clinical trials that is provided by the International Conference on Harmonization (ICH), an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
What are my Training Options?
NIH also offers GCP training that is free of charge, including options from NIAID , NIDA, and NCATS. Other free courses as well as fee-based courses are available.
What is the question added to the EIRB application?
A question will be added to the eIRB application requiring Principal Investigators to certify that they, and all members of the study team, have completed the required GCP training. PIs will be required to answer this question as part of all new applications and new change in research applications submitted after the next eIRB update. Random audits for certificates of completion will begin in the spring of 2017. If GCP training is taken other than through CITI, individuals must print the certificate of completion and keep it on file.
What is a GCP?
A standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.
How often does JHM training need to be updated?
The entire research team ( (Principal Investigator (PI) and all clinical trial staff)) must complete the training. The training must be updated every three years. While the new JHM policy only applies to individuals conducting clinical trials, ...
When did the NIH start requiring GCP training?
NIH leadership released a new policy requiring GCP training as of January 1, 2017 (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html ).
What is clinical trial staff?
The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, data analysis, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with the research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
What is a prospective study?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control ) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Where to send GCP training questions?
Questions related to GCP training should be sent to [email protected] .
What is clinical practice?
Good Clinical Practice. FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply ...
What is the role of clinical investigators?
These laws and regulations are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.
What Is It?
- The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to e...
Who Is It for?
What Are The Benefits of A GCP Qualification?
Why Whitehall Training?