Good Clinical Practice_ICH GCP Courses
All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments (RA) to be conducted by the sponsors and CROS. However, conducting RA and developing adequate Risk Management Plans are not easy tasks, and not all the organizations conducting clinical trials have robust QRMs programs. In clinical trials we manage risks every day, this training covers a systematic approach on how to better do it according to ICH GCP E6 (R2).
Do you want an effective, efficient and engaging GCP training course that will HELP YOU to finally understand the GCP requirements, and what is more important, GUIDE YOU on how to implement those requirements in your daily clinical research activities? We have DISCOUNTED this course by €200 for the next 24h hours only so more people can access it. Apply this coupon code in the checkout to get 200€ OFF (from 297€ to 97€): SM200
Working on clinical research, we need to keep on working to safeguard first the safety and well-being of all those patients currently participating in a clinical trial, and to protect their rights. The Regulatory Authorities need to be more proactive than never, be flexible and provide right directions in order to protect the patients.
An effective, efficient and engaging GCP training that will help you to finally understand the GCP requirements, and what is more important, it will guide you on how to implement those requirements in your daily clinical research activities. We have discounted this course by €100! This limited time offer is valid until this Friday 20th March 2020. Apply this COUPON CODE in the checkout to get 100€ off: SM100
Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest the investigators did not receive appropriate training. This article will clearly explain what the principles of delegation are and how a Delegation Log must be completed and updated.
As GCP auditors we keep on facing the same GCP non-compliances when conducting investigator site audits and hosting regulatory inspections due to the sites staff, and also clinical operations personnel overseeing sites, lack of understanding of the seriousness of the procedures they must follow and the impact of their actions on the quality and integrity of the study data. Read more in Pharmity's blog!
ICH GCP 4.11 Safety Reporting, reinforces that as part of the essential safety monitoring process, investigators should identify and record any untoward medical events that occur during a clinical trial. To learn more about safety reporting, enroll in Pharmity's ICH GCP online course!