18 Oct 2018: ICH E2a, E8 & E9: The Essentials.
Every clinical researcher knows, or at least they should, ICH GCP E6 R2 needs to be followed for the conduct of any clinical trial. Even in the device research world, this guideline is used in tandem with ISO 14155. What most researchers are not sufficiently aware of is that this guideline should be read and applied in conjunction with other ICH guidelines relevant to the conduct of clinical trials, namely E2a, E3, E7, E8, E9 and E11 to ensure GCP compliance.
This TRIUM training is a first in a series of ICH guidelines training, starting with explaining the contents and relevance of ICH guidelines E2a (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E8 (general Considerations for Clinical Trials) and E9 (Statistical Principles for Clinical Trials) for the day-to-day conduct of a clinical trial. You will learn the safety reporting cycle from site to sponsor to regulatory bodies back to the site; including expedited reporting, the different development methodologies and trial phases and their rationale and the different types of trial designs, statistical principles and related relevant trial context, amongst others. This training is intended to ensure proper understanding of your impact as researchers on the safety reporting and statistics, rather than a training on the execution of statistical analysis.
22 Oct 2018: Risk Management and Risk Based Monitoring (RBM) Plans.
It has been more than five years by now that the risk-based approaches were introduced and recommended to be used, and even became mandatory for the conduct of clinical trials. However, in real life still a lot of sponsors and sites struggle with its implementation. This mostly due to lack of understanding of its strategies and implementation, making people think it is too complicated and expensive.
This TRIUM training provides insights into the strategies and steps to follow for setting up a company-wide risk management plan that can be used for all trials, including tips on ensuring a successful change management process and stakeholders’buy-in. Next the outcome of the risk assessments done as per the risk management plan will be translated into a lean, feasible and affordable risk-based monitoring plan. The trainer, who is a strategic risk-management consultant in real life, will share real case studies and examples to ensure proper practical understanding. Risk-based approaches can be simple and affordable, whiles ensuring a healthy ROI after the initial investments of time and resources. Risk management does not have to be costly and daunting, in other words, it is not a risk but an opportunity to ensure efficiencies. You should be equally convinced of this after this training as the trainer.
25 Oct 2018: ICH GCP E6 (R2): Risk Assessments and Control Skills to Decide on Risk-based Monitoring Strategies.
Conducting risk assessments is a key part of any clinical QMS and the first step into deciding the most efficient and effective monitoring strategies for your trial. The results of the risk assessment are used to decide on a risk-based monitoring strategy that suits the needs of the trial best. This TRIUM Session will ensure a proper understanding of the definitions of risks, risk management and risk-based monitoring strategies and plans and lists the different steps involved in conducting risk assessments to get you on the right track.