Current clinical research standards like ICH GCP E6 R2 and ISO 14155 expects researchers to apply risk-based approaches for the management of clinical trials. In practice, this entails adjusting your planning for project resources, budget, communication, monitoring, quality management, vendor management and archiving to the project’s risk management plan, of which the risk assessment log is an important part. You will learn how to write a tailored risk management plan and complete a risk assessment log that you can use to manage your trial per priority. Further, emphasis is on the impact of a risk-based approach on the budget, timelines and vendor management & oversight since these are the biggest hurdles for most PMs to overcome in practice.
We offer this through recording and in a classroom setting. The recorded sessions cannot be ordered separately and do not include exercises.
By the end of this TRIUM Training you should be able to:
- Set-up a risk management plan and related metrics
- Assess CRO (vendor) competence related to risk management during CRO (vendor) selection and ongoing
- List what risk related information to share and not to share with CROs (vendors)
- Detect and escalate red flags and issues timely and accurately
- Ensure the risk-based approach is considered in your project plans, trial related budgets and timelines
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.