Due to the current restrictions, this course will be provided as 4 live-online sessions of 2 hours at the following dates:
- 28 April from 10:00am – 12:00pm
- 12 May from 10:00am – 12:00pm
- 18 May from 10:00am – 12:00pm
- 26 May from 10:00am – 12:00pm
Sessions are to be booked as one package, and cannot be booked separately.
A sponsor conducting clinical trials has important responsibilities as per ICH GCP E6 R2, which are up for audit and inspection reviews, ensuring patient safety, rights and well-being, data quality and regulatory compliance.
It is therefore key that these requirements are not just known to management and the research staff, they also need to provide evidence of in-depth understanding, accurate application and compliance in a documented format per the level of risk of the trial and within their realm of involvement in the trial.
This course covers the different aspects of the operational management of a clinical trial, including the review of the applicable regulations and the overview of day-to-day responsibilities of each member of the clinical team (CRA and project manager) through theory and interactive discussions.
Slides, useful documentation, a training sign-in sheet and certificate are included.
By the end of this TRIUM Training you should be able to:
- Describe the applicable regulations for clinical trials
- Explain the informed consent process
- Define monitoring responsibilities in clinical trials
- Define project management responsibilities
- Ensure protocol compliance and overall quality
- Establish project oversight
- Manage study budget and deliverables effectively
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.