This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.
Investigators are at risk of litigation from errors of the study sponsor; at the same time, sponsors are at risk of litigation from mistakes or oversight by investigators or their staff. To protect each party from liability created by the other, a mutual indemnification by the sponsor and the institution is generally included in the clinical trial agreement.
This presentation will:
Why Should You Attend:
There are several types of injury that can arise in clinical trials that sponsors, investigators and staff should be aware of so that they can avoid them. Understanding the sources of risk, such as possible conflicts of interest, patient eligibility/ineligibility, informed consent and protecting patient dignity can held avoid or minimize the likelihood of errors or omissions resulting in clinical trial protocol violations and liability.Investigators are at risk of litigation from errors of the study sponsor; at the same time, sponsors are at risk of litigation from mistakes or oversight by investigators or their staff. To protect each party from liability created by the other, a mutual indemnification by the sponsor and the institution is generally included in the clinical trial agreement.
This presentation will:
- Help you distinguish between the types of litigation in clinical trial liability lawsuits
- Identify and avoid sources of risk that can bring liability
- Gain appreciation of the importance of formal training for conducting clinical trials
- Discuss clinical trial liability insurance to ensure protection
- Safeguarding trial subjects is a key priority and awareness of clinical trial liability can help preserve their rights and avoid harm. This webinar will provide inputs to protect sponsors, investigators and their staff from the cost of defending lawsuits that result from the fault of the other party.
Areas Covered in the Webinar:
- Types of litigation
- Sources of risk
- Legal duties of clinical trial sponsors
- Inventory control and defective devices
- Examples of actions considered to be fraud
- Examples of clinical trial liability lawsuits
- Insurance to provide protection
Who Will Benefit:
- Healthcare providers interested in conducting clinical research
- New clinical research coordinators
- New principal investigators
- Administrative managers in charge of clinical research
- Regulatory compliance associates and managers
Course Provider
Jonathan Mcdermed,
