Best Practices for Clinical Trial Risk Management: Common Issues and Potential Solutions
Date: January 17, 2025
Duration: 60 Minutes
Time: 12 PM EST
If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of various types of risks. Also discussed will be best practices for risk analysis and prospective planning in the project plan. At the end of the seminar, you would be able to review your current project plan for potential issues or help address these factors in the future clinical trial project plans that you may create. If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this course is a must for you.
- Common risk factors in clinical trials
- Retrospective and prospective risk analysis techniques
- Risk management: Key techniques in risk reduction, assessment, addressing, training and communication
- Risk analysis plan: identification, information gathering, decision, implementation and review
- Overview of FDA requirements for risk management
- Expectations and responsibilities of the clinical project manager
- Role of various clinical team members: CRA, coordinators, sponsors and investigators
- Challenges of large-scale and international clinical trials
- Most common issues with clinical trial initiation, execution and close-out
- Best practices for risk analysis, management and prevention
- Roles and responsibilities of various personnel in risk reduction
- Incorporating short-term and long-term measures in project plans to manage risk
- Processes to seek and document management decisions with regulatory implications
- Do’s and Don’ts for risk management of a clinical trial
The following individuals or disciplines will benefit from attending this Webinar:
- Clinical Project Managers
- Clinical Trial Professionals
- Clinical Research Associates
- Clinical Coordinators
- Principal Investigators and sub investigators
- IRB personnel
- Regulatory Affairs – Vice Presidents, Directors and Managers
- Attorneys – In-house or Outside Counsel
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
