Compliance Trainings, Online
2014-09-08
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. Managing clinical trials is arguably one of the most difficult jobs in the medical product development industry. Clinical trials are highly complex projects with numerous unpredictable factors that could influence their successful outcome. Several events could adversely affect a clinical trial outcome such as not being able to recruit subjects in a timely manner, managing difficult sites, trial supply issues, biological sample handling, regulatory trouble-shooting, and many more. A key component of clinical project management is the ability to identify potential risks and implementing measures to manage them. This seminar will provide the basics of clinical trial risk management and analysis techniques and practical tips to clinical trial professionals and sponsors using case studies from the presenter’s experiences. Areas Covered in the Session : 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 Roles and responsibilities of various personnel in risk reduction 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 Do’s and Don’ts for risk management of a clinical trial Who Will Benefit: Clinical Project Managers Clinical research associates Clinical coordinators Principal Investigators and sub investigators IRB personnel Regulatory Vice Presidents, Directors and Managers at sponsors Attorneys – In-house or Outside Counsel Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information contact Compliance Trainings 5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Canada
Customer Support : 416-915-4458 Email : support@compliancetrainings.com
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