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. 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 trialsRetrospective and prospective risk analysis techniquesRisk management: Key techniques in risk reduction, assessment, addressing, training and communicationRisk analysis plan: identification, information gathering, decision, implementation and reviewRoles and responsibilities of various personnel in risk reductionOverview of FDA requirements for risk management Expectations and responsibilities of the clinical project managerRole of various clinical team members: CRA, coordinators, sponsors and investigatorsChallenges of large-scale and international clinical trialsDo’s and Don’ts for risk management of a clinical trialWho Will Benefit:Clinical Project ManagersClinical research associatesClinical coordinatorsPrincipal Investigators and sub investigatorsIRB personnelRegulatory Vice Presidents, Directors and Managers at sponsorsAttorneys – In-house or Outside CounselPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information contactCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : 416-915-4458
When
8 Sep 2014 @ 01:00 pm
8 Sep 2014 @ 02:30 pm
Duration: 1 hours, 30 minutes
Timezone: GMT -8:00
Where
Online Webinar
Language
English en
Organised by
Compliance Trainings (deactivated) Event published: 2 Sep 2014
Event last updated: 18 Jul 2016