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Clinical Study Closeout Program  

Date & Time: Tuesday, February 28, 2012

10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Gbolahan Fatuga

Location: Online

Price : $245.00

 

  

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(for one participant)

Instructor Profile:

Overview: Gbolahan Fatuga CEO, Caligeo Clinical CRO

This webinar will provide initially provide information basic study closure procedures. Then, we will discuss a more comprehensive list of closure procedures.  Lastly, we provide strategies to make the process run effectively and efficiently. The term "close-out" refers to procedures undertaken to fulfill administrative, regulatory, and human participant requirements. Study close-out may be also defined as the time when all participant visits have been completed, data base has been locked, and all lab specimens are accounted for/reconciled. The period leading to study closure activities often invokes high-stress, anxiety emotions from many clinical research professionals.

Areas Covered in the Session: l

Preparing for study close-out visit from various perspectives (e.g., DM, PM, CRC, CRA perspectives)

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Managing study close-out visit Sponsor's Responsibilities Disposition of supply of investigational products Assurance of IRB review

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Investigator recordkeeping & archiving/record retention Inspection of investigator's records & reports Quality Assurance Responsibilities Data Review Meetings Proactive Vendor Management Financial/Accounting Reconciliations Regulatory Obligations (Sponsor & Site)

 

Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. ...more

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Click here to register for this webinar Who Will Benefit: l l l l l l l

CRAs CRCs

 

Nurses Clinical Trials Associates Regulatory Affairs Clinical Team Managers Clinical Trials Project Managers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Clinical Study Closeout Program