Trial Master File (TMF) for Research Sites: Set-Up and Maintenance
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| Description: | This clinical compliance webinar will discuss the elements of a Trial Master File (TMF) and show how to set-up and maintain the TMF to ensure it can pass inspection by a clinical trial monitor or auditor. Why Should You Attend: - How would you handle missing elements of a regulatory file? - Who is responsible for which essential elements in a TMF? - How do you handle versioning of protocols in a TMF? This course will go over the essential documents which make up the Trial Master File. The presenter will help you understand the fundamentals of the set-up and maintenance of the TMF so you can ensure that when a monitor or auditor visits, the appropriate documentation will be easily located and you will be assured that you have all the documentation required. Areas Covered in the Webinar: - ICH guidelines and Good Clinical Practice (GCP) - Organization of the TMF - How to write good Memos for TMF - Versioning in a TMF - Access and control of the TMF - Staff responsibilities of the TMF - Long term storage of the TMF |
| URL: | http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703012?channel=telesemin |
| Date: | Friday, July 19, 2013 |
| Time: | 2:00pm-3:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Webinar*, Health* |
| Created by: | Public Access |
| Updated: | Thursday, July 11, 2013 7:12am UTC |
| : | $199 |
| : | +1-650-620-3915 |
| : | referral@complianceonline.com |
| : | Referral |
| : | +1-650-620-3915 |
| Comments: | None |