Why Should You Attend:
Your clinical trial has zero possibility of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.
The FDA regularly states that if compliance isn’t documented, it didn’t occur. Your TMF serves as living proof that you are adhering to GCP, and that your top quality system is in a state of control.
Beyond simply getting a get out of jail free card, a properly-maintained TMF can make trial management simpler with a typical TMF containing thousands of pages of documentation, you could simply save, or lose, hundreds of hours over the life of a trial looking for person pieces of information.
Places Covered in the Seminar:
Documents that should, and ought to not, make up a Trial Master File.
Upkeep and high quality handle of the TMF.
Start smart—the steps to take from Day A single to produce a compliant and valuable TMF.
Red flags that scream “noncompliance”.
Frequent pain points that you can count on to encounter, and how to hold them from driving your TMF into noncompliance.
Note to File (NTF).
CRA contributions to and adequate monitoring of the investigator TMF.
Who Will Advantage:
This webinar will give beneficial help to all personnel in:
Clinical Analysis Manager
Clinical Research Coordinators
Clinical Study Associates
Clinical Trial Investigators
Administrative managers in charge of Clinical Research
Regulatory, Compliance Associates and Managers
Research Web site Personnel involved in set-up and maintenance of any trial TMF
Good quality Assurance of Research Sites
Study Internet site Personnel in Charge of Policy Improvement and Upkeep
Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has worked in the healthcare sector in a variety of roles for the past 20 years. She has worked in healthcare analysis with a primary focus on cardiology for 7 years. She has experience with conducting clinical trials, investigator initiated trials, starting a investigation program in a hospital, overall health services investigation, grant submission, enterprise improvement and fundraising. She served on a study coordinator advisory committee of a worldwide CHF/hyponatremia clinical trial.
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