Trial Master File for Research Sites: Can You Pass FDA Inspection?

Why Should You Attend:

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control. Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

In this webinar, you will get guidance on the TMF. We will review the investigator TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed, as well as common deficiencies and challenges. You will learn the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors.

Areas Covered in the Seminar:

• Documents that should, and should not, make up a Trial Master File.
• Maintenance and quality control of the TMF.
• Start smart—the steps to take from Day One to create a compliant and useful TMF.
• Red flags that scream "noncompliance".
• Common pain points that you can expect to encounter, and how to keep them from driving your TMF into noncompliance.
• Note to File (NTF).
• CRA contributions to and adequate monitoring of the investigator TMF.

Who Will Benefit:

• Clinical Research Manager
• Clinical Research Coordinators
• Clinical Research Associates
• Clinical Trial Investigators
• Administrative managers in charge of Clinical Research
• Regulatory, Compliance Associates and Managers
• Research Site Personnel involved in set-up and maintenance of any trial TMF
• Quality Assurance of Research Sites
• Research Site Personnel in Charge of Policy Development and Maintenance

Instructor Profile:

Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has tremendous experience in the healthcare industry in various roles for the past 20 years. She is well rounded in all aspects of clinical trial as she has been instrumental in healthcare research with a primary focus on cardiology and oncology. She has experience with monitoring clinical trials, conducting clinical trials, investigator initiated trials, maintaining multiple Trial Master Files, starting a research program in a hospital, health services research, regulatory /compliance submission and management, grant submission, business development and fundraising. She has successfully worked with different IRBs, CROs and sponsors. She has served on a study coordinator advisory committee of a global Congestive Heart failure clinical trial. She currently consults with helping clinical research departments in need services like starting up, regulatory, closing down and increasing productivity.

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