FDA’s expectation from site and sponsor’s documents
Required components of a TMF
Best practices for the set-up and maintenance of TMF
Electronic and Paper TMF requirements
Common errors in TMF management
If you are involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. We will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same. We will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.
Clinical Research Associates (CRAs)
Clinical Research Coordinators (CRCs)
Clinical Research Administrators
Sponsors of INDs
People investing in FDA-regulated product development projects
Dr. Malikova has over 15 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
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