TMF Fundamentals
What does TMF stand for?
Trial Master File
What is the max number of days to meet timelines compliance?
35 days since ceration/ reception
What is the historical date of the first reported formal clinical trial?
May 20th, 1747
What document is used to obtain informed consent from trial participants?
Informed Consent Form/ ICF/ICD
Which regulatory body oversees clinical trials in the United States?
U.S. Food and Drug Administration (FDA)
Which document outlines the responsibilities of the investigator?
Investigator's Brochure
What is the Max number of documents allowed to be uploaded simultaneously in PTMF?
When was COFEPRIS established and who oversees it?
2001, Secretaria de Salud del Gobierno de Mexico
What is the report that allows to track documents in QC/ QC Rework?
Aging Report
What are the three expected document categories in the Review Report?
Past Due, Comming Due, Not yet Due
How is the responsible to create SSDL, PH and reclassifying in PTMF?
TMF-SO
Which document serves as criteria guidance for readiness criteria ?
CT01-GSOP-RF02
What is the recommended frequency for TMF Quality Review?
As contracted. Every 3 or 6 months
How many new Clinical Trials were started in Mexico in 2024?
223 new trials