Category Archives: TMF

Financial Disclosure to FDA – New Draft Guidance Available

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001. The revised … Continue reading

Posted in Regulations, TMF | Leave a comment

Use of the DIA TMF Reference Model by CROs

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master … Continue reading

Posted in e-records, Records management practice, TMF | Leave a comment

eTMF Workshop, London – Thursday 15th September 2011

Due to demand, Phlexglobal and Rammell Consulting are repeating their highly successful one-day workshop entitled “Migrating from Paper Trial Master Files to Electronic”. The next workshop will be held at the Heathrow Touchbase Conference Centre located just outside Heathrow Airport … Continue reading

Posted in Technology, TMF, Training | Leave a comment