The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers. The Trial Summary (TS) dataset allows the sponsor to submit a high-level overview of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, a Trial Summary dataset is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.
With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion.
Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?
Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.
Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.