Validating cdisc sdtm compliant submission ready clinical datasets
It is very easy for FDA reviewers to review the clinical data once they load the clinical data into their JANUS database.
to properly load the clinical data into JANUS database which is maintained by the FDA.
This content exists to concisely summarize answers that are usually available buried within other documents or pages, to provide implementers with quick, unofficial, and useful answers to their questions. SEND, or the Standard for Exchange of Nonclinical Data, is an implementation of the CDISC Standard Data Tabulation Model (SDTM) which specifies a way to present nonclinical data in a consistent format. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is working to adopt CDISC standards including SEND. (Note: this pertains to updates made the initial SEND requirement laid out in the previous question, e.g., IG updates, new study types, etc.) After new standards or updates are published, pending an evaluation by CDER, CDER will add the standard to the Study Data Standards Resources page with a timeframe for requirement.
- This webinar featuring one of the US’s foremost cancer researchers as the speaker, will discuss cancer as a chronic disease and how researching cancer under this new archetype is adjusting the way in which clinical oncology trials are conducted and how cancer patients are treated - Through a case study with PTC Therapeutics, the speakers will discuss the challenges of entering a new disease area for the first time, the balance of achieving the right size global organization to meet the customer population and the considerations for proceeding independently with a global launch rather than partnering - This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency - In this webinar, Dr.It is important to start implementing CDISC standards during data collection by having Data Managers design the CRF using CDASH standards.