is being presented by Jonathan Andrus & Jennifer Price, Vice President, Data Management and Quality & Director, Clinical Solutions, of BioClinica and airs on Tuesday, March 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
Showing posts with label Jonathan Andrus. Show all posts
Showing posts with label Jonathan Andrus. Show all posts
Friday, February 4, 2011
Wednesday, September 29, 2010
Improving Data Manager and CRA Collaboration in an eClinical Environment
is being presented by Jonathan Andrus, Vice President, Data and Study Operations, eClinical Division, with BioClinica and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Subscribe to:
Posts (Atom)