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The TIG supports development of CRFs but does not formally address data collection via other sources. Guidance in this section suggests a format to be presented to those entering collected data using CRFs but does not dictate any data structure or system in which to store the collected data.  Applicants that choose to develop libraries of  



  1. Use the CDASH recommendations to develop company standards, taking into consideration the stage of clinical development and the individual therapeutic area requirements. To gain the greatest benefit from using the CDASH standard, CRFs should not be developed on a trial-by-trial basis within the implementer organization, but rather be brought into a study from a library of approved CRFs based on the CDASH Model and CDASHIG, whenever practicable. 

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