Questions and options when creating and exchanging data for SEND

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Here is the current list of questions and options we have considered. Please contribute any additional items you have as you prepare your company’s plans for interorganizational SEND.

These questions and answers have been incorporated into Handling of SEND in Study Documentation and will be maintained there. The copy here is only for historical reference:

(protocol ammendment?, memo to file?, an indication of who is accountable for the dataset)


The following questions may be topics of future discussion

versions of CT, SEND, how often, at what milestones, what level of QC for each delivery
  • When exchanging an update to a SEND package, should the entire package be re-set or just the changes?
  • What are the minimum datasets needed for any SEND package? (e.g. TK only)



Note: Related information on some GLP topics are on Talk:WG6 Nonclinical - Standardization Roadmap

Assumptions:

  • SEND will eventually replace the individual results historically included in the study report appendix.

Last revision by William.houser,03/1/2013