Questions and options when creating and exchanging data for SEND
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 The copy here is only for historical reference:
- Handling of SEND in Study Documentation:
- Should SEND be listed in the Protocol or treated only as a contract deliverable?
- Should SEND output be reviewed by the GLP Quality Assurance Unit?
- Will the study director's signature on the report also indicate accountability for the SEND dataset?
- What documentation is required for SEND datasets created retrospectively (after report finalization)?
- (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
- SEND will eventually replace the individual results historically included in the study report appendix.
Last revision by William.houser,03/1/2013