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Task list for Lou Ann and Bill:
Review domain specs: GT, OUFor Monday:- Create one .xls for MLA example, then delete content and save as a templateMake sure all "assumptions" content in the examples is present in the domain specifications (see top of each .xpt in MLA example)
Can Bill attend:SDTM for TIG (Matrix?)Tuesday for sd TCG submit
- Highest priority (for review at GGG by ):
- Clean up domain specs: TS, TX, GT, OU
- Clean up In Vitro MNT
- Clean up in Vitro MLA
- finalize finalize links to TO, DI, DU (updated on but need the final copies)
- Clean up In Vitro Neutral Red Uptake
- Apply that clean up to all else
- All other (in vivo) Domains, assumptions and also Trial design examples will be copied over verbatim.
update TIG Example and CT Completion based on updated examples (e.g. smoking regimen)- In our working docs section:
- NEW RLevering stuff! Sample and exposure typesRLevering comment at bottom: I uploaded four documents related to the micronucleus assay (MN). The OECD 497 guidelines provide details related to performing the actual assay, for example the three exposure schedules (short and long term), cell lines, positive controls, use of the cytokinesis blocker cytochalasin B, etc. The Health Canada T-503 also provides guidelines for the testing of tobacco smoke in the MN assay. THe other two documents (ICH and ISO 10993) provide additional information regarding the MN assay and other genotoxicity methods for use in testing of pharmaceuticals and medical devices, all relevant to the understanding of the MN assay.
- used to compare to assess how well the experiment is working
- If your + and _ controls produce the expected outcome, the test results of the unknown can be trusted
- positive control - has an effect
- negative control - has no effect
Review GT specification and also assumptions- Ready next Wed - Fri for GGG concept review?
- In MLA, we had the SETCD in tx.xpt = EUID in ou.xpt. I changed the SETCD but... are they the same concept??
- Make sure everything we need is in the tracker for SDTM before : SDTM New Variable Request Trackers - To Be Replaced by JIRA project (SDTMGOV)
- LAK notes on controls in an experiement:
- used to compare to assess how well the experiment is working
- If your + and _ controls produce the expected outcome, the test results of the unknown can be trusted
- positive control - has an effect
- negative control - has no effect
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