Page History

• During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
• Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
• How do we handle "toxic, no revertant colonies"?  (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
• Condition of background bacterial lawn?  Slight thinning, Very thin? - refer to SEND team's marked-up table.
  • new Test code of Cytotoxicity with GTORRES = S, V (controlled terms)
  • Each plate we would have one result record for Revertent count and another for the lawn evaluation (NORMAL, SLIGHT THINNING, VERY THIN)
• When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)
• What do we do for defined regimes (e.g. ISO Regime, Canadian ..) or all attributes should be listed as expected variables to allow for all including custom regimes (Puff volume, etc.)

Below the SETS shown in the TX table are rows A, F, I, and R (probably don't need R)