Lab Notes LB vs MB: Bess reviewed all of the proposals that Barrie decided on before he left with Shannon. Barrie had decided to go with context-drive modeling (option 4). Shannon had concerns: combining data in the future will be challenging as you don't know where to look. It is also more complicated for the users. Having 2 places to put data dilutes the idea of 'standardization'. Shannon has decided that all microbiological tests, regardless of context, to be put into MB. Discussion: Anna not fond of this. Anna's opinion is that this should all be lab and then filter on category. Sue makes the point that sponsors will need to either ask the vendors to parse the data or the company will need to do it themselves when preparing their submission data. Phil agrees this decision is cleaner for downstream use. However this will disrupt the vast majority of studies, which have no reason to have the MB domain at all. A very small part of industry seems to be dictating change for the rest of the industry. It was discussed previously that the MB domain should be retired but people seemed resistant at that time. Bess offers lab team the opportunity to come to MRC and air their concerns with Shannon. Bess will put this on the MRC agenda. -Lab team would like an understanding of the timing of this decision. When will this take effect? -Need to know when the CT should change. Two activities to consider: When to identify/move existing lab terminology to Microbiology team; this will require some MB modeling; what does the team do in the interim with new term requests for microbiology-related tests coming to lab team? -Next Step: This proposal/decision will be sent to the CDISC/FDA technical meeting for FDA input.