2018-02-07 (Lab team) and 2018-02-13 (BL, SL, EM, JL) Pieces: 1. Identify tests in LB that need to be moved. - Erin completes initial draft. 2. Create a 'communications' document describing the genesis and reasons for this change. Audiences: Both internally (GGG) and for CT public review. 2a. Include SEND-specific implementation instructions 3. Identify any changes in SDTMIG 3.3 and other TA user guides. - No examples require updating in SDTMIG 3.3. 3a. Update language in SDTMIG3.3 to describe the difference in MB and LB domains. (does this go in IG3.3?) Grey Areas to discuss: Allergen antigen antibodies. All or some? All have c-codes for TESTCDs. Human anti-mouse/sheep? keyhole limpet hemocyanin? Bacteria/ in urine, Malaria, Yeast, Ova, etc. Timing: Recommendation to put the CT change out only when the documentation is ready for release. Shannon will support this decision as the CSO. Assumption: The public review of the CT changes and documentation is not for making a decision, the decision is already made to move this forward. We will not change course but the purpose of public review will be to ensure that this decision is communicated to the correct stakeholders and to ensure people feel heard. 2018-02-14: Lab Team meeting discussion of Shannon discussion from yesterday 1. What does this mean for SEND? Pain Point - Deprecating terms from codelists is costly because even though the codelist is extensible it means that the SEND user will need to incorporate the terms and definitions that have become extensible into the define-xml and address them in the SDRG, which costs time and money. Pain Point - Use of a domain NOT in a SEND IG is more difficult for SEND users. No mechanism currently in CDISC for publishing supplements to existing IGs, which may solve some problems. It is too slow to wait for SENDIG to update and then wait for FDA to approve the new IG version. MB will be coming into SEND through the Animal Rule Project 2. Erin's concern - If the IG is not able to get updated with this wording, how doe we communicate to the community and if its not in the IG, then does it really exist?