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The Algorithm Game

Author: LMC
Across
Includes study meetings, communications and oversight tasks in preparation of an Interim Database lock; issue escalations,QC and manual data review of all required data (including cutting requirements);vTMF filing.
Includes study meetings, communications and oversight tasks in preparation of PK/IR/PP/PD Database lock for data not released in the clinical dbl; issue escalations, QC and manual data review of all required data per the Data Base Release Plan; vTMF filing.
Includes meetings, communication and oversight of migration for study update and/or ammendment;QC of eCRF changes, data,updated annotated eCRF and SAS datasets; vTMF.
Includes all meetings, communications, DM CRO specific SOWs [RFS, vendor calculators] and contracts, protocol review, FTE review [P5 resourcing], estimates for the timing and effort of interim analysis/DMC releases and task list review at the individual study level.
Includes study meetings, communications, oversight tasks, QC and manual data review, issue escalations and vTMF filing
Includes study meetings, communications, and oversight tasks in preparation of Final Data base lock; issue escalations, QC and manual data review of all data from all sources per the Data Base Release Plan and vTMF filing.
Includes meetings with clinical team for eCRF design, meeting(s) with cross-functional team; preparation of agenda, reference materials (kick-off slides) , specifications and documentation for the DM CRO Kickoff; vTMF filing.
Includes protocol review, protocol meeting attendance and preparation of clarification questions
Release to deliver final (SET/DRC/DMC) Output
Down
Includes meetings, communications and completion of data transfer specifications, UAT of test transfer datasets and vTMF filing.
Includes QC of eCRF design and UAT.
Includes coordination of eDC archival, QC of eSub bookmarking and eSub SDTM package and and vTMF filing.
Includes study meetings, communications, tasks specific SOWs and contracts, (SD Office and/or PK Office). Providing input to non-IDS owned contracts such as Covance, IVRS, Imaging, etc. Includes appropriate OOPs payments. Provide input/support to GDM for Jedi capabilities and compound consistency.
Includes meetings, communication and completion of trial datasets; review and QC for mapping of annotated eCRF to the SAS datasets; QC of dataset structure and QC of dataset content; vTMF filing
Unplanned IDS work