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