For 2.1.0, we have a total of Ten (9) Enhancement items outlined below.


2.1.0 Release


 

Bug IDSummaryProductModule
Description
721Connect a eTMF tool to a FTYN EDC trialeTMFeTMFThis ticket implements the ability to directly connect a FTYN eTMF to a FTYN EDC trial for direct information sharing.
722Assign permissions to EDC users allowing them to interface with the eTMFeTMF

eTMF

Implements the ability to create roles within eTMF Conductors that can be provided to EDC users in the DataArchitect.
730Site personnel submit documents to eTMF for review and filing from the EDCeTMF

eTMF

Implements the ability for personnel working from EDC dashboards to submit documents to the eTMF for review.
720Allow user to add custom eTMF roleseTMF

eTMF

Implements the ability to create custom eTMF roles and assign their permissions.
724EDC site users perform eTMF workflow transitions from the EDC DashboardeTMF

eTMF

Implements the ability for personnel working from EDC dashboards to perform workflow transitions on documents housed in the eTMF.
727Request documents from site personnel from eTMFeTMF

eTMF

Implements the ability to request document uploads from EDC users in the steps of eTMF document workflows.
725Compose packages of eTMF documents to be shared with Sites and Regulatory AuthoritieseTMF

eTMF

Implements the ability to prepare packages of selected eTMF documents to execute actions like bulk export on them.
1044Dependent changes for other forms shall allow a custom RFOEDC

Trial Design
This modification allows the specification of custom reason for override to be used in the case of changes to dependent fields.

This can be done with the application property "customOverrideReason". This property can be left empty.

726Provide documents from my eTMF to site personnel working in my EDCeTMF

eTMF

This implements the ability for authorized EDC users to view and download shared eTMF documents from within the EDC.
                 



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