Release Notes (v18.11)
The following features have been added as part of the Protocol First production upgrade released on November 12th, 2018.
Procedure Data Entry Mode
All procedures can now be configured to allow for data collection as source data or transcribed data at the field level. This is an optional feature and may not be implemented for all studies. If not implemented, the default mode is transcription and the below information is not applicable to the study. If a procedure is configured to allow for source data collection, a Procedure Data Entry Mode selection pop-up will appear after confirmation of initiating the procedure.
Additionally, the data entry mode can be toggled using the Data Entry Mode selection within the procedure for each field.
A blue leaf icon will display next to entries made in Source mode for all users.
PI Signature Status
Principal Investigators will have the ability to sign-off on a subject’s casebook once review of all data for the subject is complete. The status of the PI’s signature is available in the PI Signature tab within a subject.
A blue ‘X’ indicates PI signature is not complete:
A green burst indicates PI signature is complete:
Data Management Review Flag
Data Management review is a tool to allow Data Managers to notate that a procedure has been reviewed. Procedures requiring Data Management review will display “Review Required” in the Query status bar:
Procedures that require review can be filtered in the Query Listing and are noted with a review flag in Procedure Listing within the Admin function. The flag is also available in the SP domain of the Export Listing.
Icon Definitions
We've added a "cheat sheet" in the help section to define every icon used in the Protocol First EDC. Simply search "icon" in the help section and the article will appear or download the PDF here.
TLS 1.2 communication protocol
Beginning on 01-Dec-2018, the Protocol First EDC will only support TLS 1.2 communication protocol. If you have any issues connecting, please check your browser settings to ensure that TLS version 1.2 is supported and enabled. Instructions for doing this can be found here.