Supported Internet Browsers Microsoft Edge Internet Explorer (IE) version 10 and 11 Chrome version 39 or higher

ORCCID Release Notes

Version	3.0.24289
Release date:	15 Oct 2024

Updates:

• Released the new SAE module:
• The coordinator can upload source document to the SAE report.
• The coordinator can as sign the SAE report to the selected Medical Monitor
• Added Email notification when an event is assigned to Monitor
• Only the assigned report(s) shows on the Medical Monitor’s screen.
• Modified the schedule page to allow more visits to be displayed.

Version	3.0.24038
Release date:	9 Feb 2024

Updates:

• Updated eLearning requirement of inactivity accounts.
• Added source document email notification functionality.

Version	3.0.23300
Release date:	27 Oct 2023

Updates:

• Reference CRF functionality Module update based on user feedback.
• Restricted number of the EOS CRFs per subject.
• Added functionality to control number of digits in autogenerated Subject IDs per study.
• Added ability to generate pre-randomization schedule before the treatment group is assigned for randomizatiom studies.

Version	3.0.23261
Release date:	18 Aug 2023

Updates:

• Released the Reference CRF functionality:
• The system now allows coordinator to view the CRFs entered in previous visits.
• Restricted the ability to prevent external users from changing the visit status from “No Longer Required” to “Completed”, “Projected”, or “Missed”.
• Expended the email notification functionality:
• The email notification system has been expanded to capture more information entered in IRIS and/or ORCCID for sending notifications.
• Added Annotated CRFs button for Admin, Study Manager, etc. roles

Version	3.0.22857
Release date:	09 Oct 2022

Updates:

• Released the Optional Source Document functionality in the Source Doucment Module.
• Added ablitiy to include External Electronic Health Record (EHR) source doucments.
• Updated the account requisition ablitiy to include External Electronic Health Record (EHR) source doucments.

Version	3.0.21078
Release date:	27 Oct 2021

Updates:

• Updated the SAE section.
• Added Enrollment visit in ORCCID:
• The visit is for users to upload required source documents during registration or randomization.
• The visit is an auto-completed visit when schedule built.
• Updated the Validation Rules Module based on user feedback.

Version	3.0.20653
Release date:	22 Sept 2020

Updates:

• Added the source document section on the VRR page.
• Updated the Adjudication Module based on user feedback
• Updated the Validation Rules Module based on user feedback

Version	3.0.19871
Release date:	04 Sept 2019

Updates:

• Released the Adjudication Module to ORCCID:
• The coordinator can upload source document to the adjudication event.
• The coordinator can assign adjudication forms to the selected adjudicator.
• Email notification when an event is assigned.
• Only the assigned event(s) shows on the adjudicator's screen.
• Updated ORCCID Manual

Version	3.0.19723
Release date:	15 Jan 2019

Updates:

• Released the Validation Rules Module to ORCCID:
• The coordinator can add validation rules in ORCCID via a CRF liked interface.
• Extended the override flag's functionality, allowing for override auto-generation.

Version	3.0.19361
Release date:	03 Nov 2018

Updates:

• Updated the Source Document(s) Module based on user feedback
• Updated the ORCCID Manual
• Added ability to modify the subject's schedule via validation.

Version	3.0.18137
Release date:	05 Apr 2018

Updates:

• Released the new source document(s) Module:
• Added ability to upload the source document(s) per visit/event.
• Integrated the File Upload functionality to the OE and AE Modules.
• Added the redact functionality.
• Added the source document(s) mapping functionality.
• Added ability to generate source document(s) list via validation.
• Added the functionality to generate the source document(s) query.
• Added the Source Document report(s) to the Reporting Module.
• Added ability to pre-complete a visit on schedule built.
• Added ability to display the treatment information on the Subjects page.
• Changed the CRF verification method. Linked the CRF verify with Source Document(s) mapping.
• Extended the AE Module to include the SAE reporting.
• Expanded Training Log search functionality to allow searching by study and centre criteria.

Version	2.0.6541
Release date:	07 Nov 2017

Updates:

• Added the AE follow-up required notification on the schedule page.
• Added the merge function to the AE page.
• Extended the functionality of the Membership Module.
• Updated the SAE page and the SAE report.

Version	2.0.4950
Release date:	08 May 2017

Updates:

• Added an info message to the user who has no study assigned.
• Extended the functionality of the Account Requisitions Module.
• Changed the ELIG Conf section on the Subject Enrolment page.
• Updated the DSMC Module.

Version	2.0.3308
Release date:	25 Feb 2017

Updates:

• Added the confirmation message if the CRF generates another CRF.
• Added ability to show/hide schedule visits  based on user's permission.
• Changed the Event Name display of the auto-generated CRFs.
• Updated the Clear CRF Data functionality.
• Added compatibility to support the latest version of Chrome browser.

Version	2.0.1745
Release date:	09 Nov 2016

Updates:

• Extended the functionality in CRF formatting.
• Fixed the deleting last dynamic row issue.

Version	2.0.1298
Release date:	28 Aug 2016

Updates:

• Added ability to search Subject by Initials.
• Added ability to set the OE event date prior schedule start date.
• Added ability to change the visit status from "Projected" to “No longer required” through CRF validation rules.
• Added ability to set the CRF status to “No form expected” through CRF validation rules.
• Added ability to add an optional CRF to the visit through CRF validation rules.
• Added ability to dynamically build required source documents table through CRF validation rules.
• Added the Source Document report to the Reporting Module.

Version	2.0.936
Release date:	18 April 2016

Updates:

• Updated the change visit status functionality:
• When change the visit status to Missed or No Longer Required, user has to clear CRF data before changing the visit status.
• If there is a comment already entered for the visit, the comment remains editable when user click on the “Change Visit Status or Date” again.
• Updated the Auto-generated OE message.
• Resized the CRF queries page to make it fit to a browser window.
• Fixed the Change Visit Status or Date appearance issue.
• Fixed the CRF Preview`s text wrapping issue.

Version	2.0.684
Release date:	21 March 2016

New Features:

• Updated the OE and AE Modules:
• Added an option to choose from the existing auto-generated OE/AE or New OE/AE when clicked the “Add New OE/AE” and there is outstanding auto generated event CRF available.
• The system opens the auto-generated OE/AE if user selects the automatically generated OE/AE option; system opens the new one if user selects to create new.

Version	2.0.384
Release date:	08 February 2016

New Features:

• Added ability to allow users to preview/print the CRF.
• Added the Central Reader Module.
• Added new date formats.
• Added the unsaved changes warning before leaving a page.
• Added the Supported Browser message to the Login and Training pages.
• Added the CRF Queries button to the CRF page.
• Added the indication for not submitted CRFs on the CRF page.
• Added ability to add multiple unscheduled visits in between two scheduled visits.
• Added ability for user to update the Event ID if one CRF was added into a visit multiple times.
• Added a mechanism for defaulting data on CRF load from CRF in previous visit, such as displaying the medical history from previous visit.

Updates:

• Extended the session timeout from half hour to one hour.
• Made the timer on the CRF page color RED and flashing when 5 minutes before timed out.
• Set focus to the SID search box on the Home and Subject screens.
• Changed from the CRF codes to the CRF names in the visit pane of the CRF page.
• Removed the ability from external user to change the visit status to “No longer required”.
• Allowed the current SID search on the Home and Subjects pages to search by the subject initial as well.
• Added question numbers back to some of the long CRFs (upon request).
• Increased the upper limit of a textbox from 1000 characters to 2000 characters.
• Changed the CRF lock time from 2 minutes to 30 seconds.

Version	2.0.0
Release date:	19 Sep 2015

ORCCID Redesign

The ORCCID EDC system has been completely redesigned utilizing the latest advances in web browsing and the new database engine from Microsoft MS SQL Server 2014.
The enhancements and new features are a direct result of your response to the previous releases of our EDC system.

This release of ORCCID has resulted in re-organization of other OCOG’s systems:

• Moved the Study documents from OCOG’s website to ORCCID.
• Moved the Study reports from OCOG’s website to ORCCID.
• Re-designed the ORCCID training (formerly called E-Learning).

ORCCID has a new look!

Improved performance: all pages load faster.

New features:

• Added Home (Dashboard) page with Study information such as Primary Investigator, Qualified Investigator at Clinical Centre, Current protocol version, Study Coordinator.
• Added page help icons. All pages have a page help icon, which opens an online user manual and automatically displays the specific section about the current page.
• Added detailed Subject Transfer information.
• Added visit level Queries.
• Added the ability for a user to delete dynamic row on a CRF page if necessary.
• Introduced a new way of switching CRFs within a visit. To switch between CRFs within one visit it is not necessary to go back to Schedule screen.
  The next CRF can be selected from the Visit pane on the left. This pane lists all CRFs for the visit.
• Added the ability to show warnings to the validation list at the top of the CRF page.

Re-designed some existing features:

• On the Tasks pane the events list and reports have been separated from the tasks list.
• The events list (Adverse Events and Outcome Events) has moved to the Event Log pane.
• Status report was relocated to the Reports page.
• The tasks are grouped into categories and the display depends on the existence of the task.
  For example, the Overdue Assessments category will not be shown if there are no overdue assessments for a Study Centre.
• The CRF query process.
  Fields that require clarification have a red query icon beside the field. Clicking on the icon will open the query to allow you to view the query text and enter new value in the data entry field.
  If no changes to the data are required, check the "No change" checkbox and provide the mandatory comment.
  Click the Resolve button and the Query icon will become green, indicating to the study coordinator that the query was resolved.
• The Status icons (Automatically Generated icon, Entered (still in process) icon, Validated and Saved icon, Verified icon, Signed icon, etc.) have a new look.
• Introduced the help icon on the CRF page; which provides additional information for the question when the mouse is hovered over.
  Introduced the N/A Status for the Visit/CRF icon which shows when the visit status is set to No longer required, or the CRF status is set to No form expected.
• Page navigation. When a CRF is opened, the system builds a row of tabs below the horizontal menu. These Tabs allow user one-click jump to any page that was opened along the way to the CRF.
• Switching studies. This can be done from any page by selecting a different study from the Study dropdown list in the top right corner.
• The status column on the Subjects page hides or displays the Status column on the Subjects page. This ability to hide the Subject's status detailed information allows for faster loading.
• Expanding and collapsing the Subject's visit. A visit can be expanded or collapsed by clicking anywhere on the visit record.
• CRF preview process. Added the ability to preview and print all study CRFs (blank) from the Home page (Note: a CRF can no longer be open if the visit status is not "Completed").
• Set or Remove data flags. Right clicking on the data entry field opens a pop-up list with all possible data flags that can be set on the field.
• CRF skip logic.
• The timed out process. The system redirects to the login page when the system has timed out.

Removed some redundant information:

• The Centre ID column on the Subject page (it is the same as the first four digits of the SID).
• The CRF Received Date on the schedule page.

 

 

*** NOTE: Refer to the ORCCID Online Manual accessible through the Help icon for details on the above changes, and other operational details of ORCCID. ***