Release on Wednesday, September 25th, 2024 between 09:00 pm and 11:30 pm UTC.
This version adds many new features to the CTMS (Recruitment, Payment) and enhances existing ones. We have also improved performance and optimized some features.
EDC - New Features
Global
Datacapt ID Pattern - We are introducing a new feature that allows you to set up your own Datacapt Unique ID based on an incremental number, with or without a prefix. This allows you to better manage the patient unique IDs in your database.
By default, the unique ID follows a pattern of 2 random letters followed by 5 random digits (e.g. RH49302).
This option is available upon request when your environment is created and activated.Pagination - We have added a new pagination layout that is more comprehensive and intuitive. You can now see the number of records or elements, easily navigate through your pages, and flexibly display 25, 50, 100, or 150 records per page.
This new component is now available on all features with pagination.
EDC Study Add-ons
Edit Automations - You can now edit automations in the EDC at any time. This allows you to modify the title, recipients, and message of the automation.
CTMS - New Features
Patient Database Management
New KPIs - We have added new KPIs for the patient database to provide a better overview of your database. You now have access to:
Total number of subjects in the database
Evolution of the database over the last 30 days
Real-time number of searched or filtered subjects with the percentage that represents the search/filter
Number of subjects per status: Active, Inactive, Pending, Deletion Requested
The KPIs are automatically updated based on the searches and filters applied.
New Filters - We have added new filters that are easier to use and more powerful. You can now select the patient status and any questions that you have in your database to filter and create lists. You can use multiple operators such as equal to, not equal to, between, and more.
This new feature is a game-changer for filtering your database, allowing you to have better insights in real-time.
Database Survey Audit Trails - We have added audit trails to the patient's full profile to provide a complete history of the answers provided in the database questionnaire. Now, every question filled or updated is tracked in the activity logs and visible in the patient's full profile. Later on, we will add search and filter functionalities, allowing you to see specific information at any time.
Recruitment Study
We have refactored and redesigned the entire recruitment process for a better experience and improved management. Enjoy the new recruitment experience thanks to Datacapt.
Recruitment Dashboard - We have redesigned the entire interface (widgets and table), allowing you to have better insights and real-time information on your ongoing recruitment.
You now have access to the real-time recruitment target and the participant status funnel with nine statuses.
The recruitment target is based on your study settings and is a real-time calculation of the qualified participants for your study.
The participant status funnel allows you to instantly see the recruitment funnel and the number of participants per status in your study. This allows for a better overview and complete recruitment management.
Tips: you can click on a status to automatically filter the participants table.
Participant Status - Managing your participants' statuses is now easier than ever with a complete redesign of the status confirmation modal. You now have access to statuses and can update the participant's status at any time based on the ongoing recruitment tasks. The statuses are smartly displayed based on the current participant's status.
Depending on the status chosen, the modal is automatically updated with the visit or study payment.Status Descriptions:
Prospect: The participant is a prospect for your study.
Contacted: The participant was contacted to participate.
Interested: The participant is interested and has applied.
Qualified: The participant is qualified (pre-screening questionnaire).
Enrolled: The participant is enrolled in the study.
Completed: The participant completed the study.
Disqualified: The participant is not eligible or has been disqualified. This action is automatic when the patient isn't eligible based on your disqualification criterias (data validation).
Not Interested: The participant isn't interested and shouldn't participate.
Excluded: The participant is excluded (drop-out, withdrawal, no show).
Recruitment Pool (bucket) - We have introduced a new feature called the Recruitment Pool to enhance your recruitment studies. This feature allows you to effectively manage and organize potential participants for your study.
You can gather all potential participants in a single, centralized pool. This makes it easier to keep track of everyone who eligible for your study. You can utilize powerful filters to sort participants based on various criteria such as demographics and more. This helps in creating targeted groups (pools) for specific recruitment efforts.
You can also access your pools at any time to update them or change the criteria (filters) to increase the size of the pool and target more potential participants.
Payment List - We have redesigned the payment list with more details and information. You now have direct information on the amount approved, and you know if the amount is more or less than the expected amount set in the study settings. You can also add comments to the payment and easily change the payment status or amount.
This revamped table allows you to have more comprehensive payment management.
Resend Invitation - You can now resend invitations or communications to participants who haven't responded yet in "Prospect" or "Contacted" statuses. You can resend them by email or SMS at any time.
Improvements (EDC & CTMS)
General
Performance Improvement - We improved the overall performance for the builders and the eCRF answers when doing data entry for large study.
Components update - We have updated our data entry component, improving both performance and data entry aspects.
eCRF Edit answer - We fixed an issue where the "edit answer" feature was only available when the GCP study option was activated. Now, the "edit answer" feature is available at any time, regardless of the GCP option.
Patient Database Survey Status - We have fixed an issue where the status of the survey was still marked as not completed, even after the participant had completed all questions.
Pre-Screening Survey Status - We have fixed an issue where the status of the survey was still marked as not completed, even after the participant had completed all questions.
Calculation Improvement - We have improved the performance of calculations, enhancing the overall calculation experience.
Permission Recruitment Details Picture - We have fixed permissions on the recruitment study where users weren't able to upload a picture in the recruitment details for the study landing page.
Conditional Logic in Patient Database Survey - We have fixed a defect where conditions were not applied in the patient survey in their full profile for the user, leading to errors and the display of unnecessary questions.
Archive ePRO Export - We have fixed an issue where archived ePRO were exported during the raw data export.
Generic error message - We have updated our generic error messages to be more descriptive and comprehensive.
Export History Tab - We have fix an issue where the history tab was not opened properly for the export modal in eCRF and ePRO.
Service Pack - Release in the evening
Version 4.15.1 - Thursday, September 26th
Item template - We fixed an issue where the item template in the builder was missing, preventing users from accessing the item library and using it.
Version 4.15.2 - Friday, October 4th
Input Number Control - We have removed the feature that allowed updating the numeric field using the mouse wheel.
Version 4.15.3 - Wednesday, October 9th
Scheduled ePRO - We have fixed an issue where participant was able to access and answer a scheduled ePRO before the sending date.
CTMS Recruitment Participant Status (Qualified/Disqualified) - We have fixed an issue where the participant status wasn't updated correctly after the pre-screening survey.
CTMS Recruitment Participant Status (Non-Available) - We have fixed an issue where the "Non-Available" status wasn't updated when the participant indicated they weren't available.
CTMS Recruitment Participant Status (Interested) - We have fixed an issue where the "Interested" status wasn't updated in the participant list.
Version 4.15.4 - Thursday, October 17th
This minor update is purely technical and does not include any new features.
Version 4.15.5 - Wednesday, October 23th
Input Number (all solutions) - Now, we only allow the dot as a decimal to limit errors and data entry risk standardize data collection. By limiting dot as the decimal separator, we ensure consistency across different regions and systems, reducing errors in data interpretation and processing. This standardization aligns with international data formats and improves compatibility.
CTMS Recruitment Participant Status - We have fixed the participant status update when sending a communication. Now, the status correctly changes from "Prospect" to "Contacted".
eCRF Progress - We have fixed an issue where the event or form progress wasn't reaching 100% due to multiple levels of conditional logic.
System Variable Calculations (eCRF only) - You can now use system variables in the calculation question type. We've added Randomization and Center ID, which can be used for conditions and visibility. For more information, please contact your Customer Success Manager.
Automations (EDC) - We have extended the question types allowed to be used in automations when selecting "question" as the event type. Now you can user Radio button, dropdown and Numbers (slider, input number and rating).
Version 4.15.6 - Tuesday, October 29th
Conditional Logics "OR" (Global) - We have fixed an issue where the "OR" operator was not working properly when using multiple conditions for the same question.
Admin role assignment (Global) - We have improved the role edit permissions to prevent non-admin users from changing their role or another user's role to admin, enhancing access control.
Instruction - Static Content (EDC) - We have improved the static content instructions when opened in Firefox, resolving the issue where the text would disappear.
Subject Id Pattern (EDC - Settings) - We have fixed an issue where using {code} in the subject ID pattern wasn't accepted. This is now resolved.
Consent Date (CTMS - Database) - We have resolved an issue where the consent date was incorrect because the user's timezone wasn't taken into account.
Participant Profile Picture (CTMS - Database) - We have fixed an issue where the new picture wasn't displayed immediately after uploading. Now, the picture is shown right away when uploaded to Datacapt.
Restart Database Survey (CTMS - Database) - We have improved the restart survey action, allowing participants to access the survey from the first question after it's reset. Users can now send a campaign or communication to ask participants to complete the survey.
Version 4.15.7 - Tuesday, November 05th
Account activation (Global) - We have improved the workflow for user account activation. When a user clicks the activation link more than once, they are now automatically redirected to the login page.
Table/Matrix (EDC - eCRF) - We have fixed an issue where the table/matrix in the eCRF wasn't using the full width of the eCRF, resulting in small input fields.
Automation (EDC) - We updated the page title when the automation is in edit mode.
Version 4.15.8 - Tuesday, November 12th
Schedule Filter (EDC - ePRO) - We added missing filter functionality to display only scheduled ePRO surveys in the ePRO survey list view.
Calcul (EDC) - We have converted scientific notation to decimal form in calculations (e.g. "5e-05" to "0.00005") and fix calculation handling for numbers larger than 10^16.
Audit Trails (EDC) - We have restricted participant email visibility in audit trails export to authorized profiles only, addressing data privacy concerns.
Version 4.15.9 - Tuesday, November 19th
Slider Item (EDC) - Slider questions with decimal increments now correctly display all tick values, including the all tick when increment values are less than 1.
eConsent (EDC - eConsent) - We have improved clarity of error message when attempting to send eConsent invitation to subjects with incomplete profile information.
Table/Matrix (EDC - eCRF) - We have fixed an issue for Table/Matrix, new columns can now be successfully added to existing Table/Matrix questions in eCRF forms that were previously saved.
API Upload File (EDC - eCRF) - We have fixed an issue with API eCRF endpoint. This endpoint now correctly accepts UUID format for item IDs instead of requiring integer values.
ePRO Edit (EDC - ePRO) - ePRO edit (updating answers) functionality now works consistently across all supported browsers.
Campaign Activity (CTMS - Subject Database) - We fixed an issue related to the campaign. Now subject activity only displays campaigns where the subject actually received an email or SMS, rather than showing all campaigns when the subject is selected.
Subject Account Activation (CTMS - Subject Database) - We have added the possibility to resend the account activation link to the subject from the quick view or the subject full profile.
Pre-Screening Survey (CTMS) - We have fixed an issue with participant status automations. Pre-screening survey status now correctly updates to "Completed" and application status changes to "Qualified" when all survey questions are answered.
Version 4.15.10 - Thursday, November 28th
EDC - Export
Code list export - Fixed missing checkbox code list in the "Option values" for eCRF and ePRO exports
Global - Permissions
Roles and permissions - Fixed a permission issue where recruitment study permissions were visible in the permissions page even when tenant had no access to the solution.
EDC - eCRF
Missing Data (Monitoring) - Fixed an issue where hidden questions with conditional logic were incorrectly visible in Missing Data dashboard.
Randomization details - Fixed randomization issue where "Stratify by question" displayed the newest answer instead of the one used for stratification.
Version 4.15.11 - Tuesday, December 3rd
CTMS - Subject Database
Picture rotation - Fixed an issue where the participant picture wasn't rotating on IPAD.
Audit trails - We have improved some translations
Version 4.15.12 - Tuesday, December 10th
Global - Centers
Archiving centers - We have fixed on issue to prevent archived centers from appearing in the list and being archived multiple times.
EDC - ePRO
Export - We have fixed an issue where it was possible to edit an archived ePRO surveys.
Survey interface -We have improved label positioning for radio buttons and checkboxes with long text options to better display answers options. We also improved slider label for tablet and smartphone views.