Release on Wednesday, November 15th, 2023 between 08:00 pm and 10:30 pm UTC.
In version 4.10, we are rolling out a brand-new solution: Recruitment.
This solution allows sites to recruit participants more effectively. You can easily create a web landing page, and participants can apply to your study.
The solution is available only upon request.
General.
New Filters - We have introduced new, more intuitive filters for all tables in the platform. Now, you can select multiple filters simultaneously, making the filtering process even more convenient and useful.
PDF Translation - Now, you can export your eCRF, ePRO, and ePRO blank PDFs with all language settings used in the translations. In cases where a field isn't translated, it will be exported using the default language. This feature enables you to export all forms, including translations, with just one click.
PDF Customisation - All PDF exports will now utilize the primary colors and logo settings established in your study settings.
Automation Translations - We have introduced automation strings in the translation solution, allowing you to translate all your automation messages into multiple languages. If a translation isn't available, the default language set in the translation will be used.
New Slider (eCRF, ePRO) - We are introducing a brand-new slider that is more flexible and modular, designed to meet all your needs. This enhanced slider now offers four additional options. You can display the slider horizontally or vertically on any screen, and choose to show ticks with or without values to assist users in defining their desired values more effectively.
We have also added color options, particularly useful for questions related to pain. The slider comes with various validations to prevent the creation of illogical sliders.
Data Export “.hidden” – Exporting questions using conditional logic (visibility condition) has been significantly enhanced for consistency. Any data that is not visible on the eCRF due to conditional logic will be exported as “.hidden”, ensuring consistency even if data was entered in the eCRF. Additionally, the export process is now faster.
eCRF.
Table – We are introducing a new type of question that allows you to create tables in the eCRF. Every table can contain a maximum of 20 rows and columns, making them exceptionally useful for those who need to collect data in a tabular format. You can utilize text, number, date/time, and dropdown fields within the table.
Every data point entered is tracked in the audit trails and is automatically saved.
However, it's important to note that the table does not offer data validation or conditional logic, and all fields are mandatory by default.
If you need to, you can create multiple queries for your table and monitor them on a dedicated page. These queries will be linked to the entire table and not to individual data points within the table.
Additionally, you have the option to export table data to a separate sheet in SDTM format.
Flagged Missing/Unknown data – We have enhanced the missing/unknown flag in the eCRF by introducing five default reasons for flagging data as missing or unknown:
1. Not Done (Export Code: .ND)
2. Not Applicable (Export Code: .NA)
3. Unknown (Export Code: .UNK)
4. Not Asked (Export Code: .NASK)
5. Asked but Unknown (Export Code: .ASKU)
Additionally, you can include comments for traceability purposes. When you flag data as missing, the reason will be assigned to the respective question and displayed below the field. The question will appear greyed out and will be locked (not able to answer). You can remove the reason by clicking « Unlock ».
Furthermore, you have the option to flag an entire visit (section) or form (subsection) as missing. When you select a reason for these, it will automatically apply to every question within the visit or form. It's important to note that once applied, these flags cannot be undone and must be updated individually for each field.
We have introduced a new export sheet/file that contains all the details of flagged missing data.
Monitoring - Missing Data – We have introduced a new dashboard in the monitoring pages, enabling real-time tracking of missing data in your study's eCRF. Missing data refers to data that was not completed during the data collection process. This dashboard provides essential insights, including:
The total number of missing data points
The number of patients with missing data
The percentage of missing data relative to the total data collected
In addition to these metrics, you can access a comprehensive table containing information such as the question (variable and title), subject ID, center, and question's location within the visit name, form name, and question title.
Furthermore, you can click on the eye icon to be redirected to the missing question, allowing you to take actions such as adding a query.
It's important to note that flagged missing data, where users have provided a reason and flagged it as missing, is not considered in the count of missing data.
PDF Preview – You can now open and preview your PDFs directly within the platform without the need to download them. We've added an eye icon, and you can simply click on it to open the PDF. Please note that for large PDFs, there may be some loading delays.
ePRO Variable in Calcul – We have now enabled the use of ePRO variables (answers) in eCRF calculations. This feature is immensely beneficial as it allows you to seamlessly integrate ePRO and eCRF answers within the same eCRF. You can create calculations, display ePRO answers directly within the eCRF, and even employ data validation and conditional logic to establish eCRF logics based on ePRO responses. This integration offers a powerful and versatile way to work with your data.
ePRO.
QR-Code Generator – Now, you can generate a QR-Code for each ePRO in the eCRF or ePRO records table. This feature makes it easy to open ePRO on a tablet or scan it by the participant.
Calcul Question – We have introduced new questions in ePRO that enable you to perform calculations seamlessly. These calculations are not visible to the participant but are included in the export. Additionally, you can use or display the calculation results in the eCRF to create complex logic. This feature streamlines the process of automatically calculating sums or scores directly in Datacapt.
General Settings.
Multiple User Invitation – Now, you have the ability to invite multiple users at once with the same role. You can easily copy and paste a list of user emails directly into the platform, eliminating the need to invite users one by one. This feature is designed to help you save time and streamline the user invitation process.
Audit Trails Export - You can now export global audit trails in CSV format, enabling you to review changes, updates, deletions, logins, and other actions that occur across the entire platform.
Compliance Settings – We've introduced incredibly flexible and powerful automation features connected to the patient database and personal data retention. You now have the flexibility to define and set five rules and automation tailored to your specific needs and privacy policies.
Automatic Account Deletion - When this setting is enabled, subjects can request to have their account permanently deleted. When the subject sends a request, you will receive an automatic notification to the provided email address. The subject status will be updated to “Deletion Requested”. After examination, you’ll be able to permanently delete the account in the subject profile.
Data Retention Period - This setting specifies the duration in which data is stored and processed. All the data will be removed when the configured retention period expires. An automated consent extension email can be configured for this.
Consent Extension Windows - Request a new consent period from your subjects to keep their data and personal information for another retention period.
Delete Pending Subjects - Specify the time period after which personally identifiable information and data of all your subjects will be deleted if they haven't been activated.
Inactive Period - Specify the time period after which your subject becomes Inactive if there's no activity. The period is automatically reset if there's any activity with the subject. You can also set a deletion period that will delete all the data and anonymize the data.
Patient Database.
Assign to Study – With our recruitment solution, you can now assign subjects to your study effortlessly. By applying filters to your database, you can select and assign subjects to your study, streamlining the invitation process.
Previous Studies - Now, you have access to each patient's study history, including their enrollment date and eCRF status.
URL Shortening - Now, you can use shortened links in SMS campaigns to send clickable links.
Recruitment, Self-Application.
This new solution empowers sites to efficiently manage and recruit patients for clinical trials. With this new solution, you can manage applications in real time, generate QR codes for self-registration, and create pre-screening surveys to automatically qualify or disqualify applicants.
Study List – Create and access your recruitment study. We have compiled a study list that contains all the information pertaining to your recruitment study, such as recruitment progress, target date, study centers, and study name. This allows you to conveniently monitor all your studies from a single page.
Study Settings - Access study settings to configure your study and input all the relevant information, including the study name, summary, primary eligibility criteria, indemnification amount, and the link to the EDC (Electronic Data Capture) study.
Landing Page – In a matter of seconds, you can create a visually appealing landing page with all the essential information about your study for potential participants. You have the option to include a picture, title, study summary, and all the necessary details for effectively promoting your study. Participants can access this information at any time and apply to join the study 24/7. The landing page can be easily shared through a QR code or a unique link.
Pre-Screening Survey – Within your recruitment study, you can create a modern and adaptable pre-screening survey to assess eligibility criteria and gather data. Additionally, you have the ability to apply conditions that can automatically approve or disqualify applications. This feature proves highly advantageous for automating your recruitment process. You can preview the answer in real-time for every application.
Candidates List – You can access the entire list of candidates on a single page and review their applications. Each application includes the candidate's full name, contact details, application status, study center, application date, and all the responses from the pre-screening survey if you created one for your study. You can also search and apply filters to the application list, allowing you to efficiently manage all the applications.
Candidates Sign in/Sign up – When applying to your study, all candidates can either sign up or sign in to the Datacapt Platform to confirm their application or complete the pre-screening survey. Participants who are already registered will be directed to the login page, while new participants will be redirected to an account creation page to facilitate the application process. This process is automated and user-friendly for participants.
Invitation – You can invite participants from your own database or send invitations to new participants via email.
Quick View – Access a quick view for every application and check their contact information in real-time. You can also take notes, review their characteristics in the database, and check their previous study history, all within the same screen. This view is very useful for quickly accessing information and contacting the candidates.
Data export – You can export all the data from your recruitment and the pre-screening survey in one click in CSV or XLSX format for further analysis.
Improvements
eCRF.
Monitoring Filters – We've enhanced the filters in the monitoring page, now allowing you to navigate back and forth while retaining the same filters. This will significantly save you time.
Subject Database.
Settings Redesign – The subject dashboard has undergone a complete redesign, offering a more intuitive interface. Now, participants receive a personalized greeting message upon login, along with a summary of the tasks they need to complete on Datacapt. This enhancement aims to boost participant engagement significantly.
eConsent.
Timeline eConsent - We've fixed an issue that now correctly displays the full name of the investigator/doctor for the eConsent counter signature, rather than the patient's name.
Service Pack 4.10.1 - Release on Tuesday, 22th November 2023
We added an instruction in the user invitation popup to explain the new logic. The user must press enter to validate the email.
We fixed an issue with conditional logic that was not working when using calcul as a reference question.
We rectified the display of variables in the eCRF export modal to display prefixes and suffixes correctly.
We fixed an issue for the eConsent import date that was not set correctly.
We fixed an issue where it was not possible to change the subject/patient status from Inactive to Active.
We resolved a problem with the French translation for the "Verification" status in the eCRF.
We fixed an issue where Repeated Measures were not being exported for some studies.
We corrected an issue to ensure accurate display of calculation results in the eCRF and ePRO PDF exports.
We removed length character validation for translations, enabling the translation of strings even if they are longer than the default language.