Once an eCRF form for a given study is validated and switched to LIVE, this is now time to include real patient, collect data and manage eCRF. Discover the available options to perform the actions.
eCRF dashboard
In the eCRF dashboard you'll find general information about your study eCRFs and related objects:
Global eCRF progress
Progress by visit
Completed records by visit
Number of queries in the study
Number of open queries in the study (not closed)
Number of signed eCRF
Number of excluded subject
Last 5 inclusions/records
The progress is calculated based on the number of inclusion/records needed for your study and the total number of required questions.
eCRF Inclusion List
The eCRF inclusion list views are available to help the user navigating between the eCRF but also getting information and overview of the completion.
Two views are available :
Inclusion - List view
Inclusion - Visit view
To open the view, simply navigate to the section eCRF Inclusion List. Choose between the two available views on selecting the tab on top of the screen.
Inclusion - List View
A table is available showing :
The subject Study ID
If applicable and if the user has the permission , The Rando and Group ID
A start (creation) date
A Study Progress, based on the eCRF data point completion for this subject
An eCRF status
A last update date
A last column can be customized to show one data point from the eCRF. Simply activate this column using the logo
Use the available search and/or filter options to find a given subject eCRF. Access the eCRF details by clicking on the row.
Inclusion - Visit view
A visual list is available showing :
The subject Study ID
If applicable and if the user has the permission , The Rando and Group ID
As many columns as it was created sections under the eCRF form builder
Each column is showing color coded informations helping the user to quickly oversee the eCRF section (visit) completion
💡Tips:
Access the eCRF details by clicking on the row.
Click on a given column to quickly navigate to the associated section of the eCRF
🛠️ Step-by-step guide:
How to read the visit view
How to read the visit view
Exclude a participant
You can exclude a participant in the eCRF if the participant is not eligible, withdraw, or does not participate anymore in the clinical trial.
You can add a data validation in order to show an exclusion message directly in the eCRF.
To exclude a participant, click on Exclude subject, provide a reason and your password. If you've sign-in using your company credential (SSO), you can exclude a participant, provide a reason and that's it. The platform will automatically recognize your company credential.
The participant will not be displayed anymore by default in the participant list.
You will need to filter by "excluded" to display the excluded participants.
All data are kept and exported with the excluded status and the reason.
You can find the excluded raison in STATUS in parenthesis, e.g, EXCLUDED (Non eligible)
Un-exclude a participant
Un-exclude a participant so that you can add data to its eCRF again.
🛠️ Step-by-step guide:
How to un-exclude a participant
How to un-exclude a participant
Go into your inclusion list
Filter by status and select only Excluded subjects
Open its eCRF
Click on the person icon on the top right corner
Select "Un-exclude subject"
Give a reason in the pop-up
Confirm
eCRF - Export Data
Exporting eCRF data is extremely simple with Datacapt. There’s no need to code complex export queries or configure intricate options. You can obtain your data with just one click, anytime.
Exporting eCRF records allows you to:
Conduct intermediate analyses.
Investigate data trends.
Collect and analyze study data at any stage of the study.
Follow the steps below to export your eCRF records efficiently, with customizable options to tailor your export.
🛠️ Step-by-step guide:
How to export the eCRF records database
How to export the eCRF records database
Search and open your study.
Navigate to the "Inclusion list".
Select "Export".
Configure available options:
Export Format: Choose from PDF, CSV, or Excel.
Export by "Labels" or "Values": This affects how data is presented in the main table.
Export Files (Optional): If your eCRF forms collect file attachments, choose whether to include them. A dictionary match file will also be added for reference.
RM in a Separate Sheet (Optional): If enabled, repeated measure endpoints will appear on individual sheets. Otherwise, responses will be added as additional columns in the global eCRF Data page.
Domains Export (Optional): If domains are configured under the eCRF Builder at the section level, all sections with the same domain will be grouped on a specific page.
Select "Export".
Wait for the export to generate.
How to download again previous exports
How to download again previous exports
Navigate to the "Inclusion list".
Select "Export Data".
Go to the "History" tab.
Locate the export task you wish to (re)download.
Download the export.
💡Tip: For large or lengthy exports, you can close the export screen and return later. The task will remain under the "History" tab.
Information Included in Your Export
The eCRF export document consolidates the following information into a single file, with each bullet point representing a separate page:
eCRF Data: A complete list of all eCRF records. Each row represents a subject eCRF, while each column corresponds to a question configured in the eCRF Builder.
Repeated Measure Page(s) (Optional): If the "RM in a separate page" option is selected, each repeated measure question will appear on its own page. Rows represent individual responses for each subject.
Domain Page(s) (Optional): If enabled, sections with the same domain (configured at the section level in the eCRF Builder) will be grouped and isolated on specific pages.
Option Values: A page displaying the match between labels and values for questions using this option.
Items Dictionary: A detailed list of all eCRF question configurations, showing the global eCRF structure and logic. This page is especially useful for data managers and statisticians.
Queries List: A list of all queries, including their status and key details for queries attached to the eCRF.
Missing Answers Comments: A list of all declared missing answers, with detailed information.
Notes
Exporting eCRF data requires specific permissions, which can be configured under Role Management.
In the export file:
Empty cells indicate unanswered questions.
Cells labeled ".hidden" indicate questions that were not visible for a specific record due to conditional logic.
Cells labeled with special codes like ".NA" represent missing value declarations.
Frequently Asked Questions
Once the study is finished, do I need to contact the Datacapt team in order to obtain my final data export ?
No need to contact the Datacapt team (even if we ❤️ to hear from you). Any user with the appropriate permissions can export eCRF data at any time.
Must I configure a table under the study page Study > Report to obtain my data ?
No need to configure a table. The page Report is a live data observation tool, design to check live a few data points. To obtain your full export, simply use the available option "Export" available under the page "inclusion list"