
Home	Services	CDISC	News	About us

eCRFs generated from ODM MetaData: Samples

: eCRFs from ODM 1.3 files

This page contains a number of sample eCRFs, most of them were created fully automatically from CDISC ODM files version 1.2 or 1.3. You can try out all this sample eCRFs online, and see how they work.

For some of the samples, if you have IE6 or IE7 as the browser, you will need the FormsPlayer plugin, which is freely available from x-port.net Ltd.
Please note that under Windows2000 the XForms might not work correctly.

Mozilla Firefox users can also use the samples if they have installed the Mozilla XForms plugin.

Some of the samples are also available using a server-side implementation (Chiba-web, Orbeon). For these, no plugin at all is required.
Chiba-web and Orbeon use the newest Ajax (Asynchrones JavaScript und XML) technology.

Another new technology is AjaxForms. It is an offline tool to convert XForms files into HTML files with JavaScript. The resulting HTML files can be used in any modern browser that enables JavaScript. So also here, no browser plugin is required.

The samples given here are demonstrate the different possibilities when using XForms technology. As such, these are not complete examples. Each of the samples demonstrates a different aspect of the use of XForms technology in eCRFs, so none of them tries to be a complete eCRF.

P.S. - FormsPlayer users: If you are already using version 1.5, please be sure that you have upgraded to 1.5.5.1011 or later (previous 1.5 versions have a bug causing forms with XML-Schemas to crash).

A very simple eCRF (FormsPlayer plugin required)

The very simple eCRF in XForms format shown here still has little or no application logic, i.e. the edit checks are limited to validation of the data type.
However, it gives you an idea about the user-friendlyness of the XForms, and shows you how on-the-fly validation of the data (without having to send the data to the server first) is accomplished.
An example of the result that is send to the server when the user clicks the "Submit" button is given here. After you filled all the required fields correctly, and click the "Submit" button, two things will happen:

In the upper part of the screen, you will find the clinical data in ODM format that is generated from the response by the user.
The great advantage of an immediate transformation into ODM format of the received data is that it can easily be stored in a standardized format in a native XML-database, or in a relational database where the tables are mapped to the ODM (as several vendors already do). The other advantage is that the data stored as CDISC ODM data are "ready for transport", i.e. they can be send to the sponsor with little or no transformation (the transformation can e.g. be that different submitted eCRFs are concatenated into one larger file, e.g. for daily transport from CRO to sponsor).
In the lower part of the screen, you will see that a PDF image of the submitted eCRF is shown. For demo purposes, we added two extra columns to the tables that are shown, one giving the ODM question code (Item OID) response, and one giving the codelist coded value, in case a codelist was used. Very likely, in a real application, these two extra columns will not be present.
The generation of the PDF image of the submitted form is important, as the regulatory authorities require that the investigator keeps a copy of the filled CRF.
In a real application, the system could e.g. automatically make a print of the PDF on the personal printer of the investigator (the oldfashioned solution), or store the PDF in the investigator's document management system.

Dynamic eCRFs

When using XForms technology, fields can be blanked out, prefilled with data, etc.., based on conditions in other fields.
The most simple example is the one where the user (in this case the clinical Investigator) can decide whether to add an Audit Record to the eCRF. If he/she checks the chechbox, a number of new fields become available, of which at least the user and location ID must be added (mandatory fields).

Remark that the datetime stamp is automatically generated by the form itself. Also see how the datetime updates each time you jump to another field and when you click the submit button.

Try out the Audit Record example yourself (FormsPlayer plugin required).

In a real system, if a form that was already filled before is loaded, and that the Investigator wants to correct (i.e.audit), the checkbox would automatically disappear, and the extra fields become mandatory, so that the investigator cannot upload the updated form without adding the necessary information for the Audit Trail.

In a more complicated example an eCRF about Concomitant Medication, the user either can enter an exact data (using a Calendar) when the exact start or stop date of the medication is known. If the exact date is now known (choice pulldown or checkbox), the field for entering the exact date disappears, and 3 additional fields show up, allowing the user to enter the (approximate) values for year, month, and day. Even more, the fields asking for the stop date for the stop date only become available when the investigator has checked that the concurrent medication is not ongoing (i.e. has been stopped).

Try out the dynamic form for Concomitant medication (IE with Formsplayer plugin)

The same form styled for Mozilla FireFox (1.5) with XForms plugin

Try out the server side implementation of this dynamic form (no plugin required - Chiba-web)

P.S. adding conditions (in machine-readable language) for blanking out questions or group of questions is a new feature of version 1.3 of the ODM Standard.

eCRFs with repeating groups

Especially in medical forms, it often happens that a number of questions has to be repeated, e.g. for each body part in a physical examination form.
In the following example, it is demonstrated how this is implemented in an eCRF in XForms format: the investigator needs to repeat a set of 3 questions for a number of body parts.
When the form is loaded, only 1 set of 3 questions appears on the form, but each time the "Add Item" button is clicked, a new set of 3 questions pops up which can then be filled.

Repeating groups have been implemented in the CDISC ODM. This means that eCRFs with repeating groups can be produced automatically starting from the CDISC ODM

Try out the Body Examination form with repeating groups (FormsPlayer plugin required)

Try out the server side implementation of the Body Examination form (no plugin required - Chiba-web)

The ACRO/CDASH forms

ACRO, the American Association of Clinical Research Organizations started a process back in 2005 to standardize on CRFs for certain clinical domains. Soon, they realised that they should do this together with CDISC. So an effort was started, which resulted in the joint CDASH initiative.
Under this initiative, representatives from the pharma industry will develop a number of standard forms for domains like Adverse Events, Demographics, Vital Signs, Prior and Concomitant Medication, etc..
As a first result, a standard form has been developed for the Adverse Events domain, which will go in the approval process in near future.

David Iberson-Hurst from Assero has created an ODM 1.2 file for this form, and we further extended this and ported it to ODM 1.3.
Also we made a French version on the form.

You can now try out these forms online. A browser plugin is not required (Chiba-web technology). When you have correctly filled the form and click the "Submit" button, the contents of the form will be transformed to ODM Clinical Data, and at the same time, a PDF file will be created on-the-fly for your own archives.

Try out the english version of the standardized ACRO Adverse Events form

Try out the french version of the standardized ACRO Adverse Events form

ODM 1.3 examples

The new version (1.3) of the ODM Standard has a whole set of new features and enhancement to support EDC. There is better support for internationalization (multilangual labels are possible on all metadata levels), and the concept of Conditions was introduced.
The latter allows to define (in machine- and/or in human-readable) language to define under which condition(s) a form must not be used, a group of items can be blanked out, a question must not be answered (as it is not relevant).

We have implemented these new features in our system that creates eCRFs from the ODM on the fly.
For example, in the Baseline eCRF, the ODM study setup defines that the question about the number of cigarettes, and the whole group of questions about smoking complaints must not be answered when the subject is a non-smoker. When you use the form, you will see that these questions only appear in case the user has ticked that the user IS a smoker (and disappear when the user ticks that the subject is a non-smoker)

For each of the on-the-fly generated forms that you can try out, four implementations are available:

Implementation	Explanation
	Chiba-web: Chiba is a server side implementation of XForms. The advantage is that it is browser-independent, so you do not need a browser plugin.
	FormsPlayer: Requires that you install the Formsplayer plugin into your Internet Explorer installation. The plugin can be retrieved from the FormsPlayer website. The advantage here is that the plugin exploits the full potential of the IE browser.
	Firefox: The popular Mozilla browser that is challenging MS IE has an XForms plugin available that can be downloaded from the Mozilla XForms website. If you use Firefox and have the XForms plugin installed, this implementation may be your choice. It is expected that in future, the plugin will be a native part of the Firefox browser.
	AjaxForms: AjaXForms is a tool that transforms XHTML/XForms documents to HTML with (Ajax) Javascript documents. This means that an XForms transformed by the tool can be used in any modern browser that supports JavaScript. As such (just like Chiba-web), it is server-independent. We are currently looking into using the tool from within a servlet.
	Orbeon: Just like Chiba, Orbeon is an open source, server side implementation of XForms (browser independent). Unlike Chiba however, there is much more available than the XForms engine, like XML-pipelining (XPL), allowing e.g. to generate PDFs on the fly. Orbeon's XForms implementation is used by big companies like Volkswagen, CISCO, CSC, Electricté de France; and many more.

eCRF	Explanation	Implementation AjaxForms	Implementation Orbeon
Baseline form	Baseline form. Special is that the question about the number of cigarettes, and the whole group of questions about illness related to smoking must not be answered when the subject is a non-smoker
Adverse Event form	Adverse Event. Lots of use of condition logic here. The group for giving the adverse event details only becomes available when the user ticks that the subject has experienced an adverse event. The user can then add one or more adverse events by clicking a button. Another implemented logic (defined in the ODM study design) is that the end date of the adverse event can only be entered when the user ticks that the adverse event is not continueing.
*Adverse Event form in Korean ()**	The same Adverse Event form, now in the Korean language. Remark that not all error messages are not yet translated to the Korean language, and that in the PDF generation, support for Korean characters still need to be added (work in progress). P.S. If you see strange characters, ensure that your browser settings are correct: - IE: View -> Encoding -> Unicode (UTF-8) - Firefox: View -> Character Encoding -> Unicode (UTF-8)	coming soon	coming soon

Much more samples will be made available soon !

Our Services

Convinced about the advantages of automated transformation of ODM metadata into eCRFs ?

XML4Pharma can help you with the development of the technology for automated generation of eCRFs from CDISC ODM metadata, being it using XForms technology, or any other technology for use in web browsers, on PDAs or on smart phones.

For more information, contact us at info@XML4Pharma.com.

(*) Acknowledgements: Special thanks to prof. Inyoung Choi, The Catholic University of Korea, College of Medicine, Department of Preventive Medicine, for providing the Korean translations and adding them to the ODM file.