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[Users] What's new in development - What would you like to see in Print CRF?

Hello Alicia,

I agree with the request for the annotated CRFs, from my experience anything that could ease the statisticians work in that aspect is worth investing in.

As for the printed CRF, they will be a great help.
In all the Clinical Studies I have been involved so far, there is a source binder containing the forms and questionnaires being filled in during patients visit. The data entry into the system takes place subsequent to the patients visit; then approximately 70% of the source documents, required for the statistical analysis are manually entered into the system.
Being able to print out the CRFs will save a lot of work preparing the source and validating it. In this case, I believe having the 'group repeat maximum' available with their headers repeating is necessary.

I tried to imagine how it will look so far I have a few questions:
1. What about the page heather. This is an extremely important issue; each page of the eCRF/ Source documents contains space to fill in the Study Subject ID, patient initials and site name. In case the pages are printed is it possible to add constant heather to those pages?
2. Currently when using jQuery script to manipulate the eCRF design. When printing those eCRFs the entire script comes out in a wired format with the script listed on the top. Will the new version support jQuery?
3. In case an eCRF is divided into tabs- will it be printed out on separate pages. Sometimes a tab contains only a few item…
4. Is there a way to mark an automatic calculated field in order to distinguish them? If not, I guess it could be noted at the eCRF itself.


Hope this help,
Thanks for the update,
Liora Bosch - Hommfor
Clinical Data Manager
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A. Stein - Regulatory Affairs Consulting
Beit Hapaamon (Suite 102)
20 HaTaas Str. (P.O.B. 124)
Kfar Saba 44425 ISRAEL
Tel: +972-9-7670117
Fax: +972-9-7668534
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Sent: Tuesday, April 30, 2013 10:53 AM
To: '[email protected]'
Subject: Re: [Developers] [Users] What's new in development - What would you like to see in Print CRF?

Hi Alicia

The requests I listed were for annotated CRFs, and the primary users of them are statisticians. At the moment we need to provide a set of annotated CRFs for every study that is built. While it would be nice if I could teach all the statisticians how to use OpenClinica, the reality is they receive data for projects from a range of systems, and an annotated CRF is a good quick-reference.

Regarding the group_repeat_max question – that makes sense, but I thought the blank CRFs were more for documentation purposes, which is why I suggested the annotated CRF things. We only maintain paper back-ups for extremely time-critical CRFs like enrolment and expedited safety reporting, which is a small part of the study data. The other main usage for paper I can think of is patient reported outcomes / quality of life, but most instruments already have a validated paper version, and hopefully the ‘patient portal’ that seems to be in the works for OpenClinica will further the amount of data captured electronically.

Best regards,

Lindsay Stevens | Clinical Data Coordinator
NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
Mail: Locked Bag 77 | Camperdown | NSW | 1450
T +61 2 9562 5369 | F +61 2 9562 5094
E [email protected] | W www.ctc.usyd.edu.au
Sent: Tuesday, 30 April 2013 4:42 AM
To: [email protected]
Subject: Re: [Developers] [Users] What's new in development - What would you like to see in Print CRF?

Hello Krister et al,
I should add some more information/clarification on what is working or not in the developer release and what our plans are.
From a technical perspective, we're completely redoing Print CRF and doing it in an entirely different way. We are now using ODM to generate the printed views. What does this mean? We've had to do a lot of work on the ODM and not everything is working just yet. If we look at this in 3 parts, there are: "Global CRFs" (Administer & Manage CRFs which may not be study-specific), Event Definition CRFs (at the study level) and Site Event Definition CRFs (which may have site-specific parameters).
Global CRFs are not working yet as we're having to do work on ODM to be able to access this information. Currently ODM only gives you study ODM which means if the CRF is not part of the current study, then it won't be in the ODM. We'll be doing some work so that all of the information will be accessible with the right permissions, whether it is part of the study or not.
Event Definition CRFs are working as we're working with the study ODM. We've also had to add some details to the ODM to be able to reliably use this with all of the study detils/configurations, etc.
Site Event Defintion CRFs are not working yet as we discovered that many of the OpenClinica attributes were not being generated at the site level. We are working on the site-level ODM and schema updates now and this work is nearly done.
Regarding multiple pages that have printed, what we were thinking for grids is that we would print the "GROUP_REPEAT_MAX" rows. The rational was that if someone were to use the printed CRF for data collection that they would have the max value of rows as defined in the CRF. Because this could span more than one page, we're repeating the column headers (LEFT_ITEM_TEXT) for each new page the grid is displayed on. Do you think this is the right approach?

For this release, we will first plan to release unpopulated Print CRFs (all of the views that are not subject specific). After that we will be working on populated (subject and subject case books with PDF capability).
Lindsay - Thank you for the feedback. This seems to be for 'annotated CRFs'. Are you primarily using these to send to your statisticians? I don't think this will be in the scope of this release, but may be worth considering for future. How important are these to your (and others) studies?
Best Regards,
Alicia


On Sun, Apr 28, 2013 at 11:16 AM, Krister Kristianson wrote:
Hello Nick,

Thanks. I had actually found it but nothing happens when I hit “Print” only a blank page shows up for the majority of my CRF’s. The AE page printed, though, but it showed up in 12 copies (attached). A very short CRF printed as expected (only one copy, attached).

One other question: We are currently looking into a method to increase the security for log on to OC. The European agency are increasing the security requirements as soon as you include any personal identifiable data and we are looking into various possibilities. My question: Is data current login module something that you have develop yourself at OC or is it a commercial piece of software?

Best regards

Krister
Sent: Saturday, April 27, 2013 11:42 PM
To: [email protected]
Subject: Re: [Developers] [Users] What's new in development - What would you like to see in Print CRF?

Hello Krister,

The Web Services aspect that handles PrintCRF is included in the web application so there is no need to include WS for printing.
The printer icons are somewhat small but they are found where you would mostly expect to see them near the "looking glass" view icon.

Thanks,

Nick Sophinos
Developer, OpenClinica

On Sat, Apr 27, 2013 at 1:41 PM, Krister Kristianson beta-JUDO, Uppsala University wrote:
Hi Alicia,

I have downloaded the SNAPSHOT and loaded some 200 patients into it. I have so far failed to locate the new print functions. Should I load WS as well?
Regards

Krister
Sent: Friday, April 26, 2013 10:58 PM
To: [email protected]; [email protected]
Subject: [Users] What's new in development - What would you like to see in Print CRF?

Dear OpenClinica Community,

Our development team is doing some exciting work and we would love to share it
with you and get your feedback.

We’re putting out a developer release so that you can download and test out some of the new functionality. The primary focus of the next release will be around the next generation of Printed CRFs, and this developer release will give you a good preview. For the techies out there, you can dig into some more of the details here: http://blog.openclinica.com/2013/04/26/new-openclinica-developer-release-revamped-print-module/

There has been a lot of discussion lately on the forums about what is being worked on so I’d like give everyone an overview:

What’s New:
Next generation of Print CRF!
RESTful architecture for access to metadata and Print CRFs
LDAP integration - OpenClinica has been configured to work with LDAP

Changes and Fixes:
Updates to Enterprise Data Mart* to address column and table naming conventions; control of width with truncation and new mapping table.
Updates to the javascript libraries so that OpenClinica can run on more browsers and versions of browsers (primary fix for Firefox update 20+)
Fixed discrepancy notes rendering. Addressed a niche issue where duplicates may be displayed on CRFs which were hidden from a site. For more information please see the Jira ticket: http://50.57.189.131:8081/secure/RapidBoard.jspa?rapidView=1&view=detail&selectedIssue=MR-330
Updates and enhancements to Metadata ODM 1.3 Full with OpenClinica extensions. The metadata is now more robust; work was done to support the new model for Print CRF.

In addition to the work directly related to the product, we’re also making some great operational changes. We’re moving to a new issue tracking/project management tool, Jira. We’re using this internally until we’ve completed the work to make it publicly accessible with your www.openclinica.com username and password – once this is done you’ll have the same type of access that you did to the OpenClinica Issue Tracker but hopefully you’ll find the tool a lot nicer to work with and have better visibility into what we are currently working on. We’re also making progress on continuous integration and automated regression testing.
Again, we would love to get your feedback. We really appreciate all of the contributions made from the community and early feedback is a great way you can help shape the product and future of OpenClinica!

To download the Development release go here: https://community.openclinica.com/project/openclinica#dev

Best Regards,
Alicia & The Development Team
OpenClinica, Product Owner

Comments

  • LizRLizR Posts: 60
    Alicia wrote:
    Lindsay - Thank you for the feedback. This seems to be for 'annotated CRFs'. Are you primarily using these to send to your statisticians? I don't think this will be in the scope of this release, but may be worth considering for future. How important are these to your (and others) studies?
    Regarding annotated CRFs, they go to the programmers, but they're also a required part of our Trial Master Files. Having to do them by hand isn't the end of the world since it's only once per study, but it would certainly be a lovely thing to be able to just have. My suggestion that printing down the metadata for each page and attaching it to the printed blank CRF page caused my regulatory people to actually scoff at me out loud, sadly.
    Kind regards,
    Liz
    Liz Robertson
    Director of Data Management and IT
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
This discussion has been closed.