Tag Archives: affordable EDC systems

X EDC: The Next Generation of EDC?

RaveX is an EDC system that is powerful and easy to learn. Medidata has one of the best eLearning and training courses to get anyone up and running from the first time you use the system.

The study design setup still requires high technical skills including C# sharp for most complex data cleaning and study setup tasks.

Let’s discuss the new study hierarchy:

We already understand the relationship between the studies, sites, and subjects in Rave EDC.

At the navigation bar in RaveX EDC, we choose the study from the list of studies assigned to your role. At the second level, we can see the study dashboard. The dashboard contains information about the sites and subject enrollment.  From the sites, you can drill down to the subject level or subject related eCRFs.

Subject’s landing page:

  • Access eCRFs
  • Perform role-specific functions (e.g. SDV, DM data review, PI signature, enter data)

Understanding Status Icons in EDC:

On a form, when you click on an icon, the action is taken on that data point. Based on your roles and permissions, you could apply this action individually or to “Apply All”.

Common status icons:

When you select a subject, you arrive at the subject landing page. Some old features are the scheduled visit dates (a feel and look of the matrix in Rave Architect), the subject status and the status of their eCRFs and some additional information.

At the scheduled level (for Oracle InForm users, this is the Time and Event Scheduled with the traffic lights), you can open a folder and access a particular form residing on that folder.  You can then proceed with normal data entry.

There are several ways to access the same eCRF for another subject. Navigate to it by selecting a subject from the subject list.

Performing data cleaning and data review:

At the study level, select the RaveX study then select the study name you would like to perform a task.

On the screen, select ‘View Task Management’ link and then select the open queries link. At this level, you can select the particular subject and form a query that is opened on. For example, I noticed an open query on the informed consent form. To view it, select the query link on the screening informed consent row.

What modules are still available in this new design?

  • Rave Architect
  • Rave User Administration
  • Rave Site Administration
  • Rave Reporter
  • Rave Configuration
  • Rave PDF Generator
  • Rave Lab Administration
  • and more…

Overall, the EDC solution has been easy to use for database development, data entry, and data validation. The online, real-time validation feature is a plus as it does no longer requires the form to be saved for the checks to fire.

Have we lost any features to this new fancy design? Find out next.

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Want to become an {EDC} Developer? Take this test

I have been contacted on multiple occasions in recent years about how to become an {EDC} Developer or clinical programmer.

If you are currently working in the industry, the transition should be swift.  But for those working outside the pharmaceutical/biotechnology industry, I recommend you take a SAS programming course or data analytics/ visualization course since {EDC} training only is available for those already in the industry and for those sponsored by your employer.  There is no official public training for a specific {EDC} tool. Your company must be a user (Customer) of the tool for you to gain some knowledge.

Here are some examples of custom programs. Test your readiness.

Example 1:

Comparing two (2) strings a and b:

string dbtool=”Rave”;

if (dbtool == “Rave”)

if (dbtool.Equals(“Rave”))

OR how about…

String strA;

String strB;

If (strA == strB)

{

System.console.writeline (“StringA’s value is same as StringB’s value.”);

}

 

Example 2:

Switch case:  to store a value in int x if the value of n is “RAVE”, 2 if y is “INFORM”, 3 if y is “OCRDC”, and 0 otherwise.

switch (n)

{

case “1”:

Console.WriteLine(“You choosed RAVE”);

intVarEDC ==1;  break;

case “2”:

Console.WriteLine(“You choosed INFORM”);

intVarEDC ==2; break;

case “3”:

Console.WriteLine(“You choosed OCRDC”);

intVarEDC==3;  break;

default:

Console.WriteLine(“Invalid selection {0}”, n);

Console.WriteLine(“Please input 1, 2, or 3”);

intVarEDC == 0; break;

}

Example 3: Arrays

Can you guess the output to this program?

public static void printf(params object[] args)

{

for (int i = 0; i < args.Length; i++)

{

Console.WriteLine(“args[{0}] = {1}”, i args[i]);

}

}

public static void Main()

{

printf(“Thank you”, 4, “visiting”, “EDC Developer.”, “Says”);

}

Some tips or best practices when working with Rave Edit checks and custom fuctions:

  • Always put record position 0 in Edit Check Steps and Actions for standard DataPoints
    • Note: In the recent release of Rave, this is mandatory.
  • Use ChangeCount Property wherever possible to execute only for the submitted datapoints.
    • ex: If (dpAETERM != null && dpAETERM.Active && dpAETERM.ChangeCount  > 0)
  • Avoid using “true” parameter in the FetchAllDataPointsForOIDPath for Log forms.
    • Bad example: datapoints dpAE = CustomFunction.FetchAllDataPointsForOIDPath(“AESEV”, “AE”, “AE”, subject, true)
    • Good example: datapoints dpAE = CustomFunction.FetchAllDataPointsForOIDPath(“AESEV”, “AE”, “AE”, subject)

If you wrote similar programs or are comfortable writing these types of programs then you are ready for your next challenge. But if you do not know anything about C sharp programming or {EDC} in general, don’t despair. We are here to help.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on the latest news, articles, and tips. I am available on LinkedIn or my personal webpages: EDC Developer or Clinical Programmer. Or contact me to discuss any projects or contracts you may have and need support with.

Got Medrio? The Next Best EDC…

Medrio is a low cost solution that offers easy mid-study                changes and intuitive phase I workflows.

Medrio

One of my favorite features of Medrio is the Skip logic functionality. So what is Skip logic?

Let’s demonstrate this feature by using the Demography form / Race field:

In many EDC systems that I am currently using or used in the past, we have to create separate fields for each option and write a custom edit check to flag when data has been entered under the specify field. This scenario request data on the specify field if the OTHER race option is checked but with skip logic, no other option will be allowed to enter data (e.g. White or Black or Indian) if the user did not select OTHER as an option and the required field ‘Specify’ is made visible and available (mandatory) for data entry.

Medrio

eCRF – DEMO – Medrio

 

 

 

 

 

 

 

 

DM form – Skip Logic

 

 

 

 

 

 

 

In the above screenshot,  the query resulting from the skip logic configuration if OTHER specify is not completed. In other words, when Race other than ‘OTHER’ is checked, the specify field will be skipped (not enterable). To make this work and as a best practice, you will need to make the ‘OTHER’ field required during data entry.

If you are looking for a study builder or clinical programmer to support your clinical trials and data management department, please use the contact form.

Source: medrio.com

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

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HTML Tips to Enhance Your eCRF

In some cases, the display of your OpenClinica eCRF may not be exactly what you had in mind. You may want to highlight key words or phrases, create a bullet point list, or insert a URL or image. Using HTML tags, you can make some simple manipulations to change the look and feel of your case report forms and make them more inviting for data entry.

Using HTML tags to enhance your eCRF

The HTML tags described in this document can be used in the following columns in the CRF Excel template:

  • Items Tab: LEFT_ITEM_TEXT
  • Items Tab: RIGHT_ITEM_TEXT
  • Items Tab: HEADER
  • Items Tab: SUBHEADER
  • Sections Tab: INSTRUCTIONS

What are HTML tags?

HTML, or Hyper Text Markup Language, is a markup language that is commonly used for web page development. HTML is written using “tags” that surround text or elements. These tags typically come in pairs, with a start tag and an end tag:

<start tag>Text to format</end tag>

To insert an HTML tag, simply surround the text you want to format with the desired tag. Below are the HTML tags that work in OpenClinica:

Table

You can download this HTML Tags Knowledge Article to help you to get started.

Inserting URLs and Images

HTML also allows you to insert a URL or Image into your CRF, which may be used to provide users with additional information or references.

Insert a URL

A URL may be inserted into a CRF in order to provide a link to further instructions or protocol information. To insert a URL into your CRF, use the following format:

Inserting images - using HTML tags to optimize your eCRF

Simply replace the areas highlighted in yellow with (a) your URL (inside the quotation marks) and (b) the hyperlinked text that you want to display to the user.

The following example will prompt the user to “Click Here!” and will open the OpenClinica website in a new browser tab:

<a href=”https://www.openclinica.com&#8221; target=”_blank”>Click Here!</a>

Inserting an image - using HTML tags to optimize your eCRF

Insert an Image

Similarly, HTML can be used to insert an image into your CRF. You might consider using an image to display a pain scale (or other reference image), or even to display your company’s logo.

Inserting an image - using HTML tags in OpenClinica

To insert an image into your CRF, use the following format:

<img src=”images/ImageName”>

Again, simply replace the highlighted text with your image name. You can use PNG, JPG, or GIF image extensions. You can control the height and width of the image using the following format:

<img src=”images/ImageName” width=“n” height=“n”>

The highlighted n corresponds to the desired width and height of the image in pixels.

The following example will insert an image (image1.png) with a width of 300 and a height of 150:

<img src=”images/image1.png” width=”300″ height=”150″>

You can download this Images & URLs Example CRF to help you practice.

The examples included in the above CRF Excel template will insert an image that already exists in the images directory of your OpenClinica application. To insert a custom image, community users will need to place the image in the following directory of the OpenClinica application:

\tomcat\webapps\OpenClinica\images

OpenClinica Enterprise customers can request an image be placed on the application server by reaching out to the OpenClinica Enterprise Support team via the Issue Tracker.

Have you used HTML in your CRFs? Let us know if you have any other suggestions or tips!


IMPORTANT NOTES:

 The RESPONSE_OPTIONS_TEXT field is not included in the list above, as HTML tags are currently not supported for response options.

 The QUESTION_NUMBER field will display the text properly, but has been known to cause issues when extracting data. Therefore, HTML should not be used in this column.

 

Source: This article was posted by OpenClinica.

Clirinx EDC Demo

Quick overview of Clirinx EDC

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation of EDC systems, please contact us

 

Castor EDC – Data Management Made Easy!

I recently was approached by a group of scientists that have developed a unique EDC system for researchers. Usually, you have a group of developers or gurus / geeks around some science major staff trying to understand how the EDC system they purchased works. But to hear that the system was actually developed by the scientists itself was news to me. So the email piqued my curiosity.  And as the email stated ‘our goal is make professional data management systems available for every researcher,’ I proceeded to spend time researching more.

As per my previous post, I like to ask the question about ‘names’ so here I asked the founder of Castor the same question…What is in the name besides letters? 

Castor is the Latin name for the beaver family, and the logo is designed as a safe haven (the wall around the dot) for data (the dot in the center), but still accessible, just like a beaver’s ‘lodge’: hard to get into, but safe and comfortable inside.-Derk, founder

Why Castor?

Affordable multicenter EDC, GCP compliance, that is self-managed and you can do everything yourself. The system works on any platform and everybody can use it.

How to get started?

There are NO contracts or third-party involvement. You go to CastorEDC portal and click on –> Register

Anayansi Gamboa - Castor EDC

Create a new Study – once you have registered, you start building your study with ‘form builder’ tool. In order to build a form, you need to create phases (called usually visits like screening, visit 1, visit 2 and so on) and forms (that are referred by Castor EDC as ‘steps’ such as ‘Inclusion / Exclusion Criterias, Demographics, Vital Signs’, etc).

Now that you have defined your visits and forms, you need to add your fields. To the left of the form builder, you will find pre-defined set of fields from yes/no radio buttons to text fields to date fields and checkboxes. There are a lot of field types with several properties for each fields.

Another good feature is called ‘dependencies’.  For example, if you have a RACE field that collects multiple races codes including the OTHER, specify option; you can have a dependency text field appears ONLY when the OTHER option is checked.

Castor EDC Demo Castor EDC - Demo

Is Castor EDC CDISC-Compliant?

Currently, the system is being upgraded to comply with CDISC standards and this feature should be available by end of 2015.

Is castor EDC Affordable?

To calculate your own price or to have an idea of how much it will cost you to run your trial or research project, go to Pricing and Features.

Why people are choosing Castor EDC?

Reason 1 – It is fast –  your trial is up and running in days.
Reason 2 – Affordable – packages to fit any budget. No more Access or Excel to collect data.
Reason 3  – Easy to Use – Everyone can enter data with Castor EDC

Using Castor EDC is very easy, just follow these 10 steps:
1. Create your account.
2. Create your Study.
3. Build your Study structure.
4. Build forms for study data, reports for repeated data (i.e. SAE forms) and surveys for patient questionnaires (ePRO’s).
5. Test your forms via record management.
6. Check your settings , set randomization, record ID generation, and multicenter options.
7. Invite colleagues and participating researchers.
8. Set rights for every individual user.
9. Set your Study to live to start collecting real data.
10. Collect clean and valid data for your study!

Need more information?

See castoredc.com if you need affordable Electronic Data Collection for your study.

If you are looking for a study builder or clinical programmer to support your clinical trials and data management department, please use the contact form.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.