Tag Archives: clinical programmer

Using PROC UNIVARIATE to Validate Clinical Data

Using PROC UNIVARIATE to Validate Clinical Data

When your data isn’t clean, you need to locate the errors and validate them.  We can use SAS Procedures to determine whether or not the data is clean. Today, we will cover the PROC  UNIVARIATE procedure.

  • First step is to identify the errors in a raw data file. Usually, in our DMP, in the DVP/DVS section, we can identify what it is considered ‘clean’ or data errors.
    • Study your data
  • Then validate using PROC UNIVARIATE procedure.
  • Find extreme values

When you validate your data, you are looking for:

  • Missing values
  • Invalid values
  • Out-of-ranges values
  • Duplicate values

Previously, we used PROC FREQ to find missing/unique values. Today, we will use PROC UNIVARIATE which is useful for finding data outliers, which are data that falls outside expected values.

proc univariate data=labdata nextrobs=10;
var LBRESULT;
run;

Lab data result using Univariate

 

 

 

 

 

 

 

 

 

For validating data, you will be more interested in the last two tables from this report. The missing values table shows that the variable LBRESULT has 260 missing values. There are 457 observations. The extreme observations table can tell us the lowest and highest values (possible outliers) from our dataset. The nextrobs=10 specify the number of extreme observations to display on the report. To suppress it use nextrobs=0.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

 

Advertisements

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.

Medrio eClinical – Integrated SaaS platform for eClinical

Since 2005, Medrio has offered an integrated SaaS platform for eClinical with a fully hosted Electronic Data Capture (EDC) system.

Some of the features provided by Medrio are:

Faster  – No programming required and you can build and deploy studies in days not weeks.

Medrio’s unique Electronic Data Capture (EDC) model optimizes time and investment by providing users with fast study startup and deployment times and easy mid-study changes. Medrio studies are built using our web-based platform and can be configured 100% through a web browser using drag-and-drop functions, eliminating the need for custom programming. Build your study in days, not weeks or months.

More Control – Build studies completely online and view live data anytime, anywhere .

Medrio’s web-based, customizable interface is designed for researchers to build and configure studies without reliance on software programmers. Study management capability is made easier as users can access live data anytime and anywhere with an internet connection. Data managers can make mid-study changes, control data integrity and utilize reporting tools, making study management faster, more accessible, and more efficient.

Configure – Medrio gives you unprecedented speed and agility in building your study.

  • Intuitive point-and-click interface
  • Extensive form libraries, variables, and templates
  • Dynamic form rules and custom skip logic
  • Easy mid-study changes

Collect Data -Sites appreciate the ease of use and simplicity in entering data.

  • Enter data from anywhere via a browser
  • Intuitive workflow and task list
  • Double-data entry to support Paper or Hybrid studies
  • Real-time edit checks for accuracy Manage

Manage -Data Managers have increased visibility throughout the study and instant access to their data and task list.

  • Control data integrity with range checks and queries
  • Configurable field level and form level monitoring
  • Query management, alerts, and dynamic schedules
  • Role-based access and user management

Analyze & Export –Capturing and managing data in real-time with a unified database gives you full control.

  • Ad-hoc reporting and analysis
  • On demand export to SAS, Tab-delimited, and others
  • Standard and custom reports; Patient casebooks
  • Submission-ready reports and data sets

Medrio is unique in that you’ll be able to have full control of your study from beginning to end without relying on Medrio.

For further information about Medrio products and services, please contact Medrio directly.  If you are looking for a study builder to support your clinical trials and study build using Medrio, please use the contact form.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinica.

Trademarks and Copyright
All trademarks on this web site are the property of the {EDC} Developer, unless otherwise noted or in any other way perceivable as third party rights. The logos and trademarks or other materials used on this article are property of Medrio.