Tag Archives: anayansi vanderberg

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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The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

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 Clinical.

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

Source:

SAS Institute
CDISC