Category Archives: RAVE

Freelancer / Consultant / EDC Developer / Clinical Programmer

* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC)
* Creation of electronic case report forms (eCRFs)
* Validation of programs, edit checks
* Write validation test scripts
* Execute validation test scripts
* Write custom functions
* Implement study build best practices
* Knowledge of the process of clinical trials and the CDISC data structure

 

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Top 3 Posts at (EDC Developer)

Fist, I would like to thank everyone who has read articles posted at {EDC} Developer. Especially, my colegas and friends from India. The highest reading and hits have come from people living in India.

New to the industry? Want to get in as clinical data manager or clinical programmer? Looking for a particular topic or an answer to a question? check the contact me section.

Here are the top most searched articles this past few months:

1- Data Management: Queries in Clinical Trials

2- How to document the testing done on the edit checks?

3- Why use JReview for your Clinical Trials?

Others most read articles:

Role of Project Management and the Project Manager in Clinical Data Management

4 Programming Languages You Should Learn Right Now (eClinical Speaking)

Data Management Plan in Clinical Trials

For the search term used to find {EDC} Developer:

1-types of edit checks in clinical data management

2-Rave programming

3- pharmaceutical terminology list

4-seeking rave training (better source is mdsol.com)

5- edc programmer

6-central design tips and tricks

Thank you for reading!

How to document the testing done on the edit checks?

Since the introduction of the Electronic Data Capture (EDC) in clinical trials where data is entered directly into the electronic system, it is estimated that the errors (e.g. transcription error) have been reduced by 70% [ Clinical Data Interchange Standards Consortium – Electronic Source Data Interchange 2005].

The Data Management Plan (DMP) defines the validation test to be performed to ensure data entered into the clinical database is complete, correct, allowable, valid and consistent.

Within the DMP, we find the Data Validation Plan. Some companies call it ‘DVS’ others ‘DVP’.  The Good practices for computerized systems in regulated GxP environments defines validation as a system that assures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, qualification, maintenance, and retirement.

As an {EDC} Developer or Clinical Programmer, you will be asked to:

  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordinate of UAT of eCRF build with clinical ops team members and data management and validating documents, included but not limited to: edit check document, issue logs, UAT summary report and preparation and testing of test cases.

Remember not every EDC system is alike. Some systems allow you to perform testing on the edit checks programmed; others allow you to enter test data on a separate instance than production (PROD).

Data Validation and UAT Module.png

For example, some EDC systems facilitate re-usability:

  1. There is a built-in test section for each study – where data can be entered and are stored completely separate from production data. This allows you to keep the test data for as long as needed to serve as proof of testing.
  2. The copy function allows for a library of existing checks (together with their associated CRF pages) to be copied into a new study. If there are no changes to the standard checks or pages then reference can be made back to the original set of test data in a standards study, thus reducing the study level overhead.
  3. The fact that many of the required checks (missing data, range checks, partial dates etc.) do not require the programming of an edit check at all. Each of these and many others are already there as part of the question definition itself and therefore do not need any additional testing or documentation for each study.

If you have not documented, you have not done it-FDA

The “ideal world” scenario would be to reduce the actual edit check testing by the system generating a more “human readable” format of the edit checks. The testers that way would not have to test each boundary conditions of the edit checks once the system is validated. All they would have to do is inspect the “human readable” edit checks vs the alerts and would also be easy for the clients to read and sign off.

You can leverage the EDC systems audit trail under certain conditions. First of all – the system you are testing with must be validated in itself. Some EDC products are only ‘validated’ once a study is built on top of them – they are effectively further developed as part of a study implementation process – in this situation, I would doubt you could safely use the audit trail.

Secondly, you need to come up with a mechanism whereby you can assure that each edit check has been specifically tested – traceability.

Finally, you need to secure the test evidence. The test data inside the EDC tool must be retained for as long as the archive as part of the evidence of testing.

The worst methods in my view are paper / screenshot based. They take too long, and are largely non-reusable. My past experience has been creating test cases using MS Word then performing each step as per test case and take a screenshot, where indicated. Then attached to the final documentation and validation summary. This obviously a manual and tedious process. Some companies create test cases using HPQC or similar tool. This is a bit more automated and traceable yet, it is still prone for errors. It is better than documenting using MS Word or Excel but it is still a manual process.

Re-usability is what it is all about, but, you need to ensure you have methods for assuring the test evidence produced for edit checks you are reusing is usable as part of the re-use exercise.

Edit Check Design, Development and Testing is the largest part of any typical EDC implementation. Applying methods to maximize quality and minimize time spent is one of the areas I have spent considerable time on over the last couple of years.

For additional tips on writing effective edit checks please go here -Effective edit checks eCRFs.

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

Source images: provided courtesy of Google images.

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eClinical Training

eClinical Training

Training—Make the most of affordable, informative, educational events to polish your professional skills.

Electronic Data Capturing

Medidata Rave
Web-based Data Management System for the collection of clinical trials data.
Our consultants are available short- and long-term projects.
Credentials:
– Medidata Rave Certified
– 4+ years experience in study build
– Custom Functions / C# Developers
– Crystal Reports Developers / JReview Developers

InForm Architect / Central Designer / InForm EDC
Learn InForm at your own paced or via online

Data Management Training 101
For entry levels and those seeking to enter the clinical research industry.

BASE SAS Training 101
Interested in learning SAS for clinical programmers? Coming soon…Contact us for more details…

One-on-One Training
Interested in learning RAVE / InForm / Oracle Clinical? Contact us for more details…

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

What Is In A Name Besides Letters?

Disclaimer: This is based on a fictional story in this fictional world.

Deciding on a name for your company or product is among the first steps an entrepreneur takes. Entrepreneurs often angst over the perfect name for their EDC tool. That name is a break or make deal for many. Your users will either identify with it or completely turn the other way and use your competitor’s EDC system.

It seems straightforward. Who wouldn’t want to stand out?

A rose by any other name is still a rose…

Let’s look at some Mythological names for several {EDC} systems.

  1. Medidata Rave: “Rave” at first thought, it is not an unique name. The traditional meaning of ‘Rave’ was to show signs of madness or delirium (rave. (n.d.). The American Heritage® Dictionary of Idioms by Christine Ammer) but most recent and contemporary meaning is ‘wild party’. For many of us, during the college years, we associated the word ‘Rave’ with underground parties, fun, entertainment and much more. I have been to several White Sensation parties here in Europe. Rave is my favorite name by far.
  2. Cmed Timaeus: Timaeus resonates with ‘Amadeus’. You know, the famous ‘Mozart’, Austrian composer, widely recognized as one of the greatest composers in the history of Western music. If you were born near the 80’s music era then this music video will come to mind.
  3. RDC: In contracts, RDC is “running down” clause, provides coverage for legal liability of either the shipper or the common carrier for claims arising out of collisions. Oracle RDC stands for ‘Remote data capture’. It is easy to remember and catchy.
  4. InForm: Is it ‘information forward’? Information in the form? InForm has been around for several years now. It started becoming popular in the 90s. There has been several modifications and upgrades but the name has stayed the same. It is now part of a group of systems own by Oracle.
  5. OpenClinica: I believe this name refers to the ‘open’ source capability of this tool. Open-source software (OSS) is computer software with its source code made available with a license in which the copyright holder provides the rights to study, change and distribute the software to anyone and for any purpose. (St. Laurent, Andrew M. (2008). Understanding Open Source and Free Software Licensing. O’Reilly Media. p. 4. ). I believe some users may confuse this name with Oracle Clinical, another popular CDM system.
  6. ClinCase: In computer science, CASE tools can be used for simple operations such as routine coding from an appropriately detailed design in a specific programming language, or for more complex tasks such as incorporating an expert system to enforce design rules and eliminate software defects and redundancies before the coding phase. (“CASE”. Encyclopædia Britannica. Encyclopædia Britannica Online). I personally has not used this tool but was asked recently so I added it to the fictious name list.
  7. RedCap: This is a catchy name as well. It can infer many meanings. Cap for capital letters, the cap or ceiling placed on mortgage rates, to protect or to seal? the hat that you wear, a member of the military police. Some further research, wikipedia has the following description of ‘redcap’: Redcaps are said to murder travellers who stray into their homes and dye their hats with their victims’ blood (from which they get their name) (Briggs, Katherine M. (1967). The Fairies in English Tradition and Literature. London: University of Chicago Press. p. 57) Regardless of definition, it is still a creative name.

You want a name that your employees and customers will want to say

Should You File For a Trademark? Here is some information about trademarks.

Having a brandable business name is one of the reason for the growth of business. Every EDC system is different and choosing the right name is key on getting the attention your {EDC} tool deserves.

One final reminder. When searching the list of fictitious names (also called “doing business as,” or DBAs) for your county and looking for names in your “class” (or industry) on the U.S. Patent and Trademark Office website (www.uspto.gov), be sure to look up variations on spellings, too, because names that sound alike can’t be registered in the same class. Also check Register.com to see which Internet domain names remain available.

what happens when you find out that your {EDC} name is also the name of another business in a different city/state? Keep it simple, as short as possible (check domain availability) and don’t play too much with spelling alternatives.

What is your favorite {EDC} name? Can a name make or break your chances of business success?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

 

Credit: The title of this article was an inspiration from a recent readingKate Of Gaia With Michael McCracken – What Is In A Name Besides Letters.” What an eye opening that was.

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If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

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.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

 

 

Your Strongest Characteristics

The reason I am writing is that I am looking for a new challenge and I felt we might have some areas for discussion, or at least you might be able to point me in the right direction.

My services basically represent a low-cost alternative to the traditional consultancy companies, which usually demand high prices for their services. My services are always the right partner for you – no matter if you are looking for an interim solution due to personnel shortage in your company, if you demand creative and unconventional solutions or if your project requires up-to-date knowledge – direct cost savings.

My current work and skills:

I’m currently working on several initiatives but there is always room for new challenges. I hold a project management degree and several certifications in different fields.

 My style?

I’m a quick-learner, flexible to change, achievement oriented and proactive.

 What you will gain from working with me:

  • Clarity on what you want
  • Tools and approaches for getting it
  • Insight into your patterns that work and roadblocks that don’t
  • An ability to see options and take action, in other words, results.

 What you can expect from me:

Honesty, straightforward yet sensitive advice and confidentiality.

Are these the kinds of skills you look for in a project leader?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Complexity and effectiveness of edit checks

ABSTRACT
Much effort goes into the specification, development, testing and verification of programmatic edit checks to ensure that the error rate in clinical trial data is sufficiently low as to have no statistically significant effect on the overall trial results. An analysis of several thousand clinical trials, containing over 1.1 billion data values and 1.1 million edit checks, shows that the majority of edit checks (60%) have no impact on data quality; none of these 678,000 edit checks have generated a single data query or discrepancy. What can be learnt from this analysis; can we reduce the overall number of edit checks without compromising data quality; can we identify the ‘high-performing’ edit checks and improve CRF design to avoid data entry errors; are there novel methods that might achieve similar standards of data quality with less effort?

Edit checks are necessary to ensure data quality reaches acceptably high levels.

Since programming edit checks takes time and resources, it’s important to ensure that the effort invested maximizes the benefit and re-usability of each edit check.

See attached document for full article information published by:

Optimizing Data Validation by Andrew Newbigging, Medidata Solutions Worldwide, London, United Kingdom

 

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Fair Use Notice: This article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

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.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

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

 

Where in the World is Ana?

First, I want to say thank you for reading my blog, connecting with me on LinkedIn or following whenever I go [thank you NSA].

Many of you, for months, have asked me if I was going to write more articles related to clinical trials. For sometime now, I have taking time-off from this EDC blog and concentrated on some other projects of equal importance. I will share some new insights and information as I get myself back on track.

So what is a girl who has a master’s degree in project management and computer networks doing as a programmer? It’s not that I didn’t like project management, per se. And entering in the IT network business years ago was quite difficult for girls like me in a world dominated by men. It’s basically that I didn’t find myself with the same passion for project management or computer networks that I have for programming and technology in general.

Because I am so interested in technology and programming, I tend to spend a lot more time than my peers in learning new technologies, and enhancing my existing skills. Many of my co-workers and ex-collega (Dutch) have commented on their admiration that my skill level is as high as it is, and that I am able to learn new technologies so quickly. But beyond just learning new technologies and APIs, I’m passionate about becoming a better overall programmer. Reason why in the last few months, I spent time learning IOs development (iPhone and Android apps). I am actually working on an app to ‘hack’ into my own car. 🙂 Well, not exactly. I want to be able to open my car and do some other basic command (like opening the garage door) using an APP.

Given my degree in project management, it should be clear that I have useful skills beyond the programming world. In fact, having a project management background has helped me interface with various groups in various organizations in which I’ve worked.

I have installed, maintained, and designed numerous relational databases and small networks. As a freelancer, I have worked in projects doing data analysis, project support and computer training.

Now you know a little about me personally. If you think I might be the type of developer you’re looking for, feel free to browse my resume and contact me.

Anayansi Gamboa
Resume / CV .

Comments? Join us at {EDC Developer}

P.S. I will be releasing some training videos / training material for several EDC tools in the near future including tips and best practices. Price has not been setup yet. All training will be web-based, password protected. If you wish to consult with me for a face-to-face training or on-site training, please contact me to discuss further.

Fair Use Notice: This video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

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.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

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

Professional Timeline – Clinical Programmer

Professional Timeline

Curriculum Vitae
CV

 

anayansi gamboa