Tag Archives: EDC Developer Consultant and clinical programmer

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.

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Successful Interview – Get The Job That You Want

Lifetime entrepreneurs, consultants and freelancers have a real problem of working for someone else or working a 9-5 office environment. Who could you work for right now and be happy? But if you find yourself invited to attend an in-person interview, I have listed some suggestions for a successful interview.

Steps for a successful interview:

  1. Build Rapport — very obvious, but it warrants mentioning. First impressions mean so much, so be friendly and open. Be sure to shake hands with each person you are interviewing with and introduce you. You might also ask for a card at this point.

  2. Establish needs — This is as much the opportunity to learn about us as for us to learn about you. Establishing what we are specifically looking for will help you target your answers regarding your own qualifications. Asking questions also shows your interest. Have 3 questions prepared before the interview. You will want to have different questions for each person, if known in advance. This shows you’ve done your homework and reinforces your interest in the company. Have them memorized, but if you get stuck or nervous, you can refer back to these questions.

    Take the time to review the website:CLIENT WEBSITE: check the company’s website prior to the interview.

  1. Flesh out concerns — At the end of the interview, ask if there are any questions or concerns about your qualifications. Be direct about asking, “Do you have any concerns about my qualifications?” This gives you the opportunity to answer these questions or concerns on the spot.

  2. Ask for the job — At the end of the interview, let them know the level of your interest. Let them know you want the job. This lets the interviewer(s) know exactly where you stand. It also makes you stand out in his/her (the interviewer) mind.

  3. Restate your interest — best in the form of an emailed “Thank You.” The “Thank You” e-mail should be a brief email to the interviewer(s) to highlight the strengths you’ll bring to the position and restate your interest. I will expect a call after your interview, so you can provide a summary of your interview experience.

Don’t be shy about your qualifications. Be direct and be prepared.

  • Bring paper and a pen, as well as two (2) copies of your resume, one in case an interviewer needs one and the other for you to be able to reference for dates, etc. Be prepared, you might be meeting with multiple people, bring extra copies of your resume in case they need copies as well.

  • Don’t discuss the “What’s in it for me questions?” – in terms of salary, benefits, vacation. It is NOT appropriate to discuss these questions even if the interviewer opens this discussion topic. If the interviewer persists, please consider the following response: “the financial arrangement has already been discussed and confirmed between my agency and myself. I assure you that I am very interested in this opportunity.” or “I would prefer to discuss the salary requirements when an offer is made”.

Remember that when you go for a job interview, you are not asking them to pay you money. You are offering a PROFIT!

anayansigamboa-you are hired

Remember, it cost the company double to hire you (hiring, training, firing, benefits, etc). You are making the company money and providing value.

GOOD LUCK! and tell me about it in the comments!

Anayansi Gamboa specializes in Pharmaceutical Technologies and is available for short-term contracts or ad-hoc requests.

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

I am someone who influence my own development. I look for a company where I have the opportunity to pursue my interests across functions and geographies, and where a job title is not considered the final definition of who I am, but the starting point.

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.

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