Tag Archives: EDC developer

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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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.

Castor EDC Demo

Castor EDC Training and Support

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 CDISC SDTM clinical data click here.

InForm EDC Features and Functionality

InForm 4.x Training
Learn the differences between 4.5 and 4.6 and new features

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 CDISC SDTM clinical data click here.

You need a certified translation now what?

Translations and interpretation services in Panama City, Panama

#1  Translation

What is a certified translation?

​In Panama, a certified translation is one performed by a professional translator, also known as “Traductor Publico Autorizado”, who attests in writing to the completeness and accuracy of the translation. You cannot do the translation yourself, even if you are otherwise qualified. Other countries (or consulates) may have their own rules, so check with them first.

#2 Do you need to see an original or certified copy?

No. We work with any legible copy of your document. Typically, the fastest way to get started is to e-mail the documents. You can use a scanner or even a digital camera to take a high-quality photo of your certificate or other document…

#3 How will I receive my certified translation?

However you like! A member of our team can send you an electronic copy (PDF) as soon as it’s ready. For notarized documents, you will want the hard copy as well. We can mail or deliver in person the translation anywhere in Panama or around the world if you are not local (we charge only for destinations outside Panama. or for overnight delivery).

#4  How long does it take?

Send us your document for a free quote and time estimate.

Generally a 1- or 2-page document takes just a couple of days, but it does depend on the language and how busy we are.

Please note that obtaining the notary’s signature will delay delivery of your translation by at least two-three business day.

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.

CDISC/CDASH Standards at your Fingertips

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials.

There are some defiance in implementing CDISC in EDC CDMS:

1. Key personnel in companies must be committed to implementing the CDISC/CDASH standards.

2. There is an initial cost for deployment of new technology: SDTM Data Translation Software, Data Storage and Hosting, Data Distribution and Reporting Software.

3. It can be difficult to understand and interpret complex SDTM Metadata concepts and the different implementation guides.

4. Deciding at what point in a study to apply the standards can be challenging: in the study design process, during data collection within the CDMS [CDASH via EDC tools], in SAS prior to report generation [ADaM], or after study completion prior to submission [SDTM].

5. Data management staff [CDM, clinical programmers], biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.

6. Implementing new standards involves reorganizing the operations of (an organization) so as to improve efficiency [processes and SOPs].

7. Members of Data Management team must be retrained on the use of new software and CDISC/CDASH standards.

standards8. There are technical obstacles related to implementation in several EDC systems, including 8 character limitations [SAS] on numerous variables, determining when to use supplemental qualifiers versus creating new domains, and creating vertical data structure.

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 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}.

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21 CFR and Passwords: Mistakes You Don’t Want to Make

The free Internet that many of us loved has become a surveillance web, serving governments and mega-corps, while abusing the rest of us. It is important that you start protecting your data, while browsing the internet and using communication tools while performing your role. This article will guide you through a new set of skills using secure technology and developing careful practices.

As we know, the FDA regulates computerized systems used in clinical trials under the authority of Title 21 the Code of Federal Regulations Part 11 (21 CFR Part 11). These regulations apply only to use of systems in trials the results of which will be submitted to the FDA as part of the drug development/approval process.

As we are currently in the wake of yet another password breach, this time encompassing over 5 million Gmail passwords, it seems like no matter what you do, your password can and will be stolen. What should you do if your organization is a victim? Furthermore, how can your staff pick a safer password?

CRF 21 requires rigid and rigorous password de-activation and temporary generation protocols and data encryption and transaction safeguards to prevent sniffing (SSL, JavaScript) during a software development process of computerized systems used in clinical trials.

Here are some recommendations on how to manage your passwords:

  • Use a two-factor authentication or two-steps login: I know that it can be a pain, but it will help keep your online accounts safer. If for any reason your password is hacked, someone won’t be able to login to your account without the 2nd authentication.
  • Don’t be lazy. We have heard it all before. Using common passwords like

password
admin
12345678
iloveyou

    • Do not choose a password that is related to anything that has special meaning to you, ie: your pets name, birthday, address, family members names, etc. We know, we know, it’s easy to remember though.
    • Use a string of random words.
Source: Free Stock Photos
Source: Free Stock Photos

Which of the following two passwords is stronger, more secure, and more difficult to crack?

D0g…………………

PrXyc.N(n4k77#L!eVdAfp9

ENTROPY: If you are mathematically inclined, or if you have some security knowledge and training, you may be familiar with the idea of the “entropy” or the randomness and unpredictability of data. If so, you’ll have noticed that the first, stronger password has much less entropy than the second (weaker) password. Virtually everyone has always believed or been told that passwords derived their strength from having “high entropy”. But as we see now, when the only available attack is guessing, that long-standing common wisdom  . . . is  . . . not  . . . correct! (Retrieved from: https://www.grc.com/haystack.htm)

Consider alphanumeric password of n characters. A-Z, a-z, numbers: Total 56 possible options for each slot. Therefore, a truly random password would have 56^n possible options. (Ten-character: 303,305,489,096,114,176; or, 2^58 and then some.) Of course, generating such of a password is more difficult. One way is to condense an easy-to-remember phrase, though this does limit the search space, too, if your method is know.

For disk encryption (and password safe), we recommend selecting a minimum of six words

A company I used to work for had a nice password generator for their massive database administration, which even low-level employees need to access regularly. It generates 3 words, bridges them together with special case characters and adds a spelling mistake (repeated or missing character) to one of the words.

Should your IT department provide a password generator (manager) to all clinical staff? Additionally security encryption should be taken in consideration. To make this password creator page more safe though, you should set up this page so that it didn’t cache in browser so that the initially generated password is visible there. Optionally, using SSL connection to encrypt page and hence password so that traffic isn’t intercepted.

Ask your systems administrators to look for software offering an implementation of the open standard “Time-Based One-Time Passwords” or RFC 6238.

Remember to keep a backup of your password safe

What tricks do you use when choosing and creating passwords AND keeping them safe? As far as password management goes, I’ve personally found KeePass to be an excellent solution. I use a combination of password management tools (my personal computer has a fingerprint recognition system with keepass embedded in it).

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.

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}.

Professional Timeline – Clinical Programmer

Professional Timeline

Curriculum Vitae
CV

 

anayansi gamboa

Before Your Trial Goes Live – InForm FastStart

When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff.

CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linked electronically.

e-CRFs may include special display elements, electronic edit checks and other special properties or functions used for both capture and display of the linked data.

Prior to submitting a request – FastStart, you should throughly test your trial.

Technically speaking, FastStart requests ensures base is cooked when sending all UAT versions of the trial, Training and Production versions of the trial to Oracle implementation team. This will vary on the type of contract your company / sponsor has with them.

Your company or sponsor may have a setup of ‘Implementation’ instructions that will be provided to Oracle HSG (formerly PhaseForward) that includes all files, summary and instructions for each implementation. Some of these required files or special files are listed below.

Special Files:

Filename Contents
Customresources.XML Collects references to any html files that will be use to override standard InForm functionality within the trial. Includes the visit calculator (VISITCALCULATOR.HTML) and confirmation of enrollment message (ENROLLMENTCONFIRM.HTML).
InsertUsers.XML User details
InsertSites.XML Site details
InsertSiteGroups.XML Links users with specific sites
InsertGroups.XML Defines the properties and contents of groups e.g. queries, items
InsertRightsGroups.XML Groups multiple access rights, with details of specific users that are assigned those rights.Also contains details of any overrides to default levels of access at item level
InsertSignCRF.XML Defines form to be signed and group who have access to sign
Crbaffadavit.TXT Affadavit text which appears when signing the eCRF (used at eCRF level). The text is standard, but protocol number must be amended for each trial. NOTE: This file will be used for any trials using casebook level signatures.
logo.jpg Your company logo
EnrollmentOverride.htmlHomedefault.html Here you can modify your trial name

The eSignature is a replacement for the Investigator’s physical signature (paper form). This file captures confirmtion from the Investigator that he has reviewed and confirmed the information on each eCRF is accurate. This Affidavit text contains something like ‘I, Principal Investigator, for study 9999999, confirm I have reviewed this CRF form….’

Investigator– 21 CFR 50.3(d) defines the investigator as “The individual who actually conducts a clinical investigation – i.e., under whose immediate direction the test article is administered.”

Some recomendations about eSignature can be further research on Secure Access For Everyone (SAFE) standards. The goal is that once the investigator is credentialed by SAFE, his/her identity and electronic signature can be used by all SAFE compliant sponsors.

InsertUsers File

Training must be provided to sponsors users prior to granting access to an InForm trial. For example, CRAs will need to be well trained on all aspects of the EDC system in order to provide coaching for the investigator. This file documents all sponsors and site staff users within each clinical trial.

Easy, wasn’t it? Again, build your trial and test to make sure all files were cooked and working as expected. Log into your trial and ensure that the special files appear correctly. Enroll a subject to ensure the enrollment confirmation screen appears and, if used in the trial, the visit calculator appears.

Reference:

Electronic Clinical Data Capture, Position Paper Revision 1, May 1, 2005

How to manage Sites and Users in InForm Trial

Your comments and questions are valued and encouraged.
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.