Tag Archives: tutorial programming edc

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.

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

 

 
The Scenario:

The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

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.

PM Hats – Six Thinking Hats in Project Management

Six Thinking Hats

Looking at a Decision From All Points of View

‘Six Thinking Hats’ is an important and powerful technique. It is used to look at decisions from a number of important perspectives. This forces you to move outside your habitual thinking style, and helps you to get a more rounded view of a situation.

This tool was created by Edward de Bono’s book ‘6 Thinking Hats‘.

Many successful people think from a very rational, positive viewpoint. This is part of the reason that they are successful. Often, though, they may fail to look at a problem from an emotional, intuitive, creative or negative viewpoint. This can mean that they underestimate resistance to plans, fail to make creative leaps and do not make essential contingency plans.

Similarly, pessimists may be excessively defensive, and more emotional people may fail to look at decisions calmly and rationally.

If you look at a problem with the ‘Six Thinking Hats’ technique, then you will solve it using all approaches. Your decisions and plans will mix ambition, skill in execution, public sensitivity, creativity and good contingency planning.

How to Use the Tool

You can use Six Thinking Hats in meetings or on your own. In meetings it has the benefit of blocking the confrontations that happen when people with different thinking styles discuss the same problem.

Each ‘Thinking Hat’ is a different style of thinking. These are explained below:

  • White Hat: neutral and objective, concerned with facts and figures
    With this thinking hat you focus on the data available. Look at the information you have, and see what you can learn from it. Look for gaps in your knowledge, and either try to fill them or take account of them.This is where you analyze past trends, and try to extrapolate from historical data.
  • Red Hat: the emotional view
    ‘Wearing’ the red hat, you look at problems using intuition, gut reaction, and emotion. Also try to think how other people will react emotionally. Try to understand the responses of people who do not fully know your reasoning.
  • Black Hat: careful and cautious, the “devil’s advocate” hat * 
    Using black hat thinking, look at all the bad points of the decision. Look at it cautiously and defensively. Try to see why it might not work. This is important because it highlights the weak points in a plan. It allows you to eliminate them, alter them, or prepare contingency plans to counter them.Black Hat thinking helps to make your plans ‘tougher’ and more resilient. It can also help you to spot fatal flaws and risks before you embark on a course of action. Black Hat thinking is one of the real benefits of this technique, as many successful people get so used to thinking positively that often they cannot see problems in advance. This leaves them under-prepared for difficulties.
  • Yellow Hat: sunny and positive 
    The yellow hat helps you to think positively. It is the optimistic viewpoint that helps you to see all the benefits of the decision and the value in it. Yellow Hat thinking helps you to keep going when everything looks gloomy and difficult.
  • Green Hat: associated with fertile growth, creativity, and new ideas
    The Green Hat stands for creativity. This is where you can develop creative solutions to a problem. It is a freewheeling way of thinking, in which there is little criticism of ideas. A whole range of creativity tools can help you here.
  • Blue Hat: cool, the color of the sky, above everything else-the organizing hat 
    The Blue Hat stands for process control. This is the hat worn by people chairing meetings. When running into difficulties because ideas are running dry, they may direct activity into Green Hat thinking. When contingency plans are needed, they will ask for Black Hat thinking, etc.

Exercise:

Here’s an exercise (inspired by Bono ideas) which will work very well with those who have been required to read Six Thinking Hats prior to getting together to brainstorm. Buy several of those delightful Dr. Seuss hats (at least one of each of the six different colors, more if needed) and keep the hats out of sight until everyone is seated. Review the agenda. Review what de Bono says about what each color represents. Then distribute the Dr. Seuss hats, making certain that someone is wearing a hat of each color. Proceed with the discussion, chaired by a person wearing a Blue or White hat. It is imperative that whoever wears a Black hat, for example, be consistently negative and argumentative whereas whoever wears a Yellow must be consistently positive and supportive. After about 15-20 minutes, have each person change to a different colored hat. Resume discussion.

Six Thinking Hats” is about improving communication and decision-making in groups.

Summary: Bono puts thinking into steps: 1. Information 2. Benefits 3.Critical thinking 4. Feelings 5. Creative thinking 6. Thinking about the thinking and creating and action plan for implementation.

How would you incorporate the ‘Six Thinking Hats’ in clinical data management?

Reference:

Six Thinking Hats by Edward de Bono, 1999

http://www.mindtools.com

Fair Use Notice: This blog/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}.

7 questions to ask yourself before you choose to set up your own Clinical Data Management department

The arguments to set-up your own Clinical Data Management department are various. You want to learn something new. You can do Clinical Data Management yourself because you could allocate resources for it. Conducting Clinical Data Management in-house could get you more in control of your clinical study data. Clinical Data Management done in-house could cost you less. You could perform Clinical Data Management better yourself. You want to spend your Clinical Data Management budget internally. You see a chance to make (more) money. You see a chance to (better) serve your Customers. You want to complete the gap in your clinical service(s).

Before you make the final decision you could ask yourself 7 questions:
1. For what type of studies should I want to conduct clinical data management myself? For all the studies I conduct? For the first clinical trials in the market application process? For phase III/IV clinical trials? Or for clinical studies conducted post registry?

2. Does a Clinical Data Management group fit in, and does it add value to my company’s core business? Is dedication to the Clinical Data Management performance part of my daily business targets?

3. Do I have enough studies, enough workload for Clinical Data Management to return investments? Is the cost-benefit ratio in my advantage?

4. Can I allocate enough resources, e.g. time, capacity, knowledge and money to the Clinical Data Management department to get clinical data quality from it?

5. Is this the right moment? Right now, should I invest in setting up a new department in my company? Is my company ready for the next step; an own Clinical Data Management group?

6. What are the benefits for my organization when we can conduct Clinical Data Management ourselves? What will it bring us?

7. What are the requirements for this Clinical Data Management department regarding the type of studies and the amount of studies. What are our user requirements for a Clinical Data Management system(s)? What is the capacity we need to handle that Clinical Data Management system and what information do we need?

The number one question in my experience; is a Clinical Data Management department a logical fit within your companies core dedication? Logical like ‘clinical research to get your products accepted for marketing’ or ‘providing clinical research services’. Dedicated Clinical Data Management can start returning investments.

Source:

This is an ezine of Maritza Witteveen of ProCDM. For Clinical Research Directors who struggle with clinical data management to get reliable, quality clinical study data successfully. Receive tips and the free e-book ‘Five strategies to get reliable, quality clinical data’ by subscribing via http://www.procdm.nl/pages/knowledgebase.asp.

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”.

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”.

 

Simple Ways for Project Managers to Spend Less Time on Email

inbox

One of the ironies of digitized communication is that it’s far more permanent than paper. Dash off a hasty memo and you can shred the evidence. But once you’ve sent an email, it’s out there. Five minutes before you realize your mistake it’s already been forwarded to everyone and their brother, and probably blogged. And nine times out of ten, they never read past the first 4 sentences.

So just about everyone has an email address these days, whether it’s for work, personal use or both. As a result, each morning millions of us turn on our computers or check our smartphones, only to find our in-boxes packed with emails. Most of us live very busy lives and ain’t nobody got time to manually filter their inbox each and every morning, ain’t nobody!

Following some of the following advices, this will allow you to concentrate more on the things you really need to do during your busy day as project manager:

1. Read and respond

If you’re reading an email and you can reply back in 3 minutes or less, do it. It’s a total waste of time to go back to it later in the day when you can deal with it now. Answer it and move on.

2. Set a time to check emails

Most people constantly check their in-boxes several times a day – that time really adds up, distracting you from other more meaningful tasks. Find a schedule that works for you and keep to it.

In some cases, sending an email at 8 pm is just as effective as sending it first thing in the morning as most people won’t check their in-boxes till they are back at work the following day.

3. Make email work for you

With everything we have to do in our lives, the task of filtering your email account everyday, deleting spam and spending time unsubscribing is a real pain. Using message filters, with one click you can move senders into the spam / delete folder, and their emails will never been seen again in your inbox.

4. The Email Jumble up

The Email Jumble occurs when you receive an email in your inbox that you don’t need to read or reply immediately, but needs to be addressed sometime in the near future. These are the emails that you remind yourself mentally you will get around to, but they either end up getting lost in the abyss that is your inbox, you end up forgetting about them, or you spend too much mental time thinking about them each time you see them sitting in your inbox.

emailfilter

5. Reshuffle your attachments

Having attachments in various emails that are swimming in a pool of thousands of other emails is like looking for a needle in a haystack. Your IT department might have a limit per email message and attachment. The use of automated archive feature will help you reduce size of your inbox too.

For example, AttachmentExtractor add-on for Thunderbird, let you save all attachment from several emails at once. You can select all the e-mails from which you wish to download the attachments, right-click, and then click “Extract From Selected Messages To” > “(0) Browse“, and then pick the directory you want to save the attachments to.

saveas
1 email save as / detach
extract
How to save attachments from several eMails

6. Get rid of the distractions

Whether email notifications or social media notifications it doesn’t take too much to distract us. Electronic communication can be difficult on the best of days.

The average information worker–basically anyone at a desk–loses 2.1 hours of productivity every day to interruptions and distractions, according to Basex, an IT research and consulting firm. Turn off the notifications on your inbox and your mobile device, and combine this with tip #2 to waste even less time on emails.

mobiledistractions

As the old saying goes, time is money, and the more time you spend managing your emails, the less time you have to be productive. Your typical office workers spends 2.6 hours per day messing about in their inbox. Multiply that by the number of employees your business has or the amount of days you work and you realize there’s a big gaping hole that really needs to be patched up.

Follow all 6 tips today and watch the hours you, as a Project Manager, used to spend on emails disappear.

Conclusion

The need for communication does not automatically translate to the need for formality. For some projects, deliverables might be easily satisfied by email rather than formal released documents.

Project leaders and the team are empowered to tailor the guidelines to each project, using appropriate formality or informality of deliverables for the project’s activities, simply keeping in mind other company communication and documentation needs.

As we described above, one of the communication channels -email- used by a project manager, we also need to find a balance between real projects and the need to answer each email that comes through out mailbox.

Inexperienced project managers tend to focus too much on urgent day-to-day tasks while more pressing responsibilities languish. Even experienced project leaders can descend into survival mode now and then. It’s something akin to driving 100 kilometers per hour while staring at the windshield wipers. In the worst situations, I’ve discovered so-called leaders spending the bulk of their time sending and reviewing email while their bewildered team gropes their way toward a fuzzy finish line or sinks into the icy couch of despair.

Amateur project manager? Want a safer password?

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}.

Data verification puzzles

 

Important part of the data management job is to verify received data. Checking for inconsistencies and unexpected patterns. Verifying that the data is complete, legible, logical and plausible.

However, how to perform data verification?

You could regard the data verification job as completing a couple of puzzles. Each puzzle is one subject participating in the clinical trial or clinical study at stake. As such, the puzzles resemble each other a great deal. But they are not exact copies. Each subject, each puzzle, is (slightly) different, unique.

Pleasant and thoughtful team action:

Do you have a puzzle somewhere in a cupboard? More than one from the same series? At least 2 puzzles with > 100 pieces each? Open the boxes, drop their content in one pile on the table and start completing the puzzles/subjects. The more pieces in place of a puzzle, the more evident which pieces to expect.

1. Get the parts received, divide them per subject/puzzle and start making all the puzzles. The clinical information up on each subject is coming in pieces, per completed visit data, per available adverse event information. In the beginning you’ll thus work with lots of incomplete puzzles.

2. Any holes in any puzzle/subject, any missing parts, you need to look for/query. Note that holes are allowed if your puzzle/story is as such! However, leave no unexpected holes. Meaning that if an assessment took place, you want to have the corresponding result(s) completed.

3. Any duplicate pieces, get rid of them. Please query.

4. Any pieces not fitting your puzzle/subject story, you need to check up on. Maybe they belong to another puzzle/subject. Or they are incomplete and can therefore not fit (yet). They could even be wrong delivered and not belong to the study at all.

5. Any pieces fitting but rotated 90 or 180 degrees, please turn/query. Get the puzzle showing a logical story.

6. Any pieces damaged, please try to fix the damaged parts. E.g. spilled coffee over a paper CRF. Illegible text parts. Or unclear texts that can be interpreted differently.

7. Any pieces added at the wrong place, query and bring to their right position. E.g. an error in an assessment date.

In trial/study language, the more data for a subject received and in the database, the easier to get the subject’s story complete. However, the more care needed to get the true story. The logical, plausible subject story. Attention to medication given for an adverse event but missing in the concomitant medication list. Or laboratory shifts to worse results but missing corresponding adverse events listed.

Completing the holes in a puzzle is easy, for data management the edit checks help you tremendously with that. Getting a logical, plausible story for each patient, reflecting the truth, is the real data management challenge. Which takes more than just structuring pieces. It asks you to look and understand the pictures up on the pieces received.

Good luck with your data management puzzles,

Source:

“This is an article of ProCDM. Clinical data management training. Receive tips and the free e-book ‘Five strategies to get reliable, quality clinical data’ by subscribing via http://www.procdm.nl/pages/knowledgebase.asp.”

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

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.

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”.

How to write query texts – 6 template sentences

How to write queries unambiguously expressing what is asked for? Using short, polite sentences? Objectively explaining the underlying inconsistency?

First of all my general guidelines.

My preference is to use no more capitals then needed. Capitals in the middle of a query text, e.g. for CRF fields or for tick box options, could distract from getting the actual question asked. E.g. compare the same query texts, with and without extra capitals. Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify Stop date. (Ensure that Stop date is after or at Start date AND that Stop date is not a future date.)

Referring to CRF fields as they are shown on the CRF. To easily find the involved field(s).

I prefer to leave any ‘the’ before a CRF field referral out of the query text. For more to-the-point query texts. E.g. compare the same query texts, with and without ‘the’ before data fields. Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify the stop date. (Ensure that the stop date is after or at the start date and that the stop date is not a future date.)

Consistency in phrasing a query text can help to quickly write query texts or pre-program query texts in a structured, familiar way. That’s the thought behind the following 6 template sentences for query texts. Which you can use to help you write or program your queries.

The six ‘template’ sentences for query texts:

Please provide…

For asking the study site people to provide required data from patient care recordings. Examples: Please provide date of visit. Please provide date of blood specimen collection. Please provide platelet count. Please provide % plasma cells bone marrow aspirate. Please provide calcium result.

Please complete… For asking the study site people to complete required data as required by the study CRF design. (Not necessarily required for patient care). Examples: Please complete centre number. Please complete subject number. Other frequency is specified, please complete frequency drop-down list accordingly.

Please verify…

For asking the study site people to check date and time fields fulfilling expected timelines. Or for asking the study site people to check field formats. Examples: Please verify start date. (Ensure that start date is before date of visit.) Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify date of blood specimen collection. (Ensure that date of blood specimen collection is before or equal to date of visit and after date of previous visit.) Please verify date last pregnancy test performed. Please verify date of informed consent. (Ensure date of informed consent is equal to date of screening or prior to date of screening.) Please verify date as DDMMYYY.

…., please correct.

For asking the study site people to correct a data recording inconsistent with another data recording. Example: Visit number should be greater than 2, please correct.

…., please tick…

For asking the study site people to complete required tick boxes. Examples: Gender, please tick male or female. Pregnancy test result, please tick negative or positive. Any new adverse events or changes in adverse events since the previous visit, please tick yes or no. Laboratory assessment performed since the previous visit, please tick yes or no. LDH, please tick normal, abnormal or not done.

Please specify…

For asking the study site people to specify the previous data recording. Examples: Please specify other dose. Please specify other frequency. Please specify other method used. Please specify other indication for treatment.

Finally, for query texts popping up during CRF data recording, it could be helpful to put location information in it. Like: Page 12: Please verify start date. (Ensure that start date is after or at start date on page 11.)

Good luck finding your way to structure query texts…

Source:

This article is written by Maritza Witteveen of ProCDM. For clinical data management. You can subscribe to her blog posts at www.procdm.nl.”

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}.

OpenClinica: Printing subject casebooks, blank casebooks and blank CRFs

Wanna print subject casebooks using OpenClinica? This article is an extract from a video demo from the OpenClinica blog website. Click the link below now.

Source: http://blog.openclinica.com/2014/10/06/video-demos-printing-subject-casebooks-blank-casebooks-and-blank-crfs/

Happy Printing!!!

 

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.

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}.