Category Archives: Tips and Tricks

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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Contract for Consultants/Freelancers: Part I

As a consultant/freelancer, you have to deal with contracts. In the last few years, I have come to the realization that there is no such things as LAW. CONTRACT Law is the only law. So forget about what you think you know (e.g. bill of rights, constitutions, or State or local laws). It doesn’t exists. Those are codes or regulations. Statutes and not real law. It only applies to legal persons. Are you a legal person (corporation)? Read on…

Remember, anything that requires your signature, or a swearing thereto in order to give it application, is not law, but a contract.– Ron Branson (J.A.I.L. – Judicial Accountability Initiative Law)

If there is no contract there is no case. Contract is the law.

All CONTRACTS in order to be valid, must be signed by someone able to bind the corporation in contract. So next time you receive a piece of paper in the mail, know that they (i.e. corporations) are trying to contract with you.

If you simply tell them you don’t want to contract with them where is the controversy? What is there to judge? The only reason any matter ever goes to court is because the officers of the court know that at some point you will unwittingly grant them JURISDICTION over you. Until you do this, they cannot hold you –no matter what you think you might have done.

This brings me to my first (1st) point when you get a contract from a recruiter, agency or corporation: make sure the JURISDICTION is your JURISDICTION. This is sometimes difficult as you are at the mercy of the corporation offering you the job or contract. Hence, 9 out of 10 times, you will have two choices: decline the offer or negotiate the contract. If they know you are the only best candidate for the contract/assignment, then most likely they will negotiate with you and accommodate your requirements. Otherwise, walk-away. You will avoid headaches and contract disputes in the future.

Remember that no recruiter can bind their corporation in contract. They probably have a legal department or lawyer working on their behalf. So make sure you know how to read those contracts. By the way, the language used in most contract is called ‘legalese’. It is not English or Spanish or Hindu. It is legalese.

Anayansi Gamboa - Signatures on Contract
Detail view of the signature box of a contract with a pen.
 All Law is Contract; Every Interchange Between People is Contract; All Commerce is Contract; Contract Makes the Law

Now I will leave you with an excerpt from the book: HOW I CLOBBERED EVERY BUREAUCRATIC CASH-CONFISCATORY AGENCY KNOWN TO MAN – Mary Elizabeth: Croft

At common law, these eight elements are essential to the creation of a contract: offer, acceptance, intention, sufficient and equal consideration, mental and lawful capacity to contract, legality of purpose, genuine consent (knowingly, willingly, and voluntarily), certainty of terms and conditions.

You are usually tricked into contracting. I heard of a woman who was charged with writing ‘bad cheques’ and prior to sentencing was asked by the judge if she had anything to say. This is called, ‘allocution’ and is the time for the ‘defendant’ to say what’s so. Unfortunately, most defendants fail to take advantage of this opportunity to set the record straight. She, however, told the judge, “With all due respect, I do not accept your sentence.” The judge then said, “I sentence you to 25 years.” Again she said, “I do not accept your sentence.” He called both attorneys, who were now visibly irate, to come forward. The judge then asked, “Well, Ms. … , would you think it kind of the court to sentence you to only 10 years?” Again she said she would not accept his sentence. The judge’s final words, to the dismay of the attorneys, were, “I hereby dismiss this case and all charges are dropped.” He couldn’t do anything without her agreement. This is the power of contracts.

By the way, it is impossible to write a ‘bad cheque’; there is no such thing. If it has a date, a payee, a $$$ amount, and an autograph it is a lawful commercial instrument because the funds are created by those four requirements. If it is kept by the corporate entity to which one has specified ‘credit/pay to the order of’, then it is clearly being used as such. Don’t let anyone tell you that you wrote a ‘bad cheque’. Sure, there might not have been debt funds in the account to cover it yet that doesn’t mean that the private side hasn’t been accessed. In fact, you can be certain that it has been if it weren’t returned to you and if it has been returned then keep in mind that a debt/ legal tender (payment) offered in honour (in good faith) and refused, is a debt discharged. There is no commercial crime here except on the part of the entity trying to charge you with ‘writing a bad cheque.’

Remember: A Promissory Note is a Promissory Note is a Promissory Note…….more later when I recount my latest adventures with RBC (Royal Bank of Canada) and CRA (which continues to change its name – so just remember it as the Canadian version of IRS).

An offer of contract becomes binding after 72 hours (3 days); after seven (7) days there is a default and after ten (10) days there is a summary judgement. So handle your offers immediately.

The basis of 99% of all legal actions is derived from a ‘person’ (strawman) being sued, or accused of having entered into and breached a commercial contract, or being presumed to have entered into and breached a commercial contract. If the contract does not meet the four legal requirements, it is void. In order to live free we must remain eternally vigilant of these invisible contracts and avoid the presumption of their existence.

The most significant presumptions are:
1. that you are a resident;
2. that you depend upon the government for benefits;
3. that you are not responsible for your behavior; and
4. that you need protection – an attorney, a financial advisor, a doctor, a fiat currency, etc.
(Protect me from the protectors.)

All the above are false presumptions the existence of which is perpetuated upon the belief that all land and people are collateral for a debt which supports a fraudulent monetary system. All are based upon the presumption that certificates of ‘birth’/ ‘title’, etc., in commercial law, waive our right to take responsibility for our own affairs and own our bodies, plus life, liberty, and the property we accumulate through trading our labour with others or creating from raw materials, if we don’t object to or arrange our affairs otherwise.

The PTB, FED (Federal Reserves private bank), IMF (International monetary funds), ECB (European Central Banks) have established a long history (hundreds of years) of lending what is considered ‘money’ or ‘credit’ and then calling in debts, and creating wars around the world over these debts.

On Part II, I will cover what ‘legalese’ language you should look for (‘red flags’) and how to make it work for you. And one more thing, avoid recruiters from the UK or London areas. Most of them are not even registered in the country they represent (e.g. Germany or Belgium). Avoid umbrellas companies too. For European contracts, registered yourself as business and handle your affairs directly, if possible. For USA/North American contracts, you do not need to be registered as corporation (not yet though, things are changing rapidly in this part of the world). Just make sure you look for the legalese keywords. More on this on my next article.

No Disclaimer: There is no disclaimer in this article because the reader will learn that we are all responsible for our perception and interpretation of anything and everything we experience. I have no intention of disclaiming anything I write. – Anayansi Gamboa, DBA GAMBOA

Images: Copyright images from Google images

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}.

Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks  (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:

project plan sample
image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also  due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in:  ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project. riskplan

5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to  meet new standard requirements. Some changes will occur during this step: For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDIDefine-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented  to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation. The last step in the project plan for CDISC implementation is to generate the documentation in either PDF  or XML format.

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.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

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

Society of the Sojourner – Part II

Well it’s been quite a journey since my last post – sojourner. To sum it up I would say that I have come to the realisation that the world we live in, with its social structures that we have come accustomed to, are quite different than what they appear.

Anayansi decided to change her name to “Sojourner” literally because of her belief.  She openly believed that God told her to change her name, and it is so interesting how her name (Anayansi) has a profound meaning [She was an indigenous woman, a woman in love, who opened her heart to the blond conquistador with his steel armour, newly arrived to win glory in the Isthmus of Panama-KEY TO HAPPINESS]. She changed her name to “Sojourner” because she planned to travel.

anayansigamboa sojourner Panama
Images courtesy of Google -Panama Kuna Island, San Blas

As for my story, what I feared in 2007/2008 when I began to awake to the political and social turmoil going on in the United States of America is now coming true, I decided to return to my home country.  I had a fear then for the lack of respect for the sovereignty of individual human beings. Government has a monopoly on human beings. Without a birth certificate or passport or ID, you are nobody even though we are alive, living flesh and blood man; we are who we say we are and no government ID can change that. We have been brainwashed in believing, we are some name written on a passport ID.

I would like to go into the issues I have with the whole government system but lets just not waste time. Let’s just say, once you are awake, your eyes can never closed again. It is like a light bulb is on 24-7.

So while I was preparing to travel back to Panama [“Panama” is of indian origin, from a word meaning “the abundance of fish” or “the abundance of butterflies”], a friend of mine from the States told me to visit this psychic lady from down town (she was the one interested in having a palm reading). I don’t believe it much so I went along. After her reading, the lady asked me if I wanted a palm reading. I said, “why not.” Nothing to lose as I am already here.

All I can remember her saying ”…soon you will meet someone and move…I see a lot of water surrounding this place…lots of water…” I said to myself. “That must be Panama.” We have the canal, rivers, lakes and two oceans…When her last words were “I see a trip to Europe”. That was 2008 and now fast forward to 2014.

anayansigamboa sojourner Panama
Images courtesy of Google – Panama Canal, Amador, Balboa, Punta Pacifica

My decision was, that I must leave this city; it was not place for me; yea, I felt on called it spirit to leave it and to travel east.

It’s been 5 years since I got out of Dodge for the…onto Society of the Sojourner III -to be continued. Until then…

anayansigamboa sojourner Panama
Images courtesy of Google – Panama City, Balboa, Pacific Ocean

 Saludos y hasta luego!

Notes: sojourner means a temporary resident. Who knows that one of the most beautiful stories of the Spanish Conquest belongs to Panama? The story in question is related with Vasco Núñez de Balboa, who was a Spanish explorer and conquistador. He was the first European to see and stand in the waters of the Pacific Ocean, on September 1513. He claimed the Pacific Ocean and all its shores for Spain, which opened the way for Spanish exploration and conquest along the western coast of South America. But it was the Portuguese explorer, Ferdinand de Magalhães (not Balboa), who, because its waters seemed so calm, gave this ocean the name Pacific (meaning peaceful).

anayansigamboa Panama Pacific Ocean
Courtesy of Google – Balboa, Parque Anayansi, Pacific Ocean

What is your story? Leave your comments below.

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.

Fair Use Notice: This article/image/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 start a career as a Freelance Translator

The work of freelancer is quite comprehensive. In reality, there are hundreds of professions that can use a freelancer. However, one of the most common is the freelance translator. This business area has increased greatly in recent years, especially from the time when the internet has become a common tool for all professionals. Nowadays, it’s much easier to find job offers in the field of translator. Furthermore, the number of tools for translation grows with every passing day. For this and more for a few reasons, in this post we get to know some essential steps to work this niche market so attractive these days.

It is undeniable that the translation market today is far more aggressive and dynamic than at the time of Stridon Jerome, patron saint of translators, who translated nothing more, nothing less, than the Bible, the ancient Hebrew and Greek into Latin in the first century IV AD. Therefore, the purpose of this article is to guide the first steps of those who intend to enter to the fascinating universe satisfying – and sometimes lucrative – the translation. However, before we address the issue directly we open a parenthesis and define three aspects which, although rudimentary, are very important to practice, and, if not properly observed, it will be impossible for any freelancer keeping active as a translator professional.

First: It is imperative that the translator freelancer has a great mastery of their mother tongue. Maybe that’s why professionals with training in writing, or translation, are the most highly rated by some agencies to fill vacancies available in the market. Must be considered that, despite the translation profession not regulated in many countries – the fact that technology allows the execution of the function by anyone, even without any specific training – it is obvious that the translation quality will depend on the level of knowledge that professional has its own language.

Second: We need to clarify what it is, or who is eligible to be a translator. In this case, I always say that I know, or “like” a second language does not authorize anyone to translate. There is no point saying that he lived many years in another country, or who are descendants of aliens. The process of mastering a second language is not limited only to this. The real mastery of any language usually is due to the four basic skills, which are: To understand, read, speak and write a language perfectly, be it foreign or domestic. The ability to faithfully adapt one language to another, constitutes what we call translation. Therefore, it would translate a fifth skill, which, by the way, is a prerequisite for the prospective translator qualification.

Third: The translation is an adaptation of a foreign text to our mother tongue. When we find the opposite situation, ie, when adapted written in our mother tongue into a foreign language text, called “Version”. It is recommended, especially for beginners, working only with the translations, because the fact of better master their own language will help reduce the possibility of mistakes, which, if they occur successively, can damage your reputation and prematurely terminate their career as a translator. A solution to not lose customers would associate with native speakers of other nationalities. Thus, we are assured to be paying a service of unquestionable quality. Now, armed with these three essentials, it’s time to get down to business.

Let’s start commenting on some contemporary challenges that freelance translators face on the job.

anayansi gamboa translatorThe translator is a freelancer worker with the same rights and duties of its citizens. Therefore, you should pay special attention to factors like Social Security, the IRS, issuing invoices, contracts, operating licenses, records in government agencies, in short, all bureaucracies required by law to perform any economic activity. Hiring a life insurance, private pension plan and consolidate savings are imperative, after all, it never hurts to protect themselves from the ups and downs, quite common, who performs this work.

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}.

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.

Consular Legalization of Documents

Consular Legalization of Documents

Warning: The information on this page is provided in good faith and are general information about the process of legalization of documents for use abroad.

We do our best to keep this page updated, but changes in legislation, rules and procedures of the countries occur without warning.

This information does not replace the most current information provided in the pages of consular officers and government officials accountable for every act.

If you believe any information on this page is outdated or wrong, please notify us by e-mail.

anayansi gamboa legalization of documents

Legalisation Usage Overseas

Many countries require a certified translation. In Brasil, for example, the legalization takes place at the Ministry of Foreign Affairs of Brazil (MRE) and in Panama, at the Ministry of Foreign Affairs and then at the consulate of the destination country of the document. This process is also called consularization or authentication.

Some countries may first require the legalization of the original document and only then legalize certified translation. That’s because they want the data of stamps and seals legalization of the original document included with the translation.

In general, the rules are relatively simple, but the whole process is quite laborious. In some cases, the legalization of a single set of documents may require more than ten trips between the Foreign Ministry, notary, translator and consulate office.

We can always help you with this process.

Firstly, our management team can help you understand what needs to be done in your particular case. After performing legalization of hundreds of documents from consulates in major English and Spanish speaking, our team has extensive experience on the procedures usually adopted in each country.

It also aimed to facilitate the legalization process for customers, all our translators have autograph card registered in the offices of the Ministry of Foreign Affairs of Brazil or Panama and the consulates of major countries speaks English and Spanish (Canada, United States, Spain and others). As a result, shoppers rarely need to recognize the notarized signature of the translator. Moreover, the consulates in some countries directly receive our sworn translations.

Legalisation foreign documents

All official foreign documents relating to persons, such as birth certificates, unmarried status declarations, marriage certificates or judicial decisions regarding adoption, must either be legalised or provided with an Apostille by the competent authorities of the issuing country. Unmarried status declarations may not be older than 6 months.

As the legalisation of foreign documents can take a long time, please arrange this several months before submitting any application with the local government authority.

You are advised not to submit any application without legalised or apostillised foreign documents. We always check with the embassy or consulate as to which foreign documents need to be legalised and how.

We also offer service support for legalization. We work with specialized carriers to bring their documents the specific country and consulates and bring them back with security and privacy to our office. With the consent of the customer, always thinking of their convenience, we can also arrange interviews for service and represent it by proxy at consulates that require this kind of formalization.

In addition, we serve businesses and individuals in cities where there is a consulate office with complete solutions sworn translation, legalization of documents and shipping documents by post.

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}.

Effective Project Manager

anayansi gamboa PM planThe art of managing projects comes with many different approaches.

There are three skill groups a project manager must have in order to be effective: a technical skills group, a project management skills group, and a people skills group (a skill group is different from a skill set, which you will see later).

First, the project manager must know what the task is all about from a technical standpoint

Second, a project manager must possess project management skills—that is, the ability to create schedules and budgets, the ability to implement and manage change control systems, the ability to implement and manage risk management systems, and the ability to implement and manage the many other project management skills as well project manager must possess the so-called ‘‘Soft’’ skills. These skills are frequently called the people skills: The ability to get things done, and the ability to anticipate problems.

Here’s a scenario of a project manager leader:

During the project the leader must continue to treat the {EDC} Hands-On team, keeping them informed and closely coupled with the in-house {EDC} team members. He must continue to highlight to the team upcoming dependencies between groups.

The new liaison manager must promote frequent exchanges of information that will show what progress is being made and highlight immediately any misunderstandings regarding project or product goals.

As part of a team-building activity, {EDC} manager offered certain incentives to both site (first-class air fare, hotel accommodations, etc) in order to improve communication and collaboration between the two teams.

The {EDC} team members must be fully assessed against the alignment factors for their suitability for this job.   For each factor the liaison manager must identify possible issues, discuss them with the potential team member, and make a conscious decision. The following questions can aid the liaison manager in his assessment:

  • Are metrics of team performance collected and analyzed on a regular basis throughout the project?
  • Is regular feedback provided by management on team and individual performance?

Frequent interim informal reviews should be held on works in progress such as requirements specifications and designs, to uncover misunderstandings as early as possible.

In order to overcome the problems encountered in the past, the {EDC} team established weekly meetings between both teams. The project manager is responsible to build a positive, supportive atmosphere where team members operate cohesively.

So does your organization give ownership and empowerment to their employees?

Conclusion:

When a mixture of ideas and backgrounds come together in a group to design a project, it’s expected to have variations. There is no single right way to performing all the tasks needed as long as each is done with appropriate precision. This kind of diversity prepares a project for success if everyone is willing to work towards the common goals of the organization.

If a company believes that those who contribute to the success of the organization should benefit from its success then it must allowed for their project manager to work together with their team members to accomplish the end goal. As it is, employees would feel part of the big picture because they care. It’s not just investing in a company; it’s investing in themselves, their performance and their future.

Do you provide regular feedback to your team? How do you reward them? Share your thoughts in the comment section.

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

Translation as a Profession

Contrary to popular belief, the translation is an occupation, a profession. Translation is a profession, not a chore, as is unfortunately regarded by service users who venture to provide services without adequate training or qualification.

In the university, translation courses provide basic training, but graduation is not a condition but to practice, because graduates do not always follow it as a career, either by change of plans or market requirements for which they are unprepared, and many reputable professionals have no graduation.

Unfortunately, most of the translators, as in other professions, also have the proper qualification, which reinforces the claim that a title or union membership is important, but not always designates qualification.

The stepping stones is to qualify themselves!

Success in this profession depends largely on the competence and efficiency of professional, remembering, of course, it is essential to master the languages you translates.

The labor market has its ups and downs. Globalization, the flow of information around the world and investments in international partnerships generate great demand, but simply a political or financial change to cause a slowdown. Therefore, the more skilled and flexible for the translator, he will have more stability.

English is still the language in highest demand. However, due to changes in international politics, other languages are gaining more space, eg, Spanish, German, French, Italian, and now with the approach of Brazil and China, Mandarin.

The work is divided between the translation of documents, texts, contracts, publications, audios, movies and legends and interpreting at conferences and events.

The simultaneous spoken translation can be made with the use of live cabin and electronic equipment, or consecutive, made in the next moment the speaker speaks in short time intervals.

Several segments of translation and include books, legal texts, medical, chemical, metallurgical, IT, marketing, among others. On one hand specialize in a certain segment results in quality improvement, on the other, placing the eggs in one basket can only be dangerous. Choose your area, but be ready to act in case the other is down.

In future articles I will talk about how to work – working alone or in teams? – Who are translation agencies? – And what price to charge?

Leave your comments, questions and suggestions.

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}.