Category Archives: Risk

CTCAE: Common Terminology Criteria for Adverse Events

The National Cancer Institute issued the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 on November 27, 2017.

So what is CTCAE and what is it used for?

The terminology NCI CTCAE is a descriptive terminology that can be used for the declaration of adverse events (AEs). A grade scale (or severity) is provided for each term.

The oncology community has a standard classification and severity grading scale for adverse events in cancer therapy clinical trials and this is what it is described in the CTCAE reference.

The SOC (System Organ Class or Organ Class) is the highest level of the hierarchy of the
MedDRA dictionary. It is identified by a physiological or anatomical classification, etiological or a result (ex: SOC investigations for laboratory results). The terms of the CTCAE are grouped together according to the MedDRA primary SOCs. Within each SOC, the terms are listed and accompanied a description of the severity (grade).






An adverse event is an unexpected sign, symptom or disease, unexpected (this includes
biological results), associated chronologically with the use of a treatment, a procedure,
to be connected to this treatment or procedure. An IE is a unique term representing an event
specifically used for the medical report and the scientific analyzes. Each term of the CTCAE is a
MedDRA LLT level term (Low Level Term, lowest level of the hierarchy).
Grades refer to the severity of AEs. The CTCAE is divided into 5 grades, each with
unique medical description for each term, based on the following main lines:
Grade 1: Light; asymptomatic or mild symptoms; diagnosis on clinical examination only; born
not requiring treatment
Grade 2: Moderate; requiring minimal, local or non-invasive treatment; interfering with activities instrumentalities of everyday life
Grade 3: Severe or medically significant but without immediate life-threatening;
indication of hospitalization or prolongation of hospitalization; invalidating; interfering with activities elementary of everyday life
Grade 4: Life-threatening; requiring emergency care
Grade 5: Death related to AE and it is not appropriate for some AEs and therefore is not an option.
MedDRA code CTCAE v5.0 Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Definition
10007515 Cardiac arrest Life-threatening
consequences; urgent
intervention indicated<
Death A disorder characterized by cessation of the pumping function of the heart.

CTCAE is still the formal reporting for AEs and grading dependent upon clinician judgement of medical significance.

A copy is located here: CTCAE version 5.0.

Sources:

https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5×11.pdf

Feature image: CTCAE-4 by Stefano Peruzzi (apple app)

Fair Use Notice: Images/logos/graphics on this page 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).

Advertisements

Vandaag is GDPR dag! GDPR is in place! Are you ready for it?

According to the EU General Data Protection Regulation (GDPR), which comes into effect today, May 25th, 2018, most companies will need to inform you of their privacy policy for processing and protecting your personal information and your privacy.

The General Data Protection Regulation (GDPR) is already in place, but many companies are not yet ready - more precisely, only 45% of organizations said they had a structured plan to comply with it.

A recent survey also reveals that 54% of large organizations (with more than 5,000 employees) are better prepared to deal with GDPR; in small ones, this index drops to 37%. And, only 24% of companies use external consulting to become compatible.

With this  Regulation, individuals have the right to request that their personal data be erased or transferred to another organization. This raises questions as to what tools and processes they will need to implement. For 48% of respondents, it is a challenge to find only personal data in their own banks. In these cases, compliance with the GDPR rules will be an even more serious task.

55% of organizations are not prepared for GDPR

For EU citizens and residents, this is a welcome law. But for US citizens and residents, they will continue to suffer identity theft and data privacy violations in the hands of the same companies the EU is trying to fined and control under this law. The Googles, the Facebooks, the Twitters and most social media will be scrutinized heavily after this day.

Who does the GDPR affect?
The GDPR not only applies to organizations located within the EU but it will also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behavior of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location.

What are the penalties for non-compliance?
Organizations can be fined up to 4% of annual global turnover for breaching GDPR or €20 Million. This is the maximum fine that can be imposed for the most serious infringements e.g.not having sufficient customer consent to process data or violating the core of Privacy by Design concepts. There is a tiered approach to fines e.g. a company can be fined 2% for not having their records in order (article 28), not notifying the supervising authority and data subject about a breach or not conducting an impact assessment. It is important to note that these rules apply to both controllers and processors — meaning ‘clouds’ will not be exempt from GDPR enforcement.

Source:

https://www.eugdpr.org/

https://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en

Fair Use Notice: Images/logos/graphics on this page 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).

Legalese: Employment Contracts vs At Will Contracts Part I

In this world, we have two kinds of contracts, invisible contracts; those that somehow we have with governments (there are no paper trails and because they say so) and the paper contracts, those in which we have at least two parties agreeing to terms and conditions written on a piece of paper.

For the purpose of this article, we will refer to Employer or Company and Employee or consultants or freelancer moving forward.

the typed contracts were full of confusing legalese

So what happens when a party violates the terms of a contract to which they’ve agreed to?

Before we can answer that question, we will need to understand the legalese or legal language used and the different clauses that appear on each contract.

Trial Period / Probation Period Clauses

This clause may have something similar to:

***This agreement is subject to a trial period of 1 month.****

***The First Six (6) months of the employment contract shall be deemed a ‘probation period’. During this probational period each party of the contract shall be entitled to terminate the contract within 30 days notice to the other party.***

This clause should be pretty easy to understand. The company wants to have at least 30 days to up to 60 days to decide whether they want to keep the new employee and be able to terminate such employment contract within the specify time. If the employer does not terminate the contract within the 6 months, the contract is fully enforceable and only via court order or mutual agreement with the employee can this contract be terminated.

gamboa

At Will – Only applicable to the United States.

Many of us who has worked and lived in the USA have seen the so called ‘at will’ contracts.

At-will employment is a term used in U.S. labor law for contractual relationships in which an employee can be dismissed by an employer for any reason (that is, without having to establish “just cause” for termination), and without warning. -Wikipedia

Such a clause may read as follow:

***Employment at ABC Corporation is “at-will.” This means that you may resign at any time, for any reason or for no reason, or with or without notice. Similarly, ABC Corporation may terminate your employment at any time for any reason or for no reason, with or without notice. This offer letter is not a contract of employment for any purpose or duration. ABC Corporation reserves the right to change its policies and procedures, with the exception of its “at-will”
policy, at any time, with or without notice.***

Example 2 – At Will Clause

***Employee acknowledges that the employment relationship created by this agreement is at will and is, to the extent set forth in this agreement, temporary in nature and can be terminated at any time by Company for any reason whatsoever.***

gamboa

 

 

 

 

Termination Clause

While most At-Will contract clearly specifies that a contract can be terminated with or without reason and at any time, most employment contracts provide a clear end date.

For temporary and limited short-term contracts, there should be an end-date, for example:

***This agreement shall continue in force from the dd Month year until the dd Month year or until earlier terminated in accordance with this agreement.***

Example 2:  Common in Employment contracts

The project agreement is entered into for a fixed term and is valid for the duration of 6 months and therefore ends automatically and by operation of law, without written termination being necessary for that purpose, on <end date>.

***Either party can immediately end the employment, without a termination period and without regard to the conditions regarding termination in the event of an urgent reason, as stated in articles <xxxx> and <xxx> of the Country Civil Code.***

***The employment contract will end on the last day of the month prior to the month in which the employee reaches the retirement age.***

On part II, we will cover the confidentiality agreement clause, and some other benefits clauses added to the employment contract like bonus, relocation, job responsibilities, competing clauses, and more.

Conclusion:

Most Europeans have what we called ‘Employment Contracts’ whereas Americans have ‘At Will’ contracts. The main differences between having an European contract versus an American contract are: stability (notice period is a must) and financial compensation (severance package equals one month salary for every year you worked for the company). Usually, an employer or employee must give 3 months notice before terminating the employment contract. Americans can be terminated the same day they report to work without notice. In the other hand, Americans make more money. For example, a clinical programmer for a pharmaceutical industry could make over 80,000/year salary depend upon experience while someone from the UK will be making less than 50,000 pounds or an EU employee less than 70,000 euros/year.

Americans make the money up front which means Americans should be saving on average one month salary per year while Europeans will receive a final check , usually one month salary for every year they have worked for the company, as part of their exit package or termination of employment also knowns as ‘severance payment’.

Need legal advice in Panama? Relocating to Panama for work and need legal advice? Panamanian work visas?

Contact Us here: Panama Lawyers and click on Consultation Form

Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

-FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Cracking the Code: Estimate at Completion (EAC) of a Clinical Trial

Project management is a continuous loop of planning what to do, checking on progress, comparing progress to plan, taking corrective action if needed, and re-planning. The fundamental items to plan, monitor, and control are time, cost, and performance so that the project stays on schedule, does not exceed its budget, and meets its specifications.  Of course all of these activities are based on having an agreed upon Work Breakdown Structure (tasks/activities) on which to base the schedule and cost estimates.  During the planning phase of a project, the project manager with the assistance of the project team needs to define the process and procedures that will be used during the implementation phase to monitor and control the project’s performance.

Productivity in the pharmaceutical/biotech/medical device industry is going down. Some compounds have reached the billions expenditures cost without any guarantee that it will ever be approved or reach the market.  So how can we evaluate the performance of some of these clinical trials?

I will not go into details in the degree of project management activities managed and performed by a data manager since this can vary widely per company.  A good clinical data manager or manager of data management should be able to implement basic PM principles that will improve quality and timeliness of a clinical trial, regardless if the trial is fully outsourced (e.g. CRO performed most of the work).

You can find my article about the Role of Project Management in Clinical Data Management (2012) here for further reading.

So what is Estimate at Completion or EAC? or What is the project likely to cost?

There are several methods we could use to calculate EAC.

Let’s look at one formula. EAC =  AC (Actual Cost) + ETC (Estimate to Complete)  so what happens when you don’t know the ETC?

We could use the following formula to derive that value: ETC = (BAC – EV) / CPI =>>>>??? So what? More formulas? How do I get BAC or EV or CPI?

Let’s look at those in more details.

 BAC =>>>Budget at Completion (how much did you
budget for the total project?)
CPI =>>> Cost Performance Index (CPI): BCWP/ACWP

EV = Earned Value

Earned Value Analysis example for a phase 1 trial (*figures in the thousands / millions = fictitious  numbers)

The final clinical trial results includes 100 subjects. The estimated cost is $20 per subject.  That results in an estimated budget of $2000 (100 x 20). During the planning, the CRO indicated that would be able to enroll 5 subjects per week.  Therefore the estimated duration of the trial is 20 weeks (100 / 5)

EV blocks: From the project plan

Estimated Budget: $2000

Estimated Schedule: 20 weeks

Planned Value (PV): at the end of the trial is $2000

Variance between planned and actual at the end of the first week:

Based on the estimated scheduled, I should have 25 subjects enrolled. At $20 per subject, the planned value at the end of the week is $500 (25 x 20)

PV = $500

At the end of the first week, the CRO reports that he has enrolled 20 subjects  and the actual cost of that study is $450. With this information we can look at schedule and cost variance.

SV = EV – PV

SV = $400 – $500 = – 100 ($100 work of subject recruitment is behind schedule).

CV = EV – AC

CV = $400 – $450 = -50 ($50 work of the project is over budget)

*negative figures means bad.

Using early results to predict later results:

Schedule Performance Index (SPI)

SPI = EV/PV

SPI = 400/500 = .80

Cost Performance Index (CPI)

CPI = EV/AC

CPI = 400/450 = .89 –> over budget or expending more

These rations can be used to estimate performance of the project to completion based on the early actual experience.

Estimate to Completion (ETC)
ETC= (PV at completion) – EV)/CPI

ETC= (2000 – 400)/CPI

ETC = (1600/.89) =$ 1798 from end of week one (after 5 days) and it will take additional $1798 to complete the study

Estimate at Completion (EAC)

EAC = AC + ETC

EAC = 450 + 1798 = $2248

If nothing changes, based on the actual results at the end of the first week, the study is estimated  to cost $2248 (rather than the planned cost of $2000) and will take 20 percent longer.

The formulas assumes that the accumulative performance reflected in the CPI is likely to continue for the duration of the project.

You do not need to memorize all of these formulas. There are plenty of tools in the industry that does the computation for you. But if you do not have it available, you can use Excel, set-up your template and plug in the numbers.

Earned Value

 

 

 

 

 

 

 

As per PMI – PMBOK definition, Cost management “…includes the processes involved in estimating, budgeting, and controlling costs so that the project can be completed within the approved budget.”   A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

We have shown you, that PM tools such as Earned Value  Analysis, can be applied to clinical trials or specific work break down (WBS) activities within the data management team.

Based on the above outcome of the project performance related to the schedule, the data manager should be able to determine if she should modify the current plan or revise the original plan.

It is a perfect tool for data managers and managers of data managers and could be part of your risk based processes.

If bringing efficiency, improving data quality and significantly reducing programming time after implementing CDISC standards is on your radar screen, I’d love to chat when it’s convenient. All the best.

Anayansi Van Der Berg has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical. SAS, CDASH/SDTM (CDISC standards implementation and mapping), SAS QC checks and clinical data reporting.

Source:

A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

Notes from my PM class at Keller 2007-2009

Images – Google images

FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

USA Corporations Dead Policy: Got Drug Test?

The Pointlessness of the Workplace Drug Test in the USA

There’s very little evidence it’s worth the cost or hassle and yet, USA Corporations insist on drug testing their prospective employees prior to their start date.

After living and working in Europe and Latin America, I do not understand why US Citizens do not complain? Why not ask their government to place laws into place to prohibit this practice? I feel not only it is a violation of my body but my privacy. Mind you, I do not smoke or drink anything and more or less, I have been a healthy person since I can remember. I barely use the socialist health system that it is mandated upon me. I am forced to pay for mandatory insurance so someone else can afford it even though I do not use it and when I use it, I have to pay out of my pocket anyway, so what’s the point of mandatory insurance???

So back to the mandatory drug test. Many of us have been asked to pee into a cup. As a condition of employment, and with bills to pay, we head to the lab to deliver our samples. I can understand someone operating forklifts or driving 18-wheelers should be required to some type of testing, however, someone seating at an office desk, cannot cause any injury by smoking some legalized marijuana. I do not know the details in law in each of the states where marijuana now is legal. Do corporations ask for drug testing anyway? That should seen pointless and waste of time.

US worker drug testing

As the article posted on Slate.com -Why Do Employers Still Routinely Drug-Test Workers?, explained that ‘…some testing critics, such as Adam Moore of the University of Washington, have argued that it would make more sense to do regular testing of an employee’s actual, on-the-job state of mind, rather than his or her recent drug use. If a worker nods off all the time, or sits there in an unproductive daze, what’s the difference if his problem is caused by tested substances such as marijuana or heroin, as opposed to other, legal ones? (Remember the pilot who crashed into the USS Nimitz and kicked off the modern testing frenzy? The one doped up on cold medicine?) Drugs may not even be the central problem: An airline pilot who suffers from chronic and debilitating insomnia, for example, could be more dangerous than one who does whippets on the weekend…”

But what about The Netherlands, as I can remember, Dutch people probably smoke more marijuana and joint than any US worker could dream off. Yet, they go to work, go home and smoke a joint and back to work again. Do you hear about killings at the workplace in The Netherlands? Do you hear about any other workplace related problems in The Netherlands? Remember, The Netherlands has legalized most of the marijuana consumption. Tourists come to Amsterdam just to smoke a joint. You can smell marijuana from the moment you leave the airport so what makes an European worker different than a US worker?

The same corporations operating in Europe are also operating in the USA. Do these corporations ask EU workers to pee into a cup? The answer is NO.

Drug Testing t’s an American invention

HR, recruiters and those working on workplace policies. Stop wasting people’s time. Time is money so you should be able to pay for the time I spend going into a lab for non-sense drug test. Even better, send somebody from the lab (of course,they won’t come) to my house to get a pee sample.

Time is money. Do not waste my time. Drug testing is not an indicator of my past, present or future performance as an employee.

And one more statistics by ThinkProgress:

To that end, one simply tallies up the money spent on public screenings, and compares it to the money saved by cutting off drug-abusing applicants. An analysis of seven state testing programs by ThinkProgresssuggests that governments are in the red from testing.

Source:

Why Do Employers Still Routinely Drug-Test Workers?

The Pointlessness of the Workplace Drug Test

Fair Use Notice: Images/logos/graphics on this page 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).

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.

-FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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

Carfilzomib FDA Approved

FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple ymemloa who have received one to three prior lines of therapy. July 24, 2015.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455873.htm

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

HR: The Useless Department?

Everybody has a Human Resources horror story, which is why, in the words of one writer, HR is widely thought of as “at best, a necessary evil — and at worst, a dark bureaucratic force that blindly enforces nonsensical rules, resists creativity, and impedes constructive change.” HR, goes the refrain, is too important to be left to HR. [Forbes, 2013]

My experience goes for good, to bad to worse. In the consultancy business, you almost never deal with HR except during the interview process or during termination of contract (this includes, contract ending by contractual agreement or termination).

HR was useless

As an employee, I find this department to be useless because they serve their masters ‘the managers’ and not the slaves ‘the employees’. HR does what the manager wants. If they want to get rid of you or replace you, they will use HR to accomplish that.

You are fired

In other words, employees bring their concerns to the attention of the human resources personnel, and the response was less than helpful, and perhaps even made the situation worse.

If HR’s ‘real job’ is to cover up for poor morale and negligent behavior of line managers or executives then HR should be an extension of the general legal office and be staffed with attorneys to document everything, in preparation for either individual or class action suits.

dysfunctional organization

In the book, “How Organizations Empower the bully boss: a criminal in the workplace,” employees MUST understand there is no one in the organization willing to assist in any fight or survival of a hostile workplace with a bully boss. Workers are like a commodity treated no better than cattle in some workplaces where there is a bully boss waiting to devour them. I have witnessed the beaten up demoralized workers who were once exceptional, reduced to a far less productive individual, thanks to bully bosses.

Frankly, the only message I am sending to folks is protect yourself anyway you can because there is no one out there coming to rescue you from the bully boss or those who protect the bully-M.Veincentotzs

Conclusion:

Corporations have Human Resource Departments, it’s sickening when you recognize the language they use to describe us, but they won’t use the word slave as people would catch on too quick.  Egos like to have titles or at least identify others who have lesser titles than they.  It is always about who has more.  They fight each other using the slaves as their cannon fodder in their wars to determine who gets to control what, in the end the slaves never have a better future.

So how do we deal with the managers of the HR system that are doing what they are doing out of survival and ego? Questions or Comments? Join us on the discussion.

Reference:

It’s time for companies to fire their human resources department by Forbes, 2013

How Organizations Empower the Bully Boss:A Criminal in the Workplace by MARILYN E. VEINCENTOTZS, 2009

Justin is a Sr. Analyst / Consultant. He has been a dedicated SAS programmer for over 5 years now.

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.