Category Archives: Project Management

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)

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Motto of the Month – Success

Success is the progressive realization of the worthy goal or ideal. – Earl Nightingale

I have been listening to motivational audios for over 2  years now, and this is TRUE FACTS! Never give up on your values, beliefs and morals.

A man/woman is what he / she thinks about all day long. Think about this too, All the hate in the fake news (a.k.a. communication channels whether radio, tv or internet) about racism,  gender or economic classes can affect you at your subconscious level and limit your potential for growth.

Success - Anayansi Van Der Berg

 

The real problem with people isn’t simply fear but conformity as we do what we see or are told to believe what we see or hear. GOD is within you.

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).

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

 

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.

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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’.

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Motto of the Month – Prove Them Wrong

I don’t need to defend myself from people that doubt me. I let my actions speak for me. – Tom Brady

Tom Brady MottoTom Brady’s 10 Rules For Sucess

  1. Earn Your Success
  2. Care Deeply
  3. Love the Game
  4. Live in The Present
  5. Execute Well Under Pressue
  6. Believe in Yourself
  7. Set your Priorities
  8. Earn it Every Single Day
  9. Evolve
  10. Stay Hungry, Stay Humble

10 Rules of Sucess