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Tag Archives: anayansi van der berg
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.
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.
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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.
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.***
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’s 10 Rules For Sucess
- Earn Your Success
- Care Deeply
- Love the Game
- Live in The Present
- Execute Well Under Pressue
- Believe in Yourself
- Set your Priorities
- Earn it Every Single Day
- Evolve
- Stay Hungry, Stay Humble
Hashgraph: Electronic Data Capture Future?
Hashgraph technology, created by Leemon Baird, it is probably going to replace blockchain technology.
Since the introduction of bitcoin there have been many thousands of blockchain based crypto currencies created and there are more being created every single day so what’s different about hashgraph?
Well it isn’t a blockchain it’s totally different in fact the way it works is a real Mindbender and a bit difficult to explain.
Instead of a block in a blockchain hash graph calls their packages of information “events”. Your computer takes a transaction like a payment or anything else for that matter such an action in the eCRF form (e.g. SDV) you want to record and puts it in the event for transmitting information quickly hash graph uses a technology that has been the gold standards in computer science for decades. Its super fast and its called ‘gossip protocol’. Your computer randomly tells another computer in the network about the even you’ve created and that computer responds by telling your computer any events it heard about then that computer tells another computer about your event and the other events it heard about and the computer its talking to responds by telling all the events its knows about. Its absolutely the best most efficient way to spread information and it’s exponentially fast And the best part, it also includes the information of the time it heard it and who it heard it from and the time they heard it and who they heard it from and so on and it is called ‘gossip about gossip’ and it lets everyone knows what everyone else knows and exactly when they knew it and just fractions of a second.
Another key feature is ‘virtual voting’. Even though an old technology, it was slow but with hash graph, there is no voting instead because everyone already knows what everyone else knows you can mathematically calculate with 100% certainty how they would vote and allows hash graph to come to consensus almost instantly so instead of recording things on a block and adding it to the block chain once every 10 minutes hash graph events are added to the system instantly the moment they are created so they don’t have 10 minutes worth of information in them. That means they are small and contain far less data so they use very little bandwidth and are much easier to transmit and uses a minuscule amount of power which makes it fast, fair and more secure than block chain.
All events are time-stamped the moment they are woven into the system so the record of whose event came first and whose came second is instant and there is no such thing as soft forking or unconfirmed events.
It can also replace huge portions of the internet that are currently run by centralized servers by replacing them with the shared computing power of all of our own computers, iPads and cell phones.
It looks like hash graph might have all the potentials of fulfilling all the original hopes and dreams of a true Electronic Data Capture system (e.g. eCRF forms collected at site, ePRO/eCOA data directly from subjects, external or local lab or ECG data from any lab, eSAEs, Inform consents, and more). In other words, sites, sponsors, labs, regulatory and all vendors working seamless with each other.
Imagine an investigator or research site completing an ‘event’ (e.g. Enrolled or randomized) and the system automatically sent the payment to the site at the end of each event.
The power to decentralize and remove the middleman with the speed at which technology is evolving the future is looking bright.
One of the challenges of any new technology is how do you really explain to people how do you make a compelling case for what makes a technology so compelling and one of the things that is so compelling about this technology is throughput – the speed.
You are probably thinking but what about eSignatures? Or Informed Consents? or Regulations? There is another technology ‘smart contracts‘ that could lead to substantial improvements in compliance, cost-efficiency and accountability.
What is a Smart contracts? are contracts whose terms are recorded in a computer language instead of legal language. Smart contracts can be automatically executed by a computing system, such as a suitable distributed ledger system. The potential benefits of smart contracts include low contracting, enforcement, and compliance costs; consequently it becomes economically viable to form contracts over numerous low-value transactions. The potential risks include a reliance on the computing system that executes the contract. [Distributed Ledger Technology: beyond block chain, UK Government Office for Science, 2006]
Bitcoin technology uses a tremendous amount of energy to run the system and also it is scaled up it became slower and slower to where it was no longer a currency it was basically a speculative vehicle you could make some gains in purchasing power. A transaction with bitcoin technology can take 4 hours for confirmation. With hashgraph, compared to Bitcoin, uses no power.
If Bitcoin were to replace the entire world monetary system and financial markets, it would use more power than the entire world produces. It’s completely unsustainable.
Hashgraph, smart contracts, distributed ledgers and similar technologies offer new ways to share information, reduce errors, and it is cost effective to all users. Perhaps a new Electronic Data Capture system for clinical research will emerge.
Source:
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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.
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
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Motto of the month: We Become What We Think About
Source:
http://www.azquotes.com/quote/519399
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7 (Audio) Books You Should Read in 2018
Do you want to be successful? Looking for your life purpose? Are you feeling down? Unmotivated? Lost? Do you want a better career or business? The following books have helped me obtain the life I desire and guide me through difficult times.
My goals and desires are different than yours but I am sure you will benefit from these books. If anything, you will feel motivated again and eager to embark on a new life. Good luck and share your success stories.
- The Richest Man In Babylon – Napoleon Hill
2. The Strangest Secret by Earl Nightingale
3. Think And Grow Rich – Napoleon Hill
4. Change your life in 20 minutes – Earl Nightingale
5. Use This For 30 days and Watch Your Prosperity Grow! – Catherine Ponder
6. W. Clement Stone and Napoleon Hill – Success Through A Positive Mental Attitude
7. Ask and it is Given – Abraham Hicks
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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.
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
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Pentacles – A New Beginning – You become what you think about
Prepare yourself for a new year. Make a list of your resolutions. Write your goals down and create a discipline to manifest them into reality.
Something good is coming. Open your heart to receive it. The universe wants to give you something new. A new job, a new opportunity. This is something new.
You have done the work and finally the universe wants to give you a gift. This is magical. An unexpected gift that you have work hard for it.
Let the new come in.
The information you received was hurtful and painful but it will give you a change you need for the new beginning.
Those were some of the words I heard during my regular self-communication. I use a combination of tarot cards and other spiritual sources to find the guidances I need when in doubt.
Recently I wrote an article about success and law of attraction and how you can bring what you desire closer and closer to you.
Read more about it here: One-Year Success Plan
Ace of Pentacles
Work: You may be moving to a new position or a new set of responsibilities. If you’re wondering whether or not to leave your current position, this card is an encouraging one to see. This new position may happen whether you are looking for it or not. Either way, this is good news.
8 of Pentacles
Work: If you are seeking employment, this card can indicate that you will be hired into a new position that tests your skills and is demanding. Have faith in yourself, that you can do what is needed to be successful in the position. If you are currently working, you may be saddled with far more responsibility and tasks than can be accomplished well. Don’t hesitate to request assistance from supervisors with prioritizing. You can only do so much; be realistic.
9 of Pentacles
Work: If you’re looking for a position, the 9 of Pentacles could well point to a better job coming your way than you would have thought possible. Even if you’re currently employed, expect a change for the better, both in terms of your circumstances and your pay. You’ll have a lot to be grateful for.
One of your dreams is on its way to coming true
Change, change, change – the universe wants to give you a wonderful gift. The hard work has paid off.
Source:
images courtesy of google image
http://www.psychic-revelation.com/
http://littleredtarot.com/nine-of-pentacles/
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