Category Archives: Risk

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}.

Freelancing/Consulting 101: Don’t send your CVs/Resumes yet until you…

What successful freelancers/consultants wish they’d known from the start?

Before you send over your CV or resume to that agency claiming they have a contract/project in your related field, ask who the client is, job responsibilities and location of the project to be performed.

After you gather enough information (most companies will come forward with this information some will not release the name of the company until you have sent them your CV), check out LinkedIn or similar professional social media and find an ex-employee or current employee and ask those serious questions about the work environment, management style and what is a day-to-day look like at your company/department?

They’re easy to get along with

After a while you’ll find that some jobs/clients are better than others. So you don’t feel desperate and you’re able to say “no I don’t need to take on this project, I can wait for something better to come along” and it usually does.

I hope you don’t feel daunted by this! I just learnt this stuff the hard way and I don’t want you to as well. You will make mistakes, but everyone does and the important thing is to learn from them.

Not every client is worth it!

Next time, I will cover contracts, legalese languages and what to look for with some examples. I will also cover USA [Employment at Will] and EU [Right to work] laws and which agencies or third parties you should avoid.

Beware, agencies already have a boiler-platter contract and may not be applicable to the jurisdiction where you currently reside and/or where the client is located at. We will get in some stuff you don’t supposed to know.

Anayansi Gamboa, “I am someone who influence my own development. I look for a company where I have the opportunity to pursue my interests across functions and geographies, and where a job title is not considered the final definition of who I am, but the starting point.”

Looking for a clinical programmer? Use the Contact Me! form to get in touch.

Legista sine canonibus parum valet, canonista sine legibus nihil

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

How Much are Bad Managers Costing Your Company?

Harassment, discrimination or labor exploitation can become poison in the work environment. Bad attitude, micro-management, unqualified managers can be as toxic in the workplace.

How to cope with a toxic work environment?

We often hear in hours of leisure (lunch breaks) employees telling the terrible stories that turn their heads as the worst bosses they have ever known.

A toxic work environment is as harmful to health as smoking. That is why, some experts have provided advice on how to survive and come through with certain harmful working circumstances. In addition there are some strategies to determine why we can come to feel animosity towards our work.

How do you know if your workplace is or is not toxic? What happens to your boss or your coworkers? What to do about it ?

If all these questions come to your mind at times of tension in the company, you are probably in a toxic work environment. If you ask one or some of the following questions:

• Do you hate going to work every day?

• Does the work of two or more people, but you get paid the same salary?

• Do you feel little or no worth?

• Does your superior yells at you and your colleagues constantly?

• Have you asked for help, but nothing changes?

• Have you been asked to falsify reports?

• Have you been the victim of sexual harassment?

• Have you been the victim of discrimination based on race, sex, age, religion or sexual preference?

Toxic work

If you answered YES to one or more of these questions, you are working in a toxic work environment and this is due to people in positions of authority operate through abuse of power, ego, mistrust, paranoia, cruelty, injustice, inequality, pressure, greed, ambition and brutal disrespect that negatively effect everyone around them.

What could be possible solutions to a toxic work environment?

Of course, communicating to HR. Unfortunately, we don’t believe HR is there to help employees. We will cover Human Resources department role on a later article.

Changing Departments? Unfortunately, when you work for a very small company, this option may not be available. Even if you work a large corporation, most often than not, you won’t be able to transition to another department that easily.

Get a lawyer to write a letter to your boss, human resources and legal department, indicating that if the situation does not change, you will file a lawsuit for a hostile work environment, sexual harassment, unsafe conditions, etc. Companies hate lawsuits and bad publicity, and may well react.

When you start noticing that more full-time staff are leaving and consultants contracts terminated, you know there is a problem with the environment. There is not rapport and no team attitude among the ones left behind. The morale of the staff has been diminished by all of the coming and going of new employees. You can’t call that a ‘productive work environment’.

And if that does not work, it’s time to find a good company that respects its workers, you don’t need living in an adverse employment situation when the price to pay for your health is too high for something worth so little.

People leave managers not companies. I QUIT!

Share your bad managers moments or toxic work environments in the comment section.

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.

Marketing without Research

The topic of marketing research is an excellent place to start learning about marketing. A marketing campaign is only as good as the research that backs it up.
Consider the case of Coca Cola introducing “New Coke”, replacing their traditional formula. The product caused such a sensation that television programs were interrupted to tell consumers.

My question to you all is this? Why did New Coke fail so miserably? What was wrong with the research that Coke did before they introduced the product ?

Focus groups are still very popular today when doing initial marketing research. I have run focus groups and participated in many.

I remember when my marketing professor in my MBA program did some consulting for the name for a new drink. The two names that he did focus group research on were “Rattlesnake Cooler” and “Cactus Cooler.” I am sure you all know Cactus Cooler now, and it is a very successful product.

anayansi gamboa Cactus Cooler

I think one of the things researchers did was a focus group. The results of the focus group were much more negative than expected so the researchers did a different survey. The results of that survey were negative, but not as much as the focus group. They already knew what they were going to end up doing and they didn’t listen to what the surveys said. With such a common product as Coke, you have to be careful with changes. They didn’t listen to what their consumers were telling them.

Think that when a mega-company like Coca Coke disregards focus group results, it shows that they really care about the profits they’re after and not keeping loyal customers. Part of the marketing department’s job is not to create the thirst for Coke, but to create the desire for Coke over another soft drink. The whole point of using a focus group should be to get a handle on what the public wants, not what the company wants the public to drink.

According to the text, “companies can conduct their own marketing research or hire other companies to do it for them. Good marketing research is characterized by the scientific method, creativity, multiple research methods, accurate model building, cost-benefit analysis, healthy skepticism, and an ethical focus.” A perfect example of this is to remember the part in the movie “Daddy Day Care” where Eddie Murphy’s character is responsible for marketing cereal to kids. What he does is holds a focus group for the kids to see if they like the cereal. Focus groups are great if researchers are willing to listen to the people they are tying to sell to.

That is an excellent point. If the people who hired the focus group professionals, they need to be prepared to listen to the results. Too often, company executives or others in the company have “pet projects” that they want to see succeed no matter what the cost. There are many cases where marketers or other high level people did not listen to what data the focus group produced.

This is a fatal mistake.

This is one reason why companies are outsourcing a lot of marketing functions because everything is so specialized. Rather than having a large internal marketing force, companies will often outsource focus groups or other research to ensure that the results are unbiased. Of course, if the company execs don’t listen, the research is wasted.

What did the focus group concentrate on?

Comments? Join us at {EDC Developer}

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)

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”.

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}.

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}.

Monte Carlo Simulation? Why?

So why would you use Monte Carlo instead of Decision Tree?

Monte Carlo or Risk Modeling is a simulation using random numbers (computes generate millions of samples quickly).

It’s powerful, simple and realistic.

Cons: It’s hard to incorporate into the overall project, and the probabilities put in may be biased.

In the other hand, Decision Tree analysis is a diagram with options and their probabilities. You would probably want to use Decision Tree over Monte Carlo Simulation when you need to evaluate several options prior to selecting one of them or guide project choices based on costs.

The name Monte Carlo simulation comes from the computer simulations performed during the 1930s and 1940s to estimate the probability that the chain reaction needed for an atom bomb to detonate would work successfully. The physicists involved in this work were big fans of gambling, so they gave the simulations the code name Monte Carlo.

Let us examine this scenario.

Your manager has asked you to use your new knowledge of management science techniques (aka project management) to perform an analysis showing which alternative would be best for the company. She tells you one of the following you may assume during your analysis:

* There are many significant uncertainties and contingencies

* The decision involves a portfolio of projects

* Outcome probability distributions are desired

Since there are many significant uncertainties and contingencies, Monte Carlo simulation is usually preferred over decision tree analysis. But what if you don’t have any sophisticated tools but instead Microsoft Excel?

Well, we have a solution for that.

Let’s assume that a project has five (5) activities. Each activity has a total cost in a specified range. In some cases the value is fixed (activity C), but generally it can assume any value within an interval.

One more important assumption that we can make is that each of these variables is independent of the others. The cost is not influence by the cost of any other activity.

activities

The total cost of a project is a random variable with a value between the minimum and the maximum.

montecarlo
Monte Carlo Simulation

Step 1: Generate random values for each activity cost

Step 2: Add each sequence of random values

Step 3: The expected project cost is the average of these values

montecarlo_formula
Monte Carlo Simulation Iteration 1 example

The random cost activity for A will look like this:

=RAND()*(25,000-20,000)+20,000

This formula will generate a value from 20,000 to 25,000.

If we add this formula to each activity and sum them all, we will obtain the total project cost.

Remember that the RAND () function always automatically recalculates the numbers it generates when a worksheet is opened or when new information is entered into the worksheet or when you press F9 key to recalculate the random numbers.

Conclusion:

Monte Carlo simulation is perhaps the most popular of the various management science techniques. The simple, elegant method provides a means to solve equations with probability distributions. (Schuyler, 2001, p. 81).

For more complex decisions use of Monte Carlo Simulation is desired. So be prepared — you may need to put your thinking cap on.

Reference: Microsoft Excel Monte Carlo Simulation samples.
Schuyler, 2001 Project Risks

Your comments and questions are valued and encouraged.
Anayansi Gamboa 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.

anayansi gamboa

A Risk-Based Approach To Monitoring

A risk is any uncertain event or condition that might affect your project. Not all risks are negative.

No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Not all risks are negative
Some events (like finding an easier way to do an
activity) or conditions (like lower prices for certain
materials) can help your project! When this happens,
we call it an opportunity… but it’s still handled just
like a risk.

avoid_mitigate
avoid_mitigate
transfer_accept
transfer_accept

Image Source: Head First PMP, by Jennifer Greene, PMP and Andrew Stellman, PMP

FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”.

Unfortunately, a lot of people in the industry are speaking about risk-based monitoring, but few have a broad understanding of the whole life-cycle process. Great opportunities exist for savings, but then again, most EDC platforms dont work effectively with risk-based monitoring. Switching to risk-based monitoring increases rather than decreases work because it can break the EDC workflow – refuting much of the value of EDC.

In conclusion, Risk-based monitoring is yet another desperate attempt to deal with what all Electronic Data Capture (EDCs) systems have failed to deliver – quality of clinical data.

Source: FDA Guidance

Your comments and questions are valued and encouraged.
Anayansi Gamboa 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.

 

anayansi gamboa

Professional Timeline – Clinical Programmer

Professional Timeline

Curriculum Vitae
CV

 

anayansi gamboa