PM Hats – Six Thinking Hats in Project Management

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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

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The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

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On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

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.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

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.

Source:

SAS Institute
CDISC

Project Plan: CDISC Implementation

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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.

Medrio eClinical – Integrated SaaS platform for eClinical

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Since 2005, Medrio has offered an integrated SaaS platform for eClinical with a fully hosted Electronic Data Capture (EDC) system.

Some of the features provided by Medrio are:

Faster  – No programming required and you can build and deploy studies in days not weeks.

Medrio’s unique Electronic Data Capture (EDC) model optimizes time and investment by providing users with fast study startup and deployment times and easy mid-study changes. Medrio studies are built using our web-based platform and can be configured 100% through a web browser using drag-and-drop functions, eliminating the need for custom programming. Build your study in days, not weeks or months.

More Control – Build studies completely online and view live data anytime, anywhere .

Medrio’s web-based, customizable interface is designed for researchers to build and configure studies without reliance on software programmers. Study management capability is made easier as users can access live data anytime and anywhere with an internet connection. Data managers can make mid-study changes, control data integrity and utilize reporting tools, making study management faster, more accessible, and more efficient.

Configure – Medrio gives you unprecedented speed and agility in building your study.

  • Intuitive point-and-click interface
  • Extensive form libraries, variables, and templates
  • Dynamic form rules and custom skip logic
  • Easy mid-study changes

Collect Data -Sites appreciate the ease of use and simplicity in entering data.

  • Enter data from anywhere via a browser
  • Intuitive workflow and task list
  • Double-data entry to support Paper or Hybrid studies
  • Real-time edit checks for accuracy Manage

Manage -Data Managers have increased visibility throughout the study and instant access to their data and task list.

  • Control data integrity with range checks and queries
  • Configurable field level and form level monitoring
  • Query management, alerts, and dynamic schedules
  • Role-based access and user management

Analyze & Export –Capturing and managing data in real-time with a unified database gives you full control.

  • Ad-hoc reporting and analysis
  • On demand export to SAS, Tab-delimited, and others
  • Standard and custom reports; Patient casebooks
  • Submission-ready reports and data sets

Medrio is unique in that you’ll be able to have full control of your study from beginning to end without relying on Medrio.

For further information about Medrio products and services, please contact Medrio directly.  If you are looking for a study builder to support your clinical trials and study build using Medrio, please use the contact form.

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 Clinica.

Trademarks and Copyright
All trademarks on this web site are the property of the {EDC} Developer, unless otherwise noted or in any other way perceivable as third party rights. The logos and trademarks or other materials used on this article are property of Medrio.

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