Category Archives: Knowledge Areas

Motto of the Month

It’s better to know it and not need it than it is to need it and not know it. Bill Benson

‘Tis a lesson you should heed

Try, try, try again.

If at first you don’t succeed,

Try, try, try again.

 

Source:

pictures courtesy of Google images.

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).

Society of the Sojourner – Part III (Moving to The Netherlands)

As I mentioned in part II, a psychic told me I would move overseas – to a place surrounded by water. 

I honestly never thought of living in Europe until I came to the Amsterdam Central train station to meet up with someone. That day it changed my life forever.

Most of the time, I never felt like home. I have this ‘melancolia‘  or ‘saudade‘ as we say in Portuguese. The Dutch have a nice word for it ‘Heimwee‘. I was missing stuff from home.

One day you are riding a Corvette the next you’re riding a bike in Holland. Life is so wonderful unpredictable sometimes.

Working in Holland with a high cost of living and high taxes is not a good reason to move there so there must be a convincing motive ….love. Nothing else, nothing less. I came here for love.

How romantic but romance alone cannot get you far. I always regarded myself as an independent person, and not the marrying kind. But that changed dramatically when I saw Yvs. The moment I look into to Yvs eyes I saw myself holding a ring.

The Dutch always find a good reason to buy flowers for their loved ones. Call me crazy but I fell head over heels in love with Yvs.

The long-distance relationship was not working out. So I packed my bags and moved to Holland.

Holland, a country full of Dutch people. The open-minded, laidback Dutch. The warm, the cozy and the nosy Dutch. The Dutch with their big mouth for such a small country. Strange and different from all of us.

Everything is Holland is so regulated.  And who has to pay for all of this? Me and You. Making more than 55K euros a year means paying more taxes (52%). And before making any money at all, you have to register with the local government called ‘city council’ then get a SOFI or BIN number. They make me felt like a number.  Lost amount creatures from another planet, with different traditions, rules and regulations.

There is a lot of good stuff too. Like public transport. Always on time and well-organized. But how hard can it be in such a small country? And food, how should I put it? They have this very unique Ollie-bollen, or (Oliebollen) or Dutch doughnuts. There are my favorites but only available between Christmas and New Year’s eve.

The Dutch Language? To me and to many foreigners, Dutch sounds like you are spitting up. However, the good thing about Holland, most Dutch speak good English. It is advisable, however, to master the local language.

Dutch or no Dutch. I always say ‘Home is where the heart is‘ and that’s got nothing to do with words. It is a feeling.

The Dutch are not the friendliest people you will ever meet. If you are expecting service with a smile you will get “we are working on it“.

The Dutch like the climate. Sometimes it rains. Sometimes it rains.

I’ve had my moments of doubts but I have no regrets. I enjoy every minute of my new life with Yvs. If I had a chance to go back in time, I’d do it all over again, right now.

Until the next Society of the Sojourner IV -to be continued. Until then…

 

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.

Fair Use Notice: This article/image/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}.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Motto of the Month – Those Who walk Alone

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).

Dov’è l’amore – Non c’e nessuno – Dov’e se, amore mio

“Dov’e L’Amore”

Dov’e se adesso
Dov’e se, amore mioDov’e l’amore
Dov’e l’amore
I cannot tell you of my love
Here is my storyI’ll sing a love song
Sing it for you alone
Though you’re a thousand miles away
The feeling so strong

Come to me, baby
Don’t keep me waiting
Another night without you here
And I’ll go crazy

There is no other, there is no other
No other love can take your place
Or match the beauty of your face
I’ll keep on singing ’til the day
I carry you away
With my love song
With my love song

Dov’e l’amore
Dov’e l’amore
Where are you now, my love?
I need you here to hold me

Whispered so sweetly
Feel my heart beating
I need to hold you in my arms
I want you near me

Come to me, baby
Don’t keep me waiting
Another night without you here
And I’ll go crazy

There is no other, there is no other
No other love can take your place
Or match the beauty of your face
I’ll keep on singing ’til the day
I carry you away
With my love song
With my love song

Non c’e nessuno
Non c’e nessuno
Non c’e nessuno
Bello come te, e ti amo

[English translation:
There is no other
There is no other
There is no other
As beautiful as you, and I love you]

Come to me, baby
Come to me, baby
Another night without you here
And I’ll go crazy

There is no other there is no other
No other love can take your place
Or match the beauty of your face
I’ll keep on singing ’til the day
I carry you away
With my love song
With my love song
With my love song
With my love song

Where’s the Love – By Cher from the Believe album

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).

I still Cry – Ilse Delange

I Still Cry
I’m making flowers out of paper
While darkness takes the afternoon
I know that they won’t last forever
But real ones fade away to soon
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
It’s just that I recall September
It’s just that I still hear your song
It’s just I can’t seem to remember
Forever more those days are gone
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
I still cry sometimes when I remember you
I still cry sometimes when I hear your name
I said goodbye and I know you’re alright now
But when the leaves start falling down I still cry
But when the leaves start falling down I still cry
Source: LyricFind

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).

Clinical Trials – Computerized Systems

The Food and Drug Administration (FDA) established the Bioresearch Monitoring (BIMO) program of inspections and audits to monitor the conduct and reporting of clinical trials to ensure that data from these clinical trials meet the highest standards of quality and integrity and conform to FDA’s regulations.

Computerized systems used in clinical trials refer to the creation, modification, maintenance, archiving, retrieving or transmitting clinical data intended for submission to the Food and Drug Administration (FDA).

Key Definitions:

Audit Trail: a secure, computer-generated, time-stamped electronic record that allows reconstructions of the data course of events relating to the creation, modification, and deletion of an electronic record.

Certified Copy: it is a copy of the original information that has been verified, as an exact copy having all of the same attributes and information as the original. It must have a dated signature.

Computerized System: it is the computer hardware, software, and associated documents (i.e manuals) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial.

Electronic Case Report Form (e-CRF): designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.

Electronic Patient Diary: an electronic record into which a subject participating in a clinical trial directly entrees observations or directly responds to an evaluation checklist or questionnaire

Electronic Record: a combination of text, graphics, data, audio, pictorial, or any other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.

Electronic Signature: a computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be legally binding equivalent of the individual’s handwritten signature.

Software Validation: verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose. For these guidelines, the design level validation is that portion of the software validation that takes place in parts of the software life cycle before the software is delivered to the end-user.

Source Documents: original documents and records including, but not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments,copies or transcriptions certified after verification as being accurate and complete, microfiches,photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.

Principles:

Security measures should be in place to prevent unauthorized access to the data and to the computerized system.

1-Identify at which steps a computerized system will be used to create, modify, maintain, archive, retrieve, or transmit data.

2-Documentation should identify what software and, if known, what hardware is to be used in computerized systems that create, modify, maintain, archive, retrieve, or transmit data. This document should be retained as part of the study records.

3-Source documents should be retained to enable reconstruction and evaluation of the trial.

4-When original observations are entered directly into a computerized system, the electronic record is the source document.

5-The design of a computerized system should ensure that all applicable regulatory requirements for recordkeeping and record retention in clinical trials are met with the same degree of confidence as is provided with paper systems.

6-Clinical investigators should retain either the original or a certified copy of all source documents sent to a sponsor or contract research organization, including query resolution correspondence.

7-Any change to a record required to be maintained should not obscure the original information. The record should clearly indicate that a change was made and clearly provide a means to locate and read the prior information.

8-Change to the data are stored on electronic media will always require an audit trail, in accordance with 21 CRF 11,.10(e). It should include who made the changes, when, and why they were made.

9-The FDA may inspect all records that are intended to support submissions to the Agency, regardless of how they were created or maintained.

10-Data should be retrievable in such a fashion that all information regarding each individual subject in a study is attributable to that subject.

11-Computerized systems should be designed so that all requirements assigned to these systems in a study protocol are satisfied and to preclude errors in data creation, modification, maintenance, archiving, retrieval or transmission.

As we read in this blog about guidance for the industry around computerized systems revolts around data quality and data integrity. The users or people using the data from these systems should have confidence that the data are no less reliable than data in paper form.

In the next blog, we will cover audits and inspections, data entry into this computerized system, security and electronic signatures as a way of certifying the data.

Source:

CFR 11 and ICH

FDA.com

 

 

 

X EDC: The Next Generation of EDC?

RaveX is an EDC system that is powerful and easy to learn. Medidata has one of the best eLearning and training courses to get anyone up and running from the first time you use the system.

The study design setup still requires high technical skills including C# sharp for most complex data cleaning and study setup tasks.

Let’s discuss the new study hierarchy:

We already understand the relationship between the studies, sites, and subjects in Rave EDC.

At the navigation bar in RaveX EDC, we choose the study from the list of studies assigned to your role. At the second level, we can see the study dashboard. The dashboard contains information about the sites and subject enrollment.  From the sites, you can drill down to the subject level or subject related eCRFs.

Subject’s landing page:

  • Access eCRFs
  • Perform role-specific functions (e.g. SDV, DM data review, PI signature, enter data)

Understanding Status Icons in EDC:

On a form, when you click on an icon, the action is taken on that data point. Based on your roles and permissions, you could apply this action individually or to “Apply All”.

Common status icons:

When you select a subject, you arrive at the subject landing page. Some old features are the scheduled visit dates (a feel and look of the matrix in Rave Architect), the subject status and the status of their eCRFs and some additional information.

At the scheduled level (for Oracle InForm users, this is the Time and Event Scheduled with the traffic lights), you can open a folder and access a particular form residing on that folder.  You can then proceed with normal data entry.

There are several ways to access the same eCRF for another subject. Navigate to it by selecting a subject from the subject list.

Performing data cleaning and data review:

At the study level, select the RaveX study then select the study name you would like to perform a task.

On the screen, select ‘View Task Management’ link and then select the open queries link. At this level, you can select the particular subject and form a query that is opened on. For example, I noticed an open query on the informed consent form. To view it, select the query link on the screening informed consent row.

What modules are still available in this new design?

  • Rave Architect
  • Rave User Administration
  • Rave Site Administration
  • Rave Reporter
  • Rave Configuration
  • Rave PDF Generator
  • Rave Lab Administration
  • and more…

Overall, the EDC solution has been easy to use for database development, data entry, and data validation. The online, real-time validation feature is a plus as it does no longer requires the form to be saved for the checks to fire.

Have we lost any features to this new fancy design? Find out next.

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).

911 – Silence

Another year has passed and another year that the culprits of 911 are at large while the war on terror (aka the war on YOU) continues.

The only ones beneficiating from 911 war on terror are the same calling for more wars, more security at the airports (of course, they have the contracts for those machines causing cancers and the security agencies are all from the same group of people)

In order to keep the wars, they need more taxes.

He who has ears to hear, let him hear.

Follow the Money….before, during and after 911

A Conspiracy Theory that happened to be truth…

To Mossad from Dick Chenney – The Elephant in the room…

Methodical Deception

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).