Fuzzy (niet) Te Koop

Nog een dag dan krijg ik een hond. Champ has been in Panama for several years and with family issues, I decided to get me another White Westie. I told my partner and even though my partner was not convenience, we head out North of Holland to find a white westie.

As we arrived, I hear a lot of barking. blaffenblaffen! As we approach the area where they have the white westie puppies, one came over to me. The puppies were friendly and playful not realizing they were females pups. I didn’t want a female dog so we asked if they had any males left. Indeed. There were two left. One was quiet and not interested in us and the other one kept coming towards us. As we asked more questions, I decided we should leave and keep looking. As we try to make our way outside, I noticed that one of them kept looking at us. Like saying ‘take me, take me’. Nu krijg wij hond. So we did.

Fuzzy te koop
Fuzzy te koop

 

 

 

Maar het is geen waakhond. Fuzzy blaft niet. Een hond die niet blaft?

Fuzzy rent hem na. Fuzzy runs after every car or motorcycle that makes noise. Or barks at everything that makes noise.

Some people are bang van honden. Hoewel mensen niets speciaals doet, lijkt het toch alsof alle honden op hem blaffen en grommen.

Honden zijn eng

Fuzzy has now turned 5 years old. He is loved with his own personality and full of energy. I regret not having training him properly because sometimes I want to get rid of him and find him a new home. Mijn hond kan het best. Maybe it is time to call on Cesar Millan’s– Dog Whisperer . 🙂

Het is al heel laat! Fuzzy (niet) te koop…

 

Bekers Zeven – 7 of Cups

This card means I have to choose between many options, all of which may be tempting but only one of which is the best choice. At others times not all of  choices are real options at all; they are delusions of the imagination.

This year I found myself trying to choose between the old or new path. Between my heart and head. Life is about choices.  I have been pulled into different directions.

Anywhere but Here. ..

It is time to let go of the past and let a new love and life in.

Is it the light at the end of the tunnel ?

You may also be feeling like you have too many choices and all of them look good. It’s like going into your favorite restaurant and not being able to decide between which meal to order, so you end up order two appetizers, one entree, order for your spouse so you can share with them and finish that off with a dessert. You order too much food and get to take it all home in a doggie bag for later. Yvonne Koelemeijer
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Pentakels Tien – Ten of Pentacles

The ten of pentacles is coming…

Ten of Pentacles

 

Feel like you have it already!

This is one of the best financial cards you can get during a tarot reading. Big money coming into the home. I remember my last tarot reading, there were pentacles everywhere but not all pentacles mean money.

A period of fullness and security

De kaart staat ook voor zekerheid van werk, goede onderhandelingen, ander gunstige zaken, een goed salaris en succes op het materiële en ideële vlak.Yvonne Koelemeijer

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Somebody That I Used To Know

Video – Gotye

When you spend quality time with your loved ones…

lastlovenote
lastlovenote

 

 

 

 

 

 

 

 

 

 

 

 

A waste of love, time and money-Yvonne Koelemeijer

As hard as it is, there is an important karmic lesson to be learned from each relationship we experience in our lives. One must remember that every ending is a blessing in disguise, for there is always a new beginning that follows it. You will love again. Like they say. What you are looking for is looking for you!

 

Anastasia – Left Outside Alone

Anastacia – One Day In Your Life

Yvonne Koelemeijer

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.” Monique Dinandt

How to document the testing done on the edit checks?

Since the introduction of the Electronic Data Capture (EDC) in clinical trials where data is entered directly into the electronic system, it is estimated that the errors (e.g. transcription error) have been reduced by 70% [ Clinical Data Interchange Standards Consortium – Electronic Source Data Interchange 2005].

The Data Management Plan (DMP) defines the validation test to be performed to ensure data entered into the clinical database is complete, correct, allowable, valid and consistent.

Within the DMP, we find the Data Validation Plan. Some companies call it ‘DVS’ others ‘DVP’.  The Good practices for computerized systems in regulated GxP environments defines validation as a system that assures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, qualification, maintenance, and retirement.

As an {EDC} Developer or Clinical Programmer, you will be asked to:

  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordinate of UAT of eCRF build with clinical ops team members and data management and validating documents, included but not limited to: edit check document, issue logs, UAT summary report and preparation and testing of test cases.

Remember not every EDC system is alike. Some systems allow you to perform testing on the edit checks programmed; others allow you to enter test data on a separate instance than production (PROD).

Data Validation and UAT Module.png

For example, some EDC systems facilitate re-usability:

  1. There is a built-in test section for each study – where data can be entered and are stored completely separate from production data. This allows you to keep the test data for as long as needed to serve as proof of testing.
  2. The copy function allows for a library of existing checks (together with their associated CRF pages) to be copied into a new study. If there are no changes to the standard checks or pages then reference can be made back to the original set of test data in a standards study, thus reducing the study level overhead.
  3. The fact that many of the required checks (missing data, range checks, partial dates etc.) do not require the programming of an edit check at all. Each of these and many others are already there as part of the question definition itself and therefore do not need any additional testing or documentation for each study.

If you have not documented, you have not done it-FDA

The “ideal world” scenario would be to reduce the actual edit check testing by the system generating a more “human readable” format of the edit checks. The testers that way would not have to test each boundary conditions of the edit checks once the system is validated. All they would have to do is inspect the “human readable” edit checks vs the alerts and would also be easy for the clients to read and sign off.

You can leverage the EDC systems audit trail under certain conditions. First of all – the system you are testing with must be validated in itself. Some EDC products are only ‘validated’ once a study is built on top of them – they are effectively further developed as part of a study implementation process – in this situation, I would doubt you could safely use the audit trail.

Secondly, you need to come up with a mechanism whereby you can assure that each edit check has been specifically tested – traceability.

Finally, you need to secure the test evidence. The test data inside the EDC tool must be retained for as long as the archive as part of the evidence of testing.

The worst methods in my view are paper / screenshot based. They take too long, and are largely non-reusable. My past experience has been creating test cases using MS Word then performing each step as per test case and take a screenshot, where indicated. Then attached to the final documentation and validation summary. This obviously a manual and tedious process. Some companies create test cases using HPQC or similar tool. This is a bit more automated and traceable yet, it is still prone for errors. It is better than documenting using MS Word or Excel but it is still a manual process.

Re-usability is what it is all about, but, you need to ensure you have methods for assuring the test evidence produced for edit checks you are reusing is usable as part of the re-use exercise.

Edit Check Design, Development and Testing is the largest part of any typical EDC implementation. Applying methods to maximize quality and minimize time spent is one of the areas I have spent considerable time on over the last couple of years.

For additional tips on writing effective edit checks please go here -Effective edit checks eCRFs.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Source images: provided courtesy of Google images.

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Count the number of discrepancies per procedure – OracleClinical (OC)

Let’s now write a quick program to count the number of discrepancies per procedure in OC/OCRDC:

Remember to comment /**/ or ***comment here*; what the program does. It is a good clinical practice to document everything so anyone can read your program and make the necessary updates, if necessary.

proc sql;
connect to oracle(path=ocpath);
create table discr as select * from connection to oracle
(Select  p.name, pd.test_order_sn detail, count(pd.test_order_sn) count, p.procedure_id procid
from discrepancy_management dm,
procedures p,
procedure_details pd
where dm.clinical_study_id=9999
and dm.procedure_id = p.procedure_id
and dm.procedure_detail_id=pd.procedure_detail_id
and p.PROCEDURE_VER_SN=pd.PROCEDURE_DETAIL_PROC_VER_SN
and dm.PROCEDURE_VER_SN=p.PROCEDURE_VER_SN
and dm.de_sub_TYPE_CODE=’MULTIVARIATE’
group by p.name, pd.test_order_sn, p.procedure_id
order by count(p.name)desc
);
/*document your code*/
proc sql;
connect to oracle(path=ocpath);
create table name as select * from connection to oracle
(select distinct p.procedure_id procid, p.name, pd.TEST_ORDER_SN detail
from  procedures p,
procedure_details pd
where p.clinical_study_id= 9999 *replace with your studyid;
and p.procedure_status_code !=’R’
and p.procedure_id=pd.procedure_id
order by procid
);
quit;

/* merge # of discrepancies with name */
proc sort data=discr;
by procid;
run;

proc sort data=name;
by procid;
run;

data discname;
merge discr (in=d) name (in=n);
by procid;
if n;
run;

proc sort data=discname ;
by descending count ;
run;

/* print out  */
proc print data=discname label;
var name numdisc percent numdcf;
label numdisc = ‘Number of discrepancies’
numdcf = ‘Number of DCFs’;
title “Number of discrepancies per Procedure”;
title2 “RA eClnica”;
run;

You could also export the report to Excel xls and have your DM / data manager review it.

Good luck and let me know if it was helpful.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Zwaarden Tien – 10 of Swords

Everything that meant to happen..happened! Now it is over/ done.

When you get a 10 of swords on a tarot card readings it means the swords are stuck on the back. The betrayal (backstabbing) has been done.

There was a third-party situation. They lied about this third-person. The past, the ex-lover, ex-fantasy, ex-unfinished business. They betrayed (backstabbed) my love and my trust. Monique Dinandt

I gave 80% and the other person 20%.

They drained me financially, emotionally and physically. This was a narcissistic, lying and manipulative person. It was their way or no way.

They love the attention of other and flirted with other people behind my back. The only problem is that they forgot I am a programmer and into computers. I read and saw everything. They keep lying and backstabbing after this day not realizing I can read it all.

WHAT YOU DON’T KNOW ABOUT THE OTHER PERSON? Be aware – keep your eyes on the price!

tarot10swords

Zwaarden Tien-images by Google https://wintersession2012.wordpress.com/2012/01/10/10-of-swords/#jp-carousel-1591

Zwaarden Tien gaat altijd om een pijnlijk afscheid dat je beleeft met een bezwaard gevoel of met opluchting.

In relaties geeft Zwaarden Tien aan dat je “er een eind aan maakt”. Het kan gaan om het einde van een echte bedrukkende en slechte relatie. Meestal gaat het er meer om dat je met de kracht van je verstand je gevoelens afsluit en op die manier iets wat belangrijk is wegstopt. Hierdoor kan de wisselwerking in de relatie verstoord worden.


De zwaarden zijn over onze mentale wereld en de verschillende staten van het feit dat we ons in. Elke keer dat ik trek de Tien van Zwaarden voor iemand ik weet dat deze persoon heeft een zeer slechte staat van de geest. Dit is niet een happy place to be. Een heleboel keer je zal gaan door middel van een uiteenvallen van een relatie, een scheiding, een verlies, of een soort van verdriet met een relatie. Soms is het misschien heb je je hart in uw bedrijf en uw carrière geïnvesteerd en je hebt getroffen door een enorme tegenslag of er iets is niet erg goed komen, zodat je een staat van totale ondergang en wanhoop voelen. Yvonne Koelemeijer

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

A quick way to find duplicates from external lab data

There are many different options to find a duplicate obs or data using SAS.

I have just received data from an external service provider and I want to compare it with my EDC lab data. My goal is to find any duplicates before is useful or before I can compare it with my lab data.

My external data has over 400 records so this will be a tedious job if I use excel (the original format). This review could take over a few hours, but with SAS, we can do this in less than 30 mins.

A simple SAS program:
over 400 records…

This is our SAS code:

SAS code to find duplicate data from an external source

This is our final output. We found the duplicates including empty rows.

external data
external data, lab data

 

 

 

 

 

 

 

 

It is important to note that not all duplicates can be deleted or found. Further review by your clinical team members is required. Once we are confident that duplicates have been removed, we know our data set is more accurate.

One last thing: How to get this data onto SAS so we can perform this task? Here’s a snippet:

  1. Import the file using PROC IMPORT (assuming you have DBMS ACCESS)
  2. You can use a permanent or temporary library. In this example, we created a temporary lib name = IMPORT
  3. We want to bring over the column names as var names using GETNAMES=YES statement

PROC IMPORT OUT= WORK.IMPORT
DATAFILE= “H:\Labs\LocalLab\LabDataReview.xls”
DBMS=EXCEL2000 REPLACE;
GETNAMES=YES;
RUN;

Now you have learned a quick way to find duplicates on your external data. I hope this piece of code will make any data manager job easier. Remember, you can always enhance this program (add labels, formats, etc) and improve efficiency.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Mi Alma Fantasma (My soul)


Dana Kerstein (with lyrics)

These past few years, I have embarked on a spiritual journey. That journey has ended. I found the answers to my questions (even though most of it is a painful discovery, I believe this is the end of that journey). A new cycle of my career and personal life has started and I’m looking forward to this new beginning.

There are things we can’t do alone. Argue, climb and hold the ladder at the same time, etc. We think that we should have live as a couple or with your ideal partner. Even if your partner is very strange. The fact is, there are couples that ended out like a three (3) – third-party involvement; or couples that separate; there are couple that are just simple impossible or incompatibles; or couples that can still continue as a couple due to family commitments or routine, when at some point in time, there was a couple. Couples that were and today are nothing. And that’s what scare us the most in this life. When a couple breaks down, for whatever reason, the first feeling we feel is panic. The loss of control of our life and to feel alone.

The most important thing in this life is to learn how to fly alone!

So now that I am back, I am looking forward to sharing some new insights on CDISC/SAS mapping projects, new EDC systems I am testing out and some old coding.

Note: Please note I am not longer available for consultation or business. Do not contact me via the contact on this blog. I will not return your request.

Mi Alma Fantasma Yvonne Koelemeijer

Escucho un susurro silencioso,
sé que eres un fantasma,
y observo que tu sombra tarda en marcharse…
Y siento tu fantasma…

¿Cuánto tiempo; cuán lejos necesito ir?
Antes de que tu corazón roto
se abra y tome mi alma…
mi alma…

Dentro de las oscuras esquinas de una mente atormentada
veo imágenes dispersas de un solitario niño

¿Cuánto tiempo?, ¿cuán lejos necesito ir?
Antes de que tu roto corazón
se abra y toque mi alma…
mi alma…

Y todo lo siento dentro de mi,
es un espacio vacío,
sé que deseas aparecerme
pero no dejas tu rastro..

¿Cuánto tiempo?, ¿cuán lejos necesito ir?…
Antes de que tu corazón roto
se abra y toque mi alma…
mi alma
mi alma
mi alma

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”