Tag Archives: data management clinical

For Once, in the Right Place at the Right Time?

Dutch Windmills
Learning a Language – Courtesy of Babbel

One of the hardest obstacles I have had to overcome since actually ‘levende’ here as opposed to having a ‘vakantiehuis’ is having a broaden my use of Dutch. Let’s face it, the vocabulary used for shopping, restaurants, the weather and other public places isn’t much use when trying to sort out business professionals, government officials and the like. Your neighbours also expect a little more variety of conversation than ‘goedemorgen, dag, tot ziens’ when they are seeing you on a regular basis.
Learning is a very personal thing dependent on what suits you best and what kind of learner you are. Let’s just say that my memory is not what it used to be!

As far as how these experiences applied to the clinical work or projects, you need to have certain things in place:

  • Discipline and deadlines. Do not confuse this with ‘time management’. I am sort of a person who works better under pressure. Consistency is key to language learning. You can make progress in any language or technology with just a few minutes a day.

Time Management is an illusion. Time cannot be managed. All we are able to manage are activities. Bob Proctor

    • Revision. Being able to speak multiple languages in Europe is common. Most Europeans citizens speak on average two (2) languages some even three or four. Even though I can speak three (3) languages with ease, I really need so much learning with the Dutch. It is not use assuming that I have mastered one verb and then moving onto the next because I won’t have. Same, when you learn a new EDC tool,  you need to practice and revisit all what you have learned. As they say, practice makes perfect!
Map of Europe - Blank Map (summer style)
EU Map – AVG Languages Spoken
  • Writing things down. I am a visual/show me first kind of learner so I take in information better once I have written it down and even better if I use my mind to map and draw it. So find what suits you best to improve your EDC learning experiences.
  • Speaking. I need to use the new material immediately for it to go into my memory. Learn to speak the EDC programming language.
  • Reading. This will improve your vocabulary and help you with the grammar and spelling. Spend time reading online blogs, biotechnology magazines, youtube technology channels and even your own company’s WPs / SOPs as they will help you be a better EDC developer.

The knowledge that my horizons can be so much wider than I thought, that you can communicate and connect with people and make a home in a different place. I have come to embody a very different mentality. Being here has given me many opportunities, but one of the biggest changes has been having the time and money to travel, and of course, learn to speak a new language.

I hope this helps. I have found some useful resources and they are listed all over this blog. In the future, I plan to add more resources and training materials. Remember that learning and development are lifetime activities—there’s no finish line.

Amazingly, I think I can be sure for once I was in the right place at the right time.

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}.

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CDISC Clinical Research “A” Terminology

acronym: A word formed from the beginning letters (e.g., ANSI) or
a combination of syllables and letters (e.g., MedDRA) of a name or phrase.
admission criteria:Basis for selecting target population for a clinical trial.
Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study.
algorithm: Step-by-step procedure
for solving a mathematical problem;
also used to describe step-by-step
procedures for making a series of
choices among alternative decisions to
reach a calculated result or decision.
amendment: A written description
of a change(s) to, or formal clarification
of, a protocol.
analysis dataset:An organized collection of data or
information with a common theme arranged in rows and columns and
represented as a single file; comparable to a database table.
analysis variables: Variables used
to test the statistical hypotheses
identified in the protocol and analysis
plan; variables to be analyzed.
approvable letter:An official communication from FDA to an
NDA/BLA sponsor that lists issues to be resolved before an approval can be issued.
[Modified from 21 CFR 314.3;Guidance to Industry and FDA Staff

arm: A planned sequence of elements,
typically equivalent to a treatment
group.

attribute (n): In data modeling,
refers to specific items of data that can
be collected for a class.
audit:A systematic and independent
examination of trial-related activities
and documents to determine whether
the evaluated trial-related activities were
conducted and the data were recorded,
analyzed, and accurately reported
according to the protocol, sponsor’s
standard operating procedures (SOPs),
good clinical practice (GCP), and the
applicable regulatory requirement(s).
[ICH E6 Glossary]
audit report: A written evaluation by
the auditor of the results of the audit.
[Modified from ICH E6 Glossary]
audit trail. A process that captures
details such as additions, deletions,
or alterations of information in an
electronic record without obliterating the original record. An audit trail
facilitates the reconstruction of the
history of such actions relating to the
electronic record.

Source:Applied Clinical Trials

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.

Acme Pharma Develops A Drug: Part I

Learn more about how the pharmaceutical industry has traditionally developed and brought drugs to market. Watch part II of this series to learn how Network Fortress can improve the drug development process and save pharma and biotech companies time and money.

-FAIR USE-
“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.”

SAS Enterprise Guide Tip: Exporting Results and Preserving Historical Versions

SAS Instructor David Ghan shows you how to keep historical versions of your exported results using SAS Enterprise Guide.

This material is covered in the SAS Training course “SAS Enterprise Guide 1: Querying and Reporting”. To learn more about this course, visit https://support.sas.com/edu/schedules.html?ctry=us&id=492

-FAIR USE-
“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.”

Assigning Libraries to Access and Store SAS® Data

Use SAS learning software to learn how to assign libraries to access and store SAS data.

-FAIR USE-
“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.”

Source: http://support.sas.com/learn/ondemand/professionals

Clinical Trials Terminology for SAS Programmers

Entry Level SAS Programmers

Statistical Programmer:requires him to program using the SAS language to analyze clinical data and produce reports for the FDA

Bioanalyst, Clinical Data Analyst, Statistical Programmer Analyst and SAS Programmer: same as Statistical programmer.

Biotechnology:companies which is a general term used to explain a technique of using living organisms within biological systems to develop micro-organisms for a particular purpose.

protocol:outlined all the procedures and contained detailed plans of the study.

controlled experiment: the clinical trial had patients grouped into different groups such as those in the placebo controlled group which had no active drug. This is how comparisons are made within the controlled clinical trial CFR Part 11:Code of Federal Regulations set by the FDA to regulate food, drug, biologics and device industries. The part 11 specifically deals with the creation and maintenance of electronic records.
Case Report Form or CRF:forms to collect information such as demographic and adverse events. Source Data or the information collected:which include important documents because they contain the core information required to reconstruct the essential capital of the study.
sponsor:company who is responsible for the management, financing and conduct of the entire trial. randomized: subjects that are randomly assigned to groups so that each subject has an equal chance to be assigned to the placebo control
baseline: subjects are assigned to their drug change from baseline:analyses that measure differences between baseline and current visit
placebo or sugar pill:is an inactive substance designed to look like the drug being tested. blinded:they do not know if the drug that they are taking contains the active ingredient.
open-label study:all was out in the open, the drug the subject is assigned to. Pharmacokinetics or PK:analysis of that study showed that with that dosing level, there were high levels of toxicity in the subject.
informed consent: described all the potential benefits and risks involved. TLGs: Tables, Listings and Graphs
trade name:drug name that is collected from the patient and recorded into the source data. For example: Tylenol generic name: refers to its chemical compound. For example: Acetaminophen.
WHO-DRUG: list all the drug names and how they matched to the generic drug names.This dictionary is managed by the World Health Organization MedDRA:This is short for Med (Medical), D (Dictionary), R (Regulatory), and A (Activities).
SAP: Statistical Analysis Plan ANOVA: analysis of variable
confidence interval:gives an estimated range of values being calculated from the sample of patient data that is currently in the study. null hypothesis:lack of difference between the groups in a report
pilot study:perform the same analysis upon an older. DIA: Drug Information Association
CBER: Center for Biologics Evaluation and Research (medical device) CDER: Center for Drug Evaluation and Research (drug)

Source:CDER Acronym List


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.

Adverse Event Monitoring for CRAs

During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events. The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of adverse events can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

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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.”

Tip #3 – Become an Expert at Debugging

Studies have shown that we spend 50% of our time debugging, but only learn debugging by trial and error. This webcast by John Robbins was in the top 10 favorites on Microsoft web site, and it is a real goldmine. Watch this 4-hour webcast on debugging, and you are bound to save many times that in the future. Here is the handout for the webcast – be sure to download the source code for the Visual Studio macros. John Robbins is the co-founder of Wintellect and the author of several books on .NET Debugging.

Check out http://idealprogrammer.com/ if you are new to VB.NET or ASP technology.

Build me a Database

A business leader wants a database

What is a Database?
A database is a collection of data. That may sound overly simplistic but it pretty much sums up what any database is.

Different type of databases: Oracle, SQL Server, MS Access, MySQL, Postgresql etc.

Oracle databases are the de facto standard for large Internet sites, and Oracle advertisers are boastful but honest when they proclaim,

The Internet Runs on Oracle.”

-FAIR USE-
“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.”