Tag Archives: systems documentation

Where in the World is Ana?

First, I want to say thank you for reading my blog, connecting with me on LinkedIn or following whenever I go [thank you NSA].

Many of you, for months, have asked me if I was going to write more articles related to clinical trials. For sometime now, I have taking time-off from this EDC blog and concentrated on some other projects of equal importance. I will share some new insights and information as I get myself back on track.

So what is a girl who has a master’s degree in project management and computer networks doing as a programmer? It’s not that I didn’t like project management, per se. And entering in the IT network business years ago was quite difficult for girls like me in a world dominated by men. It’s basically that I didn’t find myself with the same passion for project management or computer networks that I have for programming and technology in general.

Because I am so interested in technology and programming, I tend to spend a lot more time than my peers in learning new technologies, and enhancing my existing skills. Many of my co-workers and ex-collega (Dutch) have commented on their admiration that my skill level is as high as it is, and that I am able to learn new technologies so quickly. But beyond just learning new technologies and APIs, I’m passionate about becoming a better overall programmer. Reason why in the last few months, I spent time learning IOs development (iPhone and Android apps). I am actually working on an app to ‘hack’ into my own car. šŸ™‚ Well, not exactly. I want to be able to open my car and do some other basic command (like opening the garage door) using an APP.

Given my degree in project management, it should be clear that I have useful skills beyond the programming world. In fact, having a project management background has helped me interface with various groups in various organizations in which I’ve worked.

I have installed, maintained, and designed numerous relational databases and small networks. As a freelancer, I have worked in projects doing data analysis, project support and computer training.

Now you know a little about me personally. If you think I might be the type of developer you’re looking for, feel free to browse my resume and contact me.

Anayansi Gamboa
Resume / CV .

Comments? Join us at {EDC Developer}

P.S. I will be releasing some training videos / training material for several EDC tools in the near future including tips and best practices. Price has not been setup yet. All training will be web-based, password protected. If you wish to consult with me for a face-to-face training or on-site training, please contact me to discuss further.

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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”.

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SAS Programmers Tools

Are you new to SAS and wondering how to write SAS programs?

Most SAS programmers use the built-in SAS enhanced editor for their daily works. Sometimes, this editor is replaced by the code editor of SAS Enterprise Guide which provide other features like the Log tab, Output data tab and Results tab. However, some SAS users like their text editor to be very customizable and full of features which may or may not be in the enhanced editor.

If you find that your current editor is insufficient in handling your work you are not alone. We have found some alternative editors and below are some of the text editors I have come across that you can use instead of the pre-built SAS editor:

TextPad: is a full-featured text editor offering a spelling checker, macros, and powerful formatting and file-storage options from Helios Software Solutions.

This is a great program – it’s a powerful text editing tool that’s really comfortable to use. Textpad has a very clean, simple interface that deals only with text – that is, it doesn’t let you change font halfway down the page, or make text underlined or italic; it’s built purely to deal with the content, and does that job EXTREMELY well.

These features are excellent for SAS macro programming and SCL programming. Besides these, Textpad has a built-in compiler for Java which allows for rapid switching to Java coding that is occasionally required.

Below is a screen shot of the editor:

Textpad has many macro features that allows for repetitive actions to be recorded and recycled easily.

Crimson Editor is a professional source editor for Windows Open source from Ingyu Kang and one of the most popular editor available for programmers to use.

This editor also allow programmers to install schematics (define tools) that will highlight sections of your SAS programs.

Below is a screen shot of the editor:

In summary, there are many options to help a SAS programmer increase efficiency, write cleaner code, or make SAS life easier. There are other popular editors such as Emacs but I don’t have a lot of experience using it thus I cannot comment on it properly. Your style of programming will influence the type of editor you will use.

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.

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, sponsorā€™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.

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Assigning Libraries to Access and Store SASĀ® Data

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

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

Working with SASĀ® Enterprise GuideĀ® Projects

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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.

Tip #5 ā€“ Download library of 200+ Code Samples

Download 200+ highly organized code samples with a single click of the mouse. Each sample includes an explanation of the syntax involved.

This library can become a programmerā€™s expanding toolkit that will rapidly increase productivity over time. Progress Monitor members can always download the latest version of this growing library as a single file.

CodeSamples

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

Tip #4 ā€“ Install LinqPad

Tired of querying in antiquated SQL?

Well, you donā€™t have to! LINQPad lets you interactively query databases in a modern query language: LINQ. Kiss goodbye to SQL Management Studio!

LinqPad comes with 100s of great LINQ samples. Work through the 5-minute induction under the Samples section after installing Low Impact version of LinqPad 4.0.

LinqPad

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

I Need a Relational Database

What is a Relational Database?
A relational database is a collection of database objects: tables maintaining relationships based on the primary/foreign key principle, various means of manipulating these tables, and the rules that enforce the relationships and their integrity. Unlike spreadsheet tables or flat files, RDBMS tables are related in a parent/child-like relationship.

This video was made and uploaded with Xtranormal’s State

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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.”