21 CFR and Passwords: Mistakes You Don’t Want to Make

The free Internet that many of us loved has become a surveillance web, serving governments and mega-corps, while abusing the rest of us. It is important that you start protecting your data, while browsing the internet and using communication tools while performing your role. This article will guide you through a new set of skillsContinue reading “21 CFR and Passwords: Mistakes You Don’t Want to Make”

Data Management Plan in Clinical Trials

  The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning. The data management plan typically contains the following items. They are: Introduction/Purpose of the document Scope of application/Definitions Abbreviations Who/what/where/when Project Schedule/Major Project Milestones Updates of the DMP Appendix The objective of thisContinue reading “Data Management Plan in Clinical Trials”

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 characteristicsContinue reading “CDISC Clinical Research “A” Terminology”

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 madeContinue reading “Acme Pharma Develops A Drug: Part I”

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 systemsContinue reading “Clinical Trials Terminology for SAS Programmers”

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 inaccurateContinue reading “Adverse Event Monitoring for CRAs”

Introduction to Clinical Trials

Video introducing cancer clinical trials and their use in clinical practice guidelines -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 beContinue reading “Introduction to Clinical Trials”

Standard Naming Conventions for InForm Trials

This document is intended to provide a common set of rules to apply to the naming of clinical trials build using InForm EDC system. Why use naming conventions? Naming objects consistently, logically and in a predictable way will distinguish similar records from one another at a glance, and by doing so will facilitate the storageContinue reading “Standard Naming Conventions for InForm Trials”

The Next Best Thing – Timaeus Trial Builder?

First of all, let me clarify by saying that I am not an expert when it comes to Timaeus. I recently came across this EDC tool while working on a project. We were testing out different EDC applications as part of their new infrastructure solution. At first, I was hesitant to learn about it. AllContinue reading “The Next Best Thing – Timaeus Trial Builder?”

CDER Common Data Standards Issues Document

 Source: FDA (Version 1.1/December 2011)  The Center for Drug Evaluation and Research (CDER) is strongly encouraging sponsors to submit data in standard form as a key part of its efforts to continue with advancement of review efficiency and quality. CDER has been collaborating with CDISC, a standards development organization (SDO), in the development of standards toContinue reading “CDER Common Data Standards Issues Document”