How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”. In InForm, this is accomplished by using a tool called ‘User Management Tool’Continue reading “How to Manage Sites and Users in InForm Trial?”

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”

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”

One Bad Day in a CRA’s Life

-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 fairContinue reading “One Bad Day in a CRA’s Life”

Role of Project Management and the Project Manager in Clinical Data Management

  The Project Manager is responsible for the development, oversight of implementation, and communication of clinical research studies. So what is a Project? A project is a work effort with a definite beginning and end, an identifiable end result (deliverable), and usually has limits on resources, costs and/or schedule. What is Project Management? The applicationContinue reading “Role of Project Management and the Project Manager in Clinical Data Management”