Data Management Plan – Protocol Summary

This usually describes the management plan for the data collected  during the project. It is a brief description or synopsis of  the protocol. The protocol, in terms of a clinical research study, is the plan, or blueprint, that describes the study’s objectives, methodology, statistical considerations, and the organization of the study. [CDISC.org Oct. 2012]  Continue reading “Data Management Plan – Protocol Summary”

Informed Consent Content and Process Requirements

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 ofContinue reading “Informed Consent Content and Process Requirements”

What is a clinical protocol?

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 ofContinue reading “What is a clinical protocol?”