Clinical Trial Documentation – Clinical Study Protocol

Posted on Updated on


Learn Clinical Research with AuroBlog

Clinical Trial Documentation – Clinical Study Protocol

As per ICH GCP E6 R1 Protocol  is defined as :

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. 

CSP, clinical trial, clinical research

 

A Clinical Trial Protocol should include the following topics:

  • Title Page (General Information)
  • Background Information
  • Objectives/Purpose
  • Study Design
  • Selection and Exclusion of Subjects
  • Treatment of Subjects
  • Assessment of Efficacy
  • Assessment of Safety
  • Adverse Events
  • Discontinuation of the Study
  • Statistics
  • Quality Control and Assurance
  • Ethics
  • Data handling and Recordkeeping
  • Publication Policy
  • Project Timetable/Flowchart
  • References
  • Supplements/Appendices
Advertisements

Let us know what you think!

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s