Frequently Asked Questions
How are my patient volunteers protected from undue risk?
- You are provided all safety, efficacy, and compound information prior to the trial. Your review of the protocol and the Investigative Drug Brochure will enable you to review all information known to date on the medication being used in the study.
- Prior to participating each subject must meet the protocol mandated inclusion/exclusion criteria. These requirements, along with other mandated safety parameters, will enable you and ECR to limit risks to patients.
- All Serious Adverse Events are reported throughout the trial. You will have access to them and the medical information they contain.
- All patients are given an Informed Consent Form, and must sign this document before participating. This document outlines all potential risks and benefits related to participation.