Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 8: Wrap Up (2019)

1. Monitoring Module & Clinical Research Professional Training
2. Clinical Trial Process: Identifying Legal Elements
3. Audience Polling: Questions & Answers
   • One key area where the 1572 form, CRFs and GCP all agree is:
     Answer: Investigator’s must be qualified and personally oversee the conduct of the study.
   • Investigator/Clinical Trial Agreements only address issues around payment.
     Answer: False
   • The recent changes to Good Clinical Practice in ICH E6 (R2) only impacted sponsors not sites.
     Answer: False
     Explanation:
   • When the investigator is also the study sponsor (IIT) they are responsible for ensuring the study is monitored.
     Answer: True
   • Form FDA 1572 commitments include which of the following?
     Answer: a and b (To conduct the study according to the protocol and to personally supervise the study)
   • All investigational studies require a 1572 form.
     Answer: False
     Explanation: Only studies involved with IND require 1572 form, It’s not required for observational trials & natural history trials
   • Frieda visits her physician in her hometown of Hamburg, Germany. Her physician accidentally sends all of Frieda’s medical records to the vendor who handles office supplies. This vendor is in Bakersfield, CA. What laws may apply?
     Answer: c) GDPR, because Frieda is a citizen of the EU & d) German privacy laws, because Frieda is a German citizen.
   • MonsterTech, with offices around the world, was found guilty of gross negligence in the illegal handling and sale of the personal information of 10,000 citizens of Paris, France. How much do they stand to be penalized?
     Answer: MonsterTech will lose up to 4% of all sales. World wide
   • Treating physician can file an Investigator Initiated IND for Expanded Access.
     Answer: True
   • FDA reviews Expanded Access for which of the following:
     Answer: All of the above
     Explanation: Patients should have a serious or immediately life threatening disease or condition, there should be no comparable therapies available and potential benefits justify the potential risks involved to expanded access review by FDA.

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu