Investigator Responsibilities - ICH

Question 1

Responsibilties

Answer 1

1. Investigational Products
2. Need to be in Compliane with Protocol
3. Randomization/Blinding
4. Informed Consent
5. Records
6. Safety Reporting
7. Progress reports
8. Delegation Log
9. Premature Suspension (Steps Investigators take)
10. Final Report

Question 2

Randomization and Blinding

What role does investigator have in this? (ICH)

Answer 2

Randomization: investigator should follow randomization procedures and only break randomization in accordance with the protocol

Blinding: Investigator tells sponsor about premature blinding

Question 3

What is the investigator responsible for in regards to records?

Answer 3

Investigator is repsonsible for accuracy and completeness of records
Records should be dated, initialed, and have an explanation

Question 4

Safety Reporting

Answer 4

SAE - Should be reported immediately to the sponsor and then followed up with a detailed written report

AE - reported to the sponsor according to reporting requirements specified by the sponsor in the protocol

Question 5

Progress Reports

Answer 5

Submitted to the IRB annually

Question 6

Delegation Log

Answer 6

Investigator is reponsible for maintaing this

Question 7

Premature Termination/Suspension

Answer 7

1. If terminated/suspended w/o prior agreement, Investigator informs institution, sponsor, IRB/IEC, then provides an explanation
2. If sponsor terminates/suspends, investigator tells the institution, IRB, and then provides IRB/IEC with an explanation
3. If trial is ended prematurely, investigator informs subjects