ICH E6 GCP - IRB

Question 1

IRB Function - ICH

Answer 1

1. Safeguard the rights, safety, and well-being of all trial subjects
2. IRB should obtain ICFs, IBB, Safety info, compensation info
3. Should consider qualifications of the investigator
4. should conduct continuing reviews
5. IRB may request addtl information
   6./7. IRB should determine that the proposed protocol address relevant ethical concerns and regulatory requirements
6. review the amount and method of payment to subjects to ensure no coercion
7. ensure information regarding payments is given to subkects in the ICF

Question 2

IRB Composition - ICH E6 GCP

Answer 2

-Made up of at least 5 members
-1 member must be in a nonscientifc area as primary area of interest
-1 member should be independent of the institution trial site

Question 3

IRB Procedures - ICH E6 GCP

Answer 3

1. Determine IRB composition
2. Scheduling/notifying members of meetings
   3/4. Conducting initial/continuing reviews and determining the frequency
3. Providing expedited review
4. Specifying no subject should be admitted to a trial without IRB/IEC approval
5. Specifying no deviations from approved protocl
6. Specifying the investigator should prompty report to the IRB
7. Ensuring the IRB is prompty notifying the insitution.investigaro its decisions, the reasons for their decisions, and procedures to appeal

Question 4

IRB Records - ICH E6 GCP

Answer 4

-Should be maintained for 3 years following completion of the trial