ICH Guidelines

Question 1

Standards for Expedited Reporting

Answer 1

Adverse Drug Reactions (ADR) that are serious and unexpected
(As well as Increased rate of occurrence for expecteds)

Question 2

Inappropriate Expedited Reporting

Answer 2

Serious but expected
Serious, expected or not, but not related to study product
Non-serious, expected or not

Question 3

Fatal or life-threatening unexpected ADR reporting timeline

Answer 3

ASAP, but no later than 7 calendar days after first knowledge. Report must be completed within additional 8 days of initial notification

Question 4

Serious, non-fatal or life threatening unexpected ADR reporting timeline

Answer 4

ASAP, but no later than 15 calendar days after first knowledge

Question 5

Minimum criteria for reporting

Answer 5

Identifiable patient, suspect medical product, identifiable reporting source, and the event or outcome that is serious and unexpected, with reasonable causal relationship

Question 6

IRB Required Documents

Answer 6

Trial protocol
ICF
Subject recruitment materials
Information to be provided to subjects
Investigator brochure
Safety information
Investigator’s CV/qualifications

Question 7

IRB Members:

Answer 7

Five members
One of non-scientific expertise, one not of the institution

Question 8

IRB Record Retention

Answer 8

At least 3 years after completion on trial