Research Turn Around Times - ICH Clinical Safety Data Management

Question 1

Certain adverse drug reactions (ADRs) may be sufficiently alarming so as to require very rapid notification to regulators in countries where the medicinal product or indication, formulation, or population for the medicinal product are still not approved for marketing, because such reports may lead to consideration of suspension of, or other limitations to, a clinical investigations program. Fatal or life-threatening, unexpected ADRs occurring in clinical investigations qualify for very rapid reporting. Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than (blank) after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days. This report must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar medicinal products.

Answer 1

7 calendar days

Question 2

Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than (blank) after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.

Answer 2

15 calendar days