Regulatory Terms Starting With I

ICH Q10

ICH Q10 is a recurring concept across regulatory planning, compliance operations, and global submissions.

ICH Q1a

ICH Q1a supports cross-functional regulatory execution across quality, clinical, and safety teams.

ICH Q8

ICH Q8 helps teams standardize terminology and improve decision traceability.

ICH Q9

ICH Q9 is a recurring concept across regulatory planning, compliance operations, and global submissions.

IDE (IDE)

IDE is a recurring concept across regulatory planning, compliance operations, and global submissions.

IMPORT ALERT

IMPORT ALERT supports cross-functional regulatory execution across quality, clinical, and safety teams.

Individual CASE SAFETY REPORT

Individual CASE SAFETY REPORT supports pharmacovigilance operations that protect patients and satisfy authority expectations.

Informed Consent (ICF)

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

Institutional Review Board (IRB)

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

Interim Analysis

Interim Analysis supports compliant clinical development and cleaner decision-making across trial phases.

International Council for Harmonisation (ICH)

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

Investigational New Drug (IND)

An application to the FDA to begin clinical trials of a new drug in humans.

Investigator Brochure

Investigator Brochure helps teams standardize terminology and improve decision traceability.

ISO 13485

ISO 13485 supports cross-functional regulatory execution across quality, clinical, and safety teams.