Study protocols

Study reports

Investigator Brochures (IBs)

Investigational Medicinal Product Dossiers (IMPDs)

Paediatric Investigation Plans (PIPs)

Periodic Safety Update Reports (PSURs)

Risk Management Plans (RMPs)

Clinical submission documents including eCTD format (Module 2.7.3, 2.7.4, 2.5)

Publications, manuscripts, posters, and abstracts

Standard Operating Procedures (SOPs)