- Study Protocol / Clinical Investigation Plan
- Case Report Forms (CRFs)
- Informed Consent Forms / Ascent Forms
- Investigator’s Brochure (IB) IMPD
- eCTD Modules 2.5 and 2.7
- Preclinical study reports
- Safety Narratives
- Clinical Study Reports (CSR)
- Clincal Evaluation Reports (CER)
- Abbreviated Clinical Study Reports / Synopsis
- Publication Manuscripts and Posters
- Protocol Slide Kits
- Investigator Training Material
- Site Source Documents Development – patient diaries, source document template etc.
