- Pre-clinical protocol
- Clinical protocol
- Protocol amendment and amendment summary
- Clinical Study Report Phase I or IV (figures, graphs and appendices provided)
- Clinical Study Report Phase II or III (figures, graphs and appendices provided)
- Safety narratives
- Investigator's brochure (initial)
- Investigator's brochure update
- Clinical Summary
- Clinical Overview
- Scientific Publications
- Translation from and into English
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- Policies
- Standards
- SOPs
- Work Instructions
- Training Material
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