Application Date : Study Team: Primary Investigator (PI): Co-Investigators: Study nurse/ Coordinator: (if applicable) Institution and Department: Contact details primary investigator (lead study center): Street: Postal Code: City: Country: State (for US addresses): Email: Phone: Additional study centers: Overview: Study Title: Rationale of study: (what is the reason for performing this study?) Study hypothesis: (Formulate only one hypothesis) Type of study: In vitro / Bench test Clinical study Animal study Case series design: Prospective Retrospective (in case of a clinical Controlled Single-arm (single cohort) Randomized Non-randomized Field: Implants Regenerative Prosthetics CAD/CAM Other: Number of patients Total: Per group: /animals/samples Sample size calculation: Calculated number (without drop-outs): Rationale: (if applicable) Study Device (Product Name): Control Device (Product Name):
Application Date : Study Team: Primary Investigator (PI): Co-Investigators: Study nurse/ Coordinator: (if applicable) Institution and Department: Contact details primary investigator (lead study center): Street: Postal Code: City: Country: State (for US addresses): Email: Phone: Additional study centers: Overview: Study Title: Rationale of study: (what is the reason for performing this study?) Study hypothesis: (Formulate only one hypothesis) Type of study: In vitro / Bench test Animal study Clinical study Case series design: (in case of a clinical Prospective Controlled Randomized Retrospective Single-arm (single cohort) Non-randomized Field: Implants Prosthetics Other: Regenerative CAD/CAM Number of patients /animals/samples Total: Per group: Sample size calculation: (if applicable) Calculated number (without drop-outs): Rationale: Study Device (Product Name): Control Device (Product Name):
Research%20Proposal%20Form.docx