Investigational new drug or investigational device exemption application support service

eagle-i ID

Resource Type

Properties

1. Fee for service

   Yes

2. Resource Description

   The CRSO IND/IDE Support Program guides and supports: • Investigators who are filing Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications • Investigators who are serving as a sponsor or investigator for either single- or multi-site projects • Sponsors or investigators who are completing FDA-mandated submission materials and meeting subsequent reporting and documentation requirements The office also works with The Research Institute’s leadership personnel on issues of risk and feasibility.

3. Service Provided by

   Clinical Research Support Office (CHOP)

4. Website(s)

   https://crso.research.chop.edu/

5. Related Technique

   Clinical trial technique