Process and Timeline
- Idea/Question
- Collaboration
- Funding and PCF
- Design/Statistics
- Protocol Development/Writing
- Need for NDA(Nondisclosure Agreement) or CDA
- Standard Operating Procedures (SOP)
- FDA/Clinical Trial Federal Requirements (1572), NDA, IND
- Training & certifications (CITI, HIPAA, others)
- Lifeline for Investigators with Severe Problems Completing Their Clinical Trial/Research
- Facilities (Hospitals contacts)
- Budget (Billing Compliance)
- Credentialing in the hospitals
- TRIA (if company is supplying drug/device assistance)
- Institutional Biosafety Committee (IBC)
- IRB Submission
- MIRA (if needed or other required forms)
- Hospital Approval
- Recruitment
- Monitoring
- Audits
- Close out