Process and Timeline
- NDA (Non-DisclosureAgreement or CDA)
- Protocol Evaluation
- Standard Operating Procedures (SOP)
- Clinical Trial Federal Requirements (1572)
- 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
- Institutional Biosafety Committee (IBC)
- IRB Submission
- MIRA (if needed or other required forms)
- Hospital Approval
- Recruitment
- Monitoring
- Audits
- Close out