Clinical Trial Document Provision
Our company provides the documents required for a trial in line with ICH GCP and local regulations.
Trial documents are not limited to those listed below; trial-specific documents are also provided.
- Signed and dated protocol signature pages
- FDA Form 1572
- Current CVs of investigators (signed and dated within two years)
- Current medical licences of principal investigators
- Ministry of Health notification and opinion
- Signed and dated confidentiality agreement
- Completed and signed investigator agreements (bilateral and trilateral)
- Ethics Committee member list
- Financial Disclosure Form