Study Documents
ETHIC Medical Research Ltd. provides the study documents according to local regulations and ICH GCP requirements. Study documents include as mentioned below but not limited. ETHIC Medical Research Ltd. can be provides study specific documents as well.
- Signed and dated protocol signature page,
- FDA form 1572,
- Curriculum Vitae (signed and dated within 2 years),
- Medical license of investigators,
- Submission to The Ministry of Health and provide approval letter,
- Signed and dated the confidentiality agreement,
- Contract negotiations(two way/three way),
- Ethics Committee Member list,
- Financial Disclosure Form.
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