1 | List of Application Document |
2 | Protocol Abstract |
3 | Final Report Form |
4 | Recommendation Sheet of Final Report |
5 | Approved Empty ICF(NA for Protocol Withdraw) |
6 | Copied ICF with Participants’ signature(NA for Protocol Withdraw) |
7 | SAE Record Sheet (if applicable) |
8 | All previous approval letter |
9 | Others, e.g. Proof of Payment of Review Fee______________________ |