• Ethical review application for researches involved human being

• Study Protocol

• Data Collection Forms, Case Report Forms, Patient diaries, etc

• Informed Consent Form(s)

• Patient recruitment materials

• CV of Principal Investigator

• Statement of planned tasks

• Letter of intention for co-operation

• Site list

• Site Profile

• Investigator Brochure

• Product literature

• Insurance Policy (if any)

• Other additional documents upon request