6. Data records, monitoring and management 6.1 Data records 6.1.1 Original records: Subjects' follow-up care cards are original files in this clinical trial which is in duplicate copies. One copy should be saved in hospital. Original records shall be traceable. Each researcher must strictly follow the principle of GCP and ensure that he will record any observation and discovery in the follow-up care card and case report form (CRF), all data are consistent, no optional changes are allowed. If any correction is needed, the original record must not be changed, researchers can only add extra descriptions and explain the reason, the correction needs to be signed and dated by researchers who make it.