Medical monitoring & data verification
1、Medical monitoring based on prespecified risk criteria
2、In-house source data verification with the use of photos on the APP
Data monitoring committee
1、Prepare DMC charter / operational manual
2、Assist to extract study data and transfer to the third party
3、Conduct blinded or non-blinded data analysis
4、Prepare DMC meeting slides
5、Report analysis results to DMC independently
6、Develop DMC statistical report