CDSCO has organised the workshop on hands on training/demonstration on POST APPROVAL SUBMISSION at CDSCO (HQ) on 17/11/2017.
In the workshop DCGI officials has given the live demonstration of filing the following applications for Global Clinical Trials (GCT)
1. Major Amendments
2. Minor Amendments
3. Addition/Removal of Sites
4. Change in P.I
For next few months both online and hard copies would be accepted by CDSCO. Once all the teething issues are rectified CDSCO shall notify to all stake holders for only online submission.
This is another step for ease of doing business for clinical research industry.
CDSCO making Clinical Trial Application Easy and Online – SUGAM Update
