European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on May 25, 2022, by updating the below document in Module 16- Supervise a clinical trial: Inspection records:
FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records – Module 16: The questions and answers that are added or revised in this version are –
- Section 2.8: This section was newly added by adding information if users can change the planned dates
- Section 2.13: This section was newly added by adding information on the Member States being included in the form
- Section 3.8: This section was newly added by adding information on the availability of an automated redaction tool on CTIS
- Section 4.12: This section was newly added by adding information on the availability of a page to view all inspection records
For more information, please click here.