Latest Information

Publications

• Guide to Clinical Trial Applications
• Protocol Template for Investigator-Led Trials
• Rejection Procedure

FAQs

• What types of clinical trial adverse event / reaction reports should be submitted to the Clinical Trials Unit?
• Is any additional information required by the IMB when submitting clinical trial adverse event / reaction reports?
• Can fatal or other serious outcomes, which are primary efficacy endpoints, be reported in a blinded manner?
• Should SUSAR reports be unblinded prior to reporting?
• What are the timelines for reporting suspected unexpected serious adverse reactions (SUSARs)?