Common use of Study Monitoring Clause in Contracts

Study Monitoring. Before an investigational site can enter a participant into the study, a representative of Sage Therapeutics will visit the investigational study site per Sage standard operating procedures to: • Determine the adequacy of the facilities • Discuss with the investigator(s) and other personnel their responsibilities with regard to protocol adherence, and the responsibilities of Sage Therapeutics or its representatives. This will be documented in a Clinical Trial Agreement between Sage Therapeutics and the investigator. During the study, a monitor from Sage Therapeutics or representative will have regular contacts with the investigational site, for the following: • Provide information and support to the investigator(s) • Confirm that facilities remain acceptable • Confirm that the investigational team is adhering to the protocol, that data are being accurately recorded in the case report forms, and that IP accountability checks are being performed • Perform source data verification. This includes a comparison of the data in the case report forms with the participant’s medical records at the hospital or practice, and other records relevant to the study. This will require direct access to all original records for each participant (eg, clinic charts). • Record and report any protocol deviations not previously sent to Sage Therapeutics. • Confirm AEs and SAEs have been properly documented on eCRFs and confirm any SAEs have been forwarded to Sage Therapeutics and those SAEs that met criteria for reporting have been forwarded to the IRB or IEC. The monitor will be available between visits if the investigator(s) or other staff needs information or advice.

Study Monitoring. Before an investigational site can enter a participant subject into the study, a representative of Sage Therapeutics or designee will visit the investigational study site per Sage standard operating procedures to: • Determine the adequacy of the facilities facilities; and • Discuss with the investigator(sInvestigator(s) and other personnel their responsibilities with regard to protocol adherence, and the responsibilities of Sage Therapeutics or designee or its representatives. This will be documented in a Clinical Trial Study Agreement between Sage Therapeutics and the investigatorInvestigator. During the study, a monitor from Sage Therapeutics or representative designee will have regular contacts with the investigational site, site for the following: • Provide information and support to the investigator(s) Investigator(s); • Confirm that facilities remain acceptable acceptable; • Confirm that the investigational team is adhering to the protocol, that data are being accurately recorded in the case report formseCRFs, and that IP investigational product accountability checks are being performed performed; • Perform source data verification. This includes a comparison of the data in the case report forms eCRFs with the participantsubject’s medical records at the hospital or practice, and other records relevant to the study. This will require direct access to all original records for each participant subject (eg, clinic charts). ; • Record and report any protocol deviations not previously sent to Sage Therapeutics. Therapeutics or designee; and • Confirm AEs adverse events and SAEs serious adverse events have been properly documented on eCRFs and confirm any SAEs serious adverse events have been forwarded to Sage Therapeutics or designee and those SAEs serious adverse events that met criteria for reporting have been forwarded to the IRB or IECIRB. The monitor will be available between visits if the investigator(sInvestigator(s) or other staff needs information or advice.