Study Monitoring Clause Samples

Study Monitoring. The Sponsor (or its designee) will ensure that the study is monitored in accordance with ICH-GCP Guidelines. Monitoring is the act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, Good Clinical Practice, and the applicable regulatory requirements and that the study data are accurate, complete and verifiable from source data. All study documentation and other source data will be made available to the Sponsor (or its designee), the IRB and to Regulatory Authorities for inspection upon request.

Study Monitoring. University and Sponsor-Investigator shall be responsible for monitoring and quality assurance of all data and information set forth in Section 22 below in compliance with 21 CFR Part 312.

Study Monitoring. ‌ Monitoring of the study will be conducted by the sponsor or its designee following 21CFR 50, 54, 56, and 812 and the guidelines established by the Declaration of Helsinki and ICH GCP (to the extent that they are consistent with U.S. federal regulations). A site initiation meeting will be held and periodic site visits will be performed. The monitor will maintain oral and written communications with the Investigators and study personnel. Case report forms will be reviewed with source records and compliance with the protocol will be documented.

Study Monitoring. A representative from Light Sciences Oncology or designated CRO will visit the study center periodically to monitor adherence to the protocol, adherence to applicable FDA regulations, and the maintenance of adequate and accurate clinical records. CRFs will be reviewed to ensure that key safety and efficacy data are collected and recorded as specified by the protocol. The LSO or designated CRO representative will be permitted to access patient medical records, laboratory data, and other source documentation as needed to appropriately monitor the trial. The Investigator should allocate adequate time for these visits.

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. The study will be monitored by authorized representatives of the Sponsor throughout its duration by means of personal visits to the Investigator’s facilities and through other communications (e.g. telephone calls, written correspondence). Monitoring visits will be scheduled at mutually agreeable times periodically throughout the study and at frequency deemed appropriate for the study. These visits will be conducted to evaluate the progress of the study, ensure the rights and well- being of the subjects are protected, check that the reported clinical study data are accurate, complete and verifiable from source documents, and the conduct of the study is in compliance with the approved protocol and amendments, GCPs and applicable national regulatory requirements. A monitoring visit will include a review of the essential clinical study documents (regulatory documents, CRFs, source documents, drug disposition records, subject informed consent forms, etc.) as well as discussion on the conduct of the study with the Investigator and staff. The Investigator and staff should be available during these visits to facilitate the review of the clinical study records and resolve/document any discrepancies found during the visit.

Study Monitoring. Sponsor or its designee will monitor the conduct of the trial on a regular basis throughout the duration of the study, according to the monitoring plan and in compliance with ICH-GCP E6(R2). Monitoring of the study will serve to ensure: (a) The rights and well-being of human subjects are protected; (b) The reported trial data are accurate, complete, and verifiable from source documentation; and (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). The study monitor will train site personnel on the conduct of the trial. The monitor will assess the trial site’s compliance with the protocol and will periodically review and verify a sample of the patient data recorded on CRFs against source documentation. The study monitor will also review documents that provide evidence of the proper consent and eligibility of enrolled patients, the compliant conduct of study procedures, the administration and disposition of investigational product(s), the reporting of serious adverse events and adverse reactions, and the continued maintenance of trial records. The Investigator will allocate adequate time to support such monitoring activities. The Investigator will also ensure that the monitor is given reasonable remote and/or on-site access to study-related documents, source documents (regardless of media) and study-related facilities (eg, investigational pharmacy, etc). Queries may be raised if any datum is unclear or contradictory. The Investigator and site personnel must address all queries in a timely manner.

Study Monitoring. ‌ Monitoring of the trial will be performed to verify that: • The rights and well-being of participants are protected; • The reported trial data are accurate, complete, and verifiable from source documents; and • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), ICH GCP, and local regulations and requirements. The Sponsor will be responsible for all monitoring activities. Any trial-related duty or function transferred to and assumed by a third party, including monitoring and auditing, will be specified in a clinical trial agreement and oversight provided by the Sponsor. The monitoring plan for the trial will be documented prior to the activation of the study and include the following; • Follow risk-based practices, • Document the rationale for the chosen monitoring strategy, • Reference the Sponsor’s process that will be followed to address situations of non-compliance, • Describe the monitoring responsibilities of all the parties involved, and • Outline the data and processes to be monitored. STEP-RB Protocol 1.0, 4 February 2020 The site Investigator(s)/delegate(s) will allow direct access to source data/documents for the purposes of monitoring by the Sponsor, and inspection by regulatory authorities, both domestic and foreign (if applicable). It is important that the Sponsor, site Investigator and site personnel are available during monitoring visits and inspections, and that sufficient time is devoted to the process. Monitoring procedures will be implemented beginning with the data entry system and data checks that will be run on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution. Monitoring reports will be issued after each monitoring visit for review and follow up by the Sponsor, site Investigator, and appropriate management and personnel responsible for trial and site oversight.

Study Monitoring. Internal monitoring Sponsor monitoring (periodic visits) Specific CRF handling CRF pages removing