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. 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. ‌ 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. 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. 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 investigator can enter a subject into the study, Hepion (or representative) may visit the investigational study site 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 Hepion (or representative). This will be documented in a Clinical Study Agreement between ▇▇▇▇▇▇ (or representative) and the investigator. During the study, a monitor from Hepion (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 CRF, and that investigational product accountability checks are being performed; • Perform source data verification. This includes a comparison of the data in the CRF with the subject’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 subject (e.g., clinic charts); • Record and report any protocol deviations not previously sent to Hepion (or representative); • Confirm AEs and SAEs have been properly documented on CRFs and confirm any SAEs have been forwarded to Hepion (or representative) and those SAEs that met criteria for reporting have been forwarded to the IRB. The monitor will be available between visits if the investigator(s) or other staff needs information or advice.

Study Monitoring. In accordance with applicable regulations, good clinical practice (GCP), and GW procedures, monitors will periodically contact the site, including conducting on-site visits. The extent, nature and frequency of on-site visits will be based on such considerations as the study objective and/or endpoints, the purpose of the study, study design complexity, and enrolment rate. During these contacts, the monitor will: • check and assess the progress of the study • review study data collected • conduct Source Document Verification • identify any issues and address their resolution This will be done in order to verify that the: • data are authentic, accurate, and complete • safety and rights of subjects are being protected • study is conducted in accordance with the currently approved protocol (and any amendments), GCP, and all applicable regulatory requirements. The monitor is also responsible for reviewing subject-completed health outcome questionnaires. The monitor will review the subject-completed health outcome questionnaires for extraneous written comments which could indicate possible AEs. Information collected in the CRF and in the subject-completed health outcome questionnaires are independent components of this study. Except for header section information (e.g., subject number, treatment number, visit date), neither the monitor nor the investigator will reconcile data recorded on the subject-completed health outcome questionnaire with data recorded in the CRF’s. Subject-completed health outcome questionnaires also serve as the source document; therefore, no other source document is available for data validation. The investigator agrees to allow the monitor direct access to all relevant documents and to allocate his/her time and the time of his/her staff to the monitor to discuss findings and any relevant issues. In addition to contacts during the study, the monitor will also contact the site prior to the start of the study to discuss the protocol and data collection procedures with site personnel. At study closure, monitors will also conduct all activities as indicated in Section 9.5, “Study and Site Closure”.

Study Monitoring. In accordance with applicable regulations, GCP, and the procedures of the Sponsor, or its designee, the Study Monitor will periodically contact the site, including conducting on-site visits. The extent, nature, and frequency of on-site visits will be based on study complexity, enrollment rate, and data quality at the site. Through frequent communications (e.g., letter, e-mail, and telephone), the Study Monitor will ensure that the investigation is conducted according to protocol and regulatory requirements. During these contacts, the monitoring activities will include: • Checking and assessing the progress of the study • Reviewing study data collected to date for completeness and accuracy • Conducting source document verification by reviewing each subject’s CRF against source documents (e.g., medical records, ICF, laboratory results reports, raw data collection forms), and • Identifying any issues and addressing resolutions. These activities will be done in order to verify that the: • Data are authentic, accurate, and complete • Safety and rights of the subjects are being protected, and • Study is conducted in accordance with the currently approved protocol (and any amendments), GCP, and all applicable regulatory requirements. The Investigator will allow the Study Monitor direct access to all relevant documents, and allocate his/her time and the time of his/her staff to the Study Monitor to discuss findings and any relevant issues. In addition to contacts during the study, the Study Monitor will contact the site prior to the start of the study to discuss the protocol and data collection procedures with site personnel.