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. Before an investigational site can enter a subject into the study, a representative of RIBOMIC (or designee) will evaluate the investigational study site to: • Determine the adequacy of the study facilities. • Review with the Principal Investigator(s) and authorized study staff their responsibilities regarding protocol procedures adherence, and the responsibilities of RIBOMIC (or designee). • During the study, RIBOMIC (or designee) will have regular contact with the investigational site, for the following: • Provide information and support to the Principal Investigator(s). • Confirm that facilities remain acceptable. • Assess adherence to the protocol and GCP. • Perform investigational product accountability checks and quality control procedures. • Ensure the on-going implementation of accurate data entry in the CRF. • Perform source data verification, including a comparison of the data in the CRFs with the subject's medical records 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 RIBOMIC (or designee). • Confirm AEs and SAEs have been properly documented on CRFs and confirm any SAEs have been forwarded to RIBOMIC and those SAEs that met criteria for reporting have been forwarded to the IRB or Independent Ethics Committee (IEC). RIBOMIC (or designee) may remotely access the CRFs, as applicable, at any time during the study for centralized monitoring. RIBOMIC (or designee) will be available between visits if authorized study staff needs study related information or support.
Study Monitoring. Internal monitoring Sponsor monitoring (periodic visits) Specific CRF handling CRF pages removing
Study Monitoring. In each centre a clinical monitor will be identified, who will receive ad hoc training. » In order to ensure the adequate assessment of the reliability of data management in each centre, each form will undergo verification with respect to data completeness and accuracy.
Study Monitoring. The study monitor, as a representative of the Sponsor, is obligated to follow the study conduct closely. In doing so, the monitor will visit the principal investigator and study facilities periodically, and will maintain necessary telephone and letter contact. The monitor will maintain current knowledge of the study activity of the investigator and his/her staff through observation, review of study records and source documentation, and discussion of the conduct of the study with the investigators and staff. The Sponsor or designee will monitor all aspects of the study for compliance with applicable government regulation with respect to the International Conference on Harmonisation (ICH) guideline E6(R1): Good Clinical Practice: Consolidated Guideline and current standard operating procedures. Each investigator is expected to make a reasonable effort to accommodate the monitor when monitoring visits are necessary and to be available during the site visit. Furthermore, the monitor should be provided direct access to source data and documents for trial-related monitoring and internet during the visit.
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.
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. 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.
