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. 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. 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. Before an investigational site can enter a subject into the study, a representative of Sage Therapeutics or designee will visit the investigational study site to: • Determine the adequacy of the facilities; and • Discuss with the Investigator(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 Study Agreement between Sage Therapeutics and the Investigator. During the study, a monitor from Sage Therapeutics or designee 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 eCRFs, and that investigational product accountability checks are being performed; • Perform source data verification. This includes a comparison of the data in the eCRFs 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 (eg, clinic charts); • Record and report any protocol deviations not previously sent to Sage Therapeutics or designee; and • Confirm adverse events and serious adverse events have been properly documented on eCRFs and confirm any serious adverse events have been forwarded to Sage Therapeutics or designee and those serious adverse events 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. 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. To ensure compliance with GCP, the study monitor or representative is responsible for ensuring that the study is conducted according to applicable SOPs, the protocol, and other written instructions and regulatory guidelines. The study monitor is the primary association between the sponsor and each investigator. The main responsibilities of the study monitors are to visit each investigator before, during, and after the study to ensure adherence to the protocol, that all data are correctly and completely recorded and reported, and that informed consent is obtained and recorded for all patients before their participation in the study. The study monitors will contact each investigator and visit the study center at regular intervals throughout the study. The study monitor will be permitted to check and verify the various records (CRFs and other pertinent source data records, to include specific electronic source documentation [see section 3.9]) relating to the study to verify adherence to the protocol and to ensure the completeness, consistency, and accuracy of the data being recorded. If electronic case report forms (eCRFs) are used for the study, the study monitor will indicate verification by electronically applying source document verification (SDV) flags to the eCRF and will ensure that all required electronic signatures are being implemented accordingly. As part of the supervision of study progress, other sponsor personnel may, on request, accompany the study monitor on visits to the study center. Each investigator and assisting staff must agree to cooperate with the study monitor to resolve any problems, errors, or possible misunderstandings concerning the findings detected in the course of these monitoring visits.
