Monitoring of the Study Sample Clauses

Monitoring of the Study. 8.1 SPONSOR will appoint monitor(s), bound by a professional confidentiality obligation, who will work with the INSTITUTION to ensure proper conduct of the Study (hereinafter the ”Monitor(s)”). In this study no onsite monitoring is planned. 8.2 The Monitor shall be entitled to visit the Study Site and be regularly informed about the performance of the Study and shall collect all the documents and information about the Study in accordance with the Protocol. The Monitor shall have access to all records on the Patients and all information pertaining to the Study, as well as, copies thereof, provided the Patient has not withdrawn consent for giving access to the medical records.
AutoNDA by SimpleDocs
Monitoring of the Study. In the event that sponsor makes monitoring visits, the monitor (hereinafter referred as the "Monitor") of this STUDY will be Mr. /Xxx. Xxxx clic aquí para escribir texto. from the company Xxxx clic aquí para escribir texto.. The Monitor will have access to the clinical records and other clinical documentation on the subjects included in the STUDY by means of the statement attached as Xxxxx XX. Mr. /Xxx. Xxxx clic aquí para escribir texto. guarantees that he/she will maintain the confidentiality of the data to which he /she might have access during the course of the monitoring and that these will only be used for the purposes of monitoring. The Monitor will notify, in writing and with sufficient notice, the HOSPITAL, which will inform its clinical departments participating in the STUDY and the Ethics Committee for Clinical Research of the HOSPITAL, of any monitoring visit, which he/she is to carry out. If during a monitoring visit are detected problems that affect the correct running of the STUDY, the HOSPITAL will be notified. The Sponsor shall provide the Principal Investigator with information about the running of the STUDY, if it is multicentric, and the results obtained at the end of the STUDY or in the moment they are available, and also about the serious unexpected adverse events detected by the sponsor with the STUDY drugs. The monitor shall provide the information on the Clinical Trial progression monthly, or based on the rate of billing. In addition, shall be provided any new information about the product that becomes available during the STUDY. If, at the time of signing this contract, the monitor of the study has not been appointed, the Sponsor will send the Xxxxx XX to the center when they knows their identity to be added to the file of this contract.
Monitoring of the Study. Site monitoring for safety is conducted to ensure that human subject protection, study procedures, and laboratory, study drug dosing, and data collection processes are of high quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site monitoring visits as detailed in the monitoring plan. Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and distribution forms, eCRF), pertinent hospital and site records, and source documentation for verification of the study data. Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor the following: study operations, the quality of data collected in the research records, the accuracy and timeliness of data entered in the database, and to determine that all process and regulatory requirements are met. Study monitoring visits will occur at initiation of the study site, at intervals determined by SIGA during conduct of the study, and at completion of the study. The CRA will maintain current personal knowledge of the study through observation, review of study records and source documentation, and discussion of the conduct of the study with the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% source document verification of all subject data entered into the eCRF. Discrepancies, if any, will be clarified with the study site coordinator and investigator, and corrected at the site by the study coordinator. Any questions or required data clarifications will be sent to the study site electronically.
Monitoring of the Study. The monitor, as a representative of the sponsor, is obligated to follow the study closely. In doing so, the monitor will visit the investigator and clinical site at periodic intervals in addition to maintaining necessary telephone and email contact. The monitor will maintain current personal knowledge of the study through observation, review of study records including eCRFs and source documentation, and discussion of the conduct of the study with the investigator and staff. All aspects of the study will be carefully monitored by the sponsor or its designee for compliance with applicable government regulation with respect to current ICH E6(R2) guidelines and standard operating procedures.

Related to Monitoring of the Study

  • Rescheduling of Tests If the Authority’s Engineer certifies to the Authority and the Contractor that it is unable to issue the Completion Certificate, as the case may be, because of events or circumstances on account of which the Tests could not be held or had to be suspended, the Contractor shall be entitled to re-schedule the Tests and hold the same as soon as reasonably practicable.

  • Felling of trees The Authority shall assist the Contractor in obtaining the Applicable Permits for felling of trees in non-forest area to be identified by the Authority for this purpose if, and only if, such trees cause a Material Adverse Effect on the construction or maintenance of the Project Highway. The Contractor shall fell these trees as per the Permits obtained. The cost of such felling shall be borne by the Authority and in the event of any delay in felling thereof for reasons beyond the control of the Contractor; it shall be excused for failure to perform any of its obligations hereunder if such failure is a direct consequence of delay in the felling of trees. The Parties hereto agree that the felled trees shall be deemed to be owned by the Authority and shall be disposed in such manner and subject to such conditions as the Authority may in its sole discretion deem appropriate. For the avoidance of doubt, the Parties agree that if any felling of trees hereunder is in a forest area, the Applicable Permit thereof shall be procured by the Authority within the time specified in the Agreement.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!