Data and Safety Reporting Sample Clauses

Data and Safety Reporting. 2.3.1 Institution/Principal Investigator shall submit written reports, in accordance with all laws, regulations and guidelines including the Ethics Committee standards, to Sponsor and the EC regarding the Study being conducted at the Institution on request. 2.3.2 In case Electronic Data Capture ("EDC") is used for the Study: Institution/Principal Investigator will submit Study data using the electronic system provided by the Sponsor. Institution/Principal Investigator shall also comply with Sponsor’s instructions for data entry into the system, which includes that investigational staff using the system understands that their electronic signatures are the legally binding equivalent of handwritten signatures, and they attest to the accuracy and completeness of the data entered.

Data and Safety Reporting. 4.1 Institution shall report to Sponsor adverse events as directed in the Protocol and as required by Applicable Laws. Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Sponsor will promptly report to Institution any findings that could affect the safety of Trial Subjects, influence the conduct of the Trial, or that Sponsor determines could alter the approvals from the relevant regulatory authority. 4.2 Institution shall report serious adverse events to Sponsor without undue delay, but not later than within 24 hours from obtaining knowledge of the events unless, for certain serious events, the Protocol provides that no immediate reporting is required. Where relevant, the Institution shall send a follow-up report to Sponsor if required to Sponsor´s assessment and reporting of the event. 4.3 Institution shall record and document all adverse events, unless the Protocol provides differently. Sponsor shall keep detailed records of all adverse events reported to it by Institution. 4.4 If Institution becomes aware of a serious adverse event with a suspected causal relationship to the IMP that occurs after the end of the Trial in a Trial Subject, the Institution shall, without undue delay, report the serious adverse event to Sponsor. 4.5 Sponsor shall be responsible for reporting any Suspected Unexpected Serious Adverse Reactions (SUSAR) to the relevant regulatory authority and investigators in accordance with regulatory requirements. Sponsor shall also be responsible for the preparation of the annual safety report and for the sending of the report to the relevant regulatory authority. 4.6 Principle Investigator is responsible for reporting any suspected serious breaches to Sponsor in accordance with protocol and regulatory requirements. Principle Investigator is also responsible for reporting any unexpected events, that may affect the benefit-risk balance of the Trial, to Sponsor in accordance with the Protocol and regulatory requirements. Sponsor shall be responsible for reporting the information to relevant regulatory authority in accordance with regulatory requirements.

Data and Safety Reporting. The Site agrees to provide data to secure collection of agreed resources as outlined in the Protocol and agrees to make available the data according to the timeframes outlined in the Manual of Operations/Standard Operating Procedures. The data may be used for the Study under the full and direct control, instructions and management of CHIP. Site/Principle investigator agrees to implement and use any electronic system that CHIP may specify for use in the reporting and monitoring of the Study and Study findings at CHIP’s expense. Site/Principle Investigator shall have all available data entered in the system as agreed. All data/results generated by the Site/Principle Investigator in the direct course of conducting the Study (“Data”) shall be the property of CHIP, which may use utilize the data in any way it deems appropriate, subject to and in accordance with applicable privacy and security laws and regulations and the terms of this Agreement. Site/Principle investigator retain right to use Data for further internal research and education. The Data provider (Site) agrees that the Data provided to CHIP may be used by other beneficiaries and Third Parties as agreed in the protocol and who are part of the Project provided that this remains within the appropriate ethics, regulatory and data protection approvals.