Study Information definition

Study Information means any and all Information (including Data) derived from clinical and non-clinical study conducted by Terumo (directly or indirectly, excluding IceCure and/or its Affiliates) in the Territory, for making Regulatory Submission, obtaining and maintaining Regulatory Approval and/or commercializing the Product in the Territory, but Study Information excludes IceCure Information, IceCure Patents, and Inventions.

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Study Information means with respect to a Clinical Trial for the Co-Developed Product, the Clinical Trial protocol, the primary and secondary endpoints, comparators or combination therapy, estimated number of patients, and statistical power, the responsibility for the conduct of the Clinical Trial (i.e., will specify whether co-op groups or CROs will be used, whether the study will be handled as an investigator-sponsored study, or whether it will be managed and sponsored by a Party), the estimated out-of-pocket costs for the Clinical Trial, and any other material matters pertaining to the Clinical Trial (e.g., data analysis plan) that can reasonably be ascertained at such time, and with respect to a non-clinical study [***] for the Co-Developed Product, means the study protocol including the study design, procedures, comparators (if any) and objectives.

Study Information has the meaning set forth in Section 3.6(a).

Examples of Study Information in a sentence

Principal Investigator shall be responsible for obtaining and providing Sponsor with the Study Information Consents (in the form agreed with Sponsor) from each Study Site Staff for the collection, use and disclosure of their personal data.
The institution’s department head/department approver has the ability to see all Clinical Study Information and Accessible REB Information contained in provincial-level applications and applications from their centre only.
Individuals with whom an application has been shared will have access to the Clinical Study Information and Accessible REB Information contained on that application.
To the extent that GSK conducts any clinical trials permitted under the terms and conditions of this Agreement, GSK may post the data generated from such trials in accordance with GSK’s corporate policy on Public Disclosure and Access to Clinical Trial and Observational Study Information Data.
Individual representatives of the sponsor will have access to Clinical Study Information and only Accessible REB Information associated with applications via the sharing functionality, as granted by the provincial applicant/study staff and/or centre applicant/study staff.
The institutional representative(s) of the provincial and centre applicants has the ability to see all Clinical Study Information and Accessible REB Information contained in provincial-level applications and applications from their centre only, when applicable.
Requests for access to Clinical Study Information or Accessible REB Information by individuals outside of the permissions noted above should be directed to CTO.
If the REB declines to act as the REB of Record, they will no longer have access to the Clinical Study Information within CTO Stream.
The provincial applicant and study staff at the provincial applicant centre have the ability to see all Clinical Study Information and Accessible REB Information contained within CTO Stream for that Clinical Study.
The centre applicant and study staff have the ability to see all Clinical Study Information and Accessible REB Information contained in provincial-level applications and applications from their centre only.

More Definitions of Study Information

Study Information means the documents published and updated by ▇▇▇▇ from time to time con- taining details of ▇▇▇▇’▇ Programmes of Study, Policies and other relevant information for students enrolled at ▇▇▇▇.

Study Information means all results, data, documents and information generated by MDACC as a result of conducting the Study, but shall not include Inventions, laboratory notebooks, source documents, patient records, business and compliance documents or any other documents that MD A▇▇▇▇▇▇▇ is required to retain per Applicable Law or its policies. Cyclacel has the right to review Subject records to verify entries in the CRFs during normal administrative business hours, and subject to compliance with MD Anderson’s reasonable measures for confidentiality, safety and security, and shall also be subject to compliance with generally applicable premises rules at MD A▇▇▇▇▇▇▇. Cyclacel shall not at any time disclose the name of any subject or any information which identifies a Subject to a third party unless specifically required to do so by Applicable Law or the FDA. Cyclacel, MD A▇▇▇▇▇▇▇ and Investigator agree to comply with applicable FDA reporting requirements, including those related to adverse event reporting and all reporting requirements set forth in the Protocol or as required by applicable law.