Central Database Sample Clauses
Central Database. Company shall maintain a central international Adverse Event database of Adverse Event and Serious Adverse Event reports associated with the Compound or a Covered Product (the “Central Database”). Not later thirty (30) days after the first clinical site initiation of a clinical study of Covered Product, Company shall provide NovaMedica with a copy of Company’s standard operating procedure (“SOP”) for safety-related reporting, including a detailed technical description of any data or information intended for inclusion and storage in, and retrieval from, the Central Database. Company shall periodically, but less than annually, review its SOP to ensure adequacy and compliance with then-applicable United States FDA and EMEA regulatory reporting requirements.
Central Database. Marinus shall maintain a central international Adverse Event database of Adverse Event and Serious Adverse Event reports associated with the Compound or a Covered Product (the “Central Database”). Not later thirty (30) days after the first clinical site initiation of a clinical study of Covered Product, Marinus shall provide NovaMedica with a copy of Marinus’s standard operating procedure (“SOP”) for safety-related reporting, including a detailed technical description of any data or information intended for inclusion and storage in, and retrieval from, the Central Database. Marinus shall periodically, but less than annually, review its SOP to ensure adequacy and compliance with then-applicable United States FDA and EMEA regulatory reporting requirements.
Central Database. Data Setup: CONTRACTOR shall utilize a detailed implementation guide that shall allow CONTRACTOR to work with COUNTY to identify system codes and parameters to setup the system to conform to COUNTY’S business requirements. The implementation project manager shall work directly with COUNTY to work through the implementation guide, and this data is subject to approval by COUNTY prior to entry into the system. Once the main implementation guide is approved, CONTRACTOR shall work with COUNTY project manager to develop a series of specific forms to be used by COUNTY staff to submit their park information. These forms shall be specific to COUNTY, and shall be based on COUNTY administrative rules, laws and business requirements as well as the main implementation guide. When these critical documents are completed by the CONTRACTOR, they will then be sent to each park for completion and each park shall submit their park/campground maps for CONTRACTOR to create and enter into the system. The CONTRACTOR’S inventory team shall enter all park data and create maps, which will be returned to each park for review, corrections and resubmission, which review shall not be unreasonably delayed and such acceptance not unreasonably withheld. This process shall continue until each park has ‘signed- off’ on their information within the system. In addition to the park data, CONTRACTOR shall work with COUNTY’S finance staff to review current financial procedures and requirements per the AGREEMENT to ensure that the system is setup accordingly. CONTRACTOR shall work with COUNTY in the initial contact meeting with COUNTYS auditor/controllers department, which shall occur during the initial planning and coordination meetings; and
Central Database. 1. ESMA shall establish and maintain a central database providing access to the CCP’s competent authority and ESMA, (‘registered recipients’) as well as to the members of the college for that CCP where required under the relevant Article, to all documents registered within the database for the CCP. ESMA shall ensure that the central database performs the functions under this Article.
Central Database. PharmaEngine shall be responsible for the maintenance of the central database for the Territory regarding all adverse drug reactions, suspected adverse drug reactions and other medical and technical information relevant to the safety of the Licensed Product and shall make the central database available to Xenova's Medical Affairs Liaison or such other Xenova representatives as agreed upon from time to time in writing between the Parties.
