Electronic Data Capture Clause Samples
The Electronic Data Capture clause establishes the use of digital systems for collecting, storing, and managing data related to a project or transaction. Typically, this clause outlines the specific platforms or software to be used, the responsibilities of each party in entering and maintaining data, and any requirements for data security or access. By formalizing the process of electronic data management, the clause ensures accuracy, efficiency, and traceability, reducing the risk of data loss or errors associated with manual record-keeping.
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Electronic Data Capture. The electronic data capture (EDC) system is a secure, validated, US CFR Part 11 compliant EDC program provided by the Sponsor. It is an internet-based EDC system for reporting clinical data to the Sponsor (eCRFs). All subjects who consent to participate will be registered in the EDC system. Access to the EDC system will be protected by login identification and password. The Sponsor will train delegated Site personnel on procedures for data entry into the web-based system. Following, delegated staff will be provided ID codes and passwords unique to each team member’s delegated study role and blinding requirements. They will be trained on Philips guidelines for maintenance of electronic ID codes and passwords. A staff member’s ID code/password will never be shared or used by another staff member, in any circumstance.
Electronic Data Capture. Some types of studies may require methods of data collection in addition to, or instead of, CRFs. For example, questions about a study participant’s sexual behavior or drug use may best be collected using a computerized questionnaire methodology such as an “[Audio]- Computer Assisted Self-Interview” ([A]CASI). The protocol team and SDMC will assess whether additional methods of data capture are required and if so, whether the SDMC, a contractor, or some other Network resource will be responsible for designing the required system. If the SDMC develops the system, development will follow steps similar to the design of CRFs.
Electronic Data Capture. Institution and Principal Investigator acknowledge that Sponsor may retain one or more companies to provide services involving electronic document and data collection, retention and processing associated with the performance of a Clinical Trial. Institution covenants that it shall
(a) own or have access to space, computer hardware and internet connectivity necessary to operate an Electronic Data Capture (“EDC”) terminal that will permit the input of relevant Clinical Trial data and documents and transmission of the same between Institution and Sponsor’s designee, and (b) train and maintain sufficient and appropriate staff and personnel in the operation of the EDC terminal. In such cases, Institution shall ensure that the applicable Principal Investigator will, during the Clinical Trial and throughout the term of this Agreement, be familiar with the operation of the EDC terminal and supervise the staff and personnel who are operating the same. poskytovat součinnost Zadavateli v téže souvislosti.
Electronic Data Capture. Institution and Principal Investigator acknowledge that Company may retain one or more companies to provide services involving electronic document and data collection, retention and
Electronic Data Capture. Provider and Principal Investigator acknowledge that Sponsor may retain one or more companies to provide services involving electronic document and data collection, retention and Zadavatelem v souladu s Pšíslušnými právními pšedpisy. Hlavní zkoušející je povinen evidovat takový dokument v souladu s vnitšními pravidly Poskytovatele, pšičemž poskytne jeho kopii Zadavateli na jeho žádost. Žádný Subjekt hodnocení nebude zašazen do Klinického hodnocení, nebyl-li pšedtím opatšen jeho písemný infomovaný souhlas.
Electronic Data Capture. Institution and Principal Investigator acknowledge that Company may retain one or more companies to provide services involving electronic document and data collection, retention and processing associated with the performance of a Clinical Trial. Institution covenants that it shall (a) own or have access to space, computer hardware and internet connectivity necessary to operate an Electronic Data Capture (“EDC”) terminal that will permit the input of relevant Clinical Trial data and documents and transmission of the same between Institution and Company’s designee, and (b) train and maintain sufficient and appropriate staff and personnel in the operation of the EDC terminal. In such cases, Institution shall ensure that the applicable Principal Investigator will, during the Clinical Trial and throughout the term of this Agreement, be familiar with the operation of the EDC terminal and supervise the staff and personnel who are operating the same. s tímto Klinickým hodnocením, a to včetně vyjednání smluv o klinickém hodnocení s jednotlivými ▇▇▇▇▇ výkonu klinického hodnocení, resp. centry, jménem a ve prospěch Společnosti. Instituce souhlasí, že zajistí, že Hlavní zkoušející a personál zapojený do provádění Klinického hodnocení poskytnou plnou součinnost CRO, a to z pozice smluvní výzkumné organizace jednající jménem Společnosti ve vztahu ke Klinickému hodnocení (a případně zástupci či zmocněnci CRO, dle konkrétních podmínek), stejně jako jsou Instituce a Hlavní zkoušející povinni spolupracovat a poskytovat součinnost Společnosti v téže souvislosti. 1.5