DATA HANDLING AND RECORDKEEPING Sample Clauses

DATA HANDLING AND RECORDKEEPING. Procedures for data handling (including electronic data) used in this protocol will be documented in a Data Management Plan. Electronic CRFs will be completed for each study subject. It is the Investigator’s responsibility to ensure the accuracy, completeness, and timeliness of the data reported in the subject’s eCRF. Source documentation supporting the eCRF data should indicate the subject’s participation in the study and should document the dates and details of study procedures, adverse events, and subject status. The Investigator will have access to the electronic data capture system and will receive a copy of the subject eCRF data at the end of the study. For subjects who discontinue or terminate from the study, the eCRFs will be completed as much as possible, and the reason for the discontinuation or termination clearly and concisely specified on the appropriate eCRF.

DATA HANDLING AND RECORDKEEPING. This study will utilize ClinvestiGator, under the direction of ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, as its data management system (Appendix 13). ClinvestiGator will provide full service electronic data capture (EDC), data management, and reporting. Data management includes: database specification, development and testing; edit check programming; data management plan development and maintenance; ongoing manual data review and query management; and data cleaning and locking. ClinvestiGator will generate monthly reports during the study to monitor enrollment and maintain and improve the quality of the study database and will facilitate the ability to: (1) Collaborate and communicate with the study PIs to review the proposed protocol and contribute to finalizing that document; (2) Develop case report forms; (3) Develop relevant Standard Operating Procedures (SOPs); (4) Develop and maintain full service EDC and data management that will include a web-based data entry system; (5) Create and distribute data entry processes; (6) Train and certify users in the data entry systems; (7) Receive, collect, process, store, and analyze data collected from the participating clinical practices; and (8) Participate in preparing and distributing quality control reports to the participating practices, study committees, and the sponsors and Research Coordination Unit.