Data Management Procedures. VentiRx Pharmaceuticals or its designee will prepare guidelines for database setup, data review, quality control, and database lock at the conclusion of the study—including procedures for electronic edit checks. CRF Completion Guidelines will be prepared to guide the data entry activities completed by the sites. The database will be validated following established procedures. Electronic databases that hold subject study data will conform to 21 CFR §11 requirements.
Data Management Procedures. The Respondent shall consistently document the quality and validity of field and laboratory data compiled during the RI. Document data collection activities Information gathered during site characterization shall be consistently documented and adequately recorded by the Respondent in well-maintained field logs and laboratory reports. The method(s) of documentation must be specified in the Work Plan and/or the SAP. Field logs must be utilized to document observations, measurements, and significant events that have occurred during field activities. Laboratory reports must document sample custody, analytical responsibility, analytical results, adherence to prescribed protocols, nonconformity events, corrective measures, and data deficiencies. Maintain sample management and tracking The Respondent shall maintain field reports, sample shipment records, analytical results, and QA/QC reports to ensure that only analytical data of appropriate and known quality are reported and utilized in the development and evaluation of remedial alternatives. All sampling and testing data, quality control and quality assurance documentation, and chain of custody forms that are maintained by the Respondent must be in an electronic format easily accessible by EPA and the support agencies. Analytical results developed under the WP must not be included in any site characterization reports unless accompanied by or cross-referenced to a corresponding QA/QC report. In addition, the Respondent shall establish a data security system to safeguard chain-of- custody forms and other project records to prevent loss, damage, or alteration of project documentation. Data validation management Respondent will use a 3rd party to validate datasets using the general protocol and process described in the USEPA Contract Laboratory Program National Functional Guidelines for Inorganic Data Review (NFG; USEPA, 2004), and QA Plans that are consistent with relevant guidance. All validated data, and the electronic data deliverable (EDD) shall be made available to EPA in electronic format (i.e., computer disc or equivalent). The validated data, along with QA/QC information and data validation summaries, shall be submitted to EPA in electronic format within 120 calendar days from the date of collection of the last sample from each sampling event.
Data Management Procedures. The data will be entered into a validated database. The Biostatistics and Clinical Data Management group will be responsible for data processing, in accordance with agreed procedures. Database lock will occur once quality assurance procedures have been completed. All procedures for the handling and analysis of data will be conducted using good computing practices meeting FDA guidelines for the handling and analysis of data for clinical trials.
Data Management Procedures. TDNCC utilizes Medidata Solutions, Inc. (Medidata) Rave® for their electronic data capture (EDC) studies. The Medidata Rave EDC system is designed to be US Code of Federal Regulations (CFR) 21 Part 11 compliant with a robust audit trail system and electronic signature capabilities. Study personnel at each site will enter data from a subject’s visit onto electronic CRF screens via a web browser. Study subjects will not be identified by name in the study database or on any data capture screens, but will be identified by initials and a unique subject identification number. Only study personnel at the individual sites will be able to link the study ID to the subject’s name. The Data Management group of the TDNCC will be responsible for data processing, in accordance with procedural documentation. Database lock will occur once quality assurance procedures have been completed. All procedures for the handling and analysis of data will be conducted using good computing practices for the handling and analysis of data for clinical trials. Data Quality Control and Reporting: After data have been entered into the study database, a system of computerized data validation checks will be implemented and applied to the database on a regular basis. Queries are entered, tracked, and resolved through the EDC system directly. The study database will be updated in accordance with the resolved queries. All changes to the study database will be documented.
Data Management Procedures. 11.1 Data recording/reporting requirements All field and laboratory data will be stored in the KCEL LIMS system. Laboratory results will be transferred by the project manager to an excel spreadsheet. After passing quality control and assurance inspection, the data will then be entered into the Ecology EIM database by Xxxx Xxxxxx of the Lake Stewardship staff. All data will be entered at least annually into the EIM database up to the completion of the field work. If needed, the lab project manager will write a brief case narrative to describe any significant sampling issues or QC anomalies reported from lab units. Otherwise, the lab QC reports will suffice as a complete data package along with the excel data report. Reports will be transmitted electronically to Xxxxx Xxxxxx and individual project managers.
Data Management Procedures. The data management system covers capture and management of field data, lab data, data quality assessment, data interpretation, and waste profiles and manifests into a CSM for final decision-making or use. The data management system will include, but not be limited to, final archive storage and any data sharing platforms such as ftp sites or password-protected project websites. Documentation shall follow DoD standard record-keepingpractices, standard document control systems, and electronic data managementsystems. Details are presented as flow diagrams for a conceptual overview of the data management scheme, including various organizations’ coordination, execution, and release. In order to effectively and cost efficiently manage analytical data, all contracts require definitive analytical data to be captured electronically and be evaluated by experienced environmental professionals using automated and manual data review tools. These procedures must be captured in the UFP-QAPP and approved by all stakeholders. Once specific projects are awarded, each project must prepare an electronic project library. The project library shall include all of the project-specific objectives in the form of measurement performance criteria for definitive data management. Default performance criteria are established within the DoD QSM for several analytical parameters in water and solid matrices. Modifications to widen or tighten criteria will be at the discretion of the USACE Project Chemist and be fully justified as a variance in a Memorandum for Record (MFR). Details to be included in the project library are the analytical methods, the matrices sampled, the target analytes reported, Detection Limits (DL), LOD, LOQ, associated precision and accuracy limits for method QC samples, and all method-specific criteria for investigative and investigation-derived waste data.
