Data Quality Assurance. Explain what standards will apply for data quality and how errors will be handled.
Data Quality Assurance. In order to ensure the data quality standards, Pro Public will reasonably meet the five standards of data quality as mentioned in USAID (ADS 203) framework.
i) Validity
ii) Integrity
iii) Precision
iv) Reliability
v) Timeliness Data quality will be ensured by cross-checking the data receive from the field visits. Project staff will make their presence on major activities and facilitate capacity building in reporting to DFs. In addition, project team make realizes the importance of data quality to DFs and local coordinators
Data Quality Assurance. All patient data relating to the study will be recorded on printed or electronic CRF unless transmitted to the Sponsor or designee electronically (eg, laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the CRF. The Investigator must maintain accurate documentation (source data) that supports the information entered in the CRF. The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory agency inspections and provide direct access to source data documents. Monitoring details describing strategy, methods, responsibilities and requirements, including handling of noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) are provided in the Medical Monitoring, Safety Monitoring and Global Monitoring Plans. The Sponsor or designee is responsible for the data management of this study including quality checking of the data. The Sponsor assumes accountability for actions delegated to other individuals (eg, Contract Research Organizations [CRO]). Study monitors will perform ongoing source data verification to confirm that data entered into the CRF by authorized site personnel are accurate, complete, and verifiable from source documents; that the safety and rights of patients are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH GCP, and all applicable regulatory requirements. Records and documents, including signed ICFs, pertaining to the conduct of this study must be retained by the Investigator for 2 years after the last marketing application approval, or if not approved, 2 years following the discontinuance of the study medication, unless local regulations or institutional policies require a longer retention period. No records may be destroyed during the retention period without the written approval of the Sponsor. No records may be transferred to another location or party without written notification to the Sponsor.
Data Quality Assurance. 9.1 The Parties collate data on waste collection and record that information through DEFRA's data recording system known as “Waste Data Flow”. The Parties agree to adopt the Audit Commission’s code of practice on data quality standards as set out in Schedule 6, Part C (The Standards for Better Quality Data, A Voluntary Code of Practice) in order to ensure the accuracy, validity, reliability, timeliness, relevance, completeness and security of information.
9.2 The Parties agree to apply the data quality standards within each partner organisation, ensuring that there is periodic reinforcement of the value placed on data quality.
9.3 The Parties agree to adopt a policy with regard to data quality of ‘getting it right first time’ with a view to avoiding waste in the form of time and money spent on cleansing data. The Parties aspiration with regard to data quality is to be 100% accurate 100% of the time.
9.4 The Parties agree to continue to take the preparation and reporting of performance information seriously and demonstrate commitment to improve data quality.
Data Quality Assurance. 7.1 Information shared under the agreement will be adequate to help with the effective discharge of MAPPA purposes. It will be relevant and not contain excessive detail beyond that which is required for the defined purpose(s).
7.2 Information discovered to be inaccurate, out-of-date or inadequate for the purpose should be notified to the originating owner of the data – who will be responsible for correcting the data and notifying all other recipients of the information who must make sure the correction is made.
7.3 If an agency wishes to disclose shared information to a third party, as best practice the agency should seek written consent from the agency that provided the information. If a statutory requirement for disclosure exists then consent for further disclosure is not required. Any agency must ensure that all principles of the Data Protection Act are adhered to. Therefore, if an agency makes a further disclosure to a third party they must ensure that the sharing of personal data is not processed in any manner incompatible with the purpose/s it was obtained for.
7.4 As best practise all information shared is only valid at the time of provision, and should only be used for the purpose as requested. However, the recipient organisation becomes the Data Controller for the shared information therefore the information may be used for subsequent investigations, if it is being used for a purpose that is compatible with the purpose for which it was obtained, i.e. prevention and detection of crime and disorder.
Data Quality Assurance. All participant data relating to the study will be recorded on printed or electronic CRF unless transmitted to Alexion or designee electronically (eg, laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the CRF. • The Investigator must maintain accurate documentation (source data) that supports the information entered in the CRF. • The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory agency inspections and provide direct access to source data documents. • Alexion or designee is responsible for the data management of this study including quality checking of the data. • Study monitors will perform ongoing source data verification to confirm that data entered into the CRF by authorized site personnel are accurate, complete, and verifiable from source documents; that the safety and rights of participants are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH GCP, and all applicable regulatory requirements. • Records and documents, including signed ICFs, pertaining to the conduct of this study must be retained by the Investigator for a minimum of 25 years after study completion, unless local regulations or institutional policies require a longer retention period. No records may be destroyed during the retention period without the written approval of Xxxxxxx. No records may be transferred to another location or party without written notification to Xxxxxxx.
Data Quality Assurance. All subject data relating to the study will be recorded on printed or electronic CRFs unless transmitted to the Sponsor or designee electronically (eg, laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the CRF. The investigator must maintain attributable, legible, contemporaneous, original, and accurate documentation (source data) that supports the information entered in the CRF. The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory agency inspections and provide direct access to source data documents. Details describing monitoring strategy (eg, risk-based initiatives in operations and quality such as risk management and mitigation strategies and analytical risk-based monitoring), methods, responsibilities and requirements, including handling of noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) are provided in the Monitoring Plan. The Sponsor or designee is responsible for the data management of this study including quality review of the data. The Sponsor maintains ultimate responsibility for the quality and integrity of study data, even if study-related duties and functions are transferred to other individuals or organizations (eg, contractors or contract research organizations). Study monitors will perform ongoing source data verification to confirm that data entered into the CRF by authorized site personnel are attributable, legible, contemporaneous, original, and accurate from source documents; that the safety and rights of subjects are being protected; and that the study is being conducted in accordance with the currently approved protocol and any other study agreements, ICH GCP, and applicable regulatory requirements. Records and documents, including signed ICFs, pertaining to the conduct of this study must be retained by the investigator per ICH GCP and local regulations or institutional policies. No records may be destroyed during the retention period without the written approval of the Sponsor. No records may be transferred to another location or party without written notification to the Sponsor.
Data Quality Assurance. In order to properly analyze the data, it was necessary to examine data quality by comparing the data to projected values. As more data were collected, these data were also compared to previous data sets. If a significant discrepancy was identified, the source of the variation was investigated. Each data element was assessed to ensure the quality of the data collection and transmission. If the monthly data set follows previous trends and does not appear to be a drastic outlier, further confirmation of the data set integrity was performed by reviewing operation and identifying any variances that may have affected the data set. These operational conditions were reviewed with on-site personnel to determine if any variances in operations occurred, such as an accident or significant under-utilization. If a trailer did experience one of the preceding, it was assessed further to determine if the collected data were outliers. If the data were identified as outliers, they were removed from the monthly analysis.
Data Quality Assurance. Information shared under this agreement will be adequate to help with the effective discharge of Derbyshire IOM arrangements. It will be relevant and not contain excessive detail which is beyond that required for the agreed purpose. Information discovered to be inaccurate, out-of-date or inadequate for the purpose should be notified to the originating owner of the data who will be responsible for correcting the data and notifying all other recipients of the information who must make sure the correction is made. Partner agencies will ensure that there is an effective management regime to monitor data quality, and that the arrangements for information sharing are fit for purpose.
Data Quality Assurance. The handling of data, including data quality assurance, will comply with regulatory guidelines (eg, ICH and GCP) and the sponsor’s SOPs and working instructions. Data management and control processes specific to this study will be described in a data management plan. All steps and actions taken regarding data management and quality assurance will be documented in a data handling report. When data management is outsourced, the contract organization will be responsible for the development and implementation of the data management plan and preparation of the data handling report according to the sponsor’s standards. Incoming completed CRFs will be logged into the CRF tracking system and will be reviewed for completeness, the presence of mandatory values, dated signatures, and consistency. All medication and adverse event terms recorded on the CRF will be automatically encoded in the sponsor’s database. All entries rejected by the system will be re-evaluated and corrected as appropriate according to the data on the CRF. All data on the CRF will be entered into a validated database using double data entry. Edit checks will be implemented in the data entry panel to ensure data quality and accuracy. Responses to requests for further clarification of data recorded on the CRF will be answered, dated, and signed by the investigator. Changes will be implemented in the sponsor’s database and the data review and validation procedures will be repeated as needed. All medication and adverse event information and textual comments will be proofread for consistency between the database and the CRF; the database will be corrected appropriately. In the case when data management is outsourced, the contract organization will be responsible for database quality assurance including, but not limited to, all medication and adverse event terms as described above. If eCRFs are used, data management at ImmuPharma or its designee will implement edit checks on the eCRF to enforce data entry guidelines, data consistency, and compliance to the protocol and regulatory requirements. Each study center coordinator will be responsible for entering study data on the eCRFs. Data management will track eCRFs and review them for completeness, the presence of mandatory values, consistency, and dated electronic signatures. In addition to checking for SDV flags, data management will electronically attach data clarification queries directly onto the eCRFs during the review process to ensure data quality...
