Quality Assurance and Clinical Monitoring
Quality Assurance and Clinical Monitoring
QUALITY ASSURANCE AND TESTING
Quality is an integral part of performing research studies and sample testing for clients. Whether the study and/or test data is being submitted to government regulators, is being used to make product efficacy and safety decisions, or is being used to determine safety of a food product, quality is always at the highest importance. RTI wants clients to be assured that here at RTI, our data is accurate and meaningful. We take pride in our emphasis on quality.
QUALITY ASSURANCE AT RTI
RTI Quality Assurance personnel performs a 100% review of clinical study data and reports. Quality assurance personnel inspect study events and lab testing processes regularly.
RTI's Quality System includes controlled Standard Operating Procedures (SOPs) and data collection forms to ensure consistency in RTI study and testing processes.
CLINICAL MONITORING
Quality assurance staff coupled with members from the clinical team provide clinical monitoring of clinical trials and field studies to both GLP and GCP standards nationwide. Our in-house veterinarians are available to engage on issues of clinical care, safety, and any medical alerts (adverse events) that may arise on study.
For inquiries, please contact us at RTI at [email protected]
Quality System
Good Documentation Practices (GDocP) are key components of quality compliance. All RTI staff are trained and practice good record-keeping, a formal and mandatory practice to meet appropriate industry standards and legal requirements for safety, efficacy, and product/data quality. We follow all guidelines and standards for each, and every study, which get categorized to either Good Laboratory Practices (GLP), Good Clinical Practice (GCP), or ISO/IEC 17025 (Laboratory Testing and Calibration Standards).
Record-keeping SOPs guide operations/practices and staff to meet quality, validation, calibration, and risk management standards. RTI has in place a quality management system, with a large catalog and number of SOPs that guide the work we perform on all studies and critical business practices. In certain instances, we employ at the sponsor discretion, electronic data capture on validated systems (eg, Medrio). At the minimum, basic requirements are met for:
Data Accuracy
- Recorded accurately
- Cross-checked for errors
- Not intentionally misleading (prevents fraudulent entries, editable entries)
- Validated instrumentation
Data Integrity and Quality Control
- Genuine, true data
- Validated and supported/witnessed; vs intentionally falsified
- Relevant to the reporting requirement
- Not changeable after original record-keeping entry (extensively tracked changes)
- Data is never altered or erased once entered or recorded
- No white-out permitted (specific writing instruments are designated)
- Specific rules are followed when altering a record, such as a legible cross through of the data and the correction listed with registered initials and the time/date (and reason for the change, depending on the record-keeping requirements)
Reporting/record-keeping timeliness
Information is recorded contemporaneously
- Real-time record keeping including date stamps (e.g., automated time-stamping)
Legibility
- Clarity
- Legible (readable by anyone, removing guesswork)
- Readily accessible
Identifiable
- Clear records that can identify the person who actually records the data
- No shared passwords
GDocP Investigations, Self-Inspection Findings and Audits
To avert breaches of standards regulations (GLP, GCP, ISO 17025) and achieve positive regulatory and sponsor audits, internal audits, and inspections are performed regularly.
This includes training, monitoring, and assessing the documentation practices and systems used by contractors, suppliers, transportation personnel, and other vendors and service providers.