What KPAR Has To Offerkpar_adm1n2016-04-01T15:38:07+00:00
KPAR has two office locations within the Bardstown Medical Building, a patient area and an administrative area. The patient area of KPAR is located on the first floor of the building, just down the hall from Physicians to Children & Adolescents. Providing easy accessibility for the investigators and patients to the research nurses. There are a total of 32 exam rooms (4 dedicated research to KPAR and 28 exam rooms within PTCA).
Within the first floor patient area is a large limited access storage room containing:
• Two frost free, temperature monitored refrigerators to store refrigerated Investigational Product (IP).
• Multiple shelving units for additional room temperature storage for IP
• Blood specimen processing station, with calibrated centrifuges.
• A -20°C chest freezer
• Unblinded IP preparation area
An additional limited access storage room on this floor houses a large -80°C freezer.
On the second floor of the building, is the administrative area. This area is approximately 1500 square feet, contains a conference room, copier/ fax room, monitor room, 3 document storage rooms and 8 offices. These offices are occupied by the Research Director, Regulatory Director, Study Coordinators and Research Director’s Assistant.
Office hours are Monday -Friday, 8:30 – 5:00. Saturday 9:00 – 12:00. Late hours and weekend hours are available to accommodate patient scheduling for individual trial needs.
• -80°C freezer
• -20°C chest freezer
• 2 frost free refrigerators
• All refrigerators and freezers have calibrated Min/Max thermometers
• 2 centrifuges
• Electronic blood pressure measuring equipment
• Infant scales, pediatric/ adult digital and balanced scales
• Wall mounted stadiometer
• Infant and pediatric lengthboards
• ECG machine
• Universal generator
The refrigerators and freezers have routine maintenance performed annually. All other equipment are calibrated annually. Refrigerator and freezer temperatures are recorded twice daily Monday- Friday on a temperature log, and once daily on Saturdays.
We believe the quality of a clinical trial depends on data integrity and patient protection. The increasing complexity of clinical trials has made achieving quality challenging on the site level. KPAR is constantly improving the standards of the clinical trial process within our site, to meet the ever changing expectations in the clinical research industry. These measures to maintain quality are achieved through the development of specific processes, which are standardized within KPAR, but also customized for each specific clinical trial. The quality systems included: personnel roles and responsibilities, investigator oversight, training, document development, quality assurance, quality control, record retention, corrective and preventative action and Standard Operating Procedures.
Adherence to Standard Operating Procedures and Good Clinical Practices, in conjunction with a strong knowledge of FDA regulations and ICH guidelines, are essential to running a successful trial. At KPAR, we strive to ensure all activities from the very beginning, to each patient enrolled and every data point captured in the source document will support a regulatory inspection. Because KPAR is often a high enrolling site, there is a higher probability for audits by the sponsor and regulatory agencies. By conducting every trial by beginning with the end in mind, we have developed a system proven to ensure we are inspection ready at any time. This is achieved through the following methods:
• All KPAR staff and Investigators complete a Transcelerate approved Good Clinical Practice training course, at least every 3 years.
• Maintaining regular and thorough communication with the Investigators, all research staff, the monitor, sponsor and any vendor associated with a given study.
• Continuous and ongoing training for each trial conducted.
• Improving and revising processes as often as needed.
• Development of standardized Source Document Worksheets, customized for each trial.
• Proactively identifying any potential issues, training to prevent those issues and developing documents or procedures to alleviate the potential.
• Determining the root cause of issues that occur during active participation and reacting with improvements to processes or documents and corrective action plans.
• Documentation in a clear and concise manner, providing a complete and organized picture with the goal of preventing questions.
• Quality Control reviews of source documents within 24-48 hours of a patient visit.
Investigator Oversight and Involvement
Because KPAR is closely integrated into the routine daily practice of Physicians to Children & Adolescents, the Investigators are involved in the clinical trial process throughout every day. The Principal Investigator (PI) and SubInvestigators participate in every aspect of a clinical trial, including recruitment, determination of eligibility, the informed consent process, physical examinations, clinical assessments, medical oversight and safety evaluations. The Principal Investigator maintains oversight by being directly involved with patient care and evaluations, in addition to appropriately delegating responsibilities as a protocol will allow, to qualified and trained staff members.
The Principal Investigator is involved with research staff and study patients on a daily basis, ensuring the safety of study participants, while also ensuring protocol adherence and understanding, adequate training and open communications with all staff. PI oversight is also fulfilled by reviewing the eligibility and enrollment of each patient, determining Adverse Event causality, reviewing Adverse Events, reviewing laboratory results and reviewing the source documents during the trial and/ or at the end of each patient’s participation in a study. The PI is apprised of any issues that may arise during a trial, or of any patient status or safety concerns, on an ongoing basis.
Rapid Enrollment and Retention
KPAR has a proven track record for enrolling rapidly and meeting enrollment expectations. Consideration to participate in any clinical trial is determined from past experience with the indication and the availability of the appropriate patient population. We take a conservative approach to our enrollment estimations, and have exceeded our expectations for the majority of the trials we have participated in. Our patients are predominantly recruited through our internal patient population, with very little need to advertise or seek patients through external resources. We are focused on success and proactively identifying patients upon site selection for a clinical trial. Upon selection, we will develop an effective, individualized recruitment plan for our site to ensure our enrollment expectations are met.
The majority of patients enrolled in clinical trials at KPAR are recruited by the primary care provider (who is also a KPAR Investigator) and through our database of past clinical trial patients. These long term, trusting relationships with our patients has enabled us to have successful retention in lengthy trials.
Quality Control / Quality Assurance
Maintaining accuracy and quality throughout a clinical study is a continual, systematic process. KPAR ensures the validity and integrity of the data collected, by following a quality management plan, involving quality control and quality assurance.
KPAR staff perform quality control reviews of all source documentation within 24-48 hours of a patient visit. This review allows KPAR staff to ensure the expected procedures are followed and to identify source document completion errors, missing data, etc., contemporaneously of the visit, to ensure optimal data integrity and completeness. The data is then entered into the Case Report Form (CRF) within the same time period, when an additional quality control review of the source data is completed.
Quality Control is completed on 100% of all records.
Quality Assurance is completed by management staff as needed during a trial, or at the conclusion of a trial. This review is a systematic, comprehensive review of all components of the trial, to assess the accuracy of study data and adherence to GCP standards and ICH guidelines.