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QCReview is dedicated to quality control of data in clinical trials with possible pulmonary function implications. We are a team of pulmonology specialists that act as a central reading site.
SERVICES OFFERED:
Onsite review and training of each laboratory:
- Onsite training of lab personnel at each PFT laboratory participating in the current study. Overall review of laboratory standards, practices and readiness to participate in the study will be implemented before testing of study patients begins.
Laboratory PFT and DLco Simulator Certification:
- Detailed readiness assessment of each participating PFT lab after either an onsite visit or web training and thorough study reporting review. We will work with each laboratory, regardless of how many attempts they must make, in order to become certified. We will provide a certificate for each technician and each lab to keep onsite that they have been certified for study participation. Everything will be done to bring the sites up to standard, but some laboratories cannot be certified, due to inexperienced technicians, old or poorly operating equipment and language barriers.
In-House PFT Document Prep and Blinding:
- In order to keep high quality standards, our office has the ability to scan all report pages and blind each and every PFT report before it is read for quality and grading by a central reader. Each report will be assigned a blinded ID in order to keep all patient data confidential and not create any bias in the PFT reading process. All patient or lab identifiers on the actual report will be removed at the time of scanning. The PFT over-reader will then read the report without reference to the site or patient demographics. As part of this process there will be creation and maintenance of an electronic database to track every report received and read by our office.
Review and Grading of PFT Reports:
- Review of each PFT test checking for report layout (test values, graphical assessment of spirometry, DLco and lung volume tracings), testing standards, test repeatability, test reproducibility and overall quality control. Each PFT report will take an average of 20 minutes to complete. This includes the completion of an official CRF or worksheet for each individual report and submission of testing results back to the appropriate study associate. The submission could be a web-based data entry form, paper CRF or a fax transmittal.
Direct Monthly Support – Study Associates:
- Includes any phone support, email support and interaction between the QCReview office and study associates involved in the current study. Our team is always available for the needs of the sponsor, the CRO and the testing laboratory staff.
Direct Monthly Support – Laboratories:
- Includes any phone support, email support and interactions between the QCReview office and the pulmonary function technicians concerning quality or testing issues. This will also include updating and reporting to the principal investigator at the site about quality and suggestions for improving and maintaining the PFT data quality. We will also maintain a quality support website that contains examples of proper test results, examples of excellent tests and examples of poor quality tests with recommendations on how to fix the quality problem shown.
To get a detailed quote or assessment of our possible involvement with your project, contact us at:
Phone: (801) 363-2096
Email: qcreview@msn.com
Address: 508 E. South Temple, Suite 226 – SLC, UT 84102