Rochester Clinical Research understands that the key to any successful clinical trial is having reliable and accurate data entered in a timely fashion. We set high expectations for ourselves in regard to the data that we provide to our Sponsors and the care that we provide to our study volunteers. Quality of care for our patients is our top priority, but ensuring their time and effort are worthwhile is a close second. We do this by guaranteeing to them that the time they spend working with us and the data collected from their efforts will be used to further medical research. The way we do that is by providing high-quality data to you, our Sponsors.
Rochester Clinical Research has a number of SOPs, templates, and forms to help aid in the quality of our data collection. We have two Medical Doctor’s, two Nurse Practitioners, six Registered Nurse Clinical Research coordinators, and one Registered Dietitian/Masters of Public Health/Certified Diabetes Educator Clinical Research Coordinator on staff. Additionally, we have three full-time Research Assistants dedicated to entering data who boast an average turnaround of 24 hours. Beyond that, we have instituted a Quality Assurance department. Since the onset of the QA Department, we have seen a decreased number of monitor findings at site visits and increased praise from monitors on the accuracy of our data – making their time spent at our site more productive.
Our QA Department performs study audits on a regular basis. The following is an abbreviated list of duties our Quality Assurance Department performs in order to ensure you receive data of the utmost quality:
- Review study protocols, EDC screenshots, and source documents to ensure that the source accurately and completely reflects the protocol’s requirements and the site’s documentation requirements
- Review completed source documents for accuracy, completeness, and legibility
- Compare data in source documents to data transcribed in EDC for accuracy
- Identify trends in errors to initiate improvements in the source document flow, collection, and site processes
- Review regulatory binders for proper organization, filing, delegation of authority, documentation, and completeness of training
- Review site processes and forms and suggest revisions that will make the collection of data more streamlined
- Adherence to the above processes, in combination with FDA guidelines for research and good clinical practices, is what leads RCR to constantly evolve, improve, and efficiently provide your company with quality data.
What gives us an advantage over other research sites? It is our commitment to providing high-quality work. Here at RCR, we strive as a team to exemplify quality in all aspects of clinical research. We embody our company’s mission to excel in our field by providing quality care for study volunteers and quality research data to sponsors. As a team, we take that thread of care from the beginning and weave it through all we do, ultimately providing you with data of the highest caliber.
Rochester Clinical Research Mission Statement and Commitment to Quality
The mission at RCR is to excel in the field of clinical research by providing quality care for the study volunteers, quality research data to our sponsors, and a quality team-oriented workplace. RCR has a designated Quality Assurance department. Since the onset of the QA Department we have seen a decreased number of monitor findings at site visits and increased praise from monitors the accuracy of our data – making their time spent at our site more productive. Our QA Department performs study audits on a regular basis. The following is an abbreviated list of duties our QA Department performs in order to ensure sponsors receive data of the utmost quality:
– Review study protocols, EDC screenshots, and source documents to ensure that the source accurately and completely reflects the protocol’s requirements and site’s documentation requirements
– Review completed source documents for accuracy, completeness, and legibility
– Compare data in source documents to data transcribed in EDC for accuracy
– Identify trends in errors to initiate improvements in the source document flow, collection and site processes
– Review regulatory binders for proper organization, filing, delegation of authority, documentation and completeness of training
– Review site processes and forms and suggest revisions that will make the collection of data more streamlined
All of the staff at RCR have a role in quality as described in RCR’s Quality Management Plan. RCR utilizes custom software (https://www.qualityandresearchsolutions.com/) to facilitate our query process which focuses on safety, quality, and compliance. This more accurately tracks our quality metrics and ensures our QA team has a more fluid workflow. All queries are submitted by QA into the custom software and staff receives email alerts that notify them of the query, they can also see a list of their open queries on their profile. The Resolution Log allows for the site to identify trends of where errors occur and make necessary changes to workflow and processes in order to prevent events from reoccurring. Our focus is on a timely response to data quality findings, relying on a risk-based approach centered around clinical practices such as time to resolution, performance comparison across staff, study and indication.