OPERATIONS & REGULATORY COMPLIANCE
COMMITMENT TO RESEARCH EXCELLENCE
We know of no metabolic research site more committed to research excellence than L-MARC Research Center. If you are a Study Sponsor reading this page, it is likely you are doing so because you have heard of our reputation as a high volume recruiting research center. We are certainly proud of our rapid regulatory document turnaround, and reputation as a rapidly recruiting, volume research site. But we feel it is even more important to emphasize our daily commitment to research quality. We believe in not only the letter, but the spirit of Good Clinical Practice guidelines, and the Food and Drug Administration Information Sheets.
STANDARD OPERATING PROCEDURES (SOP's)
L-MARC Research Center has one of the most comprehensive, and most practical Standard Operations Procedures in the business. Our SOP's represent a living document that is updated yearly - based upon new guidelines, as well as based upon issues that have arisen or been discovered during the previous year. Although its length is long (now approaching 100 pages), each of our research staff is required to document that they have read, and are encouraged to make comments to our SOP's at least once a year. They also refer to this document throughout the year. In addition, we routinely conduct internal assessments through our Internal Quality Assurance program. Furthermore, because we are a high volume site, we have received numerous audits by study sponsors over the years. We look at these audits as learning experiences, and in many cases, have made significant changes in our standard operating procedures based upon auditing reports. It is our philosophy that despite all the efforts we have made in the past to ensure quality, we can always find ways to improve. And it is the willingness to constantly undergo self and outside scrutiny that allows us to grow equally as well from a quality standpoint, as we have from a volume standpoint.
It is simply a reality that in Louisville KY, we have found a limited number of new prospective employees with prior research experience. Therefore, we are fortunate to have Certified Clinical Research Coordinators with a special gift for training new research coordinators. Having a training process through experienced research personnel is important because, due to the complexity of clinical research, this training process may take years to complete. In fact, it could be argued that the training of all of our staff never ends. We undergo some degree of training all the time, necessitated by the constant evolving nature of clinical research.
In addition, we have found that our relationship with study sponsors and study monitors to be one of the best sources of ongoing training. From a study sponsor standpoint, research coordinators and other research staff (such as dietitians) are encouraged to take an active role in activities before, during and after Investigator Meetings. Our site has often been chosen to provide substantial input into protocol issues both before, and after study start-up. We feel that by being an active, participating team member with the study sponsor, we become a more knowledgeable and better trained research site, and the study sponsor may get a better protocol.
As noted before, from a study monitor standpoint, we appreciate our monitors, and their advice. We also look at study monitor or study sponsor audits as a learning experience. In fact, it has been through such study audits that over the years, we have made the greatest improvements in our SOP's.
Thus, staff training at L-MARC Research Center is an ongoing process, just as our SOP's are a living document. Although we have the highest commitment towards providing the highest quality research today, we know that it is only through constant internal evaluation and introspection that we can become an even better research site tomorrow.
L-MARC RESEARCH CENTER PROTECTION OF HUMAN SUBJECTS PROGRAM AND PROCESS
In addition to training inherent in the day-to-day conduct of research activities, L-MARC Research Center also has had a longstanding commitment to the ethical conduct of clinical trials. We have one of the most intense compliance programs focusing on the protection of human test subjects. Just as the informed consent process involves much more than simply having study subjects sign an Informed Consent Document, so do we believe that the protection of human test subjects involves much more than simply completing a "course" or "on-line training."
Thus, L-MARC Research Center utilizes a time-tested specific training process that has been both approved, and mandated by this Institution. This training and "process" includes:
- When eligible, research coordinators are encouraged to become Certified Clinical Research Coordinators
- Employees attend routine research staff meetings, to go over the day-to-day matters of research activities. These routine meetings occur once or twice a week, and include discussions of proper recruitment, study conduct, and other issues pertaining to the protection of human test subjects.
- Twice a year, L-MARC Research Center conducts an off-site, mandatory, biannual meeting in which any important quality issues that may have occurred over the prior six months are discussed through a formalized, PowerPoint presentation by our Medical Director and President (Harold Bays MD, FACP). All employees are required (through documentation) to have attended these presentations, which include specific issues as to how L-MARC Research Center is committed to the protection of human test subjects, and how we may continue to improve our quality as a research site. Since 1999, all slides of these biannual presentations have been kept "on file" - thus documenting the kinds of quality issues that were discussed, as well as documenting our expectations regarding research quality and the protection of human test subjects. Although much of the basic principles towards the protection of human test subjects are are repeated each and every 6 months, we believe it is through compulsive repetition, and maintaining a stable research staff, that best promotes compliance with Good Clinical Practices, the ethical conduct of clinical trials, HIPAA guidelines, and the protection of human test subjects.
- The research staff is encouraged to attend research educational programs throughout the year, especially those related to FDA compliance aspects of clinical research, which includes discussions of the protection of human test subjects.
- Employee evaluations occur at least once a year, in which individual quality performance is evaluated, and discussed with each employee. Compliance with the protection of human test subjects is always a priority in these employee evaluations.
Finally, in addition to all the above, we feel that employees should have yet more ongoing training (and documentation as such) regarding the specific topic of the Informed Consent process. We feel that one of the most important aspect of the proper conduct of any clinical trial is the Informed Consent process. Upon our read of the FDA information sheets, the protection of patient safety and rights is the most emphasized aspect of clinical research. Therefore, prior to each biannual meeting, each research staff member is required to take an open book, detailed, 40 question, "Consent Form Quiz," that tests the employees' knowledge of the informed consent process. Each employee is required to make a 95% score or better, prior to any bonus or raise that may occur at that time. Employees are encouraged to obtain the correct answers in anyway possible, including the review of the FDA information sheets, or L-MARC Research Center SOP's. They are also free to discuss the quiz amongst themselves - with special encouragement to interact with the more senior members of this research site, who have repeatedly taken this same quiz so many times, for so many years. Every employee involved with research activity are required to complete the "Consent Form Quiz," and copies of each employee's quiz and performance are kept on file.
Again, we believe that the protection of human test subjects is an ongoing "process," and we believe it is through compulsive repetition, and maintaining a stable research staff, that best promotes compliance with Good Clinical Practices, the ethical conduct of clinical trials, and the protection of human test subjects.
CERTIFICATION FOR HUMAN RESEARCH PARTICIPANT PROTECTION TRAINING
To further ensure that the staff at L-MARC Research Center is well trained in the protection of human test subjects, staff members are required to undergo the protection of human subjects program and process as described above. Once achieved, then a biannual "L-MARC Research Center Certification for Human Research Participation Protection Training" is issued. Receipt of this Certification is contingent upon:
- Review of L-MARC Research Center's Standard Operating Procedures, which includes information from the FDA Information Sheets, Good Clinical Practice Guidelines, and the Belmont Report.
- Review of L-MARC Research Center HIPAA guidelines
- Acceptable and documented performance on the biannual informed consent quiz
- Attendance at biannual meetings, or if unable to attend, a review of the slide presentation of the biannual meetings
- Ongoing day-to-day training as might be achieved by routine noon meetings, and if applicable, frequent "signing" and learning sessions with the Investigator, as well as interactions with study monitors which may or may not include discussion of study audits
ACTIVE PARTICIPATION AND OVERSIGHT BY THE PRINCIPAL INVESTIGATOR
Active participation and oversight of the Principal Investigator is important for the most appropriate conduct of clinical trials. Our Medical Director and President, Harold Bays MD, FACP, is very active in many aspects of the day-to-day operations of L-MARC Research Center, including:
- General oversight of all clinical trials conducted through L-MARC Research Center.
- Easy, and frequent availability to study sponsor and study monitor.
- Personal review and signature on all adverse events.
- Personal review of significant physical exam abnormalities, with management plan for follow-up.
- Personal review of all abnormal laboratory, and establishment of management plan for any significant findings.
- Supervision and signature of routine letters to the primary care doctor of each study volunteer, notifying the primary care doctor of the subject's entry into (through "entry letter"), and exit from (through "exit letter") participation in the study. Initial, and final laboratory results are also included in these letters, and copies given to the study subject.
- Detailed, personalized letters for significant physical findings, and/or laboratory abnormalities found during the course of the study.
- Design of the research facility itself, through "Turbo CAD" (computer automated design), using over a decade of research experience to establish the best in quality research environment.
- Personal review, and yearly revisions of L-MARC Research Center's Standard Operating Procedures.
- Personal monthly review, and data entry of accounting information regarding this research site.
- Monthly review of individual research coordinator productivity through "Study Manager" research software
- Weekly meetings with Site Manager with discussions as to how improvements can be made in the conduct of clinical trials at this research site.
- Personal review of recruitment and general research quality matters during weekly recruitment meetings with research coordinators.
- Management and maintenance of the server, client desktops, and general software computer issues.
- Presentation of a PowerPoint presentation of quality research issues during the biannual staff meetings, with special emphasis, and repeated emphasis on the three most important principles of this research center:
Study subject safety is our #1 priority
Quality research is our #1 objective
Performance is our #1 goal
COMPUTER CAPABILITIES AND REMOTE DATA ENTRY
L-MARC Research Center is proud of its substantial, long standing history of expertise with remote data entry. In fact, L-MARC Research Center was one of the first clinical research sites to work with modem-to-modem remote data entry throughout the 1990's. Currently, L-MARC Research Center has continued to gain experience with new technologies in research data transfer, such as Internet based remote data entry, and assorted hybrid research communication systems.
In order to facilitate compatibility with virtually any and all computerized data transfer, our site and research coordinator offices have been designed, and equipped with network and computer systems - specifically for the purpose of clinical research. For example, we have:
- Rapid Internet connection through fiber optic cable (Shared T1)
- Each research coordinator office has a Dell computer with Microsoft Office Software, including full Outlook email and Word document capability.
- Each research coordinator office has glass shelving for at least 4 laptop docking stations. Behind each glass shelf is an electrical outlet, analogue modem-to-modem port, as well as access to a data port through our network for rapid Internet data transfer. In other words, behind each of the 4 glass shelves are identically replicated electrical and communication options, to ensure versatility for any potential remote data entry need.
- Each study monitor work station also has a similar array of capabilities, including phone, electrical outlet, analogue telephone port, and Internet data port through out network.)
In general, L-MARC Research Center's commitment to advance, as technology advances allows us the greatest opportunity to remain flexible, and compatible with virtually any remote data entry system. In fact, we have often been a "test site" for study sponsors who are just gaining experience with new Information Technologies.
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