Quality Improvement and Staff Training Programs
Staff education and training are keys to quality research. RCR's Quality Assurance Director is an experienced study coordinator. Continuous quality improvement is an ongoing effort with all staff involved in this commitment. Mandatory training meeting for study startup for all RCR staff. The following list highlights the major components of our quality assurance system.
- Credentialing program for investigators and staff.
- Standard operating procedures annually reviewed and updated.
- QA program includes internal audits, tracking of error rates, query rates and
interventions to respond to and reduce errors.
- Staff training programs include:
- Alliance for Multi-Specialty Research (AMR) training modules and certificates.
- National Institute of Health (NIH) human subject assurance training and certificate (online) for all investigators and coordinators.
- Association of Clinical Research Professionals (ACRP) training and Certification of Clinical Research Professionals (CCRP) certification of all study coordinators when eligible.
- Saf-T-Pak training and testing bi-annually for all SC and lab staff for shipment of human specimens.
- HIPAA compliance training for all staff.
- Lab competencies for glucose testing, ketostix, pregnancy tests and hemoccult.
- Staff training for all listed on 1572 with documentation of the study review for each sub-investigator after staff meeting with SC and PI.
- Subscription to Research Practitioner as continuing education review for CEU's.
- Training CD's from the Alliance for Multi-Specialty Research are used for all staff; the six-series set of Barnett educational textbooks are used for clinical research.
- Additional training for all PI’s: Training in the “Protection of Human Subjects,” a four-hour CME course, and NIH online course in Human Subject Protection.
- Standard Operating Procedures regarding Volunteer Informed Consent, drug accountability, drug storage, and site responsibility log for all involved in each trial.
- Adverse Event reporting: “Yellow” sheet for PI signature and review and assignment of causality to ensure PI involvement in the patient’s care and in assessment of all AE’s.
- Drug dispensation by study coordinator: Access to drug room by SC only, drug accountability documented at time of dispensation and double-checked by second nurse prior to dispensing.
- HIPAA program for compliance with OCR regulations including Site Authorization, Notice of Privacy Practices and all additional forms and security measures as required by OCR.
- Study-specific charts: Designed for each study with source documentation of ICF process documented in each chart prior to procedures. Past medical records requested as required. Primary care notification by patient required prior to participation. PCP notified after study start of each patient’s study participation.
- OSHA compliance.
- Weekly meetings with SC and Medical Director to review study progress.
- Patient satisfaction survey given to all participants at study completion.
- All recruitment materials are submitted to the IRB for review prior to use.
- Tracking program to follow sample of diabetic patients and assess disease management (Diatrends®).
- Ongoing staff inservice programs for CPR, Biohazard, new treatments and trends.
- Journal Club: Monthly meetings to review current medical literature.
- Monitor satisfaction survey requested from all monitors at each visit.
Rochester Clinical Research performs clinical research trials and studies for pharmaceutical and biotechnology companies. We rapidly recruit and screen quality volunteers to participate in clinical studies, and we maintain a large database of volunteers. Study volunteers receive free study-related medical care, investigational medicines, and a monetary stipend to compensate for their time and travel. RCR studies include therapeutic areas and drug categories such as weight loss, diabetes, hypertension, high cholesterol, flu vaccines, and smoking cessation. Our state-of-the-art medical office facility is staffed by highly qualified, caring physicians, investigators, and nurses. RCR is located in Rochester NY and serves the Finger Lakes region of New York. RCR is a WBENC-Certified Women's Business Enterprise.
