Quality Improvement & Staff Training Programs
Staff education and training are keys to quality research. 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.
1. Credentialing Program for Investigators/Staff
2. Standard Operating Procedures — annually reviewed and updated.
3. QA program including internal audits, tracking of error rates, query rates and
interventions to respond to and reduce errors.
4. Staff Training Programs include:
• AMR (Alliance for Multi-specialty Research) training modules and certificates
• NIH Human subject assurance training and certificate (online) for all investigators and coordinators
• ACRP (Association of Clinical Research Professionals) training and CCRC (Certification of Clinical Research Professionals) 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.
We subscribe 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.
5. 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.
6. OSHA compliant.
7. Weekly meetings with SC and Medical Director to review study progress.
8. Patient satisfaction survey given to all participants at study completion.
9. Tracking program to follow sample of diabetic patients and assess disease management (Diatrends®).
10. Ongoing staff inservice programs for CPR, Biohazard, new treatments and trends.
11. Journal Club — Monthly meetings to review current medical literature.
12. Monitor satisfaction survey given to all monitors at each visit.