9,000 square foot facility with temperature controlled and monitored secure drug rooms, minus 20° freezer, cold centrifuge, regular centrifuge, stadiometer, DXA (Lunar –Prodigy machine), 8 exam rooms, 4 dedicated monitor rooms, 2 large conference rooms, on-site long-term storage for record archive. Daily documentation of temperature of refrigerator, freezer, drug rooms. Automatic battery powered backup system for freezer, refrigerator. Nearby x-ray facility, endoscopy facility.
Staff8 study coordinators, 6 CCRC’s, 2 Nurse Practitioners, Phlebotomist, Full-time Registered Dietitian, Certified Diabetes Educator for weight loss, diabetic and lipid trials, 2 patient recruiters, Administrative staff for regulatory preparation. Certified DXA technician, 4 on-site physicians, MD available every day, Specialist MD’s for OB-GYN, Gastroenterology, Allergy and Immunology, Dermatology available as needed. Average years of experience per coordinator: 4 years, ranging from 2 to 25 years. Investigator experience range: 6 to 18 years.
Standard Operating Procedures for Informed Consent Process- see attached Additional SOP’s in place for staff training, drug accountability, drug storage, HIPAA, Saf-t-pak. Site responsibility log for all involved in each trial.
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. We use training CD's from the Alliance for Multi-Specialty Research for all staff and the 6 series set of Barnett educational textbooks for clinical research. All PI’s have completed training in the “Protection of Human Subjects” 4 hour CME course and NIH online course in Human Subject Protection in addition to on-site training already listed. All staff involved in shipment of lab specimens are IATA Saf-t-pak certified and trained.
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.
Nearest hospital – Rochester General Hospital 1.2 miles from facility. On site emergency equipment including airways, ambu bag, IV fluids and epinephrine, IV Benadryl.
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.
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.
Database with Clinical Conductor 14,000 patients listed: 55% female, 45% male. Affiliated with Rheumatology Associates of Rochester – office located in our building and MD’s work in our office for research visits 2 days a week. This practice has 10,000 patients in addition to our database.
Recruitment experience: We are highly experienced in placing local advertising with a variety of methods. Our database is initial method for identifying candidates, followed by advertising through radio, newspaper, flyers, web posting on Center Watch, and email newsletter to all database members. We are also experienced in working with 800 numbers and central recruitment services. All recruitment materials are submitted to the IRB for review prior to use. 2 full-time recruiters are used for patient screening.
Central IRB used for all studies. We promptly notify Central IRB of all SAE’s and IND safety reports. We have also worked extensively with WIRB, Shulman and Quorum IRB.
Member of the Alliance for Multi-Specialty Research, a group of independently owned and operated sites dedicated to clinical trials. We are not an SMO, but have sites all over the US that may help a sponsor find other high quality, experienced (average of 7 years of SC experience at each site).
Committed to Quality and to developing quality assurance through staff training, internal audit program and ongoing "query count.” 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.