Description of Event or Problem · 0
THIS IS TO REPORT AND GCP NON-COMPLIANCE OF A MEDICAL DEVICE TRIAL FOR LIVANOVA VNS THERAPY DEVICE AURA5000. PROTOCOL TITLE: TREATING OBSTRUCTIVE SLEEP APNEA USING TARGETED HYPOGLOSSAL NERVE STIMULATION - THE OSPREY STUDY (LNS005). THESE ISSUES WERE DISCOVERED BY (B)(6). AND THIS HAS BEEN GOING ON FOR QUITE SOME TIME. ALL SITES SHOULD BE AUDIT READY AT ANY TIME, BUT THAT IS NOT THE CASE. 1. THE PROJECT MANAGERS FOR THE SPONSOR, (LIVANOVA) HAVE "SDV'D SOURCE DATA" W/O A MONITORING VISIT DOCUMENTED IN CTMS, AND W/O A DOCUMENTED MONITORING VISIT REPORT OR SITE CONTACT SUMMARY, DOCUMENTING THE SDV. THIS WOULD BE AN AUDIT FINDING AND I BELIEVE A 483 FOR LIVANOVA AND THE SITES. THERE ARE NO NTFS FOR THESE FINDINGS EITHER. 2. LIVANOVA PROJECT MANAGERS HAVE INSTRUCTED SITES TO PACK ALL SUBJECT SOURCE AND SHIP TO ANOTHER SITE FOR PATIENT TRANSFERS. I BELIEVE THAT MAY ALSO BE A 483 FOR LIVANOVA AND THE SITES. THERE ARE NO NTFS ON IT EITHER. THE (B)(6) ARE TRYING TO HELP LIVANOVA CLEAN THIS UP APPROPRIATELY, DOCUMENT DUE DILIGENCE, AND PROVIDE GCP COMPLIANT GUIDANCE MOVING FORWARD. (B)(6) DID REQUEST A CAPA BE PUT IN PLACE, HOWEVER, LIVANOVA DETERMINED IT WAS NOT NEEDED. 3. IT WAS ALSO RECENTLY DISCOVERED THAT THE LIVANOVA PMS, AND THE (B)(6) WERE NOT COMPLETING AND SUBMITTING SITE CONTACT SUMMARIES OR MVRS FOR REMOTE VISITS CONDUCTING REMOTE SDV. THIS IS UNACCEPTABLE AND THERE IS NO DOCUMENTATION ON HOW THE REMOTE SDV WAS CONDUCTED AND HOW SOURCE SHARED. THERE IS ONLY AN AUDIT TRAIL OF SDV AND NO REPORTS/DOCUMENTATION OF ANY KIND. THE CLINICAL MONITORING PLAN EVEN STATES REMOTE VISITS REQUIRE A SITE CONTACT SUMMARY BE SUBMITTED, REVIEWED AND APPROVED. THIS NON-COMPLIANCE HAS BEEN GOING ON FOR YEARS. 4. (B)(6) RECENTLY DISCOVERED AN INFORMED CONSENT FORM ISSUE AT (B)(6) SITE THAT WAS NOT HANDLED APPROPRIATELY. THE PREVIOUS (B)(6) DOCUMENTED ONLY ONE PROTOCOL DEVIATION FOR THE ISSUE, WHEN THERE SHOULD HAVE BEEN A PD FOR EACH PATIENT THAT SIGNED THAT ICF. THOSE PDS SHOULD HAVE BEEN REPORTED TO THE IRB BUT THEY WERE NOT. THIS SITE HAS OVER 50 PATIENTS. 5. AT THIS SITE, AND MANY OTHERS, THE LIVANOVA PMS HAVE INSTRUCTED THEM TO PRINT OFF EDC PAGES AND USE IT AS SOURCE. NOT BLANK EDC PAGES THAT THEY CAN USE AS HARDCOPY AND FILL OUT AND USE AS SOURCE, BUT DATA PREVIOUSLY ENTERED IN EDC IS PRINTED OUT DAYS LATER AND THEY CONSIDER IT SOURCE. THAT IS NOT SOURCE. THAT WOULD BE AN AUDIT FINDING AND POSSIBLY (B)(6) SINCE THE ORIGINAL (B)(6) DIDN'T ADDRESS IT APPROPRIATELY. 6. SEVERAL PRINCIPAL INVESTIGATORS ARE NOT ASSESSING AE RELATIONSHIP TO THE STUDY DEVICE BECAUSE THE AE LOG FORM DOES NOT INCLUDE THE RELATIONSHIP TO DEVICE QUESTION. WE ARE NOT SURE WHERE THAT IS CAPTURED IN SOURCE, IF IT IS CAPTURED. PIS ARE NOT SIGNING OFF ON AES APPROPRIATELY OR IN A TIMELY MANNER. AT DR. (B)(6) SITE SEVEN (7) PROTOCOL DEVIATIONS WERE RECENTLY REPORTED FOR LATE AE REPORTING RELATED TO SUBJECTS (B)(6), BETWEEN 27 TO 50 DAYS FROM THE AWARENESS DATE. 7. AT (B)(6) SITE THEY USE CUREMD FOR EMR. WHEN THE LIVANOVA PMS MONITORED THEM, THEY COPIED/PASTED EMR ONTO A WORD DOC AND CALLED IT THEIR SOURCE. THIS IS NOT SOURCE DATA. THE STUDY HAS HIT THEIR ENROLLMENT GOAL AND PLAN TO SUBMIT A PRESS RELEASE TODAY. OUR CONCERN IS THAT A LARGE PART OF THE DATA IS INVALID. IT WOULD BENEFIT PATIENTS TO HAVE THE STUDY AUDITED BY THE FDA.