(System Info - 109113 MCWATTERS BERNARD 10/29/2009 07:45:12 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA
Submission ID: 125297/0
Product: Influenza Vaccine
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 23-Sep-2008 03:00 PM
Initiated by FDA? Yes
Communication Categorie(s): 1. Information Request Author: BERNARD MCWATTERS Brief Description: Novartis described deficiencies at Dominican Republic clinical study sites. Melisse requested report from Novartis when investigation complete. FDA Participants: Melisse Baylor, Laraine Henchal, Bernard McWatters Non-FDA Participant(s): Joanne Totosy de Zepetnek, Hilel Cohen Trans-BLA Group : No Related STNS : Related PMCs : Telecon Body:
Joanne contacted me on 9/22/08 via email to let me know that she and Hilel wanted to let the agency know that there were some issues at some of the clinical study sites, 10 and 11, used in the Dominican Republic for the pivotal trials with Agrippal. Novartis noted that after auditing some of the clinical study sites in the Dominican Republic, they found some problems with the local IRB, the hospital ethics committee (EC) and their records. These were:
It seems this local EC may not have been functioning in accord with its charter based upon the following
- Although appropriate SAE reports were submitted on a timely basis to FDA, the investigator provided SAE reports to the local EC in monthly summaries when the EC’s procedures required reports within five days.
- Documentation of the qualifications and credentials of EC members was not available on site, and documentation of investigation site staff in the review process was not always clear.
- Finally, we identified suggestions that the EC may have archived only some of the documentation sent to them.
Novartis informed us that they were still investigating the sites to determine if the problems were serious. Melisse Baylor was not overly concerned with these issues but did request that Novartis send in a follow up report after they completed their investigation of any irregularities.