package insert for the regulatory file. sponsors are required to notify sites of IND Safety Reports that have been submitted to the FDA. These IND Safety Reports must be submitted to the IRB/IEC and filed with the IB. Any other informational letters issued by the manufacturer to investigators must also be filed in this section. 21 PERIODIC REPORTS AND ANNUAL RENEWALS This section (or alternate location if other file system is used) must include the Principal Investigator's periodic reports to the IRB/IEC and any other reports to the IRB/IEC, as well as annual and/or periodic Approvals from the IRB/IEC. Maintain the entire packet together in the file the submission letter, submission report package, and IRB/IEC Approval. It is suggested – that the newest packet should be in the front.
package insert for the regulatory file. sponsors are required to notify sites of IND Safety Reports that have been submitted to the FDA. These IND Safety Reports must be submitted to the IRB/IEC and filed with the IB. Any other informational letters issued by the manufacturer to investigators must also be filed in this section. 21 PERIODIC REPORTS AND ANNUAL RENEWALS This section (or alternate location if other file system is used) must include the Principal Investigator's periodic reports to the IRB/IEC and any other reports to the IRB/IEC, as well as annual and/or periodic Approvals from the IRB/IEC. Maintain the entire packet together in the file – the submission letter, submission report package, and IRB/IEC Approval. It is suggested that the newest packet should be in the front.
Regulatory%20Document%20Guidelines.docx