GCP: A Question & Answer Reference Guide * The PI must report to the EC within 48 hours of actual knowledge of any death that occurred in a study that is their responsibility either on a sponsor's designated form, or on Form 13. The chairman of the Ethics Committee shall immediately investigate the event. * An SAE that occurred in a study that is their responsibility should be reported by the PI both to the Sponsor- according to the Sponsor's timeline requirements, and to the EC committee - according to the demands of each specific EC. * The Sponsor must report to all PIs any SUSAR which involves death within 7 days and any other SUSAR within 15 days. * A SUSAR report that occurred at the Investigator's site must be submitted to the EC immediately, whereas SUSARs that occurred at other sites are reported periodically. * Malfunction of the investigational medical device must be reported to the EC within 48 hours of actual knowledge of the event on Form 13. The Sponsor is responsible for continuous examination of safety and for reporting any new safety information to the EC. * Interim report: clinical trial approvals in Israel are granted for a period of one year. Two - three months prior to the end of the period approved for a clinical trial, the PI must submit a progress report to the EC in order to extend the validity of the approval for another year. After the EC approves a validity extension (on Form 6A), the approval is sent to the Director of the medical institution for review and the Director's final approval (on Form 7A) is sent to the Principal Investigator. * The Sponsor should submit a report on the discontinuation of a clinical trial to the EC via the investigator, and in cases where the trial is discontinued for special safety reasons, such as SAEs, the MoH needs to be informed. * A trial completion report should be submitted to the EC by the Sponsor via the investigator. * The Sponsor should submit an annual SUSAR report to the EC via the investigator within 30 days after it is signed and issued. 678