Common use of Protocol Amendments Clause in Contracts

Protocol Amendments. There will be no alteration to the protocol without the express written approval of the Sponsor. The local authorities or ethics committees must approve all major protocol amendments prior to implementation. No protocol amendments should be adopted without prior written approval from the ethics committee except in the following cases: · in order to eliminate immediate hazard to the patients, · changes involving only logistical or administrative aspects of the trial. Then notification to the relevant authorities should be submitted. In these cases, the implemented deviation or change should be submitted as soon as possible to the relevant authorities for review and approval. No protocol deviations are anticipated. However, should any protocol deviations occur, the Principal Investigator must report the matter to the Sponsor as soon as reasonably practical. Details of the deviation and, if possible, the reason for its occurrence must be included in the study report. Major modifications will need further approval, and will be submitted to the local authorities or ethics committees, according to local regulations, in the form of an Amendment. Minor administrative changes require only that the Chairman of the Ethics Committee be informed in writing without delay.