Common use of Protocol Deviations Clause in Contracts

Protocol Deviations. In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occurs. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter. 6.3

Protocol Deviations. In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occurs. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator Investigators shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter. 6.3

Protocol Deviations. In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occurs. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter. 6.3

Protocol Deviations. In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occursoccurs and competent authorities within the time limits laid down by law. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator Investigators shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter. 6.3