Common use of Medication Error Clause in Contracts

Medication Error. The Sponsor must be notified within 24 hours of any error leading to the administration of either 10% more or 10% less than the intended dose; in such cases, the event must be reported on the eCRF. If an error resulted in a SAE, a Serious Adverse Event form must be submitted within 24 hours of the event (see Section 9.2.1).

Medication Error. The Sponsor must be notified within 24 hours of any error leading to the administration of either 10% more or 10% less than the intended dose; in such cases, the event must be reported on in the eCRFclinical trial database. If an error resulted in a SAE, a Serious Adverse Event form must be submitted within 24 hours of the event (see Section 9.2.18.2.1).