Common use of Laboratory Test Abnormalities Clause in Contracts

Laboratory Test Abnormalities. Abnormalities in laboratory test values should only be reported as AEs if any of the following apply: • They result in a change in IMP schedule of administration (change in dose, delay in administration, IMP discontinuation) • They require intervention or a diagnostic evaluation to assess the risk to the subject C CI

Laboratory Test Abnormalities. Abnormalities in laboratory test values should only be reported as AEs if any of the following apply: • They result in a change in IMP schedule of administration (change in dose, delay in administration, IMP discontinuation) • They require intervention or a diagnostic evaluation to assess the risk to the subject C CI(2) CCI