Examples of Regulatory Requirements in a sentence
The Investigator agrees to immediately and fully inform the Sponsor, PSI and, when applicable, the ethics committee(s) and competent authorities, of any significant risks, adverse events or unexpected results related to the Study, according to the Applicable Regulatory Requirements and applicable Protocol provisions.
The Institution and the Investigator shall maintain true, correct, accurate, complete and current records of all Study Data, including the Case Report Forms (or equivalent electronic data), relevant source documents and any other essential documents or materials as required by the Protocol, the Applicable Regulatory Requirements and PSI’s and the Sponsor’s instructions (collectively the "Records").
The Institution and the Investigator shall keep all the Records in a safe and secure location for the period required by the Applicable Regulatory Requirements, or, as defined in the Study Protocol for the period following the completion of the Study, whichever is longer, and in accordance with the information provided to Study subjects.