Applicable Regulatory Requirements definition
Examples of Applicable 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.
To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements.
The Institution and the Investigator shall maintain 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 for a period of fifteen (15) years following the completion of the Study, whichever is longer.
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.
The Institution and the Investigator shall keep all the Records in a safe and secure location for a period of fifteen (15) years after completion of the Study or the period required by the Applicable Regulatory Requirements, whichever is longer.
The Institution shall keep all the Records in a safe and secure location for a period of fifteen (15) years after completion of the Study or the period required by the Applicable Regulatory Requirements, whichever is longer.
The Institution and the Investigator shall not use PSI’s or the Sponsor’s name, the names of any of their employees, symbols, or trademarks in any advertising, sales promotional material, or press release without the prior written permission of PSI or the Sponsor, as applicable, except to the extent such disclosure is required to comply with the Applicable Regulatory Requirements.
The Investigator agrees to immediately and fully inform the Sponsor 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.