Examples of Study Records in a sentence
CRO will inform the Institution no later than 6 months prior to expiry of the archiving period of a legal entity designated by CRO which will take over Study Records for archiving services.
The Institution will allow the CRO/the Sponsor or their representatives to conduct an inspection, monitoring of audit of the performance of Study, the Study Site, and Study Records pursuant to this Agreement at the Study Site or in other premises agreed in this Agreement, where the Study is conducted or that are used to conduct the Study, exclusively during the regular business hours.
The Institution will archive the Study Records under adequate conditions preventing their damage or destruction for the period of fifteen (15) years from the completion of the Study (further only the “archiving period”), unless a longer period is required per Applicable Laws.
Institution will archive the relevant Study Records in the manner specified by Applicable Laws, including current GCP guidelines.