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Applied Clinical Trials ; 30(5):14-15, 2021.
Article in English | ProQuest Central | ID: covidwho-20231839

ABSTRACT

During the height of the COVID-19 pandemic, this core aspect of a CRA's role was altered greatly, with many sites unable to continue research and/or unable to accommodate visitors, therefore forcing a change in the method of monitoring source documentation and challenging their relationship with site staff. Protocol mandated procedures and methods of data collection, though seemingly straight forward, have met challenges at sites when faced with hospital visitor restrictions, government travel restrictions, the risk of COVID-19 associated with visiting hospital, vulnerable patients, redeployed staff, limited time... the list goes on! Remote monitoring without SDV, though challenging, has still been found to be valuable in highlighting and resolving issues, maintaining good working relationships with the sites, ensuring data is entered, training site staff, and ensuring the ongoing success of the study.

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