Archiving of Clinical Trial Data
- Archiving of Clinical Trial Data
Архивирование (данных клинического исследования)
В соответствии с согласованным трёхсторонним руководством МКГ по качественной клинической практике, данные клинических исследований должны храниться не менее 2-х лет после получения последней лицензии на продажу в какой-либо из стран, где действуют правила МКГ, или до тех пор, пока в официальных инстанциях какой-либо из стран, где действуют правила МКГ, ещё находится заявление на получение лицензии, а также не менее 2-х лет с момента прекращения клинической разработки продукта. Данные документы могут храниться и более длительный период, если этого требуют официальные инстанции, или если это было заранее согласовано со спонсором. Спонсор обязан информировать исследователя/учреждение, когда отпадает необходимость хранения документации.
English-Russian dictionary of terms used in the conduct of clinical trials on medicinal products.
2013.
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