札幌医科大学医学部

分子医学研究部門

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**「バイオ研究者・大学院生のための便利メモ」**

***このページは2001年2月22日に更新しました***


バイオ研究者・大学院生のための簡単な英語文例集

その15 アメリカ遺伝子治療学会の見解 つづき

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Submission of a technical and non-technical abstract and current protocol on a yearly basis. The requirement to resubmit these documents on a yearly basis is not in harmonization with FDA requirements and appears to be duplicative. Our understanding of current guidelines indicates that all amendments, including a copy of the revised protocol, must be submitted to your office. Therefore, the most up-to-date documents will already be on file with your office. An alternative is to indicate the date of the last protocol amendment on the annual report. Amendments which require revision of the technical and non-technical abstract could be submitted when the amended protocol is supplied to OBA. A statement in the annual report indicating the abstracts are current would appear to be sufficient. 


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