疑義解釈資料（平成30年）
Ｑ
問３ 臨床研究法の施行後、同法第２条第２項第２号ロに規定する「用法等」と異なる用法等で用いる医薬品等の安全性及び有効性を評価する臨床研究については、特定臨床研究に該当することとなったが、こうした臨床研究の保険診療上の取扱いに変更はあるか。
Ａ
（答）特定臨床研究への該当の有無によって、保険診療上の取扱いに変更が生じることはない。
疑義解釈資料の送付について(その13)-2019.04.03－[PDF形式/161KB]
「臨床研究法」のレセプト請求・算定Q&A
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