A：请参考CFDA药物Ⅰ期临床试验管理指导原则 2011 年 12 月 02 日， 第十条 （二）主要研究者应具备医学或药学本科或以上学历、高级技术职称，具有系统的临床药理专业知识，至少5年以上药物临床试验经验，有负责过多项Ⅰ期试验的经历。

•        MHRA Phase I Accreditation Guidance (Final 28-Oct-15)：

•        The expectation is that the unit has formal procedures in place that specify what investigators require in terms of qualifications, training and experience in relation to the types of trials for which they are “authorised” to act as a PI. Therefore, it is the units’ responsibility to assign a suitably qualified PI; it is not the responsibility of the MHRA or REC to undertake this assessment when authorising/approving the clinical trial.

•        For FIH trials, the PI is required to hold a relevant post-graduate qualification; this is to provide assurance that the PI is able to review pre-clinical data, assess the pharmacology and subsequent aspects such as the proposed starting dose, dose escalation proposal/stopping criteria etc….Relevant post-graduate qualifications include: Diploma in Human Pharmacology, Completion of Speciality Training in Clinical Pharmacology and higher degrees in pharmacology.

https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme