Second, FDA will continue to exclude clinicalprotocol requests from controlled correspondence, and the related goal dates.
其次，FDA会继续将临床方案申请排除在受控通信之外以及相关的回复期限之外。
2
A clinicalprotocol was written before initiation of the study, but because this was a non-interventional study, the protocol was not formally registered.
实验前制定了临床协议书，由于本研究无其他个人或组织介入，因此并未正式注册。
3
Case report form (CRF) has been used as an essential tool to capture data in the clinical studies, which is next to a par with the clinicalprotocol development.