A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation Clinical research protocols are intricate and detailed. Regulatory authorities including the U.S. Food and Drug Administration require full documentation o... A Bansal,R Chamberlain,S Karr,... - 《Journ...
美国医疗器械法规CFR-2021-title21-vol8-part860.docx,Food and Drug Administration, HHS § 860.3 PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES Subpart A—General Sec. 860.1 Scope. 860.3 Definitions. 860.5 Confidentiality and use of data and in- formati
interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the ...
Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records; 准确表明各成份的重量或容量,各成份使用同一计量系统(公制、常衡或药衡制)。用于制剂生产的各成分的量...
Table 4 Clinical characteristics of 37 cases or controls with germline variants Full size table The SMAD4 variants predicted to create cryptic sites or abolish branch sites did not result in aberrant expression patterns, consistent with the RT-PCR results. However, BC-VAR, but not BC-REF, exhib...
interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the ...