Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Would a study report “Synopsis” (as shown in ICH E3, Annex I)26 provide a sufficiently detailed summary of the protocol and study results? 1.68K viewsFDA 0 Votes 1 Ans Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records? 1.65K viewsFDA 0 Votes 1 Ans What information should the sponsor or applicant provide to meet the requirement in 21 CFR 312.120(b)(4)? 1.39K viewsFDA 0 Votes 1 Ans What information should the sponsor or applicant submit to FDA to show that the study is adequate and well controlled under 21 CFR 314.126? 1.70K viewsFDA 0 Votes 1 Ans What does FDA consider an “adequately constituted” IEC? 1.55K viewsFDA 0 Votes 1 Ans What information must the sponsor or applicant provide to FDA and what information must the sponsor or applicant maintain with respect to the names and qualifications of all IEC members? 1.74K viewsFDA 0 Votes 1 Ans How much detail should the sponsor or applicant provide regarding the IEC’s decisions? 1.55K viewsFDA 0 Votes 1 Ans After submitting this required documentation in the IND/NDA/BLA, is the sponsor required to submit IEC actions on continuing review to FDA? 1.31K viewsFDA 0 Votes 1 Ans What level of detail is needed in this description? 1.35K viewsFDA 0 Votes 1 Ans What information should sponsors or applicants provide to address this requirement? 1.50K viewsFDA 0 Votes 1 Ans What documentation fulfills the requirement for a description of how the sponsor monitored the study and ensured that the study was conducted consistent with the protocol? 1.36K viewsFDA 0 Votes 1 Ans What documentation fulfills this requirement? 1.50K viewsFDA 0 Votes 1 Ans Is a sponsor required by 21 CFR 312.120(b)(11) to obtain signed commitments from investigators to comply with GCP and the protocol? 1.67K viewsFDA 0 Votes 1 Ans What are the criteria for a waiver? 1.57K viewsFDA 0 Votes 1 Ans Does registration imply that an IRB is in full compliance with 21 CFR Part 56 or is otherwise meeting a particular standard of competence or expertise? 1.36K viewsFDA 0 Votes 1 Ans How does an IRB submit an initial registration? 1.39K viewsFDA 0 Votes 1 Ans What if my IRB is already registered in the OHRP system? 1.51K viewsFDA 0 Votes 1 Ans What is the effective date of the final rule and, by what date, must IRBs complete an initial registration or submit additional information as required by the FDA rule? 1.71K viewsFDA 0 Votes 1 Ans Is assistance available if my IRB encounters technical problems when attempting to register electronically? 1.36K viewsFDA 0 Votes 1 Ans Will my IRB receive confirmation that its registration was completed? 1.58K viewsFDA « Previous 1 2 … 146 147 148 149 150 … 283 284 Next » Question and answer is powered by anspress.net
