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? 2.09K 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? 2.02K viewsFDA 0 Votes 1 Ans What information should the sponsor or applicant provide to meet the requirement in 21 CFR 312.120(b)(4)? 1.65K 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? 1.96K viewsFDA 0 Votes 1 Ans What does FDA consider an “adequately constituted” IEC? 1.78K 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? 1.99K viewsFDA 0 Votes 1 Ans How much detail should the sponsor or applicant provide regarding the IEC’s decisions? 1.77K 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? 1.55K viewsFDA 0 Votes 1 Ans What level of detail is needed in this description? 1.63K viewsFDA 0 Votes 1 Ans What information should sponsors or applicants provide to address this requirement? 1.72K 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? 1.61K viewsFDA 0 Votes 1 Ans What documentation fulfills this requirement? 1.75K 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? 1.90K viewsFDA 0 Votes 1 Ans What are the criteria for a waiver? 1.82K 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? 1.54K viewsFDA 0 Votes 1 Ans How does an IRB submit an initial registration? 1.58K viewsFDA 0 Votes 1 Ans What if my IRB is already registered in the OHRP system? 1.69K 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? 1.96K viewsFDA 0 Votes 1 Ans Is assistance available if my IRB encounters technical problems when attempting to register electronically? 1.54K viewsFDA 0 Votes 1 Ans Will my IRB receive confirmation that its registration was completed? 1.95K viewsFDA « Previous 1 2 … 146 147 148 149 150 … 283 284 Next » Question and answer is powered by anspress.net
