FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 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? 1.34K viewsFDA 0 Votes 1 Ans What information should sponsors or applicants provide to address this requirement? 1.49K 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? 1.66K viewsFDA 0 Votes 1 Ans What are the criteria for a waiver? 1.56K 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? 1.35K 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? 1.70K viewsFDA 0 Votes 1 Ans Is assistance available if my IRB encounters technical problems when attempting to register electronically? 1.35K viewsFDA 0 Votes 1 Ans Will my IRB receive confirmation that its registration was completed? 1.57K viewsFDA 0 Votes 1 Ans What information does the final rule require from each IRB in the U.S. that reviews FDA regulated studies? 1.27K viewsFDA 0 Votes 1 Ans Once my IRB is registered or its existing information is updated to comply with this rule, is registration permanent unless there is a change in required information? 1.50K viewsFDA 0 Votes 1 Ans Once registered, when is an IRB required to revise its registration information? 1.43K viewsFDA 0 Votes 1 Ans Do IRBs need to update the number of active protocols under review when changes occur? 1.58K viewsFDA 0 Votes 1 Ans What are the consequences of an IRB failing to register as required by the final rule? 1.68K viewsFDA 0 Votes 1 Ans Will the information in the registration system be available to the public? 1.53K viewsFDA « Previous 1 2 … 11 12 13 14 15 … 75 76 Next » Question and answer is powered by anspress.net
