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? 1.69K 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? 1.45K viewsFDA 0 Votes 1 Ans What level of detail is needed in this description? 1.51K viewsFDA 0 Votes 1 Ans What information should sponsors or applicants provide to address this requirement? 1.64K 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? 1.51K viewsFDA 0 Votes 1 Ans What documentation fulfills this requirement? 1.66K 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? 1.80K viewsFDA 0 Votes 1 Ans What are the criteria for a waiver? 1.74K 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? 1.46K viewsFDA 0 Votes 1 Ans How does an IRB submit an initial registration? 1.50K viewsFDA 0 Votes 1 Ans What if my IRB is already registered in the OHRP system? 1.62K 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? 1.86K viewsFDA 0 Votes 1 Ans Is assistance available if my IRB encounters technical problems when attempting to register electronically? 1.46K viewsFDA 0 Votes 1 Ans Will my IRB receive confirmation that its registration was completed? 1.82K viewsFDA 0 Votes 1 Ans What information does the final rule require from each IRB in the U.S. that reviews FDA regulated studies? 1.43K 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? 1.62K viewsFDA 0 Votes 1 Ans Once registered, when is an IRB required to revise its registration information? 1.54K viewsFDA 0 Votes 1 Ans Do IRBs need to update the number of active protocols under review when changes occur? 1.73K viewsFDA 0 Votes 1 Ans What are the consequences of an IRB failing to register as required by the final rule? 1.79K viewsFDA 0 Votes 1 Ans Will the information in the registration system be available to the public? 1.81K viewsFDA « Previous 1 2 … 11 12 13 14 15 … 75 76 Next » Question and answer is powered by anspress.net
