Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What should sponsors consider when deciding to validate outsourced electronic services that are used in clinical investigations? 1.67K viewsClinical Research 0 Votes 1 Ans Does FDA consider the mobile technology to contain the source data? 1.60K viewsClinical Research 0 Votes 1 Ans What should sponsors consider when implementing audit trails on data obtained directly from study participants using the mobile technology in the clinical investigation? 1.54K viewsClinical Research 0 Votes 1 Ans What should sponsors consider when using a risk-based approach for validation of electronic systems used in clinical investigations? 1.77K viewsClinical Research 0 Votes 1 Ans Under the scope of 21 CFR part 11, what will be FDA’s focus during inspections? 1.57K viewsClinical Research 0 Votes 1 Ans Are clinical trials that are funded, conducted, or supported by the Department of Health and Human Services (HHS) (i.e., subject to 45 CFR § 46) subject to the new regulation? 1.37K viewsClinical Research 0 Votes 1 Ans What are the consequences of not including the new language in consent documents for applicable clinical trials? 1.45K viewsClinical Research 0 Votes 1 Ans What is the exact statement required to be included in informed consent documents? 1.63K viewsClinical Research 0 Votes 1 Ans Why is it necessary to include the specific statement without any changes? 1.66K viewsClinical Research 0 Votes 1 Ans When must sponsors and investigators begin including the new statement in informed consent documents? 1.40K viewsClinical Research 0 Votes 1 Ans What if my study has received approval only for particular sites? 1.49K viewsClinical Research 0 Votes 1 Ans How should sponsors and/or investigators obtain approval for informed consent documents with the new statement? 1.68K viewsClinical Research 0 Votes 1 Ans What are the responsibilities of an IRB under the new rule? 1.58K viewsClinical Research 0 Votes 1 Ans In what situations may the new requirement be waived? 1.60K viewsClinical Research 0 Votes 1 Ans Does the new statement have to be featured in a particular place in the informed consent document? 1.51K viewsClinical Research 0 Votes 1 Ans What if non-compliant informed consent documents (documents without the new statement as required) are submitted to and approved by the IRB? 1.40K viewsClinical Research 0 Votes 1 Ans “If a clinical trial is not subject to the rule, do investigators have to inform trial participants about the availability of clinical trial information on www.ClinicalTrials.gov? “ 1.52K viewsClinical Research 0 Votes 1 Ans Should investigators/sponsors include the statement in consent documents for a trial that is not an “applicable clinical trial?” 1.54K viewsClinical Research 0 Votes 1 Ans Do informed consent documents for studies conducted outside of the United States have to comply with the new regulations? 1.62K viewsClinical Research 0 Votes 1 Ans What if the new statement conflicts with foreign informed consent requirements? 1.34K viewsClinical Research « Previous 1 2 … 5 6 7 8 9 … 18 19 Next » Question and answer is powered by anspress.net
