Questions Ask question Search Order By: ActiveCategoryClear Filter 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 Are the analytical data arising in the course of the validation of analytical procedures critical data? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans The calibration of equipment influences the correctness of data. Does this mean that the calibration is critical? 936 viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? Is it allowed to continue using this control? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? (The control concerned is the control of a reactor which is used for the manufacture of intermediates and APIs but not of final products). Is it allowed to continue using this control or does it have to be withdrawn from use? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the audit trail review prior to the release of each batch a regulatory requirement or is it only recommended so far? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Hybrid systems: No audit trail retrofitting possible. What can be done? 905 viewsDrugsPharmaceutical 0 Votes 1 Ans Role concept: Is a user allowed to carry out a reintegration? (GC-system) 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans It is difficult to carry out the separation between the persons of administrator and user in the CDS. Is it possible that the admin and the user being the same person? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Process validation data are category 3 data – therefore no audit trail review is required. But isn’t it required to carry out a review for the generation of validation measuring data? 1.19K viewsDrugsPharmaceutical 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? 1.65K 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 « Previous 1 2 … 121 122 123 124 125 … 283 284 Next » Question and answer is powered by anspress.net
