Questions Ask question Search Order By: ActiveCategoryClear Filter 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? “ 1.53K 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? 1.63K viewsClinical Research 0 Votes 1 Ans What if the new statement conflicts with foreign informed consent requirements? 1.35K viewsClinical Research 0 Votes 1 Ans Can sponsors or investigators translate the new required statement? 1.66K viewsClinical Research 0 Votes 1 Ans Please go over the results reporting timeline (12 months after primary outcome). 1.55K viewsClinical Research 0 Votes 1 Ans If a non-ACT is posted onto ClinicalTrials.gov, is the new consent language required? 1.32K viewsClinical Research 0 Votes 1 Ans Can you go over the requirement of registration for phase I trials for serious illnesses? Can you give an example of such a trial? 1.44K viewsClinical Research 0 Votes 1 Ans Do Phase II-IV trials of drugs, biologics, or devices not approved by FDA need to be registered? 1.63K viewsClinical Research 0 Votes 1 Ans Are you saying that trial results should be posted online at ClinicalTrials.gov before the manuscript is accepted by the journal? 1.58K viewsClinical Research 0 Votes 1 Ans Regarding registering a trial on ClinicalTrials.gov, in a multicenter trial, is the PI at the lead site responsible, or the sponsor? 1.58K viewsClinical Research 0 Votes 1 Ans We were told NOT to use the new ICF language for non-ACTs. Is there anything wrong with using the new ICF language even if it is not an ACT? 1.29K viewsClinical Research 0 Votes 1 Ans Who is responsible for registering trials on ClinicalTrials.gov – the Sponsor or the Principle Investigator on a multi-site trial? Or satellite Principle Investigators? If trials are NOT registered, who will be held liable? Is it the Institution’s IRB or Site Principle Investigator or Sponsor or The Principle Investigator listed on the Study Protocol? 1.74K viewsClinical Research 0 Votes 1 Ans The International Committee of Medical Journal Editors has indicated that they will not consider publishing to ClinicalTrials.gov as “pre-publication.” 1.68K viewsClinical Research 0 Votes 1 Ans I recently had an email about whether or not our university is auditing ClinicalTrials.gov submissions. The person said she had been trying to research this and was finding that not many people actually audited submissions. I was wondering if you had any further information on this? 1.39K viewsClinical Research 0 Votes 1 Ans What is the new requirement for informed consent documents? 1.43K viewsClinical Research 0 Votes 1 Ans Why is it necessary to include this new statement in informed consent documents? 1.44K viewsClinical Research 0 Votes 1 Ans FDA’s final rule refers to an “applicable clinical trial”—what is an “applicable clinical trial” and how do I know if my trial is an “applicable clinical trial?” 1.57K viewsClinical Research 0 Votes 1 Ans What clinical trials are specifically excluded from the definition of “applicable clinical trials?” 1.44K viewsClinical Research 0 Votes 1 Ans Is reporting of trial data for Phase I in Oncology trials required or does that apply only to phase 1 normal healthy volunteer studies? 1.65K viewsClinical Research « Previous 1 2 … 122 123 124 125 126 … 283 284 Next » Question and answer is powered by anspress.net
