Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can sponsors or investigators translate the new required statement? 1.72K viewsClinical Research 0 Votes 1 Ans Please go over the results reporting timeline (12 months after primary outcome). 1.58K viewsClinical Research 0 Votes 1 Ans If a non-ACT is posted onto ClinicalTrials.gov, is the new consent language required? 1.35K 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? 1.50K viewsClinical Research 0 Votes 1 Ans Do Phase II-IV trials of drugs, biologics, or devices not approved by FDA need to be registered? 1.66K 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? 1.63K 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? 1.61K 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? 1.32K 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? 1.80K 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.” 1.72K 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? 1.44K viewsClinical Research 0 Votes 1 Ans What is the new requirement for informed consent documents? 1.48K viewsClinical Research 0 Votes 1 Ans Why is it necessary to include this new statement in informed consent documents? 1.52K 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?” 1.62K viewsClinical Research 0 Votes 1 Ans What clinical trials are specifically excluded from the definition of “applicable clinical trials?” 1.49K 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? 1.71K viewsClinical Research 0 Votes 1 Ans Results reporting requirement for approved vs. unapproved drugs. Can you please clarify if both are currently required to report? 1.66K viewsClinical Research 0 Votes 1 Ans In terms of more detailed advice/training on results entry, especially for oncology trials, is there any one program you would recommend more than another? We have found that the way in which our data have been collected does not necessarily fit with how ClinicalTrials.gov asks for the information? 1.65K viewsClinical Research 0 Votes 1 Ans Can you explain again how a Phase I study might be an “applicable trial” and in what section of FDAMA this relates to? 1.43K viewsClinical Research 0 Votes 1 Ans Do the consent form requirements apply to both FDAAA and FDAMA, or FDAAA only (i.e., Phase I trials with efficacy endpoints)? 1.64K viewsClinical Research « Previous 1 2 … 6 7 8 9 10 … 18 19 Next » Question and answer is powered by anspress.net
