Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Results reporting requirement for approved vs. unapproved drugs. Can you please clarify if both are currently required to report? 1.63K 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? 1.61K 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? 1.39K 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)? 1.60K viewsClinical Research 0 Votes 1 Ans Are interventional studies with approved meds, used for approved label uses, have the same scrutiny that IND and NDE studies, as far as registration and results reporting goes? 1.61K viewsClinical Research 0 Votes 1 Ans I understand that there are requirements for reporting results of trials that involve drugs or devices, but what about radiation? Where does that fit in (because that is all we do)? 1.53K viewsClinical Research 0 Votes 1 Ans Do lab draws that don’t change the plan of care (only for data collection) need to be reported? 1.50K viewsClinical Research 0 Votes 1 Ans Is there additional training available for navigating Clinicaltrials.gov? 1.54K viewsClinical Research 0 Votes 1 Ans We are starting a small industry sponsored phase 1 safety/feasibility clinical trial (20 patients) using an FDA-approved device for an on-label indication in cancer patients. Sounds like we need to register based on FDAMA, but not by FDAAA. Can you clarify if we need to register and/or report on ClinicalTrials.gov? 1.65K viewsClinical Research 0 Votes 1 Ans I was under the impression that only primary outcome measures had to be included on the registry. But as it was presented today it sounds like any secondary outcome measures in the protocol must be included in the registry as well, correct? 1.53K viewsClinical Research 0 Votes 1 Ans Regarding “Primary Completion Date,” I am confused as to what date to put for that field. 1.41K viewsClinical Research 0 Votes 1 Ans If a community hospital is performing an interventional trial using dietary supplements would that require registration? 1.66K viewsClinical Research 0 Votes 1 Ans If investigators are not required to be Part 11 Compliant, what should we tell the sponsors when they ask if we are Part 11 Compliant? It seems they are picking sites that are only Part 11 Compliant. Is there an FDA document that specifically states this to show sponsors? 1.54K viewsClinical Research 0 Votes 1 Ans Would regulatory documents either generated electronically or scanned with signature be considered electronic documents subject to Part 11? 1.61K viewsClinical Research 0 Votes 1 Ans If an academic institution is managing records completed by individual investigators, should the Responsible Party be the PI or S-I? In the past, the institution’s administrators marked the university as the responsible party? 1.63K viewsClinical Research 0 Votes 1 Ans Are data reviews or exempt research excluded from reporting? 1.42K viewsClinical Research 0 Votes 1 Ans Would a phase I study of an IND drug with a limited phase II MTD expansion require results to be reported? 1.65K viewsClinical Research 0 Votes 1 Ans Is an observational study that is collecting data on patients who may or may not have taken an investigational product considered to be a clinical trial? The sponsor I am working with claims this would qualify as a clinical trial but I don’t agree. Please advise.? 1.58K viewsClinical Research 0 Votes 1 Ans At our academic institution, we register most clinical research projects whether they are ACTs or not. So, if I understand you correctly, results are not required for those trials that are not ACTs. How do we make that distinction in the posting so that it doesn’t appear that the posting is incomplete (missing results)? 1.29K viewsClinical Research 0 Votes 1 Ans If a study is prematurely closed (for any number of reasons) and an analysis is not done, how should we record that in ClinicalTrials.gov? Does it matter if there are no subjects enrolled, vs. some subjects enrolled? 1.64K viewsClinical Research « Previous 1 2 … 123 124 125 126 127 … 283 284 Next » Question and answer is powered by anspress.net
