Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 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)? 1.52K 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? 1.52K 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? 1.53K 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? 1.41K 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.? 1.57K 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 0 Votes 1 Ans As you are aware, many times oncology studies include a mortality endpoint. Therefore, many trials remain open for several years following the completion of the intervention under investigation. Should we wait until study is closed to enter results? We have received conflicting advice from clinicaltrials.gov.? 1.58K viewsClinical Research 0 Votes 1 Ans Would the use of a non-significant device used as an intervention outside it’s approved treatment vs. standard of care considered ACT? 1.76K viewsClinical Research 0 Votes 1 Ans A ClinicalTrials.gov record is flagged since it is time to upload results. However, the PI is still in the process of analyzing the data and writing the manuscript and does not want to publicly publish the results until accepted for publication. What should be done? Do you have to post anyway? Can you postpone the posting of results until a publication is accepted? 1.41K viewsClinical Research 0 Votes 1 Ans Explain “Primary Completion Date” and “Study Completion Date.” 1.59K viewsClinical Research « Previous 1 2 … 7 8 9 10 11 … 18 19 Next » Question and answer is powered by anspress.net
