Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.42K viewsClinical Research 0 Votes 1 Ans Explain “Primary Completion Date” and “Study Completion Date.” 1.59K viewsClinical Research 0 Votes 1 Ans You mentioned software that works with the ClinicalTrials.gov database for uploading registries and results. Could you please tell me again what that software is called? 1.47K viewsClinical Research 0 Votes 1 Ans Are Phase 1 trials treated differently by Medicare? 1.58K viewsClinical Research 0 Votes 1 Ans Do you have the clinical investigators sign off on the analysis? 1.52K viewsClinical Research 0 Votes 1 Ans What document do you reference for device trials? 1.61K viewsClinical Research 0 Votes 1 Ans Is a clinical study sponsor permitted to collect patient initials on any form (e.g., case report forms or any other document)? 1.64K viewsClinical Research 0 Votes 1 Ans Are there any potential implications or causes for concern in sharing a limited data set under a data use agreement with a private company that is not a Covered Entity? 1.62K viewsClinical Research 0 Votes 1 Ans As a covered entity, is it necessary that we take steps to address and contractually obligate the sponsor, or any other recipient of PHI pursuant to an authorization form, to limit their use of the PHI to the authorization’s uses? 1.65K viewsClinical Research 0 Votes 1 Ans Do EDC Systems used in academic institutions need to be 21 CFR Part 11 compliant? 1.52K viewsClinical Research 0 Votes 1 Ans If an EMR has a research component where trials, agreements and financials are housed within the EMR, and the EMR is shared between two separate clinical trial sites, does it then need to be 21 CFR Part 11 compliant? Is it ok that site A can access all the confidential documents of site B when Site A is not contractually included in the study? 1.42K viewsClinical Research 0 Votes 1 Ans Do IRB processes fall within Part 11? 1.36K viewsClinical Research 0 Votes 1 Ans Which SOPs should we write? 1.45K viewsClinical Research 0 Votes 1 Ans How detailed should the SOP be? 1.58K viewsClinical Research 0 Votes 1 Ans How will we implement the SOP? 1.33K viewsClinical Research 0 Votes 1 Ans What is the right thing to do once data has been transcribed into eCRFs – do we keep a paper copy of the data, or can it be destroyed? 1.36K viewsClinical Research 0 Votes 1 Ans If you collect emails in a database, how do you link them to specific diseases and maintain HIPAA compliance? 1.37K viewsClinical Research 0 Votes 1 Ans If your clinical trial is coming to an end and you are moving into a commercial setting to recruit patients, do you still need to get IRB approval on media materials used commercially? 1.46K viewsClinical Research « Previous 1 2 … 124 125 126 127 128 … 283 284 Next » Question and answer is powered by anspress.net
