Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 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? 1.46K viewsClinical Research 0 Votes 1 Ans Are Phase 1 trials treated differently by Medicare? 1.57K 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? 1.60K 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? 1.51K 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? 1.41K 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? 1.44K 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? 1.35K 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 0 Votes 1 Ans If a sponsor purchases an off-the-shelf system, such as an EDC, and validates it, does it also need to be certified by a third party? 1.31K viewsClinical Research 0 Votes 1 Ans Is the risk-based validation approach only applicable to sponsors, or can it also be implemented in a hospital setting? 1.47K viewsClinical Research 0 Votes 1 Ans During the presentation, you mentioned a risk-based approach to 21 CFR Part 11. Are there specific types of data that should be compliant with this regulation and would all systems used for clinical research need to be GCP compliant? 1.21K viewsClinical Research 0 Votes 1 Ans How do we get monitoring fees in the budget? It is hard to get sponsors to pay for monitoring? How do you charge for remote monitoring? Charging per page could be overwhelming? 1.28K viewsClinical Research « Previous 1 2 … 8 9 10 11 12 … 18 19 Next » Question and answer is powered by anspress.net
