Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the difference between “consent” and “authorization” under the HIPAA Privacy Rule? 1.30K viewsHospital and Healthcare 0 Votes 1 Ans When is an authorization required from the patient before a provider or health plan engages in marketing to that individual? 1.23K viewsHospital and Healthcare 0 Votes 1 Ans Will the HIPAA Privacy Rule hinder medical research by making doctors and others less willing and/or able to share with researchers information about individual patients? 1.27K viewsHospital and Healthcare 0 Votes 1 Ans Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRB) and Privacy Boards reviewing similar or identical research projects? 1.17K viewsHospital and Healthcare 0 Votes 1 Ans Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information? 1.19K viewsHospital and Healthcare 0 Votes 1 Ans Does the HIPAA Privacy Rule permit the creation of a database for research purposes through an Institutional Review Board (IRB) or Privacy Board waiver of individual authorization? 1.07K viewsHospital and Healthcare 0 Votes 1 Ans Not all cloud solutions are necessarily Part 11 compliant. How would one know? 1.51K viewsClinical Research 0 Votes 1 Ans Once a system is validated, does it need to be re-validated annually? 1.68K viewsClinical Research 0 Votes 1 Ans Regarding the application of Part 11 to our site, we utilize a cloud based CTMS which houses patient demographics (not procedure/health records). We have subjects who participate in NIH studies in the CTMS. Is the CTMS vendor responsible for being part 11 compliant? Is our site accountable in this case? 1.56K viewsClinical Research 0 Votes 1 Ans If sponsor is providing software, i.e. EDC software, are they responsible for validation? Or is the site required to have their own separate policy as well? 1.68K viewsClinical Research 0 Votes 1 Ans Is there anything in the regs that we can use to go to vendors with asking for their validation documents? Most vendors I’ve spoken to are protective of their systems and validation documents. 1.63K viewsClinical Research 0 Votes 1 Ans Is Part 11 applicable if site uses a secure drive (limited access) to archive a portion of the regulatory binder? 1.69K viewsClinical Research 0 Votes 1 Ans What documentation can a site reasonably expect a vendor to release to them, since most vendors consider their documentation proprietary. 1.70K viewsClinical Research 0 Votes 1 Ans If a site used RedCAP to collect data for investigator initiated studies that will later be sent to the FDA for approval, must the site have a System Validation process for their RedCAP? 1.31K viewsClinical Research 0 Votes 1 Ans If the vendor provides validation documents as evidence and upon review internally, it meets our requirements, do we (as the investigator site) still need a validation document? 1.30K viewsClinical Research 0 Votes 1 Ans If you validate in a test/validation system, should you re-validate once you’re in the live/production system? Can we skip the test/validation site and validate directly in production? 1.62K viewsClinical Research 0 Votes 1 Ans When do I need to be 21 CFR Part 11 Complaint? 1.66K viewsClinical Research 0 Votes 1 Ans What is the New 21 CFR Part 11 guidance emphasizes data integrity? 1.50K viewsClinical Research 0 Votes 1 Ans Why do packagers, labelers and holding companies have to have Master Batch Records and Batch Production Records from the manufacturer? 1.48K viewsClinical Research 0 Votes 1 Ans How do I deal with a software vendor who issues automated patches (such as virus scan engine updates, bug fixes, hotfixes, etc.) and won’t agree to notify us ahead of time? 1.65K viewsClinical Research « Previous 1 2 … 107 108 109 110 111 … 283 284 Next » Question and answer is powered by anspress.net
