Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How do I know that my application has been submitted successfully and received? 1.64K viewsClinical Research 0 Votes 1 Ans Will I get an acknowledgement once I apply for registration? 1.79K viewsClinical Research 0 Votes 1 Ans In case of online application, whom do I contact if I have questions about my application? 1.32K viewsClinical Research 0 Votes 1 Ans Can I save my application and submit at later date? 1.71K viewsClinical Research 0 Votes 1 Ans How do I enquire about the status of my application? 1.44K viewsClinical Research 0 Votes 1 Ans We treat monitoring reviews and audits as interrelated because they pertain to the same regulations and we use the same criteria to conduct both. Would it be acceptable during a CMS Compliance Program audit for us to demonstrate to CMS that we use monitoring reviews and audits interchangeably as evidence of an effective program, as long as both are comprehensive and routine? 917 viewsDrugsPharmaceutical 0 Votes 1 Ans We currently do not track who has read the SOC. Would it be appropriate if we took a sample of 30 employees and verify they have read and understood the SOC or must we receive confirmation from all employees? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs. 940 viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify when it is permissible for FDRs to perform their own audits. 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans What is Permanent registration? 1.53K viewsClinical Research 0 Votes 1 Ans Does my application necessarily have to be in English? 1.58K viewsClinical Research 0 Votes 1 Ans Who will issue the registration certificate? 1.72K viewsClinical Research 0 Votes 1 Ans Will there be inspection before I am granted a provisional registration certificate? 1.61K viewsClinical Research 0 Votes 1 Ans Once I receive a provisional certificate of registration, what is the validity? 1.73K viewsClinical Research 0 Votes 1 Ans When do I need to renew my provisional registration? 1.73K viewsClinical Research 0 Votes 1 Ans When will permanent registration be undertaken? 1.81K viewsClinical Research 0 Votes 1 Ans Will provisional registration continue after permanent registration begins? / Is permanent registration mandatory after notification of standards or can I continue to run Clinical Establishment with provisional registration? 1.64K viewsClinical Research 0 Votes 1 Ans Is there a penalty for not registering a clinical establishment under this Act? 1.57K viewsClinical Research 0 Votes 1 Ans What is the procedure for Appeals? 1.64K viewsClinical Research « Previous 1 2 … 216 217 218 219 220 … 283 284 Next » Question and answer is powered by anspress.net
