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? 1.70K viewsClinical Research 0 Votes 1 Ans Will I get an acknowledgement once I apply for registration? 1.93K viewsClinical Research 0 Votes 1 Ans In case of online application, whom do I contact if I have questions about my application? 1.38K viewsClinical Research 0 Votes 1 Ans Can I save my application and submit at later date? 1.77K viewsClinical Research 0 Votes 1 Ans How do I enquire about the status of my application? 1.48K 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? 971 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? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs. 989 viewsDrugsPharmaceutical 0 Votes 1 Ans Using real-life examples, please clarify the distinction between ongoing monitoring and auditing of FDRs 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify when it is permissible for FDRs to perform their own audits. 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What is Permanent registration? 1.58K viewsClinical Research 0 Votes 1 Ans Does my application necessarily have to be in English? 1.64K viewsClinical Research 0 Votes 1 Ans Who will issue the registration certificate? 1.83K viewsClinical Research 0 Votes 1 Ans Will there be inspection before I am granted a provisional registration certificate? 1.73K viewsClinical Research 0 Votes 1 Ans Once I receive a provisional certificate of registration, what is the validity? 1.80K viewsClinical Research 0 Votes 1 Ans When do I need to renew my provisional registration? 1.87K viewsClinical Research 0 Votes 1 Ans When will permanent registration be undertaken? 1.90K 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? 1.75K viewsClinical Research 0 Votes 1 Ans Is there a penalty for not registering a clinical establishment under this Act? 1.63K viewsClinical Research 0 Votes 1 Ans What is the procedure for Appeals? 1.73K viewsClinical Research « Previous 1 2 … 216 217 218 219 220 … 283 284 Next » Question and answer is powered by anspress.net
