Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans I work for an institution that is looking into designation, so I was wondering if you have any suggestions for tools to help with this involved process? 1.37K viewsClinical Research 0 Votes 1 Ans Could you provide more details on the note you made regarding DT2 and the extensive review of non-NCI peer-reviewed funding? 1.63K viewsClinical Research 0 Votes 1 Ans Do you have any examples of Membership, Publications, and Grant tracking systems? 1.26K viewsClinical Research 0 Votes 1 Ans How does a research site maintain compliance with IRB approval requirements if patient recruitment content is included in a blog? 1.51K viewsClinical Research 0 Votes 1 Ans Why is there a need for this initiative? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans How did the FDA go about this reappraisal? 832 viewsDrugsPharmaceutical 0 Votes 1 Ans What does “risk-based” approach mean? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a “risk-based” approach to CGMPs mean that certain manufacturing processes will not be regulated if only minimal risks are involved? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What is healthcare compliance? 1.61K viewsHospital and Healthcare 0 Votes 1 Ans How Your Organization Can Utilize a Research-Specific Disaster Plan? 1.57K viewsClinical Research 0 Votes 1 Ans How to Create an All-Star Disaster Recovery Team? 1.70K viewsClinical Research 0 Votes 1 Ans How Your Approach to Regulatory Management Can Affect Disaster Recovery Readiness? 1.25K viewsClinical Research 0 Votes 1 Ans Using Integrated CTMS and eReg Systems to Build New Clinical Research Efficiencies? 1.54K viewsClinical Research 0 Votes 1 Ans How do I determine if a system requires 21 CFR Part 11 compliance and validation? 1.55K viewsClinical Research 0 Votes 1 Ans Can a vendor audit be done remotely or does it need to be done in person? 1.58K viewsClinical Research 0 Votes 1 Ans If I am implementing more than one validated system, can I reuse anything from the validation process? 1.51K viewsClinical Research 0 Votes 1 Ans If I buy two products from the same company, do I have to validate twice? 1.63K viewsClinical Research 0 Votes 1 Ans Some in the pharmaceutical industry have expressed concern that the ICH E3 Guidance, Structure and Content of Clinical Study Reports (hereafter, E3), is intended as a requirement, i.e., a template that must be followed. The fact that the ICH M4 Guidelines for the CTD refer to specific structural elements described in E3 (e.g., Clinical Study Report [CSR] section headings) may have contributed to this interpretation. Interpretation of E3 as a rigid template can result in presentation of redundant and suboptimal information in CSRs. This is a particular problem when E3 is used for studies for which it was not designed (e.g., pharmacokinetic studies or studies with health economic or quality of life outcomes). Can ICH reaffirm that E3 is a Guideline and not a required template and that E3 may be adapted to report studies that fall outside the original scope of E3? 1.33K viewsClinical Research 0 Votes 1 Ans Is it an essential element to execute a disaster recovery process on a manufacturing kit during qualification, and do you see any risk with respect to software removal? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What about systems with no audit trail or an incomplete audit trail? What’s the work-around for such systems? 1.17K viewsDrugsPharmaceutical « Previous 1 2 … 126 127 128 129 130 … 283 284 Next » Question and answer is powered by anspress.net
