Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 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? 1.69K 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? 1.53K 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? 1.62K 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 What should appear in the original medical record? 1.42K viewsClinical Research 0 Votes 1 Ans What purposes does the medical record serve in the context of the clinical study? 1.47K viewsClinical Research 0 Votes 1 Ans What purpose do source documents serve? 1.70K viewsClinical Research 0 Votes 1 Ans For those who may be new to research billing compliance, could you explain, at a high-level, what exactly a coverage analysis entails? 1.53K viewsClinical Research 0 Votes 1 Ans In general, how has the Medicare Clinical Trial Policy impacted Medicare billing? 1.37K viewsClinical Research 0 Votes 1 Ans How are where should source data be defined? 1.53K viewsClinical Research 0 Votes 1 Ans How can proper documentation of eligibility be ensured? 1.48K viewsClinical Research 0 Votes 1 Ans What are the expectations of the investigator’s copy of the CRF when using a web based application? 1.59K viewsClinical Research 0 Votes 1 Ans Can the sponsor require that the investigator contacts sponsor staff before unblinding study medication? 1.32K viewsClinical Research 0 Votes 1 Ans What are the expectations of EU competent authorities concerning the use of electronic trial master files (e-TMFs)? 1.67K viewsClinical Research 0 Votes 1 Ans What are the roles and requirements for the study subject record (medical record) and related source documents in the context of a clinical trial? 1.31K viewsClinical Research « Previous 1 2 … 10 11 12 13 14 … 18 19 Next » Question and answer is powered by anspress.net
