by Dr. Yashashwini Reddy | Jul 4, 2024
Clinical Data Management Interview Questions What is annotated CRF? The annotated CRF is a blank case report form with markings or annotations that map clinical data collection fields used to capture subject data to corresponding Variables contained within the SDTM...
by Dr. Yashashwini Reddy | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
by Dr. Yashashwini Reddy | Jun 12, 2024
Once we submit the IND application, how the FDA reviews the application and what acknowledgment letter is given after the IND submission all will be discussed here. IND is an application submitted to the FDA to conduct clinical investigations in humans, once the...
by Dr. Yashashwini Reddy | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
by Dr. Yashashwini Reddy | Jun 3, 2024
Life Cycle Management of Investigational New Drug Application: Life cycle management of IND applications involves activities that ensure compliance with the regulatory requirements and the safe & smooth running of clinical trials. The important things to consider...
