Question 1: Complete the FDA CDERLearn Electronic Common Technical Document: Overview and Submission course: https://www.accessdata.fda.gov/cder/eCTD/intro/intro/index01.htm (Links to an external site.). Then complete the following task:
There are a variety of data standards that are being used during the drug development lifecycle. Based on the CDERLearn course, explain in detail (at least 3 double-spaced pages, 12 pt font) the diagram of data standards used in the drug lifecycle as provided by the FDA: https://www.accessdata.fda.gov/scripts/cder/data-standards/ (Links to an external site.). You only have to focus on the following data standards in your explanation: E, SE, SD, A, PQ, and SP. Connect the respective data standards to the drug development stages and data that is part of such standards. Although this assignment may at first appear relatively simple, it asks you to go over a lot of information, so be as detailed as possible in your explanations.
