| Popis: |
Clinical documents for both foreign and domestic regulatory submissions often are produced by professional writers and then undergo extensive review by scientists, statisticians, physicians, and others. A structured preparation and approval process was recently developed at Wyeth-Ayerst to avoid repetitive, nonproductive review cycles of regulatory documents. This eight-step process includes a report package definition meeting, a review of data processing reports, a draft document definition meeting, initial document preparation, simultaneous review, a report review meeting, corrections, and final sign-off. The writer, statistician, and clinical monitor work together as a team to prepare the document after involving other departments as appropriate. If the document is being written in the United States for a foreign submission, foreign review of the process occurs after the draft document definition meeting, during simultaneous review, and at final sign-off. Simultaneous review followed by a report review... |
