Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

CHAPTER 9

CLINICAL AND SUBMISSION RECORDS

INTRODUCTION

Maintaining clinical and regulatory data and documents is critical to bringing a therapeutic product to market and keeping it there. Failure to adequately produce and manage clinical records can be very costly. Of 5000 to 10,000 new chemical entities, five will go to the clinic, but just one will gain approval. And the cost of bringing a single drug to market is estimated to be well over $1 billion dollars US for a process that typically takes 10 to 15 years. Documents that go to the regulators, either in the United States or abroad, require tight controls so that submissions over time tell a complete story of a product slated for the marketplace. Similarly, once a product gains approval, the sponsoring company must report on it annually to confirm its continued suitability. This chapter answers the following questions.

1. What is a regulatory record versus a regulatory document?
2. We provide records to the FDA, so it is really a one-way street for information, isn't it?
3. Where can a company find assistance in understanding clinical documentation?
4. What documentation does a company need to have to begin a clinical trial in the United States?
5. How can we keep track of our submission documents and supporting records?
6. Does regulatory “own” the submission documents?
7. What are the typical submission documents for a product in development? ...