Development of software tools for managing data in multi-center clinical trials - Many cancer patients have follow-up imaging and Good Clinical Practice (GCP) requires consistent imaging over time. Likewise, it is equally important in clinical research to have consistent acquisition parameters and the ability to search and retrieve patient and scanning information. Traditional PACS and HIS/RIS systems provide limited access to these parameters. To address these needs, Dana Farber developed a comprehensive database for all PET and PET/CT procedures using MS Access 2000 to provide common accessibility with minimal costs.
Rapid validation of nuclear medicine imaging software utilized in the context of clinical trials - Nuclear medicine imaging is important tool for the development of new therapeutic drugs and might accelerate the approval of these drugs. However, data submitted to the FDA in support of drug applications must comply with regulations such as Good Clinical Practice (GCP) and 21 CFR Part 11. These regulations require Computer Systems Validation of software used to generate the results. It is challenging for the academic community to achieve compliance given the time, effort, expertise, and financial investment that is required. This presentation reviewed the validation process, the regulatory requirements, and demonstrated an approach and software used to accelerate CSV to improve regulatory compliance.
New Orleans, LA