Written by NoriYah Yisrael, MS-PM, PMP, CPPM, FAAPM
On August 11, 2022, the Clinical Research (CR) Forum of the PMI Atlanta Chapter hosted the "Tips on Study Start up, Clinical Trial Conduct and Preparing for an FDA Inspection" Special Interest Forum Event as presented by Professor Toks Onabanjo. The purpose of this event was to provide an overview of how to prepare for study start-up, patient data collection, and an FDA inspection and approval to market a new drug in the United States (US).
During this forum, Professor Onabanjo discussed the requisite skills that make for a successful Project Manager within the CR industry. He spoke about the site selection process that begins with the site completing a feasibility questionnaire which includes questions pertaining to the site’s personnel qualifications, capabilities, and patient population.
Once the sponsor and investigative site make a mutual decision for the site to participate in the study, the study start-up process commences. During this phase, sites must submit documentation to the sponsor, as required by governing entities and organizations to include regulatory agencies and institutional review boards. After everything is submitted and approved, the sponsor may conduct an Investigator Meeting and/or a site initiation visit, which are training pre-requisites that must be fulfilled before the site can begin consenting and enrolling patients in the study.
After a study is conducted, the sponsor may analyze and submit the patient study data that it collects from the sites to the Food and Drug Administration (FDA) in a New Drug Application. The FDA then reviews the application and could potentially inspect one or more investigative sites prior to making a formal decision on whether to approve the drug for marketing in the US.
- The sponsor and the investigative site must mutually decide on whether a study is feasible and beneficial for the site to be selected to participate.
- Study Start-Up is a complex process that takes the coordinated efforts of both the sponsor and the site to complete.
- The data collected on participating patients at the investigative sites are analyzed and, if appropriate, packaged for submission to the FDA for US market approval.
Join us at the next PMI Atlanta Clinical Research forum on Thursday, November 10, 2022.
Register at www.pmiatlanta.org/events/event-calendar