SOCRA’s Clinical Investigator GCP & Trials Management Program for Clinical Investigators and Key Research Staff
The purpose of this workshop is to assist Clinical Investigators and key research staff in improving their skills and their understanding of the responsibilities of the clinical research site.
This program is intended to share information and create opportunity for dialogue among clinical investigators, key research staff and program faculty. The specific goal is to enhance the participants’ ability to perform quality clinical research according to existing regulations and guidelines.
This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).
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Course 1: Setting up Your Inspection Readiness (IR) Plan at Start Up
Course 2: Implementing Inspection Readiness during Trial Maintenance
Course 3: Assessing Inspection Readiness during Trial Closure
This course discusses all areas of the start up phase of a clinical trial and how to set up an Inspection Readiness plan (including checklists and tools) based on the FDA’s expectations and requirements.
This course also focuses on how to “see through the eyes of FDA” in areas of preparing documentation and training your site staff/clinical operations team. In addition, this course will discuss how to the utilize inspection readiness tools and incorporate the PDCA (Plan-Do-Check-Act) technique in the planning phase of Inspection Readiness Plan.
Learn the essential process of utilizing the PDCA technique in your Inspection Readiness program by implementing your plan during the maintenance phase of your trial.
This course discusses trial maintenance tasks and how to utilizing monitoring visits, file reviews and mock inspections or internal audits to analyze the effectiveness of your Inspection Readiness Program.
Trial closure is the final stage when all trial data has been reviewed, queries resolved, database will be locked. Although this marks the end of a trial, it sparks the beginning of the next phase which is inspection preparation.
This course discusses trial closure tasks and how to assess and utilize your Inspection Readiness Program in preparation for an upcoming inspection.
Every year, over 1000 GCP or BIMO inspections are conducted by FDA. FDA’s goal is to increase the number of inspections, particularly at clinical sites, in order to ensure that that the final study product is safe and effective for consumer use.
Being prepared and ready are the keys to a successful inspection. This course will help you understand all about FDA and will provide best practices needed to effectively prepare for GCP inspections.
Inspection readiness is essential for sponsor companies and requires commitment from internal and external stakeholders, including clinical sites, Clinical Research Organizations (CROs) and monitors or Clinical Research Associates (CRAs).
This course will help you understand all about FDA inspections and will provide inspection readiness strategies needed to effectively prepare for GCP inspections.
Audit Readiness starts with the TMF or Trial Master File. There are two types: the investigator TMF and the sponsor TMF. The sponsor TMF will be the focus of this course. It is expected that project team members have a solid grasp on the concepts and QC strategies that contributes to an audit-ready TMF.
By the end of this course, you will be able to understand:
- Setup and organization of the Trial Master File
- Applicable regulations and TMF findings
- Quality Control (QC) strategies