Event Calendar

Investigator-Initiated Research

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2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 1:40-2:25                                       

So Your Investigator Wants to Run a Multi-Site Investigator-Initiated Research Study? 

Investigator-initiated trials are a central part of clinical research, but opening these types of trials at other sites comes with its own set of challenges… and headaches! This talk will address points to consider, responsibilities, and logistical tips to best support your investigator’s ambitions. Topics covered will include: trial funding, vetting the other institutions, study trial master file, drug supply, site initiation vists (SIVs), subject registration, adverse event/serious adverse event (AE/SAE) reporting, onsite monitoring versus remote, electronic data capture (EDC), etc. 825

Presenter: Christine Jerome, BS, CCRP, Director, QA & Process Improvement Unit, Sidney Kimmel Center at Jefferson 

Track: Investigator-Initiated Research

Saturday, September 29, 2:30-3:15                                     

How to Prepare for an FDA Audit 

The presentation is geared towards CRCs and PIs of FDA-regulated Investigator-Initiated clinical trials.  Dr. Eder will provide an introduction to the FDA Bioresearch Monitoring Program and describe when an FDA inspection is likely to be scheduled.  The talk will include the steps of an FDA inspection, expand on what the FDA inspector is evaluating based on the investigator’s responsibilities per 21 CFR 312.60 and Form FDA 1572, describe the forms and letters related to an FDA inspection, and list and expand on common findings of an FDA inspection. 827

Presenter: Astrid Eder, PhD, CCRP, CIP, Clinical Research Regulatory Specialist, Children's Hospital Colorado

Track: Investigator-Initiated Research