Event Calendar

Agenda

Clinical Investigator GCP & Trials Management Program for Clinical Investigators and Key Research Staff

For a printable PDF Agenda, click here.

Day One: Thursday, December 6, 2018    

8:00 – 8:15          Registration and Continental Breakfast

8:15 – 9:00          Welcome and Introduction to the Drug Development Process
Mike M. Rashti, BS, Consultant, BIMO Auditor & Trainer, LLC; Former FDA Investigator
Mr. Rashti will review the product development process and discuss how clinical trials are integrated into that process.

9:00 – 9:45          Investigator / Investigational Site Responsibilities

Mike M. Rashti, BS, Consultant, BIMO Auditor & Trainer, LLC; Former FDA Investigator
Mr. Rashti will highlight the importance of investigator and investigational site responsibilities, and relate Good Clinical Practice compliance to successful completion of clinical studies in support of New Drug Applications. He will describe how to prepare for an audit by FDA staff, how to address deficiencies, and will share past audit experiences.

9:45 – 10:30        Protocol Development 

Janelle Allen, MS, BS, CCRP, Consultant, Trainer, Faculty, Miami University / Director, Clin Research Operations, Quality & Ed, I-ACT for Children
Ms. Allen will discuss the fundamental guidelines for development of a clinical research protocol. This presentation will  discuss the structure of a protocol including considerations related to research methodology, plans for analysis, budget preparation, and study timelines.

10:30 – 10:45       Break (with opportunity for discussion)

10:45 – 11:30      Developing Grants for Clinical Research 

Janelle Allen, MS, BS, CCRP, Consultant, Trainer, Faculty, Miami University / Director, Clin Research Operations, Quality & Ed, I-ACT for Children
This talk will focus on types of grants, structure and requirements of grants. It will include discussion on identifying key personnel involved in the development. The talk will discuss format and required components of a writing plan. The talk will include techniques and tips on writing for the reviewers and insight into the grant review process.

 11:30 – 12:15      The Informed Consent Process

George D’Addamio, PhD, President, PharmConsult, Inc. 
Mr. D'Addamio will explain the informed consent process, including discussion of various aspects involved in administration and documentation based on established FDA Guidelines.  He will also review special considerations that may impact the process and offer suggestions for issues resolution.

12:15 – 1:15        Lunch (provided) and opportunity for discussion

1:15 – 2:00          Informed Consent Forms: Compliance? Communication? Confusion?
Nancy Wintering, LCSW, CRC, CCRP, Assistant Director of Research, Brind Center at Thomas Jefferson University
The consent process reflects basic conflicts between compliance with federal regulations vs effective subject communications. This presentation will suggest readability and plain language strategies that can help resolve that conflict. Plus, a case study will describe possible liability issues from two confusing consent forms from a single study.

2:00 – 2:45          Clinical Trial Budgets and Finance
Sandra Sarafin, BA, CCRP, Director, Research Finance Office, Ohio State University
This session will address issues involved in developing a comprehensive clinical trial budget and tracking and managing finances.  The speaker will address financial considerations and risk areas.

2:45 – 3:00          Break (with opportunity for discussion)

3:00 – 5:00          Breakout Sessions

BREAKOUT #1     Investigator-Initiated Research: Key Steps of Study Conduct
Nancy Wintering, LCSW, CRC, CCRP, Assistant Director of Research, Brind Center at Thomas Jefferson University
Ms. Wintering will provide an overview of the key steps involved in Investigator-initiated research. The roles and responsibilities of a Sponsor-Investigator will be discussed. Ms. Wintering will present critical steps designed to ensure regulatory compliance, to collect high quality data and to assure the protection of human subjects.

BREAKOUT #2    “The FDA is here”…  Are you ready?
Kimberly M. Kiner, BSc, CCRA, President, 2K Clinical Consulting, Inc.
This session will involve a Mock Audit which will simulate an actual FDA GCP audit, including the introduction, review of documents, interview process, the identification of deficiencies and the debriefing portion of the audit.  This session is designed to help effectively prepare for and implement a proactive approach to upcoming/future audits.

BREAKOUT #3     Clinical Trial Budget and Finance Workshop
Sandra Sarafin, BA, CCRP, Director, Research Finance Office, Ohio State University

This workshop session will provide hands on, interactive discussion of clinical trial budgeting and financial best practices.

Day Two: Friday, December 7, 2018

8:15 – 8:30          Continental Breakfast

8:30 – 9:30          Safety Reporting (Adverse Events / Serious Adverse Events)
Kimberly M. Kiner, BSc, CCRA, President, 2K Clinical Consulting, Inc.
This session will review the definitions of adverse events and serious adverse events and adverse drug reactions.  We will discuss the reporting requirements and evaluate scenarios related to safety reporting.

9:30 – 10:30        Source Documentation and Record Retention
George D’Addamio, PhD, President, PharmConsult, Inc.
This session will discuss source documentation required for clinical research.  Topics of discussion will include the regulatory requirements, examples of source documents, and some of the challenges associated with ensuring compliance with the regulations.  Practical considerations for managing the research efforts will be offered.

10:30 – 10:45      Break (with opportunity for discussion)

10:45 - 11:45      The Clinical Research Environment - An Overview of Research Activities:
                             Roles, Rules & Regulators

Marie Falvo, CCRP, Program Chairperson, Senior Clinical Quality Specialist, D&R Operations, Bausch & Lomb, Inc
This presentation will provide an overview of different types of research, research roles, regulatory bodies and accompanying regulations/standards. The goal of this presentation is to provide investigators and site staff with an understanding of today's clinical research environment and to provide suggestions that can help foster communication and ensure a GCP-compliant research program.

11:45 – 12:45       Lunch (provided) and opportunity for discussion

12:45 - 1:45          Standard Operating Procedures for the Research Site
Leann Speering, MS, CCRP,  Senior Clinical Study Manager, MicroPort Orthopedics
Current GCP guidelines recommend that research sites develop and follow Standard Operating procedures.  This session will review the philosophy and rational of SOPs, discuss various SOP templates and evaluate a sample SOP.

1:45 – 2:45           Monitoring Visits and Audits: Different Perspectives to Ensure High Quality Research
George D’Addamio, PhD, President, PharmConsult, Inc.
This session will discuss differences and similarities of monitoring visits and audits, two activities performed by sponsors to ensure high quality research.  The relationships between laws, regulations, guidelines, and standard operating procedures will be discuss.  The purposes of various types of monitoring visits will be described, as will the objectives and activities associated with a sponsor audit or FDA inspection.

2:45 - 3:00         Break (with opportunity for discussion)

3:00 - 4:00         Profiting From Your Clinical Research Investment
Jim Simmer, BSN, MBA, President, Research Answers
Mr. Simmer will discuss the importance of selecting the correct studies for a research site and developing a strong pipeline. The presentation will touch on enrollment strategies, study planning and performance measurements.

4:00                     Closing  / Adjournment