FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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Developing Effective Study Start-up Processes

Clinical research start-up study

Jennifer Goldfarb, CCRP
Senior Director, Clinical Research Support Office
Children’s Hospital of Philadelphia            

Grace Wentzel, CCRP
Director, Clinical Research Services
The Research Institute at Nationwide Children’s Hospital

Abstract: The study start-up process sets a study up for success or failure. This article provides an overview of study start-up, the players on the study team, and the infrastructure required for successful study start-up. Tools for the study feasibility assessment for dissecting and implementing the protocol and for ensuring compliance are described. Challenges to study start-up and solutions to those challenges are provided.

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Steps to Ensure an A+ on Your IRB Audit (Part 2)

medical practitioners having a meeting in a hospital boardroom

Click here to read part 1

IRB Audits and Inspections

IRB audits can be conducted by federal agencies overseeing research such as the FDA or the Office for Human Research Protections, research bases, study sponsors, and IRBs. Pharmaceutical sponsors do routine monitoring of their studies at regular intervals. The Toledo Community Oncology Program’s research bases only audited the program every three years. This can make it difficult to know about mistakes made years earlier and to put quality assurance processes in place when needed.

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Steps to Ensure an A+ on Your IRB Audit (Part 1)

Pamela Shoup, CCRP
Past Executive Director, Toledo Community Oncology Program
Current Research Manager and IRB Coordinator for the Toledo Clinic, Inc.

Abstract: A well-organized institutional review board (IRB) ensures excellent quality assurance in the regulatory area and enables the IRB to score an A+ on regulatory inspections conducted by the U.S. Food and Drug Administration (FDA). This article describes best practices in IRB management and tools to help prepare for an FDA audit. Lessons learned from experiences at the Toledo Community Oncology Program are highlighted.

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Effective Training Delivery and Evaluation: Professional Approaches and Tools

Group of clinical research professionals

Anatoly Gorkun, MD, PhD, Assoc CIPD
Senior Manager
Scientific and Compliance Training, MedImmune

Abstract: Different professional training techniques can be used to achieve training goals. This article describes how to deliver efficient training sessions that benefit learners, evaluate training sessions, and use the evaluation results to make necessary improvements. Topics covered include learning styles, planning the training, different training styles, monitoring learning progress and adjusting the training, and bringing the training session to a close. Examples of training evaluation tools and their role in continual improvement of training for clinical research professionals are highlighted.

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An Overview of the General Data Protection Regulation (“GDPR”) for Clinical Research Organizations

James F. Bush, Esq. [1]


In 2018, the European Union’s General Data Protection Regulation (“GDPR”) came into full force and effect. With the growth of international multi-center clinical research studies, U.S.-based research organizations and investigators will now be governed by the GDPR to the extent that they control or process Personal Data of EU citizens in the course of their research. While efforts to attain compliance with HIPAA and HITECH within the U.S. provide clinical researchers a head-start in attaining compliance with the GDPR, substantial additional efforts must be undertaken to avoid the risk of enforcement penalties for failure to meet the mandates of the GDPR in conducting clinical research. A basic understanding of the important rights granted to study subjects, the jurisdictional reach of the law, logistical and organizational considerations, and the possible risks of enforcement action is now an essential competency for those engaging in clinical research involving EU citizens. The goal of this paper is to provide a regulatory overview of the law and its effect on clinical research in order to enhance the competency of investigators, project managers, and decision-makers involved in such clinical research.

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The Value of Centralized Monitoring

group of clinical researchers

Joanne Malia
Associate Director, Clinical Documentation Management
 Regeneron Pharmaceuticals

Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of monitoring. Sponsors are looking at and beginning to use centralized monitoring. This article describes centralized monitoring, regulatory and industry expectations and initiatives related to centralized monitoring, the value of centralized monitoring in enhancing data quality in clinical trials, and use and documentation of centralized monitoring,

Disclaimer: The views and opinions expressed in this article are those of the author and should not be attributed to the Society of Clinical Research Associates or Regeneron Pharmaceuticals.

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The Changing Landscape of Human Subjects Research

Amy Waltz, JD, CIP
Associate Director – Regulatory Affairs, Reliance, Outreach
Indiana University

Abstract: Understanding context is key to understanding the regulations and complying with regulatory requirements. This article explores the historical context and events that shaped the current human subjects protection regulations and how changes in human subjects research and public perception have impacted the proposed revisions to the human subjects protection regulations. The 2017 revisions to the Common Rule (45CFR46) and the impact of these revisions on government funded research are also addressed.

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Building a Quality Assurance Program for Investigator-initiated Trials

Abby Statler, MPH, MA, CCRP
Research Regulatory Quality Assurance Coordinator
Cleveland Clinic Cancer Institute

Two clinical researchers analyzing information on a computer

Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past nine years, the program has become an integral part of the Institute’s research department, supporting the growth of IITs while improving the proficiency of regulatory operations. This article describes the program’s objectives and discusses the operational strategies employed to achieve these goals. Other clinical research sites are encouraged to consider how components of the Cleveland Clinic Cancer Institute’s QA program may be adapted to meet the needs of their organizations.


The research sponsored by Cleveland Clinic investigators supports the Foundation’s innovation initiatives, making it a top priority for the Institute’s leadership team. Thus, the development and implementation of the Cleveland Clinic Taussig Cancer Institute’s QA program was motivated by the organization’s commitment to effectively oversee the conduct of IITs. Launched in 2008, the Cancer Institute’s QA program was the first of its kind, specifically focusing on providing operational support for investigator-initiated trials.

Before the department was implemented, investigator-initiated trials had few operational resources, protocols required multiple revisions, Investigational New Drug Applications were submitted inconsistently to the U.S. Food and Drug Administration (FDA), and processes for effective essential regulatory documentation management had not been established. To date, the QA program has grown from one to five members, which has enabled the department to cohesively support the IIT profile while also improve the operations of industry-sponsored and cooperative group trials. In this article, I will outline the essential components of a QA program, discuss the challenges that our department faced during the program’s development, and highlight how the Institute’s commitment to quality has enhanced the Cancer Center’s conduct and initiation of clinical trials.

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Reducing Over-reporting to INDs and Increasing Efficiencies at Clinical Research Sites

Sarah Attwood, BSc
Director of Client Services
IntegReview IRB

Abstract: Institutional review boards (IRBs) continue to be overburdened with reports not required by federal regulations. It is important to understand the difference between what the regulations require and what has become an industry standard. Additionally, clinical research sites are often confused about reporting requirements and err on the side of conservatism by over-reporting. By clearly identifying regulatory requirements, the clinical research industry may become more efficient and eliminate unnecessary work for sites as well as IRBs.

Clinical researcher at computer


Study sites are over-reporting adverse events (AEs) and serious adverse events (SAEs) for studies conducted under Investigational New Drug (IND) applications. IRBs are required by the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) within the Department of Health and Human Services to review “unanticipated problems involving risks to participants or others.”  

IntegReview IRB is a central IRB that reviews many protocols each year, just as institutional IRBs do. In 2016, IntegReview IRB saw an increase in the number of IND safety reports and a slight decrease in SAE reports. The reason for these changes is unknown. IntegReview IRB is seeing about a four-fold increase in IND safety reports, which is far above the increase in business.

IRBs receive many IND safety reports that are not related to the current protocol at the clinical researchsite. The reports could be about something that is happening in Asia or Europe, a different use of the drug, or a different research project. These reports must be processed, even though they are not under the jurisdiction of the IRB for the current study, creating information overload.

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