What is the Purpose of GCP Training? A Quality Management Perspective

Graeme Downes, Senior Director, Clinical and PV QA, AstraZeneca

Anatoly Gorkun, Senior Manager, Scientific and Compliance Training, MedImmune

Abstract: The Good Clinical Practice (GCP) regulations require that each individual involved in conducting a clinical trial be qualified by education, training, and experience to perform the respective tasks. This article provides an overview of the purpose of GCP training, ways of delivering GCP training, and components of the GCP training package. An effective way to build a risk-based GCP training program is described.

Disclaimer: The views and opinions presented here are those of the authors and not of MedImmune or AstraZeneca.

Introduction

GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global. For example, in the United Kingdom, regulation 28 of the UK SI 2004/1031 states that, “no person shall conduct a clinical trial… otherwise than in accordance with the conditions and principles of GCP.” From a global perspective, the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice §2.8. states: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” This means that each individual involved in conducting a clinical trial must receive training in GCP.

Even though legislative requirements have been in effect for several years and most if not all companies claim to have GCP training programs in place, non-compliance with GCP is frequently identified, as evidenced through monitoring, audit, and inspection findings.

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Budget Development and Negotiation for Investigative Sites

Anna K. Rockich, MS, PharmD, Director, General Surgery Research Program, University of Kentucky Medical Center

Abstract: Effective budget development and negotiation is critical for investigative sites. This article provides an overview of budget requirements for the conduct of a study, identifies common mistakes in developing budgets, and highlights how to effectively develop the budget and negotiate with the sponsor. Tools to assist in managing the budget on a daily basis are provided.

Introduction

Study coordinators wear many hats, including organizing study operations, writing the institutional review board (IRB) submission, maintaining ongoing IRB communications, obtaining informed consent, administering investigational drugs and devices, monitoring study subjects, collecting data, and working with sponsors. Budget and billing are two of many responsibilities.

Protocols have become increasingly complex, and sponsors are demanding more work by investigative sites. According to the Tufts Center for the Study of Drug Development1, in 2000, the median number of unique procedures per protocol was 20.5; by 2011, this had increased to 30.4 unique procedures per protocol. The number of unique procedures per protocol in 2016, although not yet quantified, will be exponentially higher. The total number of eligibility criteria has also increased, from 31 in 2000 to 49 in 2007, the last date for which data are available. Scrutiny on inclusion and exclusion criteria has also increased. The median number of case report form pages per protocol has increased from 55 in 2000 to 180 in 2007.

It takes about five years for a study coordinator with minimal experience to become relatively autonomous, in the author’s opinion. Budgeting and contracting are generally the last skills that study coordinators are taught. The author recently met a very experienced study coordinator who has worked as a study coordinator for 15 years. She had never, however, developed a budget. Locally, at least at the University of Kentucky, available curriculums for training on budgets and contracts are limited. On-the-job training requires time and good mentors. Study coordinator turnover is another issue. Study coordinating is a vocation not suited for all. Some people enjoy research while others do not, and they move on to other positions or disciplines. The author must continually train new study coordinators.

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The Future of Clinical Trials Using Electronic Data Capture Systems

Adam Donat, MS, Martin Hamilton, MSN-FNP, Irfan Khan, MS, Nichole Chamberlain, MSN-FNP

Organization:   Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring

The findings and conclusions in this article should not be construed to represent any Agency determination or policy.

Technology continues to permeate every facet of the modernized world. As the medical field relies more and more on computerized technology, unique issues have emerged especially in the area of clinical trials and the use of Electronic Data Capture (EDC). Novel approaches to safeguard data integrity and human subjects need to be considered at every juncture of the research process.

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Informed Consent and the Human Experience

Cheryl B. Thomas, MS, CGC, Research Subjectinformed consent Advocate, Mayo Clinic

Abstract

Going “beyond the regulations” that govern informed consent and understanding the perspective of research participants is crucial to obtaining truly informed consent. This article describes the aspects of informed consent that involve human experience and interactions. Positive and negative feedback from research participants is reviewed to illustrate common issues in participation in clinical research. Participant suggestions for improving comprehension and the overall informed consent experience are shared.

Disclaimers: The author is sharing her own views based on conversations with many research participants. The federal regulations are not reviewed because many of the problems with informed consent arise even when the study team follows the regulations.

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