The Trainer’s Toolkit: How to Design Successful Blended Learning

artistic representation of blended learning

Anatoly Gorkun MD, PhD, Chartered MCIPD
Senior Manager, MedImmune

Abstract: Blended learning is a training program in which the audience learns the content through a combination of different learning methods with some element of self-control over time, place, and pace. This article provides an overview of audience learning preferences and styles, blended learning, and how to choose the most appropriate learning methods for a specific training program. Examples of and tools for learning methods are provided.

Continue reading The Trainer’s Toolkit: How to Design Successful Blended Learning

Virtual Project Management

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Senior Director, Project
Covance, Inc.

Abstract: Clinical research project management is increasingly conducted globally across multiple time zones and cultures. In order to be successful, certain adaptations must be made to routine practices. This article describes key terms and basic concepts of virtual project management, considerations for effective communication and collaboration tools, and ways in which the Project Management Institute knowledge areas can be applied to a virtual framework. Situational examples are provided. While this has been written in the context of clinical trials performed by a biotech or pharmaceutical sponsor engaging a CRO, the same concepts could easily be extended to any geographically dispersed project team.

Continue reading Virtual Project Management

Influencing Without Authority

Barbara van der Schalie, MS
Learning and Professional Development Manager
Clinical Research Directorate, Clinical Monitoring Research Program
Leidos Biomedical Research

Abstract: Effectively exercising influence, even when one may not have the formal authority to mandate action, is a challenge many clinical research professionals face in their daily work. This article describes the interpersonal and leadership skills necessary to ensure that one’s agenda is not only considered but actively requested, and how successful professionals build networks of relationships with stakeholders and influencers. This article explains the difference between influence and authority, identifies different sources of influence, and describes different influencing styles.

Disclaimers:

  • This project has been funded in whole or in part with federal funds from the National Institutes of Health’s National Cancer Institute, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercials products, or organizations imply endorsement by the United States government.

Continue reading Influencing Without Authority

A Modern CRA Perspective on the Use of Technology in Clinical Trials

By Takoda Roland, CCRA, CCRP

Founder of Philadelphia Pharmaceutical Research

Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely on a smartphone while flying from Philadelphia to Puerto Rico.

Continue reading A Modern CRA Perspective on the Use of Technology in Clinical Trials

Resolving and Preventing Repetitive Problems in Clinical Trials

April Bishay, BA, MBA
Senior Manager, Clinical Compliance, MedImmune

Anatoly Gorkun, MD, PhD
Chartered MCIPD, Senior Manager, Scientific & Compliance Training, MedImmune

Abstract: Clinical trial findings from audits reveal the same type of problems year after year despite the implementation of quality systems, compliance training, and corrective and preventive action plans. This article provides an overview of the root cause of these problems and how to ensure that corrective and preventive actions are addressing the actual problem rather than its symptoms. Actual case study illustrates some of the common problems in clinical trials.

Continue reading Resolving and Preventing Repetitive Problems in Clinical Trials

Evaluating the Protocol: Can the Clinical Research Site Really Do this Study?

Monika Gaa, MBA, CCRP
Senior Feasibility Coordinator, Nationwide Children’s Hospital

Christine Baker, BA, CCRP
Senior Regulatory Coordinator, Nationwide Children’s Hospital

Abstract: Protocol evaluation is critical to determining the feasibility of a study. This article describes the key elements for evaluating protocols for financial feasibility, recruitment, and practical application. Strategies that have worked well at Nationwide Children’s Hospital are highlighted.

Continue reading Evaluating the Protocol: Can the Clinical Research Site Really Do this Study?

Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

 

Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates

Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them.  Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention. Differences also exist, such as the level of detail written in the requirements or whether adherence is mandatory. This article compares GLP regulations and GCP guidance, which have similar objectives: to determine the safety and efficacy of the product and document the study results for subsequent study reconstruction.

Continue reading Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

Successful Collaboration Between the Clinical Research Site and the Monitor

Sharon Appelman-Eszczuk, BScN, RN, CCRP
Faculty of Medicine and Dentistry
University of Alberta  

Cathy Laferriere, BSc
Senior CRA
Quintiles Canada

Abstract: Good communication is the key to successful collaboration between clinical research site staff and the monitor, facilitating recruitment and ensuring compliance with Health Canada regulations. This article provides an overview of the monitor’s expectations of the site staff and the site staff’s expectations of the monitor. Tools to aid the site staff and the monitor in working together are provided. Scenarios describe possible issues that arise in monitor-site staff relationships and illustrate ways to resolve situations where the site staff and the monitor do not see eye to eye.

Continue reading Successful Collaboration Between the Clinical Research Site and the Monitor

Consent Forms in Context: How Long is Long?

Mark Hochhauser, Ph.D., Readability Consultant/IRB Member, Golden Valley, MN

Abstract: As the science and regulatory requirements behind clinical trials have evolved over the past few decades, consent forms have become very long. This article compares the word count of some oncology consent forms with other documents, and shows that those consent forms are longer than ethical guidelines and federal regulatory documents. Because too many consent comprehension tests and health literacy measures are not psychometrically sound (and of limited value), efforts to improve comprehension and health literacy continue to be serious problems now and in the future.

Continue reading Consent Forms in Context: How Long is Long?

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.

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