Adding it up to Create the Perfect Balance: Advanced Site Management Tools

Christina Talley, MS, RAC, CCRP, CCRC

Houston Methodist Research Institute, Office of Strategic Research Initiatives

a clinical research working on a tablet

Abstract: Detailed protocol analysis and feasibility objectively translated into a protocol grade or quantitative score is an effective way to manage overall workload distribution, personnel resource allocation, and financial management before the clinical trial is implemented. This article provides an overview of protocol areas for evaluation, scoring, and current effort tracking models used in clinical research. One model, the Protocol Acuity Rating Scale (PARS), is described in detail with examples of its application to different types of clinical research studies

Continue reading Adding it up to Create the Perfect Balance: Advanced Site Management Tools

BULLSEYE: What is Targeted Monitoring All About?

Jane Ferguson, RN, MN, CCRP
Senior CRA, Westat

Abstract: Targeted monitoring is the on-site component of risk-based monitoring and focuses on the aspects of clinical research that have the most potential to impact participant safety and the credibility of the study’s results. This article provides an overview of targeted monitoring, including the need for targeted monitoring and its role in risk-based monitoring. The basics of conducting a targeted monitoring visit are covered

Continue reading BULLSEYE: What is Targeted Monitoring All About?

Quality by Design for Clinical Trials

Vatché Bartekian
President, Vantage BioTrials, Inc.

Abstract: Quality by design for clinical trials comprises an independent entity responsible for quality standards and an integrated system where each person is accountable for quality. This article explores myths about quality and provides a general overview of the principles and philosophy of quality by design. Quality issues normally encountered at clinical research sites and contract research organizations as well as practical ways to build quality into a research program in order to prevent issues are highlighted. The Plan-Do-Check-Act cycle and its tie-in with risk-based monitoring are described.

Continue reading Quality by Design for Clinical Trials

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