Clinical Protocol Development Series

The goal of this two-day series is to provide researchers with the knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9:00 AM and a question-and-answer session will follow each presentation.

On the second day of the series, we will take a "deeper dive" into clinical study design, statistics, and their impact on clinicaltrials.gov reporting:
- Clinical Protocol Study Design - aims, objectives, endpoints, and outcomes
- Statistical analysis, sample size considerations, data management
- Clinicaltrials.gov - introduction, registration, and outcome measure reporting
- Protocol problem spots and ways to improve protocols

Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.

ACRP Contact Hours: 2.0 Contact Hours of clinical research education on the application for maintenance of ACRP's ccrc®, ccra® or cpi®, certification designations will be available for attendees

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Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:

Amit Garg, MD, MA (Education) FRCPC, FACP, PhD
Associate Dean, Clinical Research, Schulich School of Medicine and Dentistry
Past President, Canadian Society of Nephrology
Lead, Institute for Clinical Evaluative Sciences Kidney, Dialysis and Transplantation Provincial Program
Director, Institute for Clinical Evaluative Sciences (ICES) Western Facility
Nephrologist, London Health Sciences Centre
Professor, Medicine, Epidemiology & Biostatistics, Western University

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