Foreword

Welcome to the Clinical Trials Platform's Clinical Research Manual,

Conducting clinical research is becoming increasingly complex. In addition to subject matter knowledge and technical expertise in study design, data analysis and interpretation, nowadays a clinical investigator needs to know how to navigate the regulatory approval process, meet all ethical and regulatory obligations, engage patients and other stakeholders, and secure and effectively manage resources to implement the study plan.

The purpose of this manual is to provide practical information to clinical investigators and research project coordinators, managers and associates on how to effectively conduct clinical research studies in Manitoba. The main audience is clinicians (including students, interns and residents), graduate students and others new to clinical research or experienced researchers new to doing research in Manitoba. The manual is intended to provide a quick overview of the research process and a focused catalog of the resources and services available to support Manitoba researchers.

The manual consists of three sections:

  1. Overview of clinical research methods
    A high-level and necessarily superficial description of the most commonly used clinical research approaches and study designs. There are many excellent courses, books and websites providing introductions to clinical research methods. The objective of this section is to complement these more in-depth sources with an overview that introduces new and aspiring researchers to the topic.

  2. Research practice
    This part provides an overview of the practical steps of conducting clinical research projects from developing a research protocol and applying for funding to publishing the findings and 'closing' the project. We outline all the important steps in implementing research projects and alert the reader to important administrative procedures, such as obtaining research approvals, providing links to websites and other sources of additional information on every step along the way.

  3. Legal, Ethical and Organizational Considerations
    This part provides a high-level discussion of the international, federal and provincial laws and regulations, as well as institutional, provincial and national policies governing the conduct of clinical researchers in Manitoba.

I would like to thank current and past members of the Clinical Trials Platform who contributed to researching, writing and developing this manual. Dr. Xibiao Ye and Ms. Connie Feschuk, with assistance from Brendan Foot and Tarpan Mankand, put together the manual whereas Mr. Barret Monchka developed the Website. I am also grateful for the contributions made by many CHI staff and other colleagues. For a list, please see the credits page.

I hope you find this manual informative and useful and wish you the best in all research adventures,

Salaheddin Mahmud, MD, PhD, FRCPC
Director, Clinical Trials Platform