15. Conduct Research

15.1 Register Your Study

The International Committee of Medical Journal Editors (ICMJE) requires that clinical trials, expecting to be considered for publication, be registered with a public registry prior to enrolling participants. ICMJE defines a clinical trial as research that prospectively assigns human participants to a health-related intervention. The Bannatyne REB provides information about registering a study at Guidelines for Registering in a Clinical Trial Registry

Clinical trial registries can be found at:

15.1.1 Original research

Some of these registries are originally developed for clinical trials, but over the years the scope has been widened to include observational studies.

15.1.2 Systematic review and meta-analysis

The International Prospective Register of Systematic Reviews (PROSPERO) is a rapidly growing registry of systematic reviews. Some journals now require a registration with PROSPERO before manuscript submission.

15.1.3 Standard Operating Procedures (SOPs)

SOPs in research are written instructions to assure research processes are conducted to meet Good Clinical Practices and regulatory requirements. All staff participating in a research trial should be trained on the appropriate SOPs according to their function in the trial. Auditors will expect to see SOPs for the trial, evidence of staff training on the appropriate SOPs, and adherence to the SOPs by the study team.

The Network of Networks (N2) a national organization aiming to enhance clinical research capability and capacity in Canada has developed a set of clinical research SOPs. The George and Fay Yee Centre for Healthcare Innovation (CHI) and the University of Manitoba are N2 members. Contact CHI to learn more about N2 SOPs.

15.2 Data Collection Instruments

15.3 Research Support

  • Clinical Trial Design: The Clinical Trials Platform of the George and Fay Yee Centre for Healthcare Innovation (CHI) offers trial design consulting services and monitoring services for investigator initiated trials conducted under a Health Canada application.
  • Collaboration Opportunities: For assistance with identifying research collaboration opportunities involving the CHI platforms and external partners, contact Dr. Alanna Baldwin
  • Biostatistical Support: The CHI Data Science Platform provides a range of statistical services and linkages to data resources.

15.3.1 Useful online resources for statistical analysis:

  • Choosing the Correct Statistical Test: A table helping researchers to choose the right statistical method, originally developed by James D. Leeper. Sample SAS/STATA/SPSS/R code is provided.
  • UCLA Statistical Computing: A collection of books, videos, SAS/STATA/SPSS/R example code for various statistical analysis methods.
  • Episheet: Spreadsheets for analysis of epidemiologic data, developed by Kenneth Rothman.
  • Data Management: REDCap (Research Electronic Data Capture) is a secure web application designed to support data capture for research studies. It provides users with multiple features such as multi-site data entry, real-time data entry validation, audit trails, and a calendar to schedule and track critical study events. CHI has implemented REDCap at the University of Manitoba to provide researchers with the ability to store, manage and analyze their research data. For more information visit the CHI REDCap webpage
  • Scientific Writing: Researchers may contact a UM facilitator for assistance in identifying internal and external funding sources, reviewing proposals, facilitating the submission of large interdisciplinary team grant applications and assisting with knowledge translation, community engagement and exchange activities. University of Manitoba Research Facilitators
  • Customized IT Applications for Clinical Research: Clinical Trials Platform IT Specialist offers customized IT and mobile solutions to researchers.
  • Educational events: can be found on the Clinical Research Educational and Training Calendar hosted by CHI

15.4 Research Management

15.4.1 Regulatory Binder

The Regulatory Binder is a tool to organize essential documents that offer easy access to reference information by trial member and others (including trial monitor, auditor, REB, or regulatory authorities such as Health Canada).

According to the ICH-GCP, "Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. Learn more about essential document contents before, during, and after the conduct of trials.

A Regulatory Binder (Trial Master File) Table of Contents for Canadian trials can be found here

An FDA Regulatory Binder developed by Harvard University can be found here

15.4.2 Managing Study Drugs, Devices, and Biologics

During the design and set-up phases of a trial, the investigator should develop a detailed plan regarding the receipt, storage, dispensing, and return or final disposition of investigational products (drugs, devices, and biologics).

15.4.3 Managing Trial Data

Management of trial data is an important consideration in clinical research to ensure the data collected is of high-quality and reliable. The collected data can then be statistically analyzed to support the outcomes of the research. Data management guidelines can be found at the sites below:

15.4.4 Retention of Trial Records

All records created during the conduct of a clinical trial must be retained. The length of time records need to be retained will depend on the relevant regulations, guidelines and any other regional, institutional or local requirements. However clinical trials conducted under a Health Canada Clinical Trial Application must be maintained for 25 years. Further information from Health Canada can be found at Guidance for Records Related to Clinical Trials