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