17. Analyze, Communicate, Publish and Close Clinical Research

17.1 Trial Completion and Close-out Documents

A close-out plan should be developed at the set-up phase of the study. Close-out should not happen before data queries and analyses are completed, documentation is stored, and the trial is closed with REB.

For University of Manitoba researchers, a Final Study Status Report is required.

17.2 Analyze and Interpret Trial Data

For analysis of trial data, Health Canada and USA FDA adopt the ICH Guidance: E9 Statistical Principles for Clinical Trials.

17.3 Reporting Guidelines

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. Reporting guidelines for the following main clinical study types can be found on the website of EQUATOR and the websites of individual guidelines (randomized trials, observational studies, systematic reviews, case reports, qualitative research, diagnostic / prognostic studies, quality improvement studies, economic evaluations, animal pre-clinical studies, and study protocols).

Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals can be found at the The International Committee of Medical Journal Editors'

17.4 Communicating Findings to Study Participants and Public

Below are links to sites that offer guidelines for providing clinical trail results:

17.5 Knowledge Translation

The Canadian Institutes of Health Research (CIHR) defines knowledge translation (KT) as "raising knowledge users' awareness of research findings and facilitating the use of those findings." CIHR offers a Guide to Knowledge Translation Planning at CIHR: Integrated and End-of-Grant Approaches

Knowledge translation planning should begin early, ideally in the protocol development phase. During the protocol development phase, the CHI Knowledge Translation Platform can consult on how to develop a knowledge translation plan, provide guidance to ensure the budget is sufficient to support your plan, and provide advice on methods to evaluate knowledge translation efforts. More information can be found at the CHI Knowledge Translation Platform site or visit the CHI KT platform blog