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Clinical Research: Standards

This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.


Reporting Guidelines

Reporting guidelines for multiple trial designs are available. My suggestion is that you become familiar with these early and not wait until you are ready to report your study results. If they are reviewed in the planning phases of the study you can be sure to include critical design elements on which you need to report; these are easy to address up front, but may be impossible to correct after the study has been conducted.

The CONSORT (CONsolidated Standards of Reporting Trials) guidelines cover parallel group RCTs. They provide a 25-item checklist, a flow diagram, and a document explaining and elaborating on the items in the guidelines. The 2010 version is the most current:

In addition to the general statement, the guidelines have been extended to more specialized areas as well, including non-pharmacological trials, orthodontic trials, pragmatic trials, feasibility and pilot randomized trials, etc.  The EQUATOR Network has an excellent site with links to all of these:

For systematic reviews and meta-analyses, see PRISMA (Preferred Reporting Items in Systematic reviews and Meta-Analyses):

- Like CONSORT, they have a checklist, flow diagram, and explanatory documents.

For case studies, CARE (CAse REports):

For observational studies, STROBE (STrengthening the Reporting of OBservational studies in Epidemiology):

Study Quality Assessment / Strength of Evidence

AHRQ publication from 2002 assessing study quality scales/checklists for individual studies and grading systems for bodies of evidence on a specific subject:

For evaluating evidence across studies, GRADE (Grading of Recommendations, Assessment, Development and Evaluations):; 

Other Tools

The Physiotherapy Evidence Database (PEDro) has a scale applicable to PT therapies, such as exercise, that is included in their database:

The Cochrane Risk of Bias tool is also useful:

PCORI Methodology Standards:

FDA Guidance Documents:


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