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Clinical Research: Standards & Templates

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.

Templates

NIH

NIH has developed a protocol template for Phase 2 & 3 IND/IDE trials. The template is available as a Word doc or can be used through an e-protocol tool. For more information and links: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-064.html

The National Center for Complementary and Integrative Health, an NIH center, has a protocol template for studies they fund (typically non-pharmacologic): https://nccih.nih.gov/sites/nccam.nih.gov/files/CR-Toolbox/ProtocolTemplate_NCCIH_07-17-2015.docx

In addition, they have a toolkit with links to many other templates relevant to clinical research funded by NIH, such as: case report forms (CRFs), data and safety monitoring, regulatory/essential documents: https://nccih.nih.gov/grants/toolbox

NIH forms table has instructions for, and sometimes templates and samples of, various documents required by NIH (e.g., biosketches): https://grants.nih.gov/grants/forms/all-forms-and-formats.htm

UF

The UF Office of Research has UF-specific forms and templates: http://research.ufl.edu/faculty-and-staff/forms.html

Standards

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: http://www.consort-statement.org/

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: http://www.equator-network.org/reporting-guidelines/consort/

For systematic reviews and meta-analyses, see PRISMA (Preferred Reporting Items in Systematic reviews and Meta-Analyses): http://www.prisma-statement.org/PRISMAStatement/Default.aspx

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

For case studies, CARE (CAse REports): http://www.care-statement.org/

For observational studies, STROBE (STrengthening the Reporting of OBservational studies in Epidemiology): https://www.strobe-statement.org/index.php?id=strobe-publications

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: http://www.thecre.com/pdf/ahrq-system-strength.pdf

For evaluating evidence across studies, GRADE (Grading of Recommendations, Assessment, Development and Evaluations): http://clinicalevidence.bmj.com/x/set/static/ebm/learn/665072.html; http://www.gradeworkinggroup.org/ 

Other Tools

The Physiotherapy Evidence Database (PEDro) has a scale applicable to PT therapies, such as exercise, that is included in their database: https://www.pedro.org.au/english/downloads/pedro-scale/

The Cochrane Risk of Bias tool is also useful: http://methods.cochrane.org/bias/assessing-risk-bias-included-studies#The%20Cochrane%20Risk%20of%20Bias%20Tool

PCORI Methodology Standards: http://www.pcori.org/research-results/about-our-research/research-methodology/pcori-methodology-standards?utm_source=May+2017+Newsletter&utm_campaign=April+2017+Newsletter&utm_medium=email

FDA Guidance Documents: https://www.fda.gov/RegulatoryInformation/Guidances/default.htm

 

 

 

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