Clinical and Health Sciences

• Analysing Qualitative Data by Catherine Pope, Sue Ziebland, and Nicholas Mays
   
• Assessing Quality in Qualitative Research by Nicholas Mays and Catherine Pope
   
• Best Practices for Mixed Methods Research in the Health Sciences from OBSSR (NIH)
   
• Introductory Social and Behavioral Science Training Material from OBSSR (NIH)
   
• Guidance on Performing Focused Ethnographies with an Emphasis on Healthcare Research By Gina M. A. Higgenbottom, et. al.
   
• Mixed Methods in Biomedical and Health Services Research by Dr. Leslie A. Curry, et. al.
   
• Qualitative and Mixed Methods Provide Unique Contributions to Outcomes Research by Dr. Leslie A. Curry, Dr. Ingrid M. Nembhard, Dr. Elizabeth H. Bradley
   
• Using Qualitative Methods in Health Related Action Research by Julienne Meyer

• Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Edited by Priscilla Velentgas, Nancy A. Dreyer, Parivash Nourjah, Scott R. Smith, and Marion M. Torchia

• Systematic Review and Evidence Integration for Literature-Based Environmental Health Science Assessments by Andrew A. Rooney, Abee L. Boyles, Mary S. Wolfe, John R. Bucher, and Kristina A. Thayar

• Empirical confidence interval calibration for population-level effect estimation studies in observational healthcare data by Martijn J. Schuemie, George Hripcsak, Patrick B. Ryan, David Madigan, and Marc A. Suchard

Many of the resources below are part of NIH's Research Methods Resources. If you are looking for more resources then what is below, NIH has provided additional literature including FAQs and glossary of terms that can be found on the Research Methods Resources website. 

• Review of Recent Methodological Developments in Group-Randomized Trials: Part 1-Design by Elizabeth L. Turner, Fan Li, John A. Gallis, Melanie Prague and David M. Murray

• Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis by Elizabeth L. Turner, Melanie Prague, John A. Gallis, Fan Li, and David M. Murray

• Pragmatic and Group-Randomized Trials in Public Health and Medicine. A free, 7-part, online course presented by Dr. David M. Murray that provides a detailed guide to designing and analyzing group-randomized trials (GRTs). The course includes video presentations, slide sets, suggested reading materials, and guided activities.

• Clinical Study Design Checklist from SPIRIT

• Improved Designs for Cluster Randomized Trials by Catherine M. Crespi

• Research Methods Resources for Clinical Trials Involving Groups or Clusters by David M. Murray

• Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: a review by Clare Rutterford, Monica Taljaard, Stephanie Dixon, Andrew Copas, and Sandra Eldridge

• Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines by Karla Díaz-Ordaz, Michael G Kenward, Abie Cohen, Claire L Coleman, and Sandra Eldridge

• Sample size calculations for the design of cluster randomized trials: A summary of methodology by Fei Gao, Arul Earnest, David B. Matchar, Michael J. Campbell, David Machin

• GRT Sample Size Calculator

• IRGT Sample Size Calculator

Online Courses

• Pragmatic and Group-Randomized Trials in Public Health and Medicine. A free, 7-part, online course presented by Dr. David M. Murray that provides a detailed guide to designing and analyzing group-randomized trials (GRTs).
   

• Introduction to the Principles and Practice of Clinical Research (IPPCR). The NIH Clinical Center's Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.

• Principles of Clinical Pharmacology. This course is an online lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The course focuses on the following core principles of pharmacology: pharmacokinetics; drug metabolism and transport; drug therapy in special populations; assessment of drug effects; drug discovery and development; pharmacogenomics and pharmacotherapy.

• Other clinical training opportunities are offered by NIH's Office of Clinical Research

• NIH e-protocol writing tool: The electronic protocol writing tool aims to facilitate the development of Phase 2 and 3 IND/IDE Clinical Trial Protocol Template as well as the Behavioral and Social Sciences Research Involving Humans. The tool has been developed through the National Institutes of Health (NIH) Office of Science Policy.

Below are several resources developed by the SPIRIT Group, an international group of stakeholders with the initiative to improve the completeness and quality of trials protocols. (text adapated from website)

• SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
• SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials
• Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
• Strengthening the Credibility of Clinical Research
• Related publications and resources from SPIRIT

• Questionnaire to determine the right reporting checklist for your work from the EQUATOR library

• Instant feedback for your manuscript from Penelope- checks academic manuscripts written in Microsoft Word. In seconds, it assesses structure, declarations, statistics, referencing and other common reporting errors. 

• Principles and Guidelines for Reporting Preclinical Researchfrom NIH

• Research Reporting Guidelines and Initiatives: By Organization - This chart lists the major biomedical research reporting guidelines that provide advice for reporting research methods and findings (from NIH - NLM)

• Compilation of suggested practices for creation of a retrospective chart review form
   
• The Retrospective Chart Review: Important Methodological Considerations by Vasser Matt and Holzmann Matthew

• A Multidisciplinary Approach to Ensure Scientific Integrity in Clinical Research by Dr. Ko Bando, et. al

The INSPIRE network has collaborated with global partners (including four influential journals: Simulation in Healthcare, BMJ Simulation, Clinical Simulation in Nursing, and Advances in Simulation) to develop extensions specific to simulation-based research for both the CONSORT and STROBE statements.

• Statistics in Medicine publishes statistical tutorials  
• The Biostatistics in Action Lectures YouTube Channel 

• Biostatistics in Action: Tips for Clinical Researchers Lecture Series

• A to Z - How sex and gender influence health and disease from NIH-ORWH

• Online courses on sex and gender differences from NIH-ORWH

• Essential metrics for assessing sex & gender integration in health research proposals involving human participants by Suzanne Day, et. al. 

• Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use by Shirin Heidari

• More resources are available on Reproducibility Resource by Topic webpage

• Covidence - The cloud-based software supports import and de-duplication of citations, title, abstract and full-text screening, risk-of-bias assessment and data extraction. Columbia researchers can sign up for a free account (provided by Augustus C. Long Health Sciences Library)
   

• How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses by Siddaway AP, Wood AM, and Hedges LV

• Clarifying differences between review designs and methods by David Gough, James Thomas & Sandy Oliver 

• What is a Systematic Review? from Curtin University