Academic Research: Medical Writing

Regulatory medical writing 

• clinical study protocols
• clinical study reports
• informed consent 
• investigator brochures
• summary documents

Educational medical writing

• sales literature
• data presentations for medical conferences
• medical journal articles - target audience: nurses, clinicians, and pharmacologists 
• consumer education
• continuing education 

Journalism

• newspapers article 
• magazine articles 

Marketing 

• promotional articles
• sales training manuals 
• internet articles 
• e-modules 

Adapted from Sharma S. (2010). How to become a competent medical writer? Perspectives in clinical research, 1(1), 33–37.

Standards & Guidelines 

• The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• ICH guidelines index 
• Enhancing the quality and transparency of health research (Equator network) - reporting guidelines for the main study types 

Clinical Guidelines

• Rosenfeld, R. M., & Shiffman, R. N. (2009). Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 140(6 Suppl 1), S1–S43.
• Institute of Medicine (IOM): Clinical Practice Guidelines We Can Trust—Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)
• Council on Medical Specialty Societies. Principles for the Development of Specialty Society Clinical Guidelines  
• American Association of Family Practitioners. Clinical Practice Guideline Manual 
• AHRQ Clinical Guidelines and Recommendations 
• AHRQ Guidelines and Measures 

Clinical Data 

• Clinical Data Interchange Standards Consortium
• Clinical data management system
• Electronic Common Technical Document (eCTD) (FDA)
• eCTD EU Module 1 Specification 
• Association for Clinical Data Management
• Society for Clinical Data Management 

Medical Dictionaries 

• Medical Dictionary for Regulatory Activities 
• Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
• WHO Drug Dictionary

Medical Organizations 

• Food and Drug Administration 

• American Medical Writers Association 
• European Medical Writers Association