DMID Clinical Research Policies and Standard Procedure Documents

Serious Adverse Event (SAE) Reporting Guidelines and Forms

Vaccine Reports

• Vaccine SAE Report Form (MS Word)
• SAE Report Form Guidelines Template—Vaccines (PDF)
• SAE Report Form Guidelines Template—Vaccines Country Code (for international studies) (PDF)

Single Study Products

• Single Study Product SAE Report Form (MS Word)
• SAE Report Form Guidelines Template—Single Study Product (PDF)
• SAE Report Form Guidelines Template—Single Study Product Country Code (for international studies) (PDF)

Multiple Study Products

• Multiple Study Products SAE Report Form (MS Word)
• SAE Report Form Guidelines Template—Multiple Study Product (PDF)
• SAE Report Form Guidelines Template—Multiple Study Product Country Code (for international studies) (PDF)

SAE Cover Sheet

• SAE Cover Sheet: to be faxed with SAE report forms (MS Word)