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Safety Repo​rting and Pharmacovigilance​
The DMID-CROMS (Division of Microbiology and Infectious Disease-Clinical Research Operations and Management Support) Pharmacovigilance Group (PVG) provides safety reporting and pharmacovigilance support for DMID-supported clinical trials to ensure all systems and procedures are in compliance with FDA regulations, the European Union (EU) Clinical Trial Regulation, ICH guidelines and any other applicable Regulatory Authority guidelines relating to scientific and data gathering activities for the collection, processing, assessment of safety events and maintenance of the electronic safety database.

The DMID-CROMS Pharmacovigilance team (PVG) provides services outlined below:

  • Data entry, processing, evaluation, and closure of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).​
  • Preparation and distribution of MedWatch reports.
  • Processing, distribution and tracking of all queries.
  • Processing Independent Safety Monitor (ISM) and Safety Committee reports and requests.
  • Preparation and distribution of case narratives for DMID-sponsored clinical trials.
  • Supporting clinical trial sites with safety reporting procedures and submissions. Reconciling safety data to ensure accuracy, consistency, and completeness.
  • Preparation and distribution of safety information to investigators or third parties.
  • Mapping non-DMID SAE forms to DMID SAE forms to ensure essential safety data is collected.
  • Safety surveillance and signal detection.

Forms and Guidelines​​

​​ HiLIT QuickStart Guide​​NEW!

Version 3.0, Dated 01 February 2026

 HiLIT Print Guide​​ NEW!

Version 1.0, Dated 1 February 2026​​​​​​​​​​​​​​​​​

Safety Pharmacovigilance Fact Sheet​​

Version 5.0, Dated 05 April 2024​​​

Site Fax Cover to PVG​​

Version 2.0, Dated 28 June 2012​​​​​​​​​​

SAE Form​ Instructions

Version 5.0, Dated 18 August 2025​​​​​​​​​​​​​​​​​​​​​​​​​​​​

SAE Form​​

Version 5.0, Dated 18 August 2025​​​​​​​​​​​​​​​​​​


Please refer to​​ the Frequentl​y Asked Questions (FAQ)

If your site utilizes HiLIT for safety event submissions, please refer to the HiLIT FAQs.


If you have any questions or concerns, please contact DMID-CROMS Pharmacovigilance team (PVG) using the informati​on provided below:

Em​ail: PVG@dmidcroms.com​​

SAE Fax Line: 1-800-275-7619 (US) or 1-301-897-1710 (Outside US)

24/7 SAE Hotline available for real-time assistance with SAE reporting: 1-800-537-9979 (US) or 1-301-897-1709 (Outside US)

Mailing Address: 6500 Rock Spring Dr #650, Bethesda, MD 20817

Support Hours: Please click here for Hours of Operation​​​​​​​​​​

‭(Hidden)‬ Revised Forms

Doc Icon SAE Form Instructions
Version 4.0, Dated 20 September 2023​
Doc Icon SAE Form​ ​​
Version 4.0, Dated 20 September 2023​​​​​​​​