A comprehensive guide to pharmacovigilance requirements for clinical trials in Venezuela — covering adverse event reporting, SUSAR timelines, DSUR obligations, and safety monitoring best practices.
July 17, 2026
12
min read
By
bioaccess® Editorial Team
pharmacovigilance Venezuela
adverse event reporting Venezuela
SUSAR reporting
DSUR Venezuela
clinical trial safety monitoring
**Key Takeaways**
- • Fatal/life-threatening SUSARs: Report to INHRR within 7 days
- • Other SUSARs: Report within 15 calendar days
- • DSURs: Annual submission required per ICH E2F format
- • MedDRA coding: Standard for all adverse event classification
- • bioaccess® manages end-to-end pharmacovigilance for sponsors
**The short answer**
Pharmacovigilance for clinical trials in Venezuela is governed by INHRR under international ICH guidelines: fatal or life-threatening SUSARs must be reported within 7 days, all other SUSARs within 15 calendar days, and DSURs submitted annually per ICH E2F format with MedDRA coding. Robust PV is especially critical for first-in-human trials, where prior human exposure is limited. Safety planning should start during regulatory submission, so reporting workflows are validated before first patient enrollment.
How is pharmacovigilance governed in Venezuela?
Pharmacovigilance (PV) for clinical trials in Venezuela is governed by INHRR and follows international ICH guidelines. The framework ensures that the safety of trial participants is continuously monitored and that emerging safety signals are promptly identified and communicated to all stakeholders — regulatory authorities, ethics committees, investigators, and sponsors.
For sponsors conducting first-in-human clinical trials in Venezuela, robust pharmacovigilance is especially critical given the limited prior human exposure to the investigational product.
What are the adverse event reporting requirements?
All adverse events (AEs) occurring during a clinical trial must be documented and reported according to the protocol and Venezuelan regulations. Key requirements include:
- All AEs must be recorded in the CRF/eCRF with onset date, severity, causality, and outcome
- Serious Adverse Events (SAEs) must be reported to the sponsor within 24 hours
- Investigators must assess causality (related, possibly related, not related)
- Follow-up reports must be submitted until resolution or stabilization
- AEs must be coded using MedDRA terminology
What are the SUSAR reporting timelines?
| Event Type | Timeline to INHRR | Follow-up |
|---|---|---|
| Fatal SUSAR | 7 calendar days | 8 additional days |
| Life-threatening SUSAR | 7 calendar days | 8 additional days |
| Other SUSARs | 15 calendar days | As information becomes available |
| Unexpected SAE (non-SUSAR) | Per protocol | Follow-up until resolution |
What are the DSUR requirements?
Development Safety Update Reports (DSURs) must be submitted annually to INHRR for all ongoing clinical trials. The DSUR follows the ICH E2F format and provides a comprehensive annual safety assessment.
- Annual submission aligned with international birth date (IBD) of the product
- Cumulative safety data analysis across all global studies
- Benefit-risk assessment updated with latest safety information
- Signal detection and management summary
- Summary of safety-related regulatory actions worldwide
Which local pharmacovigilance regulations apply?
Venezuela's PV regulations are aligned with WHO and ICH standards. Key local requirements include:
- INHRR is the primary recipient of all safety reports from clinical trials
- Ethics committee must be notified of all SUSARs and significant safety findings
- Local safety reports must be in Spanish
- INHRR may request additional safety data or analyses at any time
- Pregnancy reports must be submitted regardless of adverse event occurrence
How is safety monitored during clinical trials?
Active safety monitoring during clinical trials in Venezuela includes:
- Regular monitoring visits to verify AE documentation and reporting compliance
- Medical monitoring by qualified physicians for ongoing safety assessment
- Data Safety Monitoring Board (DSMB) oversight for higher-risk studies
- Signal detection from aggregate safety data
- Periodic safety reviews with investigators and the sponsor
What are the post-trial safety obligations?
Sponsors have ongoing safety obligations even after a trial concludes in Venezuela:
- Final safety report submission to INHRR
- Follow-up of any ongoing SAEs until resolution
- Notification of any new safety findings that emerge from other studies globally
- Archival of all safety documentation per GCP requirements
How does bioaccess® support pharmacovigilance in Venezuela?
bioaccess® provides comprehensive pharmacovigilance support for clinical trials in Venezuela, including:
- 24/7 SAE intake and processing
- SUSAR identification, assessment, and expedited reporting to INHRR
- MedDRA coding and safety database management
- DSUR preparation and submission
- Medical monitoring and safety signal detection
- Ethics committee safety notifications
- Regulatory authority liaison for safety queries
**Need PV support for your Venezuela trial?**
Contact bioaccess® to discuss pharmacovigilance services for your clinical trial in Venezuela.
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