Pharmacovigilance Requirements for Clinical Trials in Venezuela

· bioaccess® Editorial Team

Complete guide to pharmacovigilance requirements for clinical trials in Venezuela. Adverse event reporting to INHRR, SUSAR timelines, DSUR requirements, and safety monitoring obligations.

Pharmacovigilance Requirements for Clinical Trials in Venezuela

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

Pharmacovigilance framework 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.

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

SUSAR reporting timelines

Event TypeTimeline to INHRRFollow-up
Fatal SUSAR7 calendar days8 additional days
Life-threatening SUSAR7 calendar days8 additional days
Other SUSARs15 calendar daysAs information becomes available
Unexpected SAE (non-SUSAR)Per protocolFollow-up until resolution

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

Local pharmacovigilance regulations

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

Safety monitoring 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

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

bioaccess® pharmacovigilance services

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.

Frequently asked questions

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Frequently asked questions

What are the SUSAR reporting timelines in Venezuela?

Fatal or life-threatening SUSARs must be reported to INHRR within 7 calendar days of awareness, with a follow-up within 8 additional days. All other SUSARs must be reported within 15 calendar days. These timelines align with ICH E2A guidelines.

Are DSURs required for clinical trials in Venezuela?

Yes. Development Safety Update Reports (DSURs) must be submitted annually to INHRR for ongoing clinical trials. The DSUR follows the ICH E2F format and provides a comprehensive annual safety assessment of the investigational product.

Who is responsible for pharmacovigilance in Venezuela clinical trials?

The sponsor is ultimately responsible for pharmacovigilance. In practice, bioaccess® as the local CRO manages day-to-day PV activities including adverse event collection, coding (MedDRA), causality assessment support, SUSAR reporting to INHRR, and DSUR preparation.

Does Venezuela use MedDRA for adverse event coding?

Yes. Venezuela follows international standards for adverse event coding using MedDRA (Medical Dictionary for Regulatory Activities). bioaccess® ensures all adverse events are coded using the current MedDRA version for consistency with global safety databases.

What happens if a serious adverse event occurs during a trial in Venezuela?

SAEs must be reported to the sponsor within 24 hours. The investigator assesses causality and provides initial information. bioaccess® manages expedited reporting to INHRR per required timelines, coordinates with the ethics committee, and ensures the DSMB (if applicable) is notified.

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