Clinical Trials and Pharmacovigilance in 2026

Clinical Trials and Pharmacovigilance in 2026

Updated 15 July 2026. Participant safety must be monitored from protocol design through site closure and the final clinical study report. In 2026, the principal international standard is ICH E6(R3) Good Clinical Practice, adopted at Step 4 in January 2025.

What ICH E6(R3) changes in practice

• the rights, safety and well-being of participants remain the priority;
• quality should be designed into the trial around critical-to-quality factors;
• sponsor oversight extends to CROs and other service providers;
• computerised systems and data must be fit for purpose, secure and traceable;
• processes should be proportionate to risks and trial characteristics.

AE, ADR, SAE and SUSAR

An AE is any untoward medical occurrence. An ADR involves a reasonable possibility of a causal relationship. An SAE is defined by seriousness criteria, not symptom intensity. A SUSAR is a serious, unexpected suspected adverse reaction requiring expedited reporting under applicable rules.

Investigator responsibilities

• provide appropriate medical care and report SAEs immediately to the sponsor unless the protocol specifies otherwise;
• provide follow-up information and medical assessment;
• comply with the protocol, informed-consent process and ethics-committee decisions;
• maintain accurate source data and essential records;
• report to ethics committees and authorities where national rules require it.

Sponsor responsibilities

• collect, medically assess, MedDRA-code and follow up safety reports;
• assess seriousness, expectedness and causality against current Reference Safety Information;
• submit SUSARs within applicable timelines and channels;
• protect blinding and document justified unblinding;
• perform aggregate review, signal detection and urgent safety measures;
• prepare the annual Development Safety Update Report (DSUR) under ICH E2F;
• oversee safety activities delegated to CROs and other providers.

Minimum information and follow-up

A valid expedited report generally requires an identifiable participant, identifiable reporter, suspected investigational product, and an identifiable serious and unexpected event with a reasonable suspected causal relationship. Clinically important missing information should be actively followed up and documented.

Practical checklist

1. Align the protocol, Investigator’s Brochure and Reference Safety Information.
2. Define SAE routes and timelines between sites, CRO and sponsor.
3. Verify agreements, training and back-up arrangements.
4. Validate the safety database, electronic forms and data interfaces.
5. Reconcile the clinical and safety databases regularly.
6. Document medical decisions, unblinding, signals and urgent safety measures.
7. Include an integrated benefit–risk evaluation in the DSUR.

Official sources

• ICH efficacy guidelines, including E2A–E2F and E6
• ICH E6(R3) Good Clinical Practice
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report

How PharmExpert can help

PharmExpert develops clinical-safety procedures, supports SAE/SUSAR workflows and DSUR preparation, performs database reconciliation and audits sponsor, CRO and site inspection readiness.

This article is for general information. Reporting timelines and recipients are determined by the applicable national requirements and trial protocol.