Pharmacovigilance

Pharmacovigilance (PhV) is the science of detecting, assessing, understanding, and preventing adverse effects of medicines. This section provides further information on PhV requirements and safety reporting procedures.

Across all types of research, ACCORD supports investigators in developing proportionate PhV, safety monitoring and reporting strategies to promote ethical conduct and effective risk management throughout the study lifecycle.

Before your trial or study begins, our PhV team will guide you through the necessary procedures and ensure your research team is familiar with the relevant SOPs. For tailored support, contact the PhV team to arrange bespoke training.

Pharmacovigilance for regulated clinical trials

If you are running a Clinical Trial of an Investigational Medicinal Product (CTIMP), there are specific regulatory requirements for PhV. ACCORD's experienced PhV team ensures that safety data is effectively captured, assessed, and reported - enabling rapid identification and response to any emerging safety signals during your trial.

SOP CR005: Identifying, Recording and Reporting AEs and USMs for CTIMPs (v8.0) 

Outlines the PhV procedures required to ensure that safety events arising during regulated clinical trials are accurately recorded and reported in full compliance with clinical trial regulations.

Read SOP CR005: Identifying, Recording and Reporting AEs and USMs for CTIMPs

Safety reporting for non-regulated clinical research

While CTIMPs have strict legal requirements, it's also important to consider safety oversight in non-regulated or lower-risk research. Studies involving non-IMP interventions, devices, or behavioural procedures may still carry potential risks to participants. 

SOP CR006: Identifying, Recording and Reporting AEs and USMs for non-CTIMPs (v9.0) 

Outlines the PhV procedures required to ensure that safety events arising are accurately recorded and reported appropriately.

Read SOP CR006: Identifying, Recording and Reporting AEs and USMs for Non-CTIMPs

Pharmacovigilance for regulated medical device trials

Some medical device trials must comply with relevant UK Medical Device Regulations, which include obligations for reporting Serious Adverse Events (SAEs), device deficiencies, and other safety concerns. 

SOP CR012: Identifying, Recording and Reporting AEs and Device Deficiencies for Regulated Medical Device Studies (v5.0) 

Outlines the reporting mechanisms to ensure that device-related safety data is managed in line with current guidance.

Read SOP CR012: Identifying, Recording And Reporting Adverse Events And Device …

The Pharmacovigilance team are available to answer your questions and provide advice.


Our Pharmacovigilance procedures at a glance

Reporting of safety events to ACCORD

  • Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs), Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported using the ACCORD SAE form to safety@accord.scot.
  • ACCORD maintains a fully QC-checked safety database of all events reported.
  • SUSARs are unblinded (where applicable) and reported by the PhV team to:
    • MHRA
    • Locations (in multi-location studies)
    • International Competent Authorities (as required)

DSURs and line listings

  • The PhV team provide support with the preparation of Development Safety Update Reports (DSURs) and review reports prior to submission to the MHRA.
  • Trial-specific line listings can be made available on request. Please provide:
    • 2 weeks notice for standard reports
    • 2 weeks for Data Monitoring Committees (DMCs)

Reference safety information (RSI)

  • The RSI (e.g. Summary of Product Characteristics (SmPC)) must remain unchanged during an annual reporting period.
  • The Pharmacovigilance team regularly reviews RSIs and will advise if a substantial modification is needed before your next annual reporting period.

Sponsor safety reviews

  • The Pharmacovigilance team performs a quarterly SAE review for trials with:
    • No DMC
    • Safety concerns raised by a DMC (minutes should be shared with ACCORD)
  • An annual SAE trend review is performed for all trials.

     

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