• Back to leedsth.nhs.uk
• Home page
• Introduction
• CTIMP
• Research Governance
• Research Proposals
• R & D Approval
• Research Ethics
• Research in Progress
• Research Complete
• Research Support
• Statistics Support
• Intellectual Property
• Key Documents
• Site map

Research & Development Website

Pharmacovigilance

	Quick Links
Pharmacovigilance Process	Pharmacovigilance SOP
Reporting SAEs and SUSARs	Annual Safety Reports
Sponsor confirmation of receipt	SAE Form
Timelines for Reporting SUSARs
Review of SAEs and SUSARs

Introduction

All clinical trials that involve the use of an investigational medicinal product (CTIMP), as defined by the MHRA, and that therefore fall within the scope of the current EU Directive 2001/20/EC and Medicines for Human Use in (Clinical Trials) Act require systems to be in place to ensure that all Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse (Drug) Reactions (SUSARs) are reported in accordance with the UK Regulations and relevant guidelines.

This Pharmacovigilance Policy applies to all CTIMPs being sponsored by the Leeds Teaching Hospitals NHS Trust (LTHT) or University of Leeds (UoL).

Pharmacovigilance Process

The Sponsor Pharmacovigilance SOP , is described in the flow diagram below. Study specific SOPs or Work Instructions must also be referred to for trial specific instructions for review and un-blinding of SAE reports.

The Investigator is responsible for undertaking the actions and processes highlighted in green.

	Sponsor Approved Template or Checklist
SAE reported to study team
Complete SAE Form	SAE Form SAE Form Supplemental Pages
Assign SAE number
Is the SAE a SUSAR
No                            Yes SAE SUSAR
Is the study double blind? No          Yes SAE Review Un-blind SUSAR Review Independent Review to be blind/un-blind?
Blind Un-blind                              Researcher arranges Independent Review         Fax SAE Report to Quality Assurance 0113 392 2863 Fax SAE Report to Quality Assurance 0113 392 2863       QA un-blinds the report QA un-blinds the report      QA arranges independent review Investigator reports to Sponsor Investigator reports to MHRA, Main Rec & Sponsor QA reports to MHRA and Main REC QA reports to MHRA and Main REC	Fax Cover Sheet Template

Legal Requirements for Reporting SAEs and SUSARs arising within a CTIMP

The following bodies must be notified of all SAEs and SUSARs arising within a CTIMP:

The following documents must be submitted when reporting a SUSAR:

Sponsor Confirmation of Receipt

The Sponsor will send a faxed confirmation of receipt notice to the reporting researcher upon receipt of notification of a SAE report. If this fax is not received within one week of notifying the Sponsor of the SAE then the notifying researcher must telephone the Quality Assurance Department to check that the SAE has been received by the Sponsor <<0113 343 1491>>. The Sponsor will enter the SAE details onto the Sponsor's Safety Database

Timelines for Reporting SUSARS

All SUSARs occuring within a CTIMP must be reported to the MHRA and the relevant Main REC within specific timelines, as follows:

Fatal or Life threatening SUSARs – The MHRA must be notified of the initial report, irrespective of the amount of information, as soon as possible, but no later than 7 calendar days after first knowledge by the research team that the case qualifies as a SUSAR. Additional information, if required, must be obtained by the research team urgently and as complete a report as possible must follow within 8 additional calendar days .

All other SUSARs – A complete report needs to be filed as soon as possible but no later than 15 calendar days after first knowledge by the research team that the case meets the minimum criteria for reporting.

The research team are responsible for reporting all SUSARs to the MHRA and MREC in line with the above stated timelines, unless the SUSAR requires un-blinding. In such cases the research team must report the SUSAR to the Quality Assurance Department leaving at least 3 working days to un-blind and report to the MHRA

Review of SAEs and SUSARs

Review of SAEs and SUSARs will be trial specific, however should be carried out as stated in the trial protocol. The CI will generally review all SAEs and SUSARs on an ongoing basis, however independent review such as by a Data Monitoring and Ethics Committee may also take place.

Home | Patients | Careers | News | Corporate | Resources | Freedom of Information | Website Help