Study Initiation and Management: Reporting

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Introduction

You will be required to report study information to relevant bodies throughout the course of your study.

Funders
External funders usually require financial updates and/or progress reports, these tend to be required annually. The details will depend on the funding body and should be outlined in the terms and conditions of the grant award. For studies that aim to recruit a large number of participants, the funding body may wish to be updated on recruitment figures.

Research Ethics Committees
Ethics committees require updates on progress and any safety issues. For further information please see the 1st resource below.

It is worth highlighting that reports of related and unexpected serious adverse events should be submitted within 15 days of the Chief Investigator becoming aware of the event, using the HRA report of serious adverse event form (2nd resource).

Research Governance Requirements
The UK policy framework for health and social care research aims to avoid adverse incidents and ensure that lessons are learned and shared when incidents are identified. The UK policy framework states that it is the responsibility of the Chief Investigator to report any adverse events.

Sponsors should have mechanisms in place to ensure all adverse incidents and study progress are reported and for monitoring the research (e.g. reviewing the ongoing suitability of the approved protocol in light of adverse events).

Regulatory agencies

HTA
At present, the system for notifying the Human Tissue Authority of any serious adverse events/reactions is only applicable to those establishments undertaking activities relating to relevant material for human application. Depending on the research project, this may be applicable (3rd resource below).

HFEA
You can find details of the reporting requirements under a research licence in Direction 0002 on the HFEA's Clinic Portal (4th resource below).

Resources

  • 1. HRA Managing your approval

    Information on what to do following NHS REC review, e.g. progress and safety reporting.

    Standard process for all research Date added: 6 September 2007
  • 2. HRA Report of Serious Adverse Event Form

    Form to report serious adverse events in research other than CTIMPs.

    Standard process for all research Date added: 7 September 2007
  • 3. HTA Adverse Event Reporting

    For projects involving human application.

    Legal requirement for specific research projects Date added: 7 September 2007
  • 4. HFEA Clinic Portal - Directions

    HFEA Clinic Portal - Directions

    Legal requirement for specific research projects Date added: 7 September 2007