What is it? Why is it important?

In order to ensure the safety of study participants and the quality of study data, the SP-INV identifies risks related to study processes and data handling.

Risk identification is based on:


Based on risk identification the SP-INV implements a risk-based QMS. The scope of the risk-based QMS is based on the evaluation of the study`s risk management, which includes to:

  • Evaluate risks on their likelihood of occurrence, ability to be detected, and potential risk impact
  • Prioritise risks, and define risk control-measures in proportion to their estimated risk significance (e.g. potential impact on primary- or secondary endpoints)


When writing the study protocol, an estimation of potential study risks and their risk control-measures are defined. During study conduct the management and adaptation of study risks might become necessary. Consequently, risk identification and managment (evaluation & prioritisation, definition of risk control-measures) is a continuous process, starting at the time of protocol writing and only ends upon study completion.

Newly identified risks during study set-up, development and conduct might potentially necessitate a protocol amendment.

What do I need to do?

As a SP-INV you are responsible for the risk identification and management of your study such as to:

  • Identify your study risks and ask yourself:
    • What can go wrong in my study?
    • What could affect patient rights, safety, and well-being?
    • What could jeopardise data quality and consequently the integrity and credibility of my study results?
  • Document all identified risks and their management in the RAF
  • Implement a risk-based QMS with the aim to support the risk identification and management of your study. Include quality assurance and quality control aspects


As a SP-INV or Site-INV:

  • Communicate and train staff on the risk management of the study
  • Regularly review risk control measures in order to test its ongoing efficacy
  • Document ongoing and newly identified risk occurrences, their implemented risk control-measures, including potential deviations and improvement procedures


Use ‘lessons learned’ from previous studies. Previous risk experience can facilitate the risk identification of a planned study.


Examples of study risks or what can go wrong:

  • Safety: non-compliant processes in the assessment and documentation of adverse events, SAE, SUSAR
  • Data protection: participant data becomes accessible to non-study staff
  • Participant right: are not properly informed regarding study withdrawal or signing of ICF
  • Data quality: data incomplete, unusable for final analysis
  • Analysis: statistical method(s) is not applicable or inappropriate for data analysis
  • Design: study feasibility is questionable resulting in poor compliance and incomplete dataset
  • Biological material: lack of standardised processes for sample retrieval, handling and storage
  • IMP/IMD: lack of optimal storage conditions and regulated access control

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.0.2 Risk identification

ISO 31000 (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines


  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • RAF – Risk Assessment Form
  • SAE – Serious Adverse Event
  • Site - INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • SUSAR – Suspected Unexpected Serious Adverse Event
Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Identification

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Identification

Please note: the Easy-GCS tool is currently under construction.