What is it? Why is it important?

Study Management is the backbone of successful study implementation and outcome.

In other words:

The ability to plan, organise, coordinate, control activities and get things done with and through other people in order to achieve overall objective(s).


For studies this would mean to ensure:


Study management must operate within an ethics framework (e.g. Ethics Committee, Declaration of Helsinki, Declaration of Taipei), regulatory requirements (e.g. Swissmedic, Federal Office of Public Healthinternational), and applicable guidelines (e.g. ICH-GCP, ISO 14155, ISO 20916)

What do I need to do?

The successful management of a study requires:

  • Adequate disposable free time for the ongoing management of the study
  • Access to experienced supporting study staff (e.g. expert physician, study nurse, project manager, monitor, statistician, data manager)
  • Access to professional supporting partners (e.g. field experts, additional study sites, laboratories, various service providers)
  • Access to adequate financial resources to realise the study


When planning a study, various fields of expertise are required, such as:

  • Specialist physician in the role as SP-INV
  • Site-INV responsible for a study site
  • Study nurse
  • Study coordinator
  • Project manager
  • Data manager
  • Quality manager or auditor
  • Regulatory manager
  • Laboratory manager
  • Statistician
  • Monitor
  • Pharmacist


Depending on study type (e.g. ClinO, ClinO-MD, HRO, Other Clinical Studies) and activities involved, other players might also be important, such as biobanking experts, lawyers, patient organisations, cohort managers, etc.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Information on further education
  • Staff List



ICH GCP E6(R2) – see in particular guideline

  • 2.0 Principles of ICH GCP

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 4 Summary of GCP principles
  • 68 Clinical investigation planning, conduct and termination

SAMW – see in handbook

  • Research with human subjects
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • GCP – Good Clinical Practice
  • ISO – International Organization for Standardization
  • SAMW – Schweizerische Akademie der Medizinischen Wissenschaft (Swiss academies of arts and sciences)
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Management ↦ Study Management ↦ Definition

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): Basic ↦ Management ↦ Study Management ↦ Definition

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