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:

  • The safety and rights of study participants
  • The quality of collected data necessary for study evaluation

More

Study management must operate within the framework of ethical and regulatory requirements.

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

More

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 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

SAMW – see in particular

  • Research with human subjects

References

ICH GCP E6(R2) – see in particular guidelines

  • 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
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Management ↦ Study Management ↦ Definition
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Management ↦ Study Management ↦ Definition

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