What is it? Why is it important?

A newsletter contains information summarising study progress so as to inform participating Site-INV(s), study staff and if applicable study participants.

It is especially useful in:

  • Multicentre studies with more than one study site
  • Studies that last over a long period of time
  • Studies that recruit a sizable amount of participants

The aim is to motivate, update and train study sites including participants in order to keep the study on everyone’s agenda.

Newsletters are reviewed and approved by the SP-INV prior to being release.

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A newsletter should:

  • Be positive and provide a general outlook on study status
  • Respect and maintain data protection issues at all times.

What do I need to do?

Edit a newsletter according to addressee

  • Language: Preferably provide information to participants in local language and refrain from using technical definitions.
  • Content: For a Site-INV(s) the newlsetter can provide more statistical and organisational information, such as:
    • Acknowledgement of participating study sites
    • Overall study progress (e.g. recruitment rate, novel sites)
    • Sharing of emerging new knowledge and experience
    • Adaptations of administrative tasks

A newsletter destined for participants should be considered for studies that last over many years.

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The aim of a participant newsletter is mainly to motivate and should be:

  • Adapted based on participant profile (e.g. age, gender, disease type)
  • Edited using easy to understand layman terms

Where can I get help?

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

Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Newsletter
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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Newsletter

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