What is it? Why is it important?

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


It is especially useful in Studies:

  • With more than one study site
  • Last over a long period of time (e.g. several years)
  • Recruiting 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.


A newsletter should:

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


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

What do I need to do?

As a SP-INV, edit a newsletter according to the intended addressee (e.g. participants, experts, age, gender, disease type). Pay special attention to the following aspects:


  • Be motivational
  • Stick to easy language and abstain from using many technical words
  • Include graphs and pictures wherever possible to facilitate understanding, and provide an easy to grasp overview
  • If possible, use the participant’s native language



  • Focus on the most relevant information and do not overload the newsletter - provide information on a need-to-know basis.
  • Ask Site-INVs with access to relevant study statistics to provide information on:
    • Overall study progress (e.g. recruitment rate)
    • Emerging new knowledge
    • Experiences of joint interest (e.g. improvement of study processes such as participant recruitment)
    • Required adaptations of administrative tasks


Ensure to include acknowledgements, be it study participants, participating study sites, or grant providers

Where can I get help?

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

  • 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

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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Newsletter

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