What is it? Why is it important?

Based on a protocol amendment the Participant Information Sheet (PIS) and the Informed Consent Form (ICF) might become incomplete, lacking amended information relevant to participants.


In order to protect the rights and safety of study participants, the SP-INV or Site-INV is responsible to inform participants of any protocol changes that could potentially affect them. As consequence, PIS/ICF should be adapted accordingly.  


Amended PIS/ICF documents require that participants re-consent to changes by dating and signing the amended ICF. If applicable, also a participant’s legal representative should be informed about the changes in a timely manner, as it might affect a participant’s willingness to continue in the study.

What do I need to do?

As a SP-INV during study conduct:

  • Ensure PIS/ICF or any other written information provided to participants is revised whenever important new information becomes available
  • If required, make applicable changes to the PIS/ICF documents or any other relevant written material handed out to participants (e.g. information leaflets)
  • In order to track your documents during study conduct ensure documents are identified as amended version(s) (e.g. document identification)
  • Submit amended documents in track-change to the Ethics Committee (EC) for approval
  • Archive any outdated documents and ensure that the study site only has access to the amended and EC approved documents (e.g. document management)
  • Implement any changes (safety amendments excluded) only after the Site-INV and participant have dated and signed the revised ICF



During study conduct, the SP-INV would like to make a change to the study protocol. For the ongoing study, the SP-INV would like to collect an additional blood sample (5 ml whole blood). This change will affect study participants as they will be asked to donate additional blood. Thus, an adaptation to PIS/ICF becomes necessary. Participants must be informed and consent to this change before additional blood samples can be collected. The participant retains the right to abstain from giving consent (e.g. safety amendments excluded).


The following procedures are set in motion:

  • PIS and ICF are adapted accordingly and submitted to EC for approval
  • Upon EC approval participants are informed about the aim of an additional blood sample including applicable safety concerns
  • Participants are asked to give consent to an additional blood sample
  • Participants are given time to decide whether to agree or not
  • Blood is only be collected form participants who agreed and signed the revised ICF

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

  • 4.8.2. Revision of informed consent
  • 5.11.2. EC change and approval


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

  • 5.8.6 New information
  • 10.5 Informed consent procedure
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • PIS – Patient Information Sheet
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Amendment ↦ Patient Information

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 ↦ Amendment ↦ Patient Information

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