What is it? Why is it important?

Based on a protocol amendment the Patient Information Sheet (PIS) and the Informed Consent Form (ICF) might become incomplete, lacking amended information relevant to participants. Thus, adaptations regarding information provided to participants will become necessary. In addition, new information might affect a participant’s willingness to participate in the study.

In order to protect the rights and safety of study participants, the SP-INV or Site-INV is responsible to inform participants of any changes to the study protocol that result in required IS/ICF adaptations.

  • In order to protect study participants, amendments that require safety and preventive measures are immediately implemented.
  • Non-safety changes can only be implemented after EC has approved the suggested amendments.

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If applicable, also a participant’s legal representative should be informed about changes in a timely manner as it might affect the participant’s willingness to continue in the study.

The communication of this information should be documented.

What do I need to do?

  • 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)
  • Submit amended documents in track-change to EC for approval
  • Archive any outdated documents and ensure Site-INV(s) have access to the revised documents
  • Implement any changes (safety amendments excluded) only after the Site-INV and participant have dated and signed the revised ICF (re-consent)

For more information refer to Protocol in this Study Guide.

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Example

During study conduct, SP-INV would like to make a change in the study protocol. Based on an additional blood sample (5 ml whole blood) additional important data can be collected. This change will affect participants as they will be asked to donate additional blood. Thus, an adaptation to PIS/ICF becomes necessary; participants must be informed and initially consent to this change. Except required safety and protective measures, the participant has the right to abstain from giving consent.

  • 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 can subsequently 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

References

ICH GCP E6(R2) – see in particular guidelines

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

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

  • 5.8.6 New information
  • 10.5 Informed consent procedure
Abbreviations
  • 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/ICF - Patient Information Sheet / Informed Consent
  • PIS – Patient Information Sheet
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Amendment ↦ Patient Information Sheet
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 ↦ Amendment ↦ Patient Information Sheet

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