Conduct↦Management↦Amendment↦Patient Information Sheet
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 PIS / 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.
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?
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)
- 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- Archive any outdated documents and ensure Site-INV(s) have access to the revised documents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.
More
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
References
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