ICF Development

The patient information and consent form (ICF) is the most carefully reviewed document by competent authorities worldwide. As such comments from Regulatory Authorities and Ethics Committees might frequently be raised should the ICF not be consistent with international guidelines (ICH-GCP) and/or local specifications. This might cause significant delays in the approval and activation of your clinical trial so a careful development of the ICF is a must.

The most important feature of the ICF should be simplicity. In many studies, especially in hemato-oncology, ICFs tend to be very big and filled with difficult language which make it nearly impossible to follow from a patient perspective. The aim of the ICF is to give to the potential patient a clear understanding of the scope and nature of the clinical trial so as to make an informed decision to participate or not. As such full transparency is required, without however making the document difficult to read. It shall be in lay language, avoiding unnecessary detail and technical terminology as much as possible.

Master vs Local ICF
For international studies, a master ICF document shall be produced first, followed by local adaptations based on each country’s local requirements. Deep and up to date knowledge of each national regulatory authority’s requirements is key in ensuring that the local adaptation is compliant (some countries have specific templates that must be used).

ICF Key Sections
Below you will find a short description of some of the key sections that are included in an ICF:

1. Introduction and General Information

Welcome the patient to this study and explain that it is important to take the time and read this document carefully and ask any questions to his/her doctor. Also explain clearly that taking part in the study is entirely optional. Also provide information on who is responsible for the study (Sponsor).

3. Details on Study Procedures

Here one shall explain simply to the patient what his/her participation will involve. An outline of the types to test that will be performed shall be given without too much detail and technical language. Also, the treatment and hospital visit schedule should be outlined clearly. For interventional studies it is very important to explain in this section what parts of the study are different than the standard care that the patient would have received for his/her condition. Finally, the expected length of time for participation in each phase of the study (treatment phase, follow up phase etc.) should be clarified to the patient with in.

5. Data handling

In this section it is very important to explain how the data gathered from during the trial will be handled and for how long they will be stored.  This section shall be compliant to GDPR of course, also clarifying:

  • the confidentiality, integrity, and availability of information collected during the study as well as the subject’s rights on their own personal data
  • how records that identify the patient will be kept
  • the possibility that authorities may inspect the records
  • availability of study details on any database / results

An explanation of what will happen with the data or samples at the end of the study period and if the data/ samples are retained for further research should also be provided here.

7. Financial Considerations and Insurance

In this section it must be made clear to the patient of any potential reimbursement or compensation of associated costs related to this study and of the insurance policy that pertains to his/her participation.

2. Background/Purpose

Explain briefly and simply the type of disease that is studied and why this particular clinical study is being performed.

4. Side-effects/Risks and Benefits

Of course, the potential side effects and risks in taking part in the study must be clearly stated together with the potential benefits so that the patient can make an informed decision. Depending on the nature of the study and involved medications, the risk language could be quite extensive. In such cases an appendix should also be used to expand on the potential side-effects and safety considerations for the treatment given.

6. Patients’ rights, including that

  • participation is voluntary;
  • they have the right to refuse treatment or may choose to stop participation in the study at any time without losing benefits for which they are entitled.

8. Contact

Details must be given to the patient for obtaining more information / file a complaint.

9. Consent Form

At the end of the ICF the Consent Form shall be placed where the patient will declare that he/she has read all the information provided and agrees voluntarily to participate in the study together with all the relevant requirements.

In this section one should also include any further considerations regarding the handling of the informed consent process when including vulnerable study populations.

1. Introduction and General Information

Welcome the patient to this study and explain that it is important to take the time and read this document carefully and ask any questions to his/her doctor. Also explain clearly that taking part in the study is entirely optional. Also provide information on who is responsible for the study (Sponsor).

2. Background/Purpose

Explain briefly and simply the type of disease that is studied and why this particular clinical study is being performed.

3. Details on Study Procedures

Here one shall explain simply to the patient what his/her participation will involve. An outline of the types to test that will be performed shall be given without too much detail and technical language. Also, the treatment and hospital visit schedule should be outlined clearly. For interventional studies it is very important to explain in this section what parts of the study are different than the standard care that the patient would have received for his/her condition. Finally, the expected length of time for participation in each phase of the study (treatment phase, follow up phase etc.) should be clarified to the patient with in.

4. Side-effects/Risks and Benefits

Of course, the potential side effects and risks in taking part in the study must be clearly stated together with the potential benefits so that the patient can make an informed decision. Depending on the nature of the study and involved medications, the risk language could be quite extensive. In such cases an appendix should also be used to expand on the potential side-effects and safety considerations for the treatment given.

5. Data handling

In this section it is very important to explain how the data gathered from during the trial will be handled and for how long they will be stored.  This section shall be compliant to GDPR of course, also clarifying:

  • the confidentiality, integrity, and availability of information collected during the study as well as the subject’s rights on their own personal data
  • how records that identify the patient will be kept
  • the possibility that authorities may inspect the records
  • availability of study details on any database / results

An explanation of what will happen with the data or samples at the end of the study period and if the data/ samples are retained for further research should also be provided here.

6. Patients’ rights, including that

  • participation is voluntary;
  • they have the right to refuse treatment or may choose to stop participation in the study at any time without losing benefits for which they are entitled.

7. Financial Considerations and Insurance

In this section it must be made clear to the patient of any potential reimbursement or compensation of associated costs related to this study and of the insurance policy that pertains to his/her participation.

8. Contact

Details must be given to the patient for obtaining more information / file a complaint.

9. Consent Form

At the end of the ICF the Consent Form shall be placed where the patient will declare that he/she has read all the information provided and agrees voluntarily to participate in the study together with all the relevant requirements.

In this section one should also include any further considerations regarding the handling of the informed consent process when including vulnerable study populations.

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