F. Population of Trial Subjects

Task topic including steps necessary for completing Section F. Population of Trial Subjects in a Clinical Trial Application draft.

Complete the information required to describe the population of subjects included in the trial. It is possible to copy and paste information into these boxes from other electronic documents.

The details surrounding the completion of the subsections can be viewed below, or by moving the mouse over the field level help adjacent to fields.

F.1 Age Range

If there are no subjects under 18 it is sufficient to answer 'No' to F.1.1 and then answer questions relevant to adults and elderly, which begins at F.1.2 (Adults (18-64 years) step 15, below).

Subjects under 18:

  1. When considering F.1.1, any subject of 18 years or older is considered an adult for the purposes of clinical trials. If 'Yes' is selected, all fields from F.1.1.1. to F.1.1.6.should be completed.
    2. E.g.: If subjects aged 2 to 11 are enrolled in the trial, select 'Yes' for F.1.1.5. and 'No' for F.1.1.1, F.1.1.2, F.1.1.3, F.1.1.4 and F.1.1.6.).
  2. Click in the text field on the left of F.1.1 and enter relevant number of subjects (up to 10 numerals).
  3. In F.1.1.1, select 'Yes' if the subjects are unborn infants, still in the womb.
  4. In F.1.1.1.1, click in the field and enter relevant number of subjects (up to 10 numerals).
  5. In F.1.1.2, select 'Yes' if the subjects are not more than 37 weeks from their conception.
  6. In F.1.1.2.1, click in the text field and enter relevant number of subjects (up to 10 numerals).
  7. In F.1.1.3, select 'Yes' if the subjects are newborn babies aged 0-27 days.
  8. In F.1.1.3.1, click in the text field and enter relevant number of subjects (up to 10 numerals).
  9. In F.1.1.4, select 'Yes' if the subjects are aged 28 days to 23 months.
  10. In F.1.1.4.1, click in the field and enter relevant number of subjects (up to 10 numerals).
  11. In F.1.1.5, select 'Yes' if the subjects are aged 2 to 11 years.
  12. In F.1.1.5.1, click in the field and enter relevant number of subjects (up to 10 numerals).
  13. In F.1.1.6, select 'Yes' if the subjects are aged 12 to 17 years.
  14. In F.1.1.6.1, click in the field and enter relevant number of subjects (up to 10 numerals).

    15. Adult Subjects:

    Tip: If F.1. is answered 'No', then the following fields should be completed.
  15. In F.1.2, select 'Yes' if the subjects are aged 18 to 64 years.
  16. In F.1.2.1, click in the field and enter relevant number of subjects (up to 10 numerals).
  17. In F.1.3, select 'Yes' if the subjects are aged 65 years or more.
  18. In F.1.3.1 click in the field and enter relevant number of subjects (up to 10 numerals).
If the above steps are completed, including mandatory fields. the subsection is complete.

Now complete sections F.2-F.5, as outlined below. Click on the blue headings to expand the other subsections, and expand the below headings for further step-by-step instructions.

F.2 Gender

Identify the sex of the subjects of the Clinical Trial.

  1. In F.2.1, select 'Yes' if the trial includes female subjects. This is mandatory.
  2. In F.2.1, select 'Yes' if the trial includes male subjects. This is mandatory.
If the above steps are completed, including mandatory fields. the subsection is complete.

Now complete sections F.3-F.5, as outlined below. Click on the blue headings to expand the other subsections, and expand the below headings for further step-by-step instructions.

F.3 Group of trial subjects

Identify the detailed constituents of the group of subjects in the Clinical Trial..

  1. In F.3.1, select 'Yes' if the trial includes subjects in good health. This is mandatory.
  2. In F.3.2, select 'Yes' if the trial includes subjects, who are currently patients. This is mandatory.
  3. In F.3.3, select 'Yes' if the trial includes subjects (healthy volunteers or patients), who are considered to be part of a vulnerable population (see ICH GCP definition of 'Vulnerable Subjects').
    4. Tip: If 'Yes', please complete sections F.3.3.1-F.3.3.7.1. This is mandatory.
  4. In F.3.3.1, select 'Yes' if the trial includes women subjects who have the potential to give birth and are not using contraception.
  5. In F.3.3.2, select 'Yes' if the trial includes women subjects who have the potential to give birth and are using contraception.
  6. In F.3.3.4, select 'Yes' if the trial includes women subjects who are breastfeeding.
  7. In F.3.3.5, select 'Yes' if an emergency situation, where urgent care is needed for the patient and this involves enrolment in the trial (for example: myocardial infarction, or head injury).
  8. In F.3.3.6, select 'Yes' if subjects who are incapable of giving consent personally are to be enrolled in the trial. For example:
    • Subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition (e.g. coma, mental disability and in accordance with national requirements).
    • Subjects under age incapable of giving consent personally.
    • Subjects with a condition which makes them incapable of giving consent personally and who need urgent care. In this last case, select 'Yes' for F.3.3.5, above.

    Note: This section is for subjects who are vulnerable for reasons other than their age alone. Children are already identified under F.1.1, but institutionalised, or mentally handicapped children should be mentioned in the free text field,F.3.3.6.1.
  9. In F.3.3.6.1, click in the free text field and include details of the groups of population subjects incapable of giving consent.
    10. Add Content in Another Language:
    • Click the Add icon button to add text in another language than English.
    • Then click Choose language drop-down imageto select the language you wish to add content in.
    • Click delete icon if you add a field in error, or if you wish to delete a previously added language translation.
    Note: This section is for subjects who are vulnerable for reasons other than their age alone. Children are already identified under F.1.1, but institutionalised, or mentally handicapped children should be mentioned here (up to 250 characters).
  10. In F.3.3.7, select 'Yes' if other categories of vulnerable subjects will be enrolled in the trial. For example:
    • Subjects who are in prison.
    • Subjects hospitalised without their consent.

    If 'Yes', complete section F.3.3.7.1 by adding details.
  11. In F.3.3.7.1, click in the free text field and include details of the other category of vulnerable populations (up to 100 characters).
    12. Add Content in Another Language:
    • Click the Add icon button to add text in another language than English.
    • Then click Choose language drop-down imageto select the language you wish to add content in.
    • Click delete icon if you add a field in error, or if you wish to delete a previously added language translation.
If the above steps are completed, including mandatory fields. the subsection is complete.

Now complete sections F.4-F.5, as outlined below. Click on the blue headings to expand the other subsections, and expand the below headings for further step-by-step instructions.

F.4 Planned number of subjects to be included

Identify exact numbers of subject to be included in the Clinical Trial. The information entered in this section should match the information presented in sections E.8.3.and E.8.4, as applicable.

  1. In F.4.1, click in the free text field and include details of the planned number of subjects to be included in the Member State to which the application is submitted (up to six numerals).
    2. Note: F.4.2.1 and F.4.2.2 should not be answered if the clinical trial takes places in a single country (i.e. E.8.5 and/or E.8.6.1 are answered 'No'.).
  2. In F.4.2.1, click in the free text field and include details of the planned number of subjects to be included in the EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein. (including the concerned Member State) in toto (up to six numerals).
  3. In F.4.2.2, click in the free text field and include details of the planned number of subjects to be included in the entire world (up to six numerals).
If the above steps are completed, including mandatory fields. the subsection is complete.

Now complete section F.5, as outlined below. Click on the blue heading to expand the subsection, and expand the below heading for further step-by-step instructions.

F.5 Post trial treatment details

Identify any planned patient treatment or care, post Clinical Trial.

  1. Click in the free text field and include details of post-trial treatment or care, if not already provided in the protocol (up to 500 characters).
    2. Add Content in Another Language:
    • Click the Add icon button to add text in another language than English.
    • Then click Choose language drop-down imageto select the language you wish to add content in.
    • Click delete icon if you add a field in error, or if you wish to delete a previously added language translation.
If the above steps are completed, including mandatory fields. the subsection is complete.

Now complete section F.5, as outlined below. Click on the blue heading to expand the subsection, and expand the below heading for further step-by-step instructions.

When all five sections are completed (in any order), click and you return to the Clinical Trial Application Menu. Once the entire section is completed to your requirements, including all sub-sections, it is suggested you move to the next section ("G. Clinical Trial Sites/Investigators in the Member State").

See Clinical Trial Application Menu Overview for more detailed information.

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