Section D.8 Placebo Information

Task topic including steps necessary for completing Section D.8 PlaceboA placebo is a control product that does not contain an active substance (a dummy treatment) that is given to people taking part in a Clinical Trial. Information of a Clinical Trial Application draft.

Include details on all the placebos that will be used in the course of the Clinical Trial.

Now click on the section headings below if more detailed information is required.

Add Placebo

Steps for adding a placebo to the Clinical Trial Application:

  1. Click 'Add Placebo' to add information on a placebo to be used in the Clinical Trial.
  2. Once you have entered the placebo information (using "D.8 Information on the Placebo " below), click 'Done' and the Placebo details table appears:
  3. Later, you may edit or delete placebos from the Placebo Details table in section D.8.

  4. Click 'Return' to return to the Clinical Trial Application Menu.

The required placebo information is added to the Clinical Trial Application.

Now go to the Clinical Trial Application Menu Overview for more detailed information.

D.8 Information on the Placebo

Once 'Add Placebo'.is selected the D.8 Information on the Placebo screen appears.

  1. Click the drop-down list, then select the Route of Administration of the placebo to be used in the Clinical Trial.
  2. In D.8.5, click the check box beside the IMPAcronym: Investigational Medicinal Product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a Clinical Trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. that the placebo you are entering information for is related to. This allows placebos to be added to Clinical Trials containing multiple IMPs. Once selected, other IMPs move down the screen.
  3. In D.8.5.2 click the relevant radio button to indicate whether the placebo is identical to the IMP (aside from the absence of the active substance).
    4. Note: This is a MANDATORY FIELD and if it is 'Yes', D.8.5.2.1 should be completed.
  4. In free text field D.8.5.2.1, specify any other major ingredients in the placebo if D.8.5.2 was marked 'Yes'.
The section is now complete. Click 'Done' to return to the D.8 Placebo Information page, with the Placebo Details table in situ.

Now go to the Clinical Trial Application Menu Overview for more detailed information.

D.8 Placebo Information Details

Once placebo information is added the Placebo Information Details table appears on D.8 Placebo Information page:

You may edit or delete placebos from the Placebo Details table in section D.8.

Now go to the Clinical Trial Application Menu Overview for more detailed information.

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