D.9 Site(s) where the qualified person certifies batch release

This section is used to identify IMPs and placebos which:

• Have a Marketing AuthorisationThe approval granted by the Regulatory Authority to market a specific product in a particular country. (MAAcronym: Marketing Authorisation) in the EUAcronym: European Union. and
• Are sourced from the EU market and
• Are used in the trial without modification (e.g. not over-encapsulated) and
• The packaging and labelling is carried out for local use only as per article 9.2. of the Directive 2005/28/ECAcronym: European Commission (GCPAcronym: Good Clinical Practice Directive).

1. If all the above conditions are met, click the tick box (D.9.2).
2. In the 'Finished 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.' table directly beneath D.9.2 select the IMPs and placebos which meet the above criteria.
3. Click to return to D.9 Site(s) where the qualified person certifies batch release.

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

This section requires the addition of sites and individuals required to certify a batch release for the Clinical Trial.

1. In D.9.2.1 and D.9.2.2 (which is one field), click the drop-down list, then select the Responsible Site Role from the list of options.
2. In D.9.2.3 click in the free text field and enter the name of the organisation responsible of the product release for its use in the concerned clinical trial (up to 120 characters).
3. Now enter the full address for the site responsible for the product release in D.9.2.4.1 to D.9.2.4.4
4. Click in the free text field D.9.2.5 and enter the manufacturer's authorisation number (up to 100 characters).
   Note: If there is no manufacturing authorisation number but the site is authorised — enter 'Site authorised' — this is applicable in some Member States (e.g. Germany) where no manufacturing authorisation number is issued.
5. In D.9.2.5.1, click in the free text field and enter the reasons why an authorisation was not given (up to 500 characters), if applicable.
6. Click 'Next' to advance to the 'Finished IMP' table. To select the IMPs and placebos which are to be certified as part of the batch release for the Clinical Trial, click the check box under 'Associate' check.

Click 'Return' to return to the Clinical Trial Application Menu. See Clinical Trial Application Menu Overview for more detailed information.

Once responsible site information is added the 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 Details table appears on D.9 Site(s) where the qualified person certifies batch release page:

You may edit or delete responsible sites from the Responsible Sites Details table in section D.9.