OpenLegislation

Division 15 The protocol shall be identified by:

United Kingdom

Original text. Later amendments are not shown.

  1. (a)

    the title of the clinical trial;

  2. (b)

    the EU trial number;

  3. (c)

    the sponsor's protocol code number specific for all versions of it (if relevant);

  4. (d)

    the date and number of the version, to be updated when it is amended;

  5. (e)

    a short title or name assigned to the protocol; and

  6. (f)

    the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.