Records
9.—(1) The responsible body must keep a written record for each notifiable adverse outcome in respect of which the candour procedure is followed.
(2) The record required by paragraph (1) must include every document and piece of correspondence relating to the notifiable adverse outcome, including but not limited to—
(a)records of notifications given under regulations 4, 5 and 6,
(b)records of attempts to contact the relevant person,
(c)any decision by the relevant person not to be contacted in relation to the candour procedure, and
(d)all documentation relating to the investigation and review of the notifiable adverse outcome undertaken by the responsible body, including any responses or interim reports issued by the responsible body under regulation 24, 26 or 31 of the 2011 Regulations.