(a) The sponsor should ensure that it is specified in the protocol or other documented agreement that the investigator(s)/institution(s) provide direct access to source records for trial-related monitoring, audits, regulatory inspection and, in accordance with applicable regulatory requirements, IRB/IEC review.
(b) The sponsor should ensure that trial participants have consented to direct access to source records for the purposes outlined in 3.16.4(a) (see section 2.8.10(n)).