Section 23: Trial master file and archiving
consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.
23. Trial master file and archiving
(1) Every sponsor shall keep a trial master file for a clinical trial in respect
of which he holds a trial licence.
(2) A sponsor shall make the trial master file readily available at all reasonable times for inspection by the Council or any person appointed by the
sponsor to audit the arrangements for the clinical trial.
(3) The trial master file shall at all times comprise documents which—
(a) enable both the conduct of the clinical trial and the quality of the
data produced to be evaluated;
(b) show whether the clinical trial has been conducted in compliance
with—
(i) this Act and regulations made under it; and
(ii) the guidelines referred to in section 4 (f); and
(c) contain information specific to each phase of the clinical trial.
(4) A sponsor shall keep, for not less than 15 years after the completion
of a clinical trial, the trial master file which shall be—
(a) readily available at all reasonable times to the Council; and
(b) complete and legible.