6.4 Trial Design

The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include:

6.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.

6.4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.

6.4.3 A description of the measures taken to minimize/avoid bias, including:

(a) Randomization.

(b) Blinding.

6.4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s).

6.4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.

6.4.6 A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial.

6.4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.

6.4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes.

6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.