ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

data, the co mmittees’ procedures, timing and activities should be described in the protocol or a separate document.

B.9

Assessment of Safety

B.9.1

Specification of safety parameters.

B.9.2

The methods, extent and timing for recording and assessing safety parameters. Where any trial-related committees (e.g., IDMC) are utilised for the purpose of assessing safety data, procedures, timing and activities should be described in the protocol or a separate document.

B.9.3

Procedures for obtaining reports of and for recording and reporting adverse events.

B.9.4

The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.

B.10

Statistical Considerations

B.10.1

A description of the statistical methods to be employed, including timing and purpose of any planned interim analysis(ses) and the statistical criteria for the stopping of the trial. The number of participants planned to be enrolled and the reason for the choice of sample size, including reflections on or calculations of the power of the trial and clinical justification.

B.10.2

B.10.3

The level of significance to be used or the threshold for success on the posterior probability in a Bayesian design.

B.10.4

The selection of participants to be included in the planned analyses, a description of the statistical methods to be employed and procedures for handling intercurrent events and accounting for missing, unused and spurious data. These should be aligned with the target estimands, when defined (see ICH E9(R1)).

B.10.5

Statement that any deviation(s) from the statistical analysis plan will be described and justified in the clinical trial report.

B.11

Direct Access to Source Records

The sponsor should ensure that it is specified in the protocol or other documented agreement that the investigator(s)/institution(s)/service provider(s) will permit trial-related monitoring, audits, regulatory inspection(s) and, in accordance with applicable regulatory requirements, review by the institutional review board/independent ethics committee (IRB/IEC), providing direct access to source records.

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