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.
B.10.2 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.10.3 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.12.2 Summary of the monitoring approaches that are part of the quality control process for the clinical trial.
B.12.3 Description of the process for the handling of noncompliance with the protocol or GCP.
B.13 Ethics
Description of ethical considerations relating to the trial.
B.14 Data handling and record keeping
B.14.1 Specification of data to be collected and the method of its collection. Where necessary, additional details should be contained in a clinical trial-related document.
B.14.2 The identification of data to be recorded directly into the data acquisition tools (i.e., no prior written or electronic record of data) and considered to be the source record.
B.14.3 A statement that records should be retained in accordance with applicable regulatory requirements.
Financing and insurance, if not addressed in a separate agreement.
Publication policy, if not addressed in a separate agreement.