Monitoring plan General outline of the monitoring plan to be followed, including access to source data and the extent of source data verification planned. 1.7 Statistical considerations With reference to 1.5 and 1.6, the description of and justification for:— (a) statistical design, method and analytical procedures; (b) sample size; (c) the level of significance and the power of the clinical investigation; (d) expected drop-out rates; (e) pass or fail criteria to be applied to the results of the clinical investigation; (f) the provision for an interim analysis, where applicable; (g) criteria for the termination of the clinical investigation on statistical grounds; (h) procedures for reporting any deviation from the original statistical plan; (i) the specification of subgroups for analysis; (j) procedures that take into account all the data; (k) the treatment of missing, unused or spurious data, including dropouts and withdrawals; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 185 of 248 (1) the exclusion of particular information from the testing of the hypothesis, if relevant; and (m) in multicenter clinical investigations, the minimum and maximum number of subjects to be included for each center. Special reasoning and sample size(s) may apply for the early clinical investigation(s), e.g. feasibility clinical investigation(s).