CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 32     4. Total study duration (anticipated starting/finishing dates). 5. Duration for each subject including post treatment period etc. Total Number of Sites and Number of Indian Sites Total number of trial sites with list of countries/geographical areas and number of sites in India. List of Investigators Qualified Investigators at each Indian site. Sample Size Rationale and calculation for sample size requirement, anticipated drop-out rate etc. The sample determination may include H0 testing and desired power of the study. Patient Population Description of specific characteristics of the trial participants (e.g. disease/stage/indication/conditions/treatment etc.) as applicable and of diagnostic criteria and assessment. Inclusion Criteria Enumeration of conditions determining participation in the proposed clinical trial. Exclusion Criteria Enumeration of conditions determining participation in the proposed clinical trial. Drug Formulation Brief description of the study drug(s) and formulation to be used in the clinical trial. The relationship to the formulations used in the preclinical and/ or other
Guidance for Industry Central Drugs Standard Control Organization Page 33   clinical trials should be delineated, as applicable. This may also include disclosures of the formulation intended to be marketed and/or any bridging studies which may be necessary, planned, initiated and/or already [performed if different formulations have been used during clinical development. Dosage Regimen Rationale for dose selection Description of the schedule(s) for using the study drug(s) including escalations/maintenance/reductions/discontinuation, as applicable. Description of other supportive measures and dose modifications for specific adverse events (anticipated toxicities), as applicable. Washout Period Description for pre-, during- and post-trial, as applicable. Pre-study Screening and Baseline Evaluation Description of the process of clinical validation for participation in the clinical study, including methodology/schedule of events. Treatment/Assessment Visits Schedule of all events/visits/procedures during the clinical study. Concomitant Medication Enumeration and description of all-/allowed drug/medications, in addition to the study drugs. Rescue Medication and Risk Management Description of available supportive measures/antidotes/ dosages/procedures (including follow-up) used to help reverse untoward effects or lack of efficacy resulting from any applications of drug(s)/procedures in connection with the clinical trial.  
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  © Central Drugs Standard Contr
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