- Title Page: This page should contain information about the title of the study, the protocol code, name of the investigational product tested, development Phase, indication studied, a brief description of the trial design, the start and end date of patient accrual and the names of the Sponsor and the participating Institutes (Investigators).
- Study Synopsis (1 to 2 pages): A brief overview of the study from the protocol development to the trial closure should be given here. This section will only summarise the important conclusions derived from the study.
- Statement of compliance with the Good Clinical Practices Guidelines:
- List of abbreviations and definitions:
- Table of contents:
- Ethics Committee: This section should document that the study was conducted in accordance with the ethical principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and dates of approvals of trial documents for each of the participating sites should be provided. A declaration should state that Ethics Committee (EC) notifications as per Good Clinical Practice Guidelines and Ethical Guidelines for BiomedicalResearch on Human Subjects, issued by Indian Council of Medical Research have been followed.
- Study Team: Briefly describe the administrative structure of the study (Investigators, site staff, Sponsor or designates, Central laboratory etc.).
- Introduction: A brief description of the product development rationale should be given here.
- Study Objective: A statement describing the overall purpose of the study and the primary and secondary objectives to be achieved should be mentioned here.
- Investigational Plan: This section should describe the overall trial design, the Subject selection criteria, the treatment procedures, blinding or randomisation techniques if any, allowed or disallowed concomitant treatment, the efficacy and safety criteria assessed, the data quality assurance procedures and the statistical methods planned for the analysis of the data obtained.
- Trial Subjects: A clear accounting of all trial Subjects who entered the study will be given here. Mention should also be made of all cases that were dropouts or protocol deviations. Enumerate the patients screened, randomised, and prematurely discontinued. State reasons for premature discontinuation of therapy in each applicable case.
- Efficacy evaluation: The results of evaluation of all the efficacy variables will be described in this section with appropriate tabular and graphical representation. A brief description of the demographic characteristics of the trial patients should also be provided along with a listing of patients and observations excluded from efficacy analysis.
- Safety Evaluation:
- This section should include the complete list
- all serious adverse events, whether expected or unexpected and
- unexpected adverse events whether serious or not (compiled from data received as per Table 5 of this Schedule).
- The comparison of adverse events across study groups may be presented in a tabular or graphical form. This section should also give a brief narrative of all important events considered related to the investigational product.
- This section should include the complete list
- Discussion and overall Conclusion: Discussion of the important conclusions derived from the trial and scope for further development.
- List of References:
- Appendices: List of Appendices to the Clinical Study Report
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