Protocol ppt
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This document outlines the components of a research protocol, including: general information about the study team and sponsor; background information on the topic; objectives and purpose; trial design; selection and withdrawal of subjects; treatment methods; assessment of efficacy and safety; statistical analysis; ethics considerations; data handling; and a project timetable. A research protocol provides the plan and guidelines for a clinical trial, clarifying the research question, compiling existing knowledge, formulating hypotheses and objectives, and deciding on study design and ethical issues. It serves to guide the research team and provide structure for the clinical project.
Protocol ppt
- 1. PROTOCOL Presented by; Aiswarya . A. T, First year M.Pharm, Department of Pharmacy Practice, Grace college of Pharmacy.
- 2. A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. The protocol contains a study plan on which the clinical trial is based.
- 3. Why a protocol? To clarify the resear ch questi on To compil e existin g knowl edge To formula te a hypoth esis and objecti ves To decide about a study design To clarify ethical consid eration s To apply for fundi ng To have a guideline and tool for the research team
- 4. 1. General Information Protocol Sponsor Persons authorized to sign the protocol Sponsor's medical expert Investigator Clinical laboratory and other medical & technical departments & institutions involved in the trial.
- 5. 2. Background Information Investigational product Summary of findings from nonclinical studies Risks and benefits Description GCP Population References to literature and data that are relevant
- 6. 3. Trial Objectives and Purpose Hypothesis Primary Objectives Secondary Objectives Potential Risks and benefits
- 7. 4. Trial Design Endpoints Type/design of trial to be conducted a) Randomization. b) Blinding Trial treatment Duration of subject participation Stopping rules" or "discontinuation criteria Accountability procedures
- 8. 5. Selection and Withdrawal of Subjects Subject inclusion criteria Subject exclusion criteria Subject withdrawal criteria
- 9. 6. Treatment of Subjects Treatment Medication permitted and not permitted before/during the trial Procedures for monitoring 7. Assessment of Efficacy 8. Assessment of Safety
- 10. 9. Statistics Statistical methods Criteria for the termination level of significance Procedure for accounting for missing, unused, and spurious data. Procedures for reporting any deviation Selection of subjects
- 11. 10. Direct Access to Source Data / Documents 11. Quality Control &Quality Assurance 12. Ethics Approval Informed consent Patient withdrawal / discontinuation. Trial monitoring.
- 12. 13. Data Handling and Record Keeping 14. Financing and Insurance Funding source Conflict of interest Subjects’ payment Cover for managing adverse events
- 13. 16. Project timetable/ Flowchart 17. References 18. Supplements/ Appendices
Editor's Notes
- #4: Study design – causal relationship between exposure and outcome is relevant Ethical considerations - in new TB drugs I still need to cure the patients Order is not relevant