clinial trail documentation ppt M pharm pharmacology

clinical trail documentation

1. Dr Rajendra Gode Institute of Pharmacy , Mardi road Amravati Subject: Clinical research and Pharmacovigilance Topic: Clinical Trial Documentation Guided by : P.A. Chandurkar (Assistant Professor) Presented by: Mansi. P. Nikhade M pharm ( 1 st year ) 1

2. Content Clinical study Report Clinical trial monitoring Safety monitoring in clinical trial 2

3. Clinical Study Report Introduction : Report: It is a document that summarizes all the incidences and facts that occurred at a given point of time, places or situation. Clinical Trial: A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment. 3

4. Cont… A Clinical Study Report (CSR) is one of many types of regulatory documents that comprise a marketing application for a drug, biologic, or device. A CSR is a descriptive account of a single clinical trial accompanied by tables, listings, and figures displaying all study data and results. CSR is an extensive and complete document which has to be submitted for obtaining a marketing authorization of IMP to the European Union or the US. 4

5. ICH E3 Guidelines for clinical study Report Structure of a full Clinical Study Report according to the International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for Human Use (ICH E3) guideline. Title Page Synopsis Table of Contents List of Abbreviations and Definitions of Terms Ethics Investigators and Study Administrative Structure Introduction Study objective Investigation plan 5

6. Study patients Efficacy evaluation Safety evaluation Discussion and overall conclusion Tables ,figure and grapes referred to but not included in the text Reference list Appendices 6

7. Section 1.Title Page Study Title Name of test drug/investigational product Studied indication, study design Sponsor name and address Dates of initiation, early termination, termination, completion of the study Completion name and address of Principal Investigator 7

8. Section 2. Synopsis: Synopsis summarizes the study in brief. Table o Section 3. table of contents for the individual clinical study report. This section contains the table include summary tables, figures and graphs. Section 4. List of Abbreviations: This section in a list of abbreviations Section 5. Ethics: Independent Ethics Committee Patient information and consent 8

9. Section 6. Investigator and administrative structure contain The administrative structure of the study, Principal investigator, Coordinating investigator, Monitoring and evaluation committees, Statistician, Central laboratory facilities, Contract research organization (C.R.O.) 9

10. Section 7.0. Introduction contains Context of the development of the test drug/investigational product. Relating the critical features of the study to that development. Section 8.0-Study Objectives A statement describing the overall purposes of the study should be provided. Section 9.0-Investigational plan Section 9.1-Overall study design and plan Description Treatments studied (specific drugs, doses and procedures) Patient population studied and the number of patients to be included Section 9.2 Discussion on study design and choice of control groups. The specific control chosen and the study design used. Section 9.3- Selection of Study Population 9.3.1 Inclusion Criteria 9.3.2 Exclusion Criteria 9.3.3 Removal of patients from therapy or assessment Section 10

11. Section 9.4- Treatments 9.4.1 Treatment administered The precise treatments or diagnostic agents to be administered in each arm of the study, for each period of the study, route and mode of administration, dose and dosage schedule. 9.4.2 Identity of Investigational Product A brief description of the test drug(s) /investigational product(s) (formulation, strength, batch number(s) 11

12. Section 10.0- Study Patients Section 10.1 - Disposition of Patients Clear accounting of all patients who entered the study. The numbers of patients who were randomized, who entered and completed each phase of the study, (or each week/month of the study) Reasons for all post-randomization discontinuations , grouped by treatment and by major reason (lost to follow-up, adverse event, poor compliance etc.). Section 10.2 - Protocol Deviations All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment and their impact on analysis. 12

13. Section 11. Efficacy Evaluation 11.1 Data Sets Analyzed 11.2 Measurements of treatment compliance 11.3 Efficacy results and tabulations of individual patient data Section 12. Safety Evaluation Extent of exposure (dose, duration, number of patients) Most common adverse events, laboratory test changes etc. Serious adverse events and other significant adverse events 13

14. Section 13. Discussion And Overall Conclusions The efficacy and safety results of the study and the relationship of risks and benefit. Section 14. Tables, figures and graphs referred to but not included in the text 14.1 Demographic Data : Summary figures and tables 14.2 Efficacy Data : Summary figures and tables. 14.3 safety data summery figure and tables Section 15: Reference list A list of articles from the literature pertinent to the evaluation of the study Copies of important publications should be attached in an appendix Section 16: Appendices This section should be prefaced by a full list of all appendices available for the study report 14

15. Clinical trial Monitoring Introduction Monitoring The act of overseeing the progress of a clinical trial , and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP, and any regulatory requirements". Monitoring Reports A written report form the monitor to the sponsor after each site visit and other trial related communication according to the sponsor SOPs. 15

16. Purpose of Monitoring Protection of rights and wellbeing of human participants. Ensure consent in place for record access. Trial data are accurate, complete and verifiable from source documents. Qualities of a good Monitor Appropriately trained, Adequate scientific and/or clinical knowledge. - Documented with training logs and CVs. Thoroughly familiar with: - IMP Protocol - Consent form - Sponsor & trial SOPs GCP Knowledge of local laws, regulations, customs & local language. 16

17. Types of Monitoring in Clinical Trials Trial Management Group- TMG; This should include individuals responsible for day to day management of the trial such as principal investigator, statistician, trial coordinator, research nurse, data management personnel etc. Trial Steering Committee- TSC; Which provides overall supervision of the trial and ensures it is being conducted as per regulatory requirements and GCP Good Clinical Practice. The committee monitors the progress of a trial including data completeness and ensures there are no major deviations. 17

18. Participant in Monitoring of Clinical Trial Participant in monitoring of clinical trial is the CRA Clinical Research Associate and other members including the project manager, medical monitor, data manager and statistician. 18

19. Project Manager- responsible for overall implementation of trial ; oversee progress of trial; global trial communications; reporting to regulators, budget and cost control. Medical Monitor- individual with expertise in trial related therapeutic area; involved in protocol developments, safety reporting, interpretation of data and clinical findings. Data Manager- generate data queries to ensure quality of data ; maintain ongoing data entry; monitor data analysis and provide reports. Statistician- analysis of data provide reports for data safety monitoring board DSMB 19

20. Monitoring Process Before Monitoring visit Review the status of data entry Review action item from last visit Review regulatory binder. During Monitoring visit Site, Staffing, research labs or other facilities. Regulatory files and study records Any problems and issues After Monitoring visit Complete site visit report Submit the report to the sponsor 20

21. Safety Monitoring in Clinical Trail Introduction Monitoring patient safety during clinical trials is a critical component throughout the drug development life cycle. Pharmaceutical sponsers must work proactively and collaboratively with all stakeholders to ensure a systemic approach to the safety Monitoring. 21

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23. Sponsors Clinical trials sponsor, usually pharmaceutical companies, are responsible for developing the clinical trial protocol . The protocol describes every aspect of the research, including the rationale for the experiment, objectives, trial populations with detailed inclusion and administration of the investigational therapies, trial procedures, data collection standard, endpoint and sample size. 23

24. Subjects Subject are patients or healthy volunteers who agree to participate in a Clinical trial and have signed. Other information provides important safety information so the subjects can make an informed decision on whether to participate in a trial. Investigators Investigators are qualified individuals who are trained and experienced to provide medical care to subjects enrolled in the clinical trials. Investigators identify potential subjects and educate them about the trial participation to ensure that can make an informed decision. They are responsible for notifying their institutional review boards and the sponsor of any issues during that Safety and subjects. 24

25. Thank you 25