IVRS INTERACTIVE VOICE RESPONSE SYSTEM IWRS INTERACTIVE WEB RESPONSE SYSTEM 4.

PROCESSES ARE CONTROLLED BY A CENTRAL COMPUTER ACCESSED via TELEPHONE (Interactive Voice Response, IVR) and WEB (Interactive Web Response,IWR) INTERFACES. VERY USEFUL IN GLOBAL TRIALS 5. USES REGISTER NEW PATIENTS RANDOMISE PATIENTS OBTAIN DOUBLE BLIND MEDICATION FOR RANDOMISED PATIENTS RECORD PATIENT SPECIFIC VISIT INFORMATION ORDER OPEN LABEL OR RUN IN MEDICATION BLINDING 6. Uses contd TO UNBLIND PATIENTS IN A MEDICAL EMERGENCY ORDER DUPLICATE REGISTRATION OR MEDICAL DISPENSING FAXES 7. Automated Supply Chain Management Automated site and depot medication inventory control Management of complex dispensing protocols, e.g.titration studies Dose calculation Help to ensure patient compliance 8. Patient Recruitment Technology Is your next patient a phone call away? Study-specific pre-qualification IVR interview No requirement for the services of a call center Complete multinational / multilingual capabilities Compliant with Data Protection regulations Simple to add new countries and centers mid-study Suitable for many patient populations and indications 9. Patient Recruitment Technology ADVANTAGES: Reduces the recruitment period Cost-effective solution Simple to administer over multinational / multilingual studies Increases site efficiency by increasing the throughput of eligible patients at site Lowers the screening failure rate and the associated cost of screening failures Real-time reporting 10. Randomization and Medication Management Do you know where your supplies need to be? Automated Supply Chain Management 11. Randomization Definition: The random allocation of treatments to patients or subjects in order of their enrollment into the study (per site), in order to produce comparable groups. 12. Randomization Types Simple by site Blocks for the whole study & blocks allocated to sites Stratification Block : A sequential set of randomization that consist of an equal number the investigational product and the comparator If block size = 6, Treatment A and Treatment B used in study Randomization numbers 1 to 6 are allocated - 3 Treatment A, 3 Treatment B 13. Randomization Stratification used when a marked variation expected in the study population with respect to response to medication related to age, sex, severity of disease etc. Gaurav Sharma Informed Consent Signed Stratification > 50 years old < 50 years old Active Active Placebo Placebo Randomisation Randomisation 14. Blinding Types of Blinds Open label Both Investigator, patient aware of the treatment Single blind Only one party blinded Double blind Both parties are blinded Observer blind Person making assessments is blinded Gaurav Sharma 15. Blinding Advantages of Double Blinding Investigator cannot choose treatment for a patient Opinions of patient and investigator do not influence outcome Additional care will not be different Endpoint not influenced by treatment knowledge Gaurav Sharma 16. Methods of Blinding Gaurav Sharma Matching Double Dummy Treatment A Treatment B Treatment A Treatment B Active Placebo Active Placebo

17. Gaurav Sharma 18. Gaurav Sharma 19. Electronic Patient Reported Outcomes Have you heard from your patients lately? Real-Time Data Capture Patient reported outcomes data are becoming increasingly important in clinical trials and regulatory submissions. In some therapy areas these represent primary efficacy data, and in many may influence drug labelling. Gaurav Sharma 20. Electronic Patient Reported Outcomes These data include symptom diaries, objective self-report measurements, health service utilization, quality of life and treatment satisfaction assessments. Many studies have identified concerns over the use of paper diaries and questionnaires, criticizing their limitations on data quality and integrity. Gaurav Sharma 21. Electronic Patient Reported Outcomes IVR represents a simple alternative to paper that offers significant improvements in data quality. Gaurav Sharma 22. Diary Compliance Assurance Because subject data are captured directly onto IVRS robust and secure central database, systems can identify all subjects that have missed, or may be at risk of missing, a scheduled diary entry. These patients may need additional encouragement to maintain the study diary entry schedule. Gaurav Sharma 23. Diary Compliance Assurance Methods to enhance patient diary compliance: Investigational site contact 1. Automated fax or email reports are dispatched to study site personnel identifying those subjects requiring contact. 2. Timely contact by site staff is successful in providing patient encouragement and enhancing diary compliance. Gaurav Sharma 24. Diary Compliance Assurance Trained local-language outbound operators provide reminder calls to consenting subjects identified at risk of missing a diary entry. This may be especially valuable in therapy areas where patient motivation is particularly low, or where the required compliance is very high. Gaurav Sharma 25. Unblinding When On study completion To manage a medical emergency Method Use of coded envelopes 24-hour phone line Gaurav Sharma 26. Unblinding Requirements of unblinding process provides only individual patient treatment code Unblinding detectable Non-concealable or seal-able Easy identification Quick Gaurav Sharma 27. Gaurav Sharma 28. After the site is selected, the site is registered into the global IVR system chain i.e., a specific number/code is allotted to the study at the particular site. This is further explained to all the study personnel during the initiation meeting. Then when you log on to the IVR/IWR system you will be able to get access to the system. Gaurav Sharma 29. PROCEDURE COMPLETE THE WORKSHEET BEFORE CALLING DIAL THE APPROPRIATE TELEPHONE NUMBER OF THE COUNTRY YOU WILL GET A WELCOME MESSAGE NEXT YOU WILL BE ASKED TO ENTER THE PROTOCOL NUMBER,THE COMPOUND NUMBER, CENTER NUMBER Gaurav Sharma 30. Procedure contd. ONCE YOU HAVE ENTERED THE INFORMATION YOU WILL BE TAKEN TO THE STUDY OPTIONS MENU THIS WILL BE TAILORED TO INDIVIDUAL STUDY REQUIREMENTS LISTEN CAREFULLY AND RESPOND TO THE PRE-RECORDED MESSAGES USE YOUR WORKSHEET TO GUIDE YOU THROUGH THE TELEPHONE CALL Gaurav Sharma

38. IVRS+ EDC Automated real-time data exchange between EDC and ClinPhone systems Randomization and dispensing data shared by both systems Protocol-specific integration touch points Data may originate in either system IVR patient diary data automatically populates eCRF Eliminates need for re-keying data and discrepancy resolution Gaurav Sharma 39. Gaurav Sharma 40. Interactive Web Response Wouldnt two routes into a study be better than one? Both interfaces interact simultaneously with the same computer engine and databases that direct and record study processes. This means that study sites can choose to utilize the most convenient and appropriate interface for a particular study. System audit trail, backup and support is independent of the mode of system access. Gaurav Sharma