1. STUDY MANAGER Tina Noonan Director of Clinical Research Administration Office of Clinical Research Indiana University School of Medicine

2. WHAT IS STUDY MANAGER? Study Manager is software purchased by the IU School of Medicine for use, free of charge, by any School faculty and staff. Study Manager is a comprehensive system which enables you to closely track your clinical trials, including patient tracking, recruitment, enrollment status, and financials.

3. Study Manager promotes better management of all clinical research studies, from the simplest to the most challenging protocols, including those that involve multi- site, multi-arm and multiple visit cycles. Using Study Manager, you can schedule patients, create budgets, and much more. Study Manager is very flexible, and can be as detailed as you need it to be.

4. Start by building a protocol...adding visits...

5. ... and procedures...

6. ...and your budget is automatically built for you

7. Then switch to the Patients Module, and add patients to the study

8. Study Manager can generate a checklist of all procedures to use during your patient’s visit...

9. View completed visits and enrollment status of all your study’s patients.

10. Study Manager uses the patient visit information to do the finances for you, automatically calculating how much the sponsor owes you.

11. Study Manager provides a convenient and easy-to-use reporting mechanism so you can extract any data you need for your study, from patient lists to financial reports.

12. SCHOOL OF MEDICINE MINIMUM REQUIREMENTS FOR REGISTERING CLINICAL RESEARCH IN STUDY MANAGER

13. What research studies should be entered into Study Manager? Only studies with the following attributes are required to be entered into Study Manager: –Externally funded –Awarded July 1, 2007 or after, and –Fit the NIH "clinical research" definition

14. NIH Clinical Research Definition Research which falls into one of the following categories: (1) Patient-oriented research. Research conducted with human subjects (or on a material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that strictly utilize human tissue. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services. Be sure to note the underlined exclusion.

15. At what point in the grant preparation/submission/award process should the required fields be entered in Study Manager? Data entry should be done at the time of award (upon receipt of the Award Digest from Contracts & Grants) [NOTE: If you are using Study Manager for clinical trial budget preparation, you will have already entered the required data.]

16. What fields are required to be entered? Study ID Protocol # (if applicable) Sponsor CRO (if applicable) Title Start Date Patient Quota (if applicable) Length of Study (in months) Therapeutic Area (Department/Division) IRB Approval Date IRB Study Number Total Direct Costs Total Indirect Costs Investigator Study Site

17. How much time will it take to enter a study? Based on our experience, users should be able to enter the required fields in less than 5 minutes. Most data entry is done on one screen, and that screen takes just 2 clicks to access once the user has signed into Study Manager

19. How do I get access to Study Manager? Group training sessions are scheduled monthly These are one-day sessions, but to train exclusively on the required fields, the user only needs to attend approximately the first hour of the session Call Karen Best at 8-5850 to register for one of the group sessions.

20. Can the Office of Clinical Research enter this data for me? YES! We will enter the data for anyone who uses the Office of Clinical Research’s budget development service. Call Jean Mercer at 8-5843 for more information about the budget development service.

21. Who will have access to the information entered in Study Manager? Study Manager’s easy-to-use reporting mechanism will be accessible at all levels with the School of Medicine, depending on assigned rights –Each unit will be able to see and report on their unit’s data; each investigator will be able to see and report on his/her own data Data is stored on a secure School of Medicine server, and access rights are limited

22. What computer hardware or software is required to access Study Manager? Study Manager is a web-based program, and can be accessed from any non-Mac computer running Internet Explorer. No special software or hardware is necessary. Access information, including user-id and password, is provided after the user successfully completes the initial Study Manager training.

23. If you’d like more information … Just call me at 278-5802 - or - E-mail me at tnoonan@iupui.edutnoonan@iupui.edu ANY QUESTIONS?