Presentation on theme: "Please Be Sure That You Have Your Audience Response Keypad With You This Morning. You Will Need It During This Session."— Presentation transcript:
Please Be Sure That You Have Your Audience Response Keypad With You This Morning. You Will Need It During This Session
How Many Electronic CRF Trials Have You Done? A. Only One B. 2-3 C. More than 3
What Other EDC Systems Have You Used? A. Datatrak B. e-trials C. Medidata D. Datatrak and e-trials E. e-trials and Medidata F. All three G. None of the Above
Which is the Easiest / Preferred System? A. Datatrak B. e-trials C. InForm D. Medidata E. Other System F. No Preference
Which is the Most Difficult System To use? A. Datatrak B. e-trials C. InForm D. Medidata E. Other System
Do You Prefer an Electronic CRF of Paper CRF? A. Electronic CRF B. Paper CRF
Clinical trials principles dictate that complete ascertainment of the primary endpoint gives the optimal chance of proving the objective. In the IMPROVE IT Trial, the primary endpoint is a composite of CV death, MI, UA, Stroke, and Revasc. If the subject withdraws from the trial and all visits, what happens in the ITT analysis? A.The subject is removed from the database and replaced with another subject who completed the entire trial. B.The subject is only analyzed in the safety analyses. C.The subject is analyzed up to the time of study withdrawal. D.The subjects data present at the time of study withdrawal is used for the remaining months of the trial in the analysis.
How should subjects be routinely managed to prevent study withdrawal? A.Schedule appointment and send reminder to the subject within 7 days. B.Schedule appointment at the end of the follow-up window to maximize the use of the study drug in the bottles (avoid waste). C.Schedule appointment and notify subject of date and time within 3 weeks of appointment. D.Maintain close contact with subject in between visits, schedule appointment when convenient for subject (be flexible), call to remind.
When is the best time to let the monitor know of a subject who is not available for follow-up? A.At the end of the trial B.After the subject has missed 1 visit C.After the subject has missed 2 visits (8-12 months) D.After the Research Team has performed all the suggested steps on the Lost to Follow Up Checklist form
If a subject expresses concern that she will not be available for the appointment within the time window and therefore wishes to finish their participation in the trial, what should the RC do? A.Communicate to the subject the need to stay on study drug. Make arrangements for the subject to see another MD in the practice B.Agree that the subject has participated for most of the study and it would be OK to finish. Continue phone contact for endpoints C.Skip that appointment and call the subject when (s)he is available.
What is the goal of Getting with the Guidelines – (GWTG)? A.To get MDs to prescribe ASA to CAD patients. B.To reduce bleeding rates to an acceptable level. C.To reduce death/disability of CHD/stroke by 25% by 2010. D.To illustrate to insurance companies that the optimal treatment is being given to the patient.
The GWTG is based on: A.The MDs personal experience. B.Evidence based medicine. C.The type of treatment options that are available: (PCI, CABG, nuclear equipment). D.Individual hospital survey.
Which one of the following is NOT a GWTG Performance Measure for Cardiovascular Disease? A. A.Perform PCI before hospital discharge B. B.Smoking Cessation Counseling C. C.ACE-I / ARB for LVSD on discharge D. D.Lipid lowering therapy on discharge
What characteristics are associated with statin use at hospital discharge? A. A.Renal insufficiency B. B.Age >60 yrs C. C.Absence of diabetes D. D.Measuring LDL in hospital
In following your IMPROVE-IT subjects do you discuss: A. A. Cessation of smoking B. B. Healthy food choices C. C. Increase physical activity D. D. All of the above
If a subject complains of persistent but mild headaches and wishes to come off study drug, what should the RC do? A. A.Agree and let patient know that it is possibly due to the study drug B. B.Acquire more information from patient, review con meds, and discuss w/PI the most likely reason for headaches C. C.Inform the patient there is nothing that can be done by that the patient should stay on study drug D. D.Give Tylenol to the patient
The PI is very busy with his/her private practice and does not have time to commit to IMPROVE-IT. What steps should the RC undertake? A. A.Perform trial tasks / responsibilities on his/her own. B. B.Seek support from the TIMI Hotline for questions. C. C.Participate in a meetings with PI to review specific areas where help / support is needed. D. D.Abandon efforts to recruit subjects
If You Are Attending the Monitor Training Session Take Your Audience Response Keypad With You. If You Are Not Attending the Monitor Training, Please Turn In Your Keypad IMMEDIATELY Following This Session at the Registration Tables.
Participant Scores 1100 Jose Saaibi 1000 Jose Nicolau 987.83 Virginia Dawney 986.55 Sebastian Nani 964.18 María Cademartori