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HELLO EVERYONE. I'M MARJORIE GOOD, MARGE GOOD. I'M A NURSE CONSULTANT WITH THE DIVISION OF CANCER PREVENTION WITHIN NCI. I'M A NURSE CONSULTANT WORKING WITH NCI GRANT FUNDED COMMUNITY BASED RESEARCH PERHAPS OF WHICH -- PROGRAMS OF WHICH THERE ARE ABOUT 46 ACROSS TUESDAY, ONE IN PAT RILEY. AND I ACTUALLY CAME FROM A COMMUNITY BASED PROGRAM WHICH HAS REALLY HELPED ME WITH THIS NEW ROLE TO HELP NEW SITES COMING ON BOARD. I WAS WITH THE PROGRAM IN WICHITA, KANSAS ACTUALLY, AND DID THE WORK FOR OVER 20 RATHER, MANAGED THE RESEARCH PROGRAM THERE WHICH WAS QUITE BUSY AND ACTIVE. WE USUALLY AVERAGE BETWEEN 600 AND 800 PATIENTS ENROLLED ION CLINICAL TRIALS IN A YEAR'S TIME. SO WE WERE BUSY. WE WERE HEAVY INVOLVED IN CLINICAL RESEARCH. WITH THAT, I CAME AWAY WITH A LOT OF KNOWLEDGE THAT I LIKE TO SHARE WITH AS MANY AS POSSIBLE. SO TODAY IS ONE OF THOSE EFFORTS TO LET YOU KNOW A Little MORE DATA MANAGEMENT AND THE DEVELOPMENT OF CASE REPORT FORMS. I KNOW THERE IS A VARYING DEGREE OF EXPERTISE AS WELL JOB ROLES. I THINK THAT WE'LL BEEN PARTICIPATING IN THIS TRAINING. Furthermore, I TRIED TO BASE THIS AROUND THAT, WITH THAT IN MIND. SO SOME IT MAY SEEM REALLY BASIC AT A OTHERS, AND MAYBE A Little ABOVE STANDARDS FOR OTHERS AS WELL. SO I'M HAPPY TO TAKE QUESTIONS AT THE END. TODAY, I HOPE WE CAN DISCUSS THE IMPORTANCE OF THE PROPER DATA COLLECTION EFFORTS, IDENTIFY TYPES OF DATA CLOTHED, LIST POTENTIAL SOURCE DOCUMENTS FOR THAT DATA COLLECTION. NAME KEY FACTORS TO CONSIDER DURING CASE REPORT FORM DEVELOPMENT. THINGS THAT ARE IMPORTANT TO CONSIDER WHEN YOU DEVELOP -- AND I ADDED MORE INFORMATION FROM MY LAST INFORMATION AS A REQUEST OF Some COMMENTS AFTER THE PRESENTATION SO HOPEFULLY THAT ADDITIONAL INFORMATION WILL BE FORMATIVE AS WELL. I WANT TO COVER WHAT CONSTITUTES A POORLY DESIGN CASE REPORT FORM. HOPEFULLY IT WILL INFORM YOU NOT TO GO DOWN THAT ROAD. THEN WE WANT TO TALK ABOUT DATA MANAGEMENT ITSELF, QUITE LARGE. WITHIN THAT, IT'S GOING TO -- I LIKE TO REVIEW THE AUDIT PROCESSES THEMSELVES, DESCRIBE THAT FIRST EVENT REPORTING AND DESCRIBE LIGHTLY ON REGULATORY REQUIREMENTS FOR DATA COLLECTION. THE USE OF DATA IS VERY, VERY IMPORTANT. DATA ANALYSIS AND REPORTING, ACTUAL CAPTURING OF THE DATA IS WHAT INFORMS THE ANALYSIS AND THE REPORTING, THE PUBLICATION THAT GOES ON AFTER THE STUDY IS COMPLETED. IT'S A METHOD OF TRACKING THE PATIENT OR SUBJECTS. USED FOR FDA SAFETY MONITORING. IT'S USED IN NEW DRUG APPLICATION SUBMISSIONS, SPORTS THOSE LABELING CLAIMS FOR NEW DRUGS THAT ARE GOING THROUGH THE FDA PROCESS. REVIEWED BY DATA SAFETY MONITORING BOARDS TO ASSESS THE TRIAL'S SAFETY AND ONGOING ACTIVITY. IT'S USED IN PUBLICATIONS AND MEDICAL JOURNALS, AND DEFINITELY HELPS TO INFORM FUTURE DEVELOPMENT OF TRIALS. SO THE ACTUAL DATA MANAGEMENT REPORTING, THE OUTCOMES OF THE CLINICAL TRIAL ARE DEPENDENT ON THIS DATA COLLECTED, NEEDS TO BE COLLECTED CREATE LY IN A TIMELY MANNER AND NEEDS TO BE VERIFIABLE. THOSE ARE THE KIND OF THINGS WE'RE GOING TO TALK ABOUT. IT...
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