IRB BASICS BETTY WILSON, MS, CIP

CONCEPTS SUBMISSION APPROVAL RECRUITING WORKING WITH PRINCIPAL INVESTIGATOR (PI) /SPONSOR POLICIES DEVIATIONS RECORD STORAGE CONTACTS

KNOW YOUR WAY AROUND E-COMPLIANCE USE THE LATEST APPROVED DOCUMENTS: CONSENT ASSENT HEALTH INSURANCE PORTABILITY & ACCOUNTABILITY ACT (HIPAA) AUTHORIZATION PROTOCOL CLINICAL INVESTIGATIONAL DRUG BROCHURE (CIBD)

KNOW YOUR WAY AROUND E-COMPLIANCE KNOW WHAT WAS SUBMITTED KNOW WHAT IS APPROVED BE ABLE TO LOCATE STUDY INFORMATION ATTEND A CLASS ON NAVIGATING!

KNOW THE PROTOCOL! WHY? ESSENTIAL FOR SUBMITTING TO THE IRB KNOWING WHAT SHOULD BE DONE/WHEN AVOID DEVIATIONS

SUBMISSION TO THE IRB ENSURE ITEMS MATCH – PROTOCOL, CONSENT, AND APPLICATION ADDRESSES THE QUESTION ASK THE SPONSOR QUESTIONS! CLINICAL TRIALS NUMBER IND/IDE NUMBERS CLARIFICATIONS ON PROCESS ASK THE PRINCIPAL INVESTIGATOR! CHECK COI FOR ALL STUDY TEAM MEMBERS

MOST COMMON ERRORS ITEMS DO NOT MATCH: ENROLLMENT NUMBERS STUDY TESTS SIDE EFFECTS RESPONSE DOES NOT ANSWER THE QUESTION COVERAGE FOR STUDY RELATED COSTS

MOST COMMON ERRORS ROLES IN CONSENTING: AUTHORIZED PARTICIPATE NON-CONSENTING SCOPE OF PRATICE AND STUDY ACTIVITES

COMMON ERRORS DATA SAFETY AND MONITORING: CHECK THE PROTOCOL FOR DATA SAFETY MONITORING BOARD KNOW THE PROTECTIONS FOR THE DATA AND SUBJECTS

NUMBER OF SUBJECTS CONSIDERATIONS: SCREEN FAILURE RATE POPULATION LENGTH OF STUDY BUILD INTO APPLICATION

SUBMISSION WORKING WITH MULTIPLE TRACKS:  COVERAGE ANALYSIS (CORPORATE COMPLIANCE)  INSTITUTIONAL REVIEW BOARD (IRB)  OFFICE OF SPONSORED PROGRAMS ADMINISTRATION (OSPA)

KNOW WHAT IS APPROVED REVIEW WHAT WAS SUBMITTED! INCOMPETENT SUBJECTS NON-ENGLISH SPEAKING RECRUITMENT STUDY TESTS AND PROCEDURES NUMBER OF SUBJECTS READ THE APPROVAL LETTER! PARENTAL CONSENT (1 OR 2) REVIEW CYCLE/STUDY EXPIRATION

RECRUITMENT FINDING THE SUBJECTS: I2B2 REDCAP ADVERTISEMENTS ENROLLING THE RIGHT SUBJECTS: RETENTION COMPLIANCE

MEDICAL RECORD PLACE COPY OF CONSENT IN MEDICAL RECORD WHEN APPROPRIATE POWER TRIALS: TURN ON WHEN SUBJECT IS ENROLLED TURN OFF WHEN SUBJECT IS COMPLETED

CLINICAL TRIALS. GOV SPONSOR IS RESPONSIBLE FOR MULTI CENTER SPONSORED STUDIES INVESTIGATOR INITIATED THE STUDY TEAM IS RESPONSIBLE DEADLINES CONTACT CORPORATE COMPLIANCE FOR ASSISTANCE

COMMUNICATION ASK THE SPONSOR QUESTIONS COMMUNICATE WITH THE PI SHOULD KNOW WHAT IS SUBMITTED SHOULD REVIEW ALL DOCUMENTS/FORMS HAS THE FINAL SAY IS ULTIMATELY RESPONSIBLE

COMMUNICATION HAVE A PLAN/MECHANISM FOR COMMUNICATING AS A TEAM!

KNOW THE POLICIES! POLICES ON OUR WEBSITE: LOOK UP THE RULE CALL OUR OFFICE SPONSOR POLICIES

DEVIATIONS AND UNANTICIPATED EVENTS RECOGNIZE/SUBMIT DEVIATIONS AND UNANTICIPATED PROBLEMS REVIEW CASE REPORT FORMS IN REAL TIME CHECK SOURCE DOCUMENTATION TO ENSURE ALL INFORMATION IS COLLECTED AND ACCURATE! CHECK LAB RESULTS AND RADIOLOGY TEST

COMMUNICATE WITH OTHER DEPARTMENTS ENSURE DEPARTMENTS KNOW THE RESEARCH PROTOCOL SCHEDULING LABORATORY /PATHOLOGY RADIOLOGY INFUSION CLINICS BILLING COMPLIANCE

DEVIATIONS AND UNANTICIPATED EVENTS DO NOT WAIT FOR THE MONITOR TO REPORT TO THE IRB SPONSORS MAY HAVE DIFFERENT RULES

DEADLINES AMENDMENTS – 30 DAYS MONITORING REPORTS – 7 DAYS DEVIATIONS/UAE- 5 DAYS

RECORD KEEPING E-COMPLIANCE IS NOT A RECORD STORAGE SYSTEM FOR STUDY DOCUMENTS KNOW RECORD RETENTION REQUIREMENTS

CONTACTS CORPORATE COMPLIANCE: BILLING COMPLIANCE COVERAGE ANALYSIS CLINICAL TRIALS. GOV INSTITUTIONAL REVIEW BOARD SUBMISSION RENEWAL DEVIATIONS OFFICE OF SPONSORED PROGRAM ADMINISTRATION: ALL GRANTS/CONTRACTS QUESTIONS AND PROCESSES INVOICING THE SPONSOR

WHEN IN DOUBT CALL!