Page 230 - eBook Version 8 Book 1 of 2 JUL 2022

Levels of Reporting July 24, 2020
RESEARCH REPORTING
FDA must make a decision to grant
permission to allow industry to market ? IP. This decision is informed by careful
review of adverse events & participant
data.
The IRB must register with the FD A and fulfill the CFR and GCP requirements .
21 CFR 56.108, .109 & GCP E6
Sponsor must have full knowledge of the required data in order to analyze the results of the study and fulfill FDA’s reporting regulations. 21 CFR 312.32, .33 & 21 CFR 812 Subpart G
What Gets Reported Where?
Institution (CHST)
Regulatory UTSW IRB
Sponsor
FDA
Study Team→ EDC (per sponsor)
All→SafeLink
Study Team→eIRB
Sponsor →FDA
Serious Events
Serious Adverse Events
All Participant Data
S/AEs
Serious Adverse Events
Deviations
S/AEs
Annual Report
Unusual Events
Violations
Concomitant Meds
New Findings
Sentinel Events
Safety Briefings
Site Updates
Protocol & IB Amendments
Research Adverse Events (Research AE email)
Protocol & IB Amendments
Enrollment/Screening
Study Team Updates
Unanticipated Problems
Unanticipated Problems
Unanticipated Problems
Unanticipated Problems Page 2 of 4
Children’s Health is committed to patient safety and quality of care. Ongoing efforts are made to improve processes and reduce potential for harm. Accurate reporting is essential t o the commitment to quality.