Acronyms
GCP
What is Good Clinical Practice?
Paper Record
What is protocol deviation log?
PI
Who is responsible for reviewing all deviations and determining if they are IRB reportable?
Additional information given within the requested timeframe
What is something the IRB may request?
Taking vitals 2 minutes outside of protocol-allowed window
What is not IRB Reportable?
CIRB
What is Central Institutional Review Board?
Electronically
What is OnCore, REDCap, Excel, etc.?
Completes the deviation report in ERICA
Who is the PI AND the Study Coordinator?
"Serious Non-Compliance" and/or
"Continued Non-Compliance"
What are the determinations the IRB can make?
Administration of incorrect IP
What is definitely IRB Reportable?
ERICA
What is Electronic Research Integrity and Compliance Administration (program)?
What is regulatory requirement, GCP principle, or protocol procedure that was not followed?
48 Hours
What is the amount of time you have to report a serious deviation to the PI?
The risk to study participants' safety, rights or welfare, or had an effect on the integrity of the scientific data
What is the IRB evaluating the deviation report for?
Repeated minor deviations
What is IRB reportable?
CFR
What is Code of Federal Regulations?
Corrective Action
What is detail describing any corrections made?
10 Business Days
How long does the PI have from the date of when the deviation was identified to report it to the IRB?
Should be retained in the study records
What is the IRB deviation reports and supporting documents?
Enrollment of a subject that does not meet all inclusion criteria
What is ... it depends?
CAPA
What is Corrective and Preventative Action?
What is date of deviation, identification of the study, subject ID, study visit, the date the deviation was identified, and identity of the individual recording the information?
IRB Reporting Requirements
1. Intended to eliminate apparent immediate hazard
2. Caused possible harm to participants or others
3. Possible serious or continued non-compliance
The study is using a CIRB
What is following the deviation reporting requirements of that IRB?
Failure to obtain informed consent prior to performing protocol-related tests or procedures
What is ... it depends?