Adverse Events
Which study-specific document defines what is reportable as an adverse event?
The Protocol
In which room is BIN 7 located?
I-306
According to FDA Regulation Title 21 Section 312.50 who is responsible for selecting qualified investigators and providing them with the information they need to conduct an investigation properly?
The sponsor of the study.
True or False?
Deviations range in seriousness according to how the changes may impact subject safety, the degree of noncompliance with federal and state regulations, and the degree of foreknowledge of the event
True
You’re entering dosing information into the database and one of the fields requests the drug lot number.
IDS pharmacy (email is preferred)
Who is responsible for submitting Serious Adverse Events (SAE) reports?
Clinical Research Coordinators
How far in advance are monitors instructed to schedule visits?
4 weeks
What is the acceptable method for making a correction to a document used in a clinical trial?
Single line through the wrong information, write in correct information, and date/initial correction
True or False?
Anticipated changes to a protocol should always be reported prior to the event occurrence unless an immediate change is necessary to protect subject safety.
True
You’re working on an oral study, and need drug diaries and accountability/pill counts.
Research nurse
Who is delegated to attribute AEs to an investigational product?
The Principal Investigator (or Sub-I)
What is the time frame after a visit within which a monitor should send a follow-up letter?
2 weeks
According to ICH GCP (an)_______ is a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s SOPs, GCP, and applicable regulatory requirements.
Audit
Select the best answer
Who makes the final determination whether or not an identified deviation is reportable?
i.The Principal Investigator
ii.The IRB
iii.The RN and IRB only
iv.The DM, regulatory and the IRB
v.Both i and ii
i
All deviations from the protocol must be reviewed by the Principal Investigator and a determination made as to the seriousness of the event (i.e., if it meets the IRB definition of a major or minor event).
You’re missing an ECG tracing
Does the protocol use a study specific ECG machine?
•Yes – Contact Biofluids Core Lab
•No – If ECG is done by heart station, tracings can be printed from EPIC
Which CTCAE term (including Grade) would be defined by a Hemoglobin level of 9.5?
Grade 2 Anemia
What PIN must a monitor enter to obtain a visitor badge?
"No PIN" should be selected
What is the FDA regulation that pertains to electronic records and signatures ( ## CFR Part ##)?
According to the regulation an electronic signature must be _____ and shall not be reused by, or reassigned to, anyone else.
21 CFR Part 11; unique
Events that qualify as a Major Deviation must be reported to (1.)______ as an Unanticipated Problem within (2.)___ working days of the investigator knowledge of the event
Events that qualify as a Minor Deviation should be recorded and logged by clinical research staff as they occur. These events are then summarized and reported to the IRB (3.)_____ as part of the continuing review process
1. The IRB
2. 10 working days
3. Anually
You’re submitting a SARF for a monitor visit next week and need the IRB approval letter
–Check AURA (https://aura.uchicago.edu/)
–Regulatory manager
Per the CTCAE, what is the “general guideline” definition for a Grade 3 AE? (at least 2 points required)
-Severe/Medically Significant, but not immediately life-threatening.
-Hospitalization or Prolongation indicated
-Disabling/limiting self-care.
When are appointments available with IDS for monitors?
Monday-Thursday, 1:30-3:30pm
According to ICH GCP what is the minimum number of members an IRB must have? How often does our IRB meet?
5; twice a month
While reviewing a subject’s medical record, you see a note from your research nurse saying the subject is complaining of grade 1 nausea, but no attribution is provided.
Providers (PI/treating MD/sub I) are delegated to provide drug attributions.