Event Types
Documentation
Definitions
Pharmacovigilance
General
100
An ER MD just admitted a subject in your trial for your PI Dr. Smith with intractable headache is this a serious or non serious event
Serious -meets SAE criteria- Hospitalization
100
A PI has a subject who has a significant adverse event. What documentation must the PI do?
PI must document in medical record, AE section of E-CRF, & complete SAE form and fax to GPV within 24 hours
100
What is AESI stand for & define it
AESI =Adverse Event of Special Interest -Events called out by trial team that may be non serious events by themselves but the team wishes to track their occurrence and has them come in as SAE
100
Does GPV send follow up to PIs after they send in SAEs? Does this sometimes include questionnaires?
Yes they do this. They have event driven questionnaires so sometimes a PI will get letter and questionnaire and sometimes will just get letter
100
Your at a cocktail party and your friend realizes you work at BI and says, my grandmother took Spiriva and she ended up in hospital with MI and stayed for 5 days. Is this an AE? What do you have to do?
It is a SAE and you have to report it to GPV by the next business day. Event= MI, Reporter=your friend, patient=grandmother, product/drug=Spiriva
200
You receive a call from a new CRA and she states that the site coordinator said a subject came in with a headache. Is this serious or non serious event?
Non serious
200
A subject advises a PI that they just found out they are pregnant and were hospitalized over the weekend for dehydration. What documentation must the PI do in this situation?
PI must complete Preg Monitoring Form side A sign and send to GPV within 24 hours & complete SAE form, document in medical record SAE, & AE portion of ECRF. PI will have to stop IMP and follow subject till delivery then complete Preg Monitoring Form side B sign and send to GPV within 24 hours
200
Implied Serious List- define this
A list of event that BI as a company has decided to capture always as serious events regardless of circumstance of report
200
What is the timeline for a Life Threatening Event to go to the FDA?
7 days
200
Is it true that the reporting clock for BI notifying the FDA starts when ever any BI agent, vendor, or PI hears of the event?
Yes this is true
300
A CML tells you that GPV just received a report of AESI. Should this case be serious or non serious?
Adverse Events of Special Interest ( AESI) are always come in as serious events
300
Is it true that PIs have to indicate on SAE form whether they feel SAE is causally related to IMP, con meds, & study design?
Yes they document this on the SAE form
300
DEDP? What does it stand for?
Drug Exposure During Pregnancy?
300
Is it the CRAs responsibility to be asking the sites when they see overlapping events?
Yes this is CRA responsibility
300
What is the timeline for GPV getting 7/15 day reports to PI & central IRBs?
15 days
400
The site coordinator calls you and says subject 56 was seen in ER and sent home. Is this a serious or non serious event?
Non-serious no serious criteria met as pt discharged from ER
400
A PI had just completed the Informed Consent Process with a subject and they signed consent. The subject fell down the outside stairs of PI office and broke both legs and is being admitted to hospital. What documentation if any does this PI need to do?
Once consent is signed AE report recording begins. PI will document in med record, AE section of E-CRF, & complete SAE form & fax to GPV within 24 hours. **Once consent is signed AE capture begins**
400
What is a Significant event?
A significant event is an event that trial team has list in protocol as an event that must come in as a Serious Event. Typically significant events are lab values such as liver enzymes (ALT/AST/BILI)
400
Can a CRA, CML, & MRA complete a SAE form for a site?
No
400
Is a drug exposure during pregnancy and SAE/AE?
No it is not an SAE or AE
500
The PI called you and said he just saw subject 300 for very mild case of rhabdomyelosis and that is on the Always Serious/Implied Serious List. Is this a serious or non-serious event?
Serious (Implied Serious List/Always Serious List) has to be treated as serious AE
500
A PI is seeing male subject on visit 8 and he advises his wife just found out she is pregnant. Does the PI need to document anything about this?
PI needs to complete Preg Monitoring Form and obtain information about subjects wife and sign and fax to GPV within 24 hours. The PI will follow pregnancy and after delivery the PI will fill out Preg Monitoring Form side B and sign and fax to GPV within 24 hours.
500
What is ICSR?
Individual Case Safety Report new terminology GPV is utilizing
500
What form does the PI utilize to capture DEDP?
What is Pregnancy monitoring form
500
What is the timeline to get a Pregnancy Monitoring Form into GPV?
Within 24 hours
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