Module 9 Records & Reporting Flashcards
Records & Reporting
When is financial information submitted to the FDA
When a marketing application is submitted
What term describes any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices that exceeds 50k during the investigation and for one year after completion
Equity Interest
T/F
When reporting financial information of a clinical investigator financial information of the spouse and each dependent child of the investigator must also be included.
TRUE
A subject of a research study is a passenger in a car involved in a car crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the ER. What should the investigator do when they learn of the crash?
Report adverse events of both the broken wrist and concussion to the sponsor according to the timetable specified in the protocol.
Subject 311 has had elevated WBC counts for the past 2 study visits with no clinical signs or symptoms. “Increased WBC count” is not listed in the investigator’s brochure (IB) as an adverse event. The investigator should ___
Report the elevated WBC to the sponsor as an unexpected adverse event.
During administration of an investigational drug, events occurred such as subject 603 unexpected sx requiring hospitalization, 415 c/o nausea relieved by otc med.
An IND safety report is filed by the sponsor with the FDA for observations associated with subject ___
Subject 603 only
According to FDA regulation, how long must an IRB retain records
3 years after completion of the research
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system is a ___
CLOSED system
An environment in which system access is not controlled by persons who are responsible for the content of electronic records is a ___
OPEN system
What are the two main objectives of FDA audits and inspecitions
- ensuring human safety & protection
- verifying data accuracy
When a signature is based on cryptography methods of originator authentication it is a ___
Digital signature
What’s the difference between a digital signature and electronic signature
a digital sig secures a document
an electronic sig verifies the document.
Which signature carries a user’s information along with electronic signature
Digital
Which signature does not contain any authentication attached to them
Electronic
According to ICH E6 GCP, an “audit” is defined as a ___ & ___ examination of trial-related activities and documents
systematic & independent
Steps taken for an FDA Inspection at an investigative site (6)
- investigator notified & date chosen
- FDA investigator presents picture ID and notice of inspection (Form FDA 482)
- Preliminary meeting
- Interviews of key personnel.
- inspection of study records
- exit interview, issuance of summary of observations (Form FDA 483)
What is
Form FDA 482
notice of inspection
What is
Form FDA 483
issuance of summary of observations
T/F
The PI is ultimately responsible for record keeping and retention.
TRUE
The overall goal of monitoring, audits, and activities is to
ensure the protection of human research subjects and data integrity
T/F
Research misconduct is defined as falsification, fabrication or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
TRUE
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system is ___
an electronic record
T/F
If the FDA has disqualified an institution the determination letter will be made available to the public.
TRUE
The FDA defines a trend as a trend of 1.___ items. if it was just a one-time item and it was corrected, the FDA may consider is a 2.___. However, if there is a trend, you receive a written finding called a 3.___
- 3
- observation
- 483 report
T/F
Clinical trial material (drug/device) can be thrown away at the end of the study by the site without notifying the sponsor.
FALSE
