Forms Flashcards
Who signs the 1572?
The investigator
What is the purpose of the 1572?
It is an agreement from the investigator that they will comply with FDA Regulations regarding clinical trials utilizing a new drug or agent
TRUE OR FALSE: The 1572 is completed at the end of a trial
FALSE, the 1572 is completed at the beginning of a trials timeline
This form is a certification that there are no financial interests and/or arrangements to disclose
3454 form
What is the 3455 form?
the investigator’s disclosure of significant financial interest and arrangements
TRUE OR FALSE- The 3500 form is for mandatory reporting of serious adverse events
FALSE- the 3500 form is for voluntary reporting of adverse events & product problems
When would a 3500A form be utilized?
when a serious adverse event needs to be reported
Case report form
paper or electronic document records of protocol required information to be sent to the sponsor
Where does the data for case report forms come from?
source documents
when can a case report form be used as source documents?
When first recordings were done on the CRFs
What is an investigator agreement form?
a form that can be used instead of the 1572 for medical device studies.
What is an IDE in a clinical trial?
a regulatory submission that permits an investigational device to be used in a clinical study in order to collect safety and effectiveness data.
