CCRA EXAM LATEST QUESTIONS AND ANSWERS
What is 21 CFR 812?
IDE
What is 21 CFR 600?
Biological Products
What is 21 CFR 11?
Electronic Records
What is 21 CFR 50?
Informed Consent
What is ICH E6: 8
Essential Documents
What is the purpose of maintaining study document and records?
Insure compliance; dealing with safety of patient, things have to be written down
What are source document?
First place data is written
What are case report forms?
Provides format for collecting protocol-required data
What is a Confidentiality Agreement?
Sponsor can protect information, don't want the researcher to disclose information
What is FDA 1572?
Legal contract between FDA and the investigator for investigational drug studies
What is the device equivalent of form FDA 1572?
Investigator Agreement or a Statement of Investigator
What law requires a CV for PI?
21 CFR 312; 21 CFR 812
What is the Financial Disclosure Certification (absense of financial interest) form?
Form 3454
What is the Financial Disclosure form for stating financial interest?
Form 3455
How long must the sponsor disclose financial interests?
One Year
How long must the sponsor maintain records after approval of the marketing
application?
2 years
Why is it important to have a Delagation of Authority Log?
Whoever is doing that specific treatment is trained; who is allowed to do what at each
site
Product safety information : adverse events, and is made available to each
investigator and routinely update. Which of the following regulatory documents
contains this information?
Investigator's Brochure
What is 21 CFR 812?
IDE
What is 21 CFR 600?
Biological Products
What is 21 CFR 11?
Electronic Records
What is 21 CFR 50?
Informed Consent
What is ICH E6: 8
Essential Documents
What is the purpose of maintaining study document and records?
Insure compliance; dealing with safety of patient, things have to be written down
What are source document?
First place data is written
What are case report forms?
Provides format for collecting protocol-required data
What is a Confidentiality Agreement?
Sponsor can protect information, don't want the researcher to disclose information
What is FDA 1572?
Legal contract between FDA and the investigator for investigational drug studies
What is the device equivalent of form FDA 1572?
Investigator Agreement or a Statement of Investigator
What law requires a CV for PI?
21 CFR 312; 21 CFR 812
What is the Financial Disclosure Certification (absense of financial interest) form?
Form 3454
What is the Financial Disclosure form for stating financial interest?
Form 3455
How long must the sponsor disclose financial interests?
One Year
How long must the sponsor maintain records after approval of the marketing
application?
2 years
Why is it important to have a Delagation of Authority Log?
Whoever is doing that specific treatment is trained; who is allowed to do what at each
site
Product safety information : adverse events, and is made available to each
investigator and routinely update. Which of the following regulatory documents
contains this information?
Investigator's Brochure
