CCRA exam question with 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
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
