FDA Forms Flashcards
FDA Form 482: Notice of Inspection FDA Form 483: Inspectional Observations FDA Form 1572: Statement of the Investigator FDA Form 3454: Certification – Financial Interests and Arrangements of Clinical Investigators FDA Form 3455: Disclosure – Financial Interests and Arrangements of Clinical Investigators FDA Form 3500: For Voluntary Reporting of Adverse Events and Product Problems FDA Form 3500A: For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting
What is FDA Form 482?
Notice of Inspection
– Issued by the FDA to notify a site that an inspection will occur.
What is FDA Form 483?
Inspectional Observations
– Lists concerns or issues found during an FDA inspection that may violate regulations.
What is FDA Form 1572?
Statement of the Investigator
– A contract between the investigator and the FDA ensuring the investigator will follow the protocol and regulations for clinical trials.
What information is included in FDA Form 1572?
- Investigator’s qualifications.
- Site information.
- Protocol details.
- Institutional Review Board (IRB) details.
- Commitment to comply with GCP guidelines.
What is FDA Form 3454?
Certification – Financial Interests and Arrangements of Clinical
Investigators – Certifies that no financial conflict of interest exists for investigators.
What is FDA Form 3455?
Disclosure – Financial Interests and Arrangements of Clinical
Investigators – Used when a financial conflict of interest exists and must be disclosed.
What is FDA Form 3500?
For Voluntary Reporting of Adverse Events and Product Problems
– Allows healthcare professionals, consumers, and patients to voluntarily report issues with FDA-regulated products.
What is FDA Form 3500A?
For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting
– Required for certain groups to report adverse events, product problems, or device issues as mandated by law.
Why are these FDA forms important?
They ensure regulatory compliance, promote transparency, and protect participant safety in clinical research and product monitoring.
