Documentation Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Documentation flashcards as text
What is the primary purpose of maintaining a Trial Master File (TMF) in a clinical trial?
Answer: To provide documented evidence of trial conduct and regulatory compliance
The TMF serves as the definitive collection of essential documents that provides documented evidence that the clinical trial was conducted in accordance with GCP, applicable regulations, and the protocol.
How long must essential clinical trial documents typically be retained after the formal discontinuation of a drug's clinical development?
Answer: At least 2 years
ICH-GCP guidelines state that essential documents should be retained for at least 2 years after the last approval of a marketing application or after formal discontinuation of clinical development of the investigational product.
Which document must be signed before a sponsor can ship investigational product to a clinical trial site?
Answer: Clinical Trial Agreement (CTA) and regulatory approval
Before investigational product can be shipped to a site, both a Clinical Trial Agreement and the appropriate regulatory approval (such as IRB/IEC approval and regulatory authority authorization) must be in place.
What is a source document in the context of clinical trial documentation?
Answer: An original document, data, or record where clinical findings are first recorded
Source documents are original documents, data, and records where clinical findings, observations, or other activities in a clinical trial are first recorded. They include hospital records, clinic charts, laboratory notes, and subject diaries.
Which section of the Investigator's Brochure (IB) contains information about the known and potential risks of the investigational product?
Answer: Summary of Data and Guidance for the Investigator
The Summary of Data and Guidance for the Investigator section provides an overall discussion of nonclinical and clinical data, including known and potential risks and anticipated adverse events to help the investigator manage subjects appropriately.
What is the purpose of a delegation log in a clinical trial?
Answer: To document the study staff authorized to perform specific trial-related duties
The delegation log (also called the delegation of authority log) identifies all persons authorized by the principal investigator to perform significant trial-related duties and specifies those duties.