Practice Test Geeks(SOCRA) Society of Clinical Research Associates Practice Test
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Essential Study Documents Flashcards

7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. What is the Trial Master File (TMF)?

    Answer: A collection of essential documents that individually and collectively permit evaluation of the conduct of a trial

    The TMF is the complete collection of essential documents that allows reconstruction of the trial, demonstrating compliance with GCP and regulatory requirements.

  2. Who is responsible for maintaining the Investigator Site File (ISF)?

    Answer: The principal investigator and site staff

    The principal investigator and site study team are responsible for maintaining the ISF (also called the Investigator's File or Regulatory Binder) at the investigative site.

  3. According to the DIA TMF Reference Model, documents are organized by:

    Answer: Study phase, zone, section, and artifact

    The DIA TMF Reference Model organizes documents into a hierarchy of zones, sections, and artifacts to provide a standardized TMF structure across the industry.

  4. During a regulatory inspection, the inspector requests immediate access to the TMF. The sponsor's TMF is electronic. What must the sponsor be able to demonstrate?

    Answer: That the eTMF system is validated, audit trails are intact, and documents are legible and complete

    For an eTMF, sponsors must demonstrate system validation, intact audit trails, document legibility, and completeness to satisfy regulatory inspection.

  5. Which ICH E6 GCP section specifically addresses essential documents and what they should demonstrate?

    Answer: Section 8 — Essential Documents for the Conduct of a Clinical Trial

    ICH E6 GCP Section 8 specifically addresses essential documents and organizes them by the three trial phases: before, during, and after clinical trial conduct.

  6. An essential document is filed in both the sponsor's TMF and the investigator's site file. Which statement is true?

    Answer: Both copies must be maintained because each party has independent regulatory obligations

    ICH E6 requires both the sponsor and investigator to maintain their respective files independently, as each has separate regulatory obligations for trial documentation.

  7. After a clinical trial is completed, how long must the sponsor retain essential documents according to ICH E6?

    Answer: At least 2 years after the last approval of a marketing application, or at least 2 years after formal discontinuation

    ICH E6 requires sponsors to retain essential documents for at least 2 years after the last approval of a marketing application or 2 years after formal discontinuation of clinical development.