CCA Cheat Sheet 2026

The 30 highest-yield CCA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Under ICH E6(R2), who bears ultimate responsibility for the quality and integrity of the trial data? → The sponsor
2. What is the function of CATO's 'Application Analytics' report in data management? → To identify which SaaS and web applications consume the most bandwidth and sessions
3. Who is ultimately responsible for the conduct of a clinical trial at an investigative site? → The Principal Investigator (PI)
4. What step follows data lock in a clinical trial? → Statistical analysis
5. What document captures the agreement between the sponsor and the investigative site regarding financial compensation and obligations? → Clinical Trial Agreement (CTA)
6. What is the primary focus of Good Clinical Practice (GCP)? → Protect participants and ensure data quality
7. A CRO contracted by a sponsor defaults on its GCP obligations. Ultimate regulatory responsibility for trial quality remains with: → The sponsor
8. Which ICH E6(R2) principle requires that the investigator be qualified by training and experience to conduct the clinical trial? → Principle 4
9. What document accompanies each shipment of investigational product (IP) to a clinical site? → Drug shipment manifest / packing slip
10. A company receives goods under a Temporary Importation under Bond (TIB). What is the standard period allowed before the goods must be re-exported or destroyed? → 1 year, extendable to 3 years
11. In CATO's network analytics, what does 'Throughput' measure on a site-level report? → The volume of data (bits per second) passing through the site's connection
12. Which regulatory body in the European Union evaluates Marketing Authorization Applications (MAA) for centralized approval? → EMA (European Medicines Agency)
13. Which regulatory document must be in place at the site BEFORE any subject can sign the informed consent form? → IRB/IEC approval of the consent form
14. Which document describes the preclinical and clinical data on an investigational product to guide safe use in a clinical trial? → Investigator Brochure
15. Which term refers to the complete set of standard operating procedures, instructions, and specifications for conducting a clinical trial? → Quality Management System
16. When reviewing CATO's Top Destinations report, what insight does this provide to an administrator? → The most frequently accessed external IP addresses or domains by users
17. Which document outlines the rights, safety, and well-being protections for clinical trial participants and must be reviewed by an IRB/IEC before a trial begins? → Informed Consent Form
18. Which CATO report would an administrator use to identify which users are consuming excessive network bandwidth? → Top Users by Traffic
19. A sponsor is conducting a decentralized clinical trial (DCT) with remote visits. GCP requires that source data captured remotely must be: → Attributable, legible, contemporaneous, original, and accurate (ALCOA)
20. The ICH E6(R2) addendum introduced which major new concept to strengthen GCP oversight? → Risk-based quality management (QRM)
21. In CATO's Single Pane of Glass, what is the primary purpose of the Analytics dashboard? → To provide unified visibility into network traffic, security events, and user activity
22. In clinical trial operations, what does 'SUSAR' stand for? → Suspected Unexpected Serious Adverse Reaction
23. Which form must a US-based investigator complete and sign to participate in an FDA-regulated clinical investigation of an investigational drug? → FDA Form 1572 (Statement of Investigator)
24. Which ICH guideline provides the framework for clinical safety data management and expedited reporting of adverse drug reactions? → ICH E2A
25. A Phase II clinical trial is primarily designed to: → Assess preliminary efficacy and dosing in patients with the target disease
26. Who at an investigative site is responsible for assessing causality of adverse events to the investigational product? → The Principal Investigator or qualified sub-investigator
27. Which GCP guideline specifically governs statistical principles for clinical trials, complementing ICH E6? → ICH E9
28. When analyzing CATO event logs, what does the 'Source IP' field typically represent in a security event? → The IP address of the device or user initiating the connection
29. What is the purpose of CATO's 'Threats' dashboard in the management console? → To provide a real-time summary of detected security threats across the network
30. Why must informed consent be obtained before trial participation? → To ensure voluntary, informed participation