Which is the best way to see site variability in eligibility screening?
Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:
When a data manager runs a report on resolution types of discrepancy status, which of the following wouldNOTbe a part of resolution types?
An external organization has been hired to manage SAE follow-up for a large study. Which of the following would be used as guidance for exchange of the SAE data between the EDC system and the vendor's safety management system?
The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?
Based on the project Gantt chart as of 01 Nov 2019, an interim analysis is scheduled to occur early Q2 of 2020. All of the following are valid for initially assessing the status of data cleanliness EXCEPT:
What does 21 CFR Part 11 dictate in regards to a minimum expectation of EDC training prior to access?
An organization is using an international data exchange standard and a new version is released. Which of the following should be assessed first?
Which is the MOST appropriate flow for EDC set-up and implementation?
Which protocol section most concisely conveys timing of data collection throughout a study?