QA is conducting an audit on a study for ophthalmology which is ready for lock. Inconsistencies are found between the database and the source. Of the identified fields containing potential data errors, which fields are considered critical for this particular study?
Which of the following is a best practice for creating eCRFs for a study?
A CRF was approved by the Sponsor and development of a clinical database has been started according to the data management plan. What is the next responsibility of the Data Manager?
A study collects blood pressure. Which is the best way to collect the data?
A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1."
Which of the following is missing from the definition?
During an inspection to determine appropriate documentation for use of a computerized system, what SOP might the inspector expect to find?
Which attribute is NOT a characteristic of a standardized data collection element?
ePRO data are collected for a study using study devices given to subjects. Which is the most appropriate quality control method for the data?
A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which search should the Data Manager do?
Which metric reveals the timeliness of the site-work dimension of site performance?
