最新的SCDM Certified Clinical Data Manager - CCDM免費考試真題
A study budgeted forty hours allocated over the three months following first protocol draft for Data Management Plan (DMP) creation. If there is a problem with this approach, what is it?
正確答案: D
說明：（僅 Fast2test 成員可見）
A Data Manager is importing lab data for a study. The lab data and the associated audit trail is kept at the central lab. What is necessary to maintain traceability of the transferred data at the Data Manager's location?
正確答案: B
說明：（僅 Fast2test 成員可見）
A study has an expected enrollment period of one year but has subject recruitment issues. Twelve new sites are added toward the end of the expected enrollment period to help boost enrollment. What is the most likely impact on data flow?
正確答案: A
說明：（僅 Fast2test 成員可見）
An organization is using an international data exchange standard and a new version is released. Which of the following should be assessed first?
正確答案: A
說明：（僅 Fast2test 成員可見）
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?
正確答案: B
說明：（僅 Fast2test 成員可見）
What should be done if the site continues to provide inconsistent data after several re-queries?
正確答案: C
說明：（僅 Fast2test 成員可見）
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?
正確答案: D
說明：（僅 Fast2test 成員可見）
Which of the following laboratory findings is a valid adverse event reported term that facilitates auto coding?
正確答案: B
說明：（僅 Fast2test 成員可見）
The result set from the query below would be which of the following?
SELECT * FROM patient WHERE medical_record_number > 9000
SELECT * FROM patient WHERE medical_record_number > 9000
正確答案: A
說明：（僅 Fast2test 成員可見）
In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:
正確答案: C
說明：（僅 Fast2test 成員可見）
A Data Manager is designing a report to facilitate discussions with sites regarding late dat a. Which is the most important information to display on the report to encourage sites to provide data?
正確答案: C
說明：（僅 Fast2test 成員可見）
Who has primary responsibility for ensuring accurate completion of the CRF?
正確答案: A
說明：（僅 Fast2test 成員可見）
What additional task does the site study coordinator role perform when utilizing an EDC application compared to paper CRF?
正確答案: B
說明：（僅 Fast2test 成員可見）
Which is a minimum prerequisite that should be in place before choosing an EDC system?
正確答案: C
說明：（僅 Fast2test 成員可見）