CCDM問題集、SCDM実際の試験問題

質問 1

Which of the following is a best practice for creating eCRFs for a study?

A. Develop eCRFs with cross-functional team members

B. Develop eCRFs that closely follow paper CRF standards

C. Set up features that automatically enter data into fields when bypassed

D. Set up coded terms so they are available to the site user

正解: A

解説: (PassTest メンバーにのみ表示されます)

質問 2

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. Programmed edit checks to detect out of range values after submission to the database

B. Data visualizations to look for site-to-site variation

C. Programmed edit checks to detect out of range values upon data entry

D. Manual review of data by the site study coordinator at the next visit

正解: C

解説: (PassTest メンバーにのみ表示されます)

質問 3

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. Prepare a communications plan

B. Plan the timelines to ensure a clinical database is ready before the first screening

C. Prepare system requirements specification

D. Prepare a data validation plan for the clinical database

正解: D

解説: (PassTest メンバーにのみ表示されます)

質問 4

A study numbers subjects sequentially within each site and does not reuse site numbers. Which information is required when joining data across tables?

A. Study number and subject number

B. Subject number

C. Site number

D. Subject number and site number

正解: D

解説: (PassTest メンバーにのみ表示されます)

質問 5

Which statement applies to the CRF Completion Guidelines (CCGs) for a multinational study?

A. CCGs must contain the list of acceptable abbreviations to be used in the CRF

B. CCGs must be translated and back-translated in each local language used in the study

C. CCGs can instruct sites to write in their local language as long as the CRA is fluent in this language

D. CCGs can instruct sites to use any abbreviations if they are documented in the subject source notes

正解: A

解説: (PassTest メンバーにのみ表示されます)

質問 6

What action should be taken regarding the clinical database when MedDRA releases a new version of its dictionary?

A. Evaluate the extent and impact of the changes.

B. Continue using the existing version to code.

C. Identify an alternative dictionary.

D. Upgrade the version immediately and recode.

正解: A

解説: (PassTest メンバーにのみ表示されます)

質問 7

In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

A. Against a valid list of values.

B. On the format of a date.

C. Against a valid numeric range.

D. Across visits for consistency.

正解: D

解説: (PassTest メンバーにのみ表示されます)

質問 8

A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?

A. Measurement using study-provisioned equipment

B. Collecting the data from the medical record

C. Asking the study subjects what their blood pressure usually runs

D. Measurement using existing equipment at sites

正解: A

解説: (PassTest メンバーにのみ表示されます)

質問 9

A Data Manager receives an audit finding of three different instances of simultaneous log-ins to the EDC system by the same site user. This was observed at three different sites. Which of the following is the best long-term response to the audit finding?

A. Requesting that the sites fire the offending users for a HIPAA violation and increasing the monitoring for the offending sites

B. Refresher training for the offending users, re-communication of the binding nature of e-signatures to all users, routine monitoring for simultaneous log-ins from the same user

C. Removing all access to the system until the situation is resolved

D. Acquiring technical controls from the same or a different system vendor that prevent simultaneous log-ins from the same user

正解: B

解説: (PassTest メンバーにのみ表示されます)

質問 10

What are the first logical specifications that need approval when building an efficient EDC database?

A. eCRF Guidelines

B. Metric Reports

C. Edit Check Logic

D. eCRF Fields

正解: D

解説: (PassTest メンバーにのみ表示されます)

SCDM Certified Clinical Data Manager - CCDM 模擬練習