Pass the SCDM Clinical Data Management CCDM Questions and answers with CertsForce

Viewing page 4 out of 5 pages
Viewing questions 31-40 out of questions
Questions # 31:

Which is the best way to see site variability in eligibility screening?

Options:

A.

List eligibility waivers by site


B.

Summarize screening rate by site


C.

Graph enrollment by site


D.

Plot eligibility rate by site


Expert Solution
Questions # 32:

Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:

Options:

A.

Portable Document Format (.pdf)


B.

Rich Text Format (.rtf)


C.

Microsoft Word (.docx)


D.

Statistical Analysis System (.sas)


Expert Solution
Questions # 33:

When a data manager runs a report on resolution types of discrepancy status, which of the following wouldNOTbe a part of resolution types?

Options:

A.

Cannot be resolved (but data incorrect)


B.

Received from site and not yet reviewed


C.

Resolved with data/confirmed as is (non problematic)


D.

Data management – self evident corrections


Expert Solution
Questions # 34:

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?

Options:

A.

Medical Document for Regulatory Activities


B.

Biomedical Research Domain Model


C.

Individual Case Safety Report


D.

Submission Data Tabulation Model


Expert Solution
Questions # 35:

The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?

Options:

A.

LLT, HLGT, PT, HLT, SOC


B.

LLT, PT, HLGT, HLT, SOC


C.

LLT, HLGT, HLT, PT, SOC


D.

LLT, PT, HLT, HLGT, SOC


Expert Solution
Questions # 36:

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:

Options:

A.

Determining CRF data entry status of received pages


B.

Identifying missing pages where visits have been completed to date


C.

Identifying the number of discrepancies resolved to date


D.

Identifying all outstanding discrepancies to date and aging


Expert Solution
Questions # 37:

What does 21 CFR Part 11 dictate in regards to a minimum expectation of EDC training prior to access?

Options:

A.

Training must be performed


B.

Training must include an exam


C.

Training must be in the user's native language


D.

Training must be face to face


Expert Solution
Questions # 38:

An organization is using an international data exchange standard and a new version is released. Which of the following should be assessed first?

Options:

A.

Availability of other standards covering the same content


B.

Existence of backwards compatibility


C.

Content coverage of the new version


D.

Cost of migrating to the new version


Expert Solution
Questions # 39:

Which is the MOST appropriate flow for EDC set-up and implementation?

Options:

A.

CRF “wire-frames” created, CRFs reviewed, CRFs printed, CRFs distributed to sites


B.

Protocol finalized, Database created, Edit Checks created, Database tested, Sites trained


C.

Database created, Subjects enrolled, Database tested, Sites trained, Database released


D.

Database created, Database tested, Sites trained, Protocol finalized, Database released


Expert Solution
Questions # 40:

Which protocol section most concisely conveys timing of data collection throughout a study?

Options:

A.

Study endpoints section


B.

Study schedule of events


C.

Protocol synopsis


D.

ICH essential documents


Expert Solution
Viewing page 4 out of 5 pages
Viewing questions 31-40 out of questions