CCDM試験無料問題集（152題）「SCDM Certified Clinical Data Manager 認定」

出題：1

Every database lock should follow documented approval of which stakeholders?

A. Clinical/Scientific Representative, Data Manager

B. Clinical/Scientific Representative, Data Manager, Biostatistician

C. Clinical/Scientific Representative, Biostatistician, Programmer

D. Clinical/Scientific Representative, Biostatistician

正解：B 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：2

Query rules were tested with test data for each logic condition within each rule. Which of the following types of testing was conducted?

A. User box testing

B. Black box testing

C. T box testing

D. White box testing

正解：B 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：3

The result set from the query below would be which of the following?
SELECT * FROM patient WHERE medical_record_number > 9000

A. Longer than the patient table

B. Wider than the patient table

C. Shorter or of equal length than the patient table

D. Narrower than the patient table

正解：C 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：4

Which metric reveals the timeliness of the site-work dimension of site performance?

A. Median and range of time from query generation to resolution

B. Time from site contract execution to first patient enrolled

C. Time from Last Patient Last Visit to database lock

D. Time from final protocol to first patient enrolled

正解：A 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：5

Which of the following processes is the most likely to remain in a study that utilizes electronic data capture?

A. Tracking case report forms

B. Resolving queries

C. Retrieving case report forms

D. Updating the in-house database

正解：B 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：6

An organization conducts over fifty studies per year. Currently each study is specified and set-up from scratch. Which of the following organizational infrastructure options would streamline database set-up and study-to-study consistency?

A. Maintaining a library of form or screen modules

B. Improving the form or screen design process

C. Implementing controlled terminology for adverse events

D. Adopting an ODM compliant database system

正解：A 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：7

A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy of an antiviral to counteract a new epidemic. The stated primary efficacy endpoint is 3-month survival. Which data element is needed for the primary efficacy endpoint?

A. Cause of death

B. Date of autopsy

C. Birth date

D. Death date

正解：D 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：8

Which of the following data verification checks would most likely be included in a manual or visual data review step?

A. Checking mandatory fields for missing values

B. Checking adverse event treatments against concomitant medications

C. Checking a value against a reference range

D. Checking an entered value against a valid list of values

正解：B 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：9

What are the key deliverables for User Acceptance Testing?

A. Project Plan

B. Training

C. eCRF Completion Guidelines

D. Test Plan/Script/Results

正解：D 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：10

An organization has completed a study and wants to submit the data to the FDA using CDISC SDTM. Which of the following must be done?

A. SDTM cannot be used in this situation

B. Re-enter the data into an SDTM compliant system

C. Map and transform the study data to SDTM

D. Provide a letter of intent to use SDTM to the FDA

正解：C 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

CCDM試験無料問題集「SCDM Certified Clinical Data Manager 認定」