SCDM Certified Clinical Data Manager - CCDM무료 덤프문제 풀어보기

A. Clinical/Scientific Representative, Data Manager, Biostatistician

B. Clinical/Scientific Representative, Biostatistician, Programmer

C. Clinical/Scientific Representative, Biostatistician

D. Clinical/Scientific Representative, Data Manager

A. Self-evident changes may be made per the listed conventions and documented to the investigative site.

B. A senior level data manager may make audited changes to the database without further documentation.

C. No changes will be made in the database without a query response signed by the investigator.

D. Self-evident corrections made in the database will be reviewed and approved by a team leader or manager.

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

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

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

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

A. Date of death

B. Coagulation time

C. Cause of death

D. Drug level

A. Data management - self evident corrections

B. Cannot be resolved (but data incorrect)

C. Received from site and not yet reviewed

D. Resolved with data/confirmed as is (non problematic)

A. Rely on the revised CRF to enforce the changes without updating guidelines or notifying sites

B. Update the guidelines and post the new version on the trial portal

C. Notify sites of the change without a guideline update

D. Update the guidelines and notify sites of changes prior to implementing the change

A. Training requirements

B. Expected and actual results

C. Root cause analysis of the system errors

D. Reconciliation datapoints

A. CCGs are designed from the perspective of the Study Biostatistician to ensure that the data collected can be analyzed

B. CCGs are developed with representatives of Data Management, Biostatistics, and Marketing departments

C. CCGs must include a version control on the updated document

D. CCGs must be signed before database closure to include all possible protocol changes affecting CRF completion

A. Upgrade the version immediately and recode.

B. Evaluate the extent and impact of the changes.

C. Identify an alternative dictionary.

D. Continue using the existing version to code.

A. Handling External Data

B. Data Backup, Recovery, and Contingency Plans

C. Data Review and Validation

D. Coding Medical and Clinical Terms

A. To identify differences in medication components based on country of source

B. To facilitate the reporting and analysis of possible drug interactions

C. To standardize recording of medications taken by patients across sites

D. To improve safety monitoring of patients in a clinical trial setting

A. Discrete values for a drop-down list

B. Enumeration

C. Unit or dimensionality of measure

D. Data type of the data element

A. Manual recording is preferred because the sites may forget to turn on the machine and lose data

B. Manual recording is preferred because healthcare devices are not validated to 21 CFR Part 11 standards

C. Electronic acquisition is preferable because more data points can be acquired

D. Electronic acquisition is preferable because the chance for human error is removed

A. Microsoft Word (.docx)

B. Rich Text Format (.rtf)

C. Portable Document Format (.pdf)

D. Statistical Analysis System (.sas)