Quiz - Data Standard Versions in Module 5

Question Title

1. Which of these STDM/TDM domains must include variables that list the data standard names and versions? Select one.

AE - ADVERSE EVENTS

TE - TRIAL ELEMENTS

DS - DATA STANDARDS

TS - TRIAL SUMMARY

SV - STANDARD VERSIONS

Question Title

2. In which STDM/TDM domains may you find data standard names and versions. Select all that apply.

TS - TRIAL SUMMARY

DS - DATA STANDARDS

AE - ADVERSE EVENTS

CM - CONCOMITANT MEDICATIONS

SUPPAE - SUPPLEMENTAL QUALIFIERS ADVERSE EVENTS

Question Title

3. True or False? It is compliant to have different medication dictionary versions in SDTM domains compared to ADaM domains within a study?

TRUE

FALSE

Question Title

4. Which Module 5 contents may list data standard versions? Select all that apply.

define.xml

csdrg.pdf

adrg.pdf

SDTM domains

ADaM domains

Question Title

5. At which website can a sponsor find out which data standards are required and supported for a US filing? Select one.

NCI CDISC controlled terminology

Clinical trials.gov

Uppsala Monitoring Centre

FDA’s Study Data Standards Resources

CDISC

Question Title

6. As of August 2023, what could a sponsor expect to happen if they do not consistently and accurately provide the name and version of standards in their filing? Select all that apply.

Information requests

Refuse to File Letter

Complete Response Letter

Technical Rejection Notification

P21 findings

Question Title

7. Per the SDTM IG Version 3.3, how is the sponsor expected to provide the dictionary name and version used to map the terms? Select one.

Listing in the Data Standards section of the Clinical Study Data Reviewer’s Guide.

Utilizing the external codelist element in the Define-XML.

Including in the external dictionary codelist segment of the Define-XML.

Selecting the version used in the validation software.

Listing in the Study Data Standardization Plan.

Quiz - Data Standard Versions in Module 5

Question Title

* 1. Which of these STDM/TDM domains must include variables that list the data standard names and versions? Select one.

Question Title

* 2. In which STDM/TDM domains may you find data standard names and versions. Select all that apply.

Question Title

* 3. True or False? It is compliant to have different medication dictionary versions in SDTM domains compared to ADaM domains within a study?

Question Title

* 4. Which Module 5 contents may list data standard versions? Select all that apply.

Question Title

* 5. At which website can a sponsor find out which data standards are required and supported for a US filing? Select one.

Question Title

* 6. As of August 2023, what could a sponsor expect to happen if they do not consistently and accurately provide the name and version of standards in their filing? Select all that apply.

Question Title

* 7. Per the SDTM IG Version 3.3, how is the sponsor expected to provide the dictionary name and version used to map the terms? Select one.

1. Which of these STDM/TDM domains must include variables that list the data standard names and versions? Select one.

2. In which STDM/TDM domains may you find data standard names and versions. Select all that apply.

3. True or False? It is compliant to have different medication dictionary versions in SDTM domains compared to ADaM domains within a study?

4. Which Module 5 contents may list data standard versions? Select all that apply.

5. At which website can a sponsor find out which data standards are required and supported for a US filing? Select one.

6. As of August 2023, what could a sponsor expect to happen if they do not consistently and accurately provide the name and version of standards in their filing? Select all that apply.

7. Per the SDTM IG Version 3.3, how is the sponsor expected to provide the dictionary name and version used to map the terms? Select one.