ON THIS PAGE
- Starter Questions
- 1. What is AESER?
- 2. How do LB, MB, and IS differ?
- 3. How should —TPT variables in PC be understood?
- Intermediate Questions
- 4. How do AETERM and MedDRA variables work together?
- 5. Does SUPPQUAL apply to TS?
- 6. Is LBCLINSIG an LB standard variable?
- Cross-Domain Questions
- 7. Can the same clinical event involve AE, MH, and CE?
- 8. How should death be represented in AE and DS?
- Follow-Up Prompts
Example Questions
Use these questions to learn how to ask SDTM Pedia for useful answers. They are not an exam and not a formal validation plan. For formal work, confirm against official CDISC materials and internal procedures.
Starter Questions
1. What is AESER?
Suggested question:
What does AESER mean in the AE domain? What are its Core attribute and controlled terminology?
Look for:
- An explanation that AESER relates to serious events.
- A distinction among variable definition, Core attribute, and controlled terminology.
- Reviewable support.
2. How do LB, MB, and IS differ?
Suggested question:
How should LB, MB, and IS be distinguished? Which domain should be considered for serum antibody titer, anti-drug antibody, and bacterial culture results?
Look for:
- Clear boundaries among laboratory, microbiology, and immunology findings.
- Scenario-based explanation rather than definitions only.
3. How should —TPT variables in PC be understood?
Suggested question:
In the PC domain, what do PCTPT, PCTPTNUM, PCELTM, and PCTPTREF represent?
Look for:
- A distinction among planned time point, time point number, elapsed time, and reference point.
- Explanation of their role in pharmacokinetic sampling.
Intermediate Questions
4. How do AETERM and MedDRA variables work together?
Suggested question:
In the AE domain, what is the relationship among AETERM, AEDECOD, AELLT, AEHLT, AEHLGT, and AESOC?
Look for:
- A distinction between verbatim CRF text, coded term, and hierarchy levels.
- Recognition that MedDRA and CDISC Controlled Terminology are not the same thing.
5. Does SUPPQUAL apply to TS?
Suggested question:
If TSVAL is too long, should SUPPTS be used? Is SUPPTS defined in SDTMIG v3.4?
Look for:
- A clear statement that SUPPTS is not an SDTMIG v3.4 dataset.
- An explanation that Trial Design cases should follow the applicable Trial Design rule rather than a subject-level SUPP— pattern.
6. Is LBCLINSIG an LB standard variable?
Suggested question:
Is LBCLINSIG a standard LB-domain variable in SDTMIG v3.4? If clinical significance needs to be represented, what should be considered?
Look for:
- Recognition that the variable name is not a standard LB variable.
- Avoidance of invented Core attributes or C-codes.
Cross-Domain Questions
7. Can the same clinical event involve AE, MH, and CE?
Suggested question:
When would the same myocardial infarction concept be represented in MH, AE, or CE? If it occurs on-study and leads to hospitalization, what should be considered?
Look for:
- Explanation based on timing and reporting threshold.
- A clear distinction among event-type domains.
8. How should death be represented in AE and DS?
Suggested question:
If an AE leads to death, should both AE and DS be recorded? What does each domain represent?
Look for:
- A distinction between the fatal adverse event in AE and subject disposition status in DS.
- A reminder that date consistency and project-level review matter.
Follow-Up Prompts
After any answer, you can ask:
Please provide the basis for that answer.Does this apply to SDTMIG v3.4?When should I check the official standard?If my CRF field is written this way, what should I watch for during mapping?
These follow-ups help turn an explanation into a reviewable work reference.