SCDM Cheat Sheet 2026

The 30 highest-yield SCDM facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. What is the purpose of a 'soft edit' (or soft stop) in an EDC system? → To allow data entry to continue after the user acknowledges a potential issue
2. In MedDRA, which level sits directly below the Preferred Term (PT)? → Lowest Level Term (LLT)
3. What is a 'SAS transport file' (.xpt) used for in clinical data submissions? → A standardized file format required by the FDA for submitting SDTM and ADaM datasets
4. In Data Management Systems, what is the purpose of implementing data validation checks? → To identify and correct data entry errors
5. Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies? → 21 CFR Part 312
6. Which coding dictionary is used for coding medications and medical devices in clinical trial data? → WHO Drug Dictionary (WHO-DD)
7. Which process ensures that clinical trial data conforms to predefined quality standards and protocols? → Data validation
8. Which CDISC standard is used to define CRF data collection fields and their mapping to database variables? → CDASH (Clinical Data Acquisition Standards Harmonization)
9. Prior to database lock, a final data review is conducted. Which of the following is a standard component of this review? → Confirming that all open queries have been resolved and no outstanding data issues remain
10. During IRT (Interactive Response Technology) reconciliation, which data element is most critical to verify? → Subject randomization numbers, treatment assignments, and kit dispensation records
11. In EDC systems, what is the purpose of 'form versioning'? → To track changes to CRF forms after protocol amendments while preserving historical data
12. Which term describes the process of assigning a unique identifier to each subject in a clinical trial database? → Subject identification coding
13. What is the purpose of an 'audit trail' in a validated clinical database? → To maintain a time-stamped, user-attributed record of all data creation and modifications
14. What is a key component of risk management in clinical data management projects? → Identifying, assessing, and mitigating potential risks to the project
15. Which standard is commonly used to ensure the quality and integrity of clinical trial data? → Good Clinical Practice (GCP)
16. What is 'data normalization' in the context of clinical trial database design? → Organizing data into tables to reduce redundancy and improve data integrity
17. During external data reconciliation, a discrepancy is found between the EDC system and the central lab data. What is the appropriate first step? → Investigate the source of the discrepancy using original source documents
18. Which GCP principle states that clinical trial records must be retained for a defined period after trial completion? → Essential document archiving requirements under ICH E6
19. What is an 'unscheduled visit' in EDC data collection? → A visit that occurs outside the protocol-defined schedule, typically for safety reasons
20. Which organization maintains and updates the MedDRA dictionary? → The ICH MedDRA Management Committee (MSSO)
21. What is the role of the Data Safety Monitoring Board (DSMB) in a clinical trial? → To independently review accumulating safety and efficacy data at planned intervals
22. How do data standards impact the quality of clinical trial data? → They ensure data is collected in a uniform manner, improving data quality
23. Which coding dictionary is primarily used for coding adverse events in clinical trials? → MedDRA (Medical Dictionary for Regulatory Activities)
24. Which organization is responsible for developing and promoting data standards in clinical research? → Clinical Data Interchange Standards Consortium (CDISC)
25. Which type of validation check verifies that a date entered in a CRF falls within the acceptable range of the study period? → Range check
26. Which metric is commonly used to measure the quality of data during validation activities? → Error rate (number of errors per 100 fields entered)
27. What is a 'range check' in clinical database design? → An edit check that flags values outside a predefined acceptable range for a variable
28. What is the primary purpose of data reconciliation in clinical data management? → To ensure consistency and completeness of data across multiple sources
29. What is the significance of a 'certificate of compliance' issued after a regulatory inspection of a clinical trial site? → It indicates the inspector found no objectionable conditions at the site
30. What is the primary purpose of a Data Management Plan (DMP) in a clinical trial? → To describe all data management processes and responsibilities