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. In MedDRA, which level sits directly below the Preferred Term (PT)? → Lowest Level Term (LLT)
2. 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
3. In Data Management Systems, what is the purpose of implementing data validation checks? → To identify and correct data entry errors
4. Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies? → 21 CFR Part 312
5. Which coding dictionary is used for coding medications and medical devices in clinical trial data? → WHO Drug Dictionary (WHO-DD)
6. Which process ensures that clinical trial data conforms to predefined quality standards and protocols? → Data validation
7. Which CDISC standard is used to define CRF data collection fields and their mapping to database variables? → CDASH (Clinical Data Acquisition Standards Harmonization)
8. In EDC systems, what is the purpose of 'form versioning'? → To track changes to CRF forms after protocol amendments while preserving historical data
9. Which term describes the process of assigning a unique identifier to each subject in a clinical trial database? → Subject identification coding
10. 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
11. What is a key component of risk management in clinical data management projects? → Identifying, assessing, and mitigating potential risks to the project
12. Which standard is commonly used to ensure the quality and integrity of clinical trial data? → Good Clinical Practice (GCP)
13. What is 'data normalization' in the context of clinical trial database design? → Organizing data into tables to reduce redundancy and improve data integrity
14. 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
15. 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
16. What is an 'unscheduled visit' in EDC data collection? → A visit that occurs outside the protocol-defined schedule, typically for safety reasons
17. Which organization maintains and updates the MedDRA dictionary? → The ICH MedDRA Management Committee (MSSO)
18. 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
19. How do data standards impact the quality of clinical trial data? → They ensure data is collected in a uniform manner, improving data quality
20. Which coding dictionary is primarily used for coding adverse events in clinical trials? → MedDRA (Medical Dictionary for Regulatory Activities)
21. Which organization is responsible for developing and promoting data standards in clinical research? → Clinical Data Interchange Standards Consortium (CDISC)
22. Which type of validation check verifies that a date entered in a CRF falls within the acceptable range of the study period? → Range check
23. Which metric is commonly used to measure the quality of data during validation activities? → Error rate (number of errors per 100 fields entered)
24. What is a 'range check' in clinical database design? → An edit check that flags values outside a predefined acceptable range for a variable
25. What is the primary purpose of data reconciliation in clinical data management? → To ensure consistency and completeness of data across multiple sources
26. 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
27. What is the primary purpose of a Data Management Plan (DMP) in a clinical trial? → To describe all data management processes and responsibilities
28. What is a 'randomization scheme' in a clinical trial? → A pre-planned method for randomly assigning subjects to treatment groups to minimize bias
29. What is the role of Standard Operating Procedures (SOPs) in ensuring data quality in clinical data management? → SOPs outline consistent procedures and practices to ensure data accuracy and quality
30. Which of the following is a key document in clinical data management that outlines the specifics of data collection and handling? → Data Management Plan (DMP)