SCDM Study Guide 2026
Everything you need to pass the SCDM exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 SCDM Exam Format at a Glance
📚 SCDM Topics to Study (22)
✍️ Sample SCDM Questions & Answers
1. What is a 'clinical study report' (CSR) in clinical trial operations?
A CSR is a structured document (per ICH E3 guidance) that comprehensively describes the trial's design, methods, conduct, efficacy, and safety results for regulatory submission.
2. Which agency publishes the FDA Bioresearch Monitoring (BIMO) guidance for clinical data management?
The FDA's CDER publishes BIMO guidance documents that outline inspection expectations for clinical investigators, sponsors, monitors, and IRBs.
3. Which CDISC standard is used to define CRF data collection fields and their mapping to database variables?
CDASH provides standardized field names and collection methodologies for CRFs, facilitating consistent data collection and easier mapping to SDTM submission datasets.
4. Which ICH guideline specifically addresses Good Clinical Practice standards for clinical trials?
ICH E6 (R2) is the international guideline that defines Good Clinical Practice standards for the design, conduct, and reporting of clinical trials.
5. What is a 'deviation log' used for in clinical trial site management?
A deviation log provides a site-level record of all protocol deviations, including when they occurred, their potential impact on subject safety or data integrity, and corrective or preventive actions.
6. What is the purpose of a 'data listing review' prior to database lock?
A data listing review involves manual examination of data listings by the data management team and sometimes clinical staff to catch residual errors not flagged by automated edit checks.