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Certification

How is the subject matter of the exam divided?

The Certification exam is divided into three sections. The following table contains a breakdown of how the competencies tested are divided amongst the three sections of the exam.

Section 1
Overall Clinical Trials Process, Roles and Responsibilities
Protocol Review
Data Management Plans
Communication of Data Trends
Processing Local Lab Data (CRF Collection)
Processing (loading/merging) Central Lab Data or Other Electronic Data
Maintenance of Lab Normal Range Info.
Application of Randomization Schemes (Breaking the Blind)
Database Lock Procedures
CRO-Sponsor Partnership
Relational Databases

Section 2
Clinical Database Design
CRF Tracking and Inventory
CRF Data Entry Process Discrepancy Resolution
CRF Data Validation (e.g. data review, cleaning, query generation, applying data handling conventions)
Safety Review
SAE Reconciliation
Review of Final Data Tables or Graphs
Archiving Database and Associated Information

Section 3
CRF Design
Query Resolution
Query Tracking
Database Updates
Coding (AEs; Signs and Symptoms)
Coding Medications
Database Quality Control Audits

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