Questionnaire development and item selection

Pretesting and pilot testing of the KAP survey

Administration methods: self-administered, face-to-face, telephone, online

Data collection techniques: surveys, interviews, focus groups

Lesson 3.1 Principles of Good CRF Design

By the end of this lesson you will be able to 1 Define a Case Report Form and explain its role in a clinical trial 2 Identify the seven principles of good CRF design and apply them to a real form 3 Read an annotated CRF and understand what each annotation means for the database 4 Distinguish between paper CRFs and electronic CRFs in a CRO context 5 Recognise common CRF design errors before they become data quality problems

lesson 3.2 Source Document Verification (SDV) and Source Data Review (SDR)

Lesson 3.3 Clinical Trial Database Structure and Architecture

Lesson 3.4 Edit Checks and Validation Rules.

Lesson 3.5 Data Discrepancy Management and Query Lifecycle

Lesson 3.6: User Acceptance Testing of Clinical Databases

Chapter 3 Assessment

Lesson 4.1 ICH E6 R3 GCP: What Changed and What It Means for CDM

Lesson 4.2 21 CFR Part 11 and EU Annex 11: Electronic Records and Electronic Signatures

Lesson 4.3 ALCOA+: The Data Integrity Framework in Full

Lesson 4.4 Audit Trails, Version Control and Change Management in EDC

Lesson 4.5 Regulatory Inspection Readiness: What Inspectors Look for in CDM

Lesson 4.6 Risk-Based Monitoring and Its Impact on Data Review

Chapter 4 Assessment

Lesson 5.1 Database Lock: Process, Criteria and CDM Sign-Off

Lesson 5.2 CDISC Standards: CDASH, SDTM and ADaM

Lesson 5.3 Medical Coding: MedDRA and the WHO Drug Dictionary

Lesson 5.4 External Data Management: Lab Transfers, ePRO and Reconciliation

Lesson 5.5 Data Transfer and define.xml

Lesson 5.6 eTMF: CDM responsibilities at close-out

Chapter 5 Assessment

Capstone project

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