Randomization Skill
Purpose
Implement proper random assignment to minimize selection bias.
Randomization Methods
1. Simple Randomization
- Coin flip, random number generator
- Best for large samples (N>200)
- Risk of imbalance in small samples
2. Block Randomization
- Ensures equal group sizes
- Blocks of 4, 6, or 8
- Example: AABB, ABAB, BABA, BBAA
3. Stratified Randomization
- Balance prognostic factors
- Stratify by sex, age group, severity
- Then randomize within strata
4. Minimization
- Dynamic allocation
- Minimizes imbalance across factors
- Used in small trials
Implementation
Steps:
- Generate random sequence (with seed)
- Document sequence generation
- Implement allocation concealment
- Execute randomization
- Document actual allocation
Example (Python):
import random
random.seed(12345) # Document seed
sequence = ['A', 'B'] * 50 # 100 participants
random.shuffle(sequence)
Version: 1.0.0
