The principles of GCP are designed to be flexible and applicable to a broad range of clinical trial designs. This guideline, along with ICH E8(R1), encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial.
PLANNING – PLANNING – PLANNING – Careful consideration of factors relevant to ensuring QUALITY TRIALS is needed for each clinical trial.
This includes evaluation of trial characteristics, such as:
- Design elements (great emphasis is placed on this),
- The investigational product being evaluated,
- The medical condition being addressed,
- The characteristics of the participants,
- The setting in which the clinical trial is being conducted, and
- The type of data being collected.
The principles are intended to support efficient approaches to trial design and conduct.