Drug Development Decision Log
This is a practical guide to building a decision log for a drug development project — a record of the key decisions made, by whom and why, adapted to the realities of developing a pharmaceutical product through regulatory stages.
What a Decision Log is
A decision log is a record of the key decisions made, by whom and why. For the full concept and how it works in general, see Decision Log. On a drug development project it plays the same role, tuned to this kind of work.
Why it matters for a Drug Development project
Drug Development projects live or die on developing a pharmaceutical product through regulatory stages. A well-built decision log gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how drug development projects drift into avoidable delay and cost.
What to include
- Decision
- Date and owner
- Rationale
- Alternatives considered
- Impact
Drug Development-specific considerations
Tailor the decision log to the risks that most often derail drug development projects:
- Regulatory approval delays
- Trial/validation failures
- Strict GxP compliance
Example
On a real drug development project, the decision log would be shaped by developing a pharmaceutical product through regulatory stages. In particular, it should explicitly account for the project’s biggest risks — regulatory approval delays, trial/validation failures, strict GxP compliance — rather than treating them as afterthoughts.