Independent Drug Monitoring
The Independent Drug Monitor (IDM) will check the validity and integrity of the drug management data as produced by the pharmacy and the maintenance of research subject blinding.
Quality Control Procedures
- Randomization and Drug Preparation / in-house
Quality control will verify the completeness, consistency and correctness of the respective Preparation Record and re-forward discrepancies or irregularities (e.g. in the dose calculation)
- Drug Accountability
On-site the IDM will check the Pharmacy File for completeness and accuracy in order to guarantee the maintenance of blinding and correct dosing within a trial.