CTS documents

Investigational medicinal product (IMP information)

Protocol
CRF
IB
CoA

Pharmacy agreements
Instructions for handling and dispensing of IMPs (if not covered in protocol)
Shipping records – inventory log
Label –sample
Packaging instructions – sample
IMP drug accountability logs – drug dispensing/distribution details
Patient blinding disclosure sheets (PBDS)
Drug discrepancy forms
Drug destruction certificates

Patient diary
Medication compliance card

Additional
Storage device/ equipments – log books, calibration certificates
Proforma invoice – IMP requisition/recall
Import licence

Pharmacy (if applicable)

• Copy of pharmacy agreement(s) (if applicable)
• Copy of drug accountability logs (if applicable)
• Records of any retained samples (if applicable)
• Instructions for handling and dispensing of any study drug used if not covered in
protocol (if applicable)
• Any other reference information regarding the study drug used (if applicable)
• Shipping records (if applicable)
• Certificates of analysis of study drug (if applicable)

DRUG MASTER FILE