Standard Operating Procedure
Title: Management of Clinical Trial Drug Supplies
b) Storage of clinical trial supplies
c) Randomisation procedures and unbinding
1.1 The purpose of this Standard Operating Procedure is to describe the†††††
††††† procedure for documenting the receipt of clinical trial drug supplies, the††††
dispensing, use and accountability of the supplies and the return of†† supplies to the sponsor company. It also describes the storage of clinical trial drug supplies and the procedure for managing randomisation codes.
1.2 These procedures must be followed to ensure with ICH-GCP guidelines.
It is the responsibility of the investigator to oversee all aspects of the management of clinical trial supplies at the site. Certain aspects may be delegated to appropriately trained co-investigator or research nurse.
A delegation of trial related duties form needs to be completed.
†3.1 Receipt of clinical drug supplies
Immediately upon receipt, supplies must be checked against any shipment form to ensure what has been††† received corresponds with what has been sent. The following checks should be made:
- Ensure supplies are correctly addressed
- Ensure all packaging intact
- Ensure that the quantity, batch/serial numbers, correspond with shipment form.
The person who received the supplies should sign the shipment form. The date the supplies were received and the date they were checked should be on the form. One copy of the appropriate form should be retained in the site file and another copy returned to the sponsor as according to their instructions.
3.2 Patient use of clinical trial drug supplies
The investigator or designee should explain the correct use and storage of the drug supply to each patient at the start of the trial and should check, at intervals appropriate to the trial, that each patient is following the instructions properly.
The patients should be instructed to return all unused supplies including empty containers at each visit. The supplies should be reconciled against the supplies dispensed to the patient and the supplies used by the patient, according to the sponsors requirements.
The sponsor company will provide a drug dispensing log and this should be completed by the investigator or designee for each patient at each time supplies are dispensed or returned. Any discrepancies must be accounted for and commented upon.
3.3 Return or destruction of clinical trial drug supplies
At the end of the study overall reconciliation of supplies must take place. Any discrepancies should be reported to the sponsor company. Once all supplies have been accounted for they should be to the sponsor company according to their instruction. A receipt slip must be obtained from the monitor at the time the supplies are removed from site.
3.4 Re-allocation of clinical trial drug supplies
Clinical trial supplies must not be re-allocated or transferred to another site unless in exceptional circumstances. In these circumstances this should only occur following discussion and agreement with the sponsor company and in accordance with their SOPís. All documentation concerning re-allocation of supplies must be retained in the site file.
3.5 Storage of clinical trial drug supplies
Immediately after checking the supplies received at site they should be stored in appropriate conditions as specified by the sponsor.
The drug storage area should be secure. It should be locked where appropriate and access to the supplies limited where possible to investigators and research nurse.
The temperature of the storage area should be monitored weekly and a temperature log maintained.
3.6 Randomisation procedures and unblinding
The randomisation procedures as specified in the clinical trial protocol should be followed at all times.
The code breaks should only be revealed if:
- Treatment of an adverse event is dependant upon knowledge of the drug administered
- The study must be terminated for safety reasons
- A third party requires the information (e.g. coroner)
The patientís welfare must always take priority over any other consideration in determining when a code break should be revealed. Except in the case of an emergency, the code break should only be revealed with the agreement of the sponsor company.
If the code break envelope has been opened; it should be re-sealed dated and signed by the opener. The reason for revealing the code must be written on the envelope and a note made in the site file. Any accidental or non-accidental opening of a code break envelope must be reported to the sponsor company.
All code break envelopes must be returned unopened (unless they have been opened for any of the above reasons) to the sponsor† the end of the study.