The investigator or the institution should be responsible for the accountability and storage of the investigational product(s).
The investigator or the institution may assign some or all of the duties for investigational product(s) accountability and storage at the trial site(s) to designated pharmacists or other appropriate individuals.

The investigator, the institution and the designated pharmacist or other appropriate individual should maintain following records:
1.Records of the product's delivery to the trial site;
2.The inventory at the site;
3.The use of the investigational product(s) by subjects;
4.The return to the sponsor or alternative disposition of unused investigational product(s).
The preceding records should include dates, quantities, batch/serial numbers, expiration dates, and the unique code numbers assigned to the investigational product(s) and trial subjects.
The investigator should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).

The investigational product(s) should be used only in the approved protocol.

The investigator, or a person designated by the investigator, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.

The investigator should follow the trial's randomization procedures.
Under the preceding randomization procedures, the code should be broken only in accordance with the protocol.
If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding of the investigational product(s).