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Problems with drug supplies
IRT must assign the specific drug units provided to subjects for these reasons:
- The study reports accurately document the drug units provided to the subject during the study.
- The depot and site inventory are properly maintained.
In each visit after screening, IRT identifies the specific drug unit that should be provided to the subject. To request replacement drugs, you must log the request in IRT so specific drug units can again be identified.
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If you are replacing damaged drugs from a previous visit, check the drugs provided in the previous visit so you know which drug units the subject received. |
Examples:
- The drug units identified by IRT are missing from inventory.
- The subject informs you that the drug units provided at the last visit are damaged, and requests replacements.
- The subject was given the incorrect drug units or was given drug units that were not identified by IRT, and the drug units must be reallocated.
When you request the replacements, you must:
- Verify the subjects' identity against the basic demographic information gathered during screening.
- Identify the specific drug units that must be replaced. You must know which units are serialized and non-serialized, for example.
- Identify the reason you are replacing each drug unit (missing or damaged).
When you complete the visit, IRT sends you an email confirmation as a record of the information you entered.
Related procedures
