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Investigational product accountability and SOPs

Investigational-product logs and SOPs should trace receipt, dispensing, remaining inventory, return or destruction, and discrepancy follow-up.

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Lisa Harding MD and Mood Institute featured on Bloomberg Television · Credit: Bloomberg Television

Investigational product, often called IP, accountability is the record of what study product arrived at a site, what was dispensed, what remains, and what was returned or destroyed under the protocol and site standard operating procedures. The goal is traceability: the research team should be able to follow the documented movement of product through the required process.

An accountability log is the record used to document those movements. Depending on delegated responsibilities and study requirements, site staff may support log maintenance and inventory documentation. Physical inventory reconciliation means comparing product on hand with the accountability record and identifying any difference that needs follow-up. A discrepancy is documented and escalated for review under the site process.

Standard operating procedures, or SOPs, are the site's written instructions for recurring work. For IP accountability, they may address receipt, storage-related documentation, dispensing records, inventory review, discrepancy handling, return, destruction, and role responsibilities. Delegation and training records help show who was assigned a task and prepared to perform it. The applicable protocol and site procedures govern the work.

Sponsors can ask practical questions during research discussions: Who records receipt and dispensing? How is physical inventory compared with the log? How are discrepancies documented and escalated? Which SOP applies to the task? Which training and delegated-role records support the process? These questions help clarify documentation expectations without assuming a specific workflow, inventory status, or study commitment.

Inspection readiness means accountability logs, SOPs, and training records can be located and reviewed in an orderly, traceable form. Public pages do not provide stock information, serve as a feasibility form, or accept shipments. Use the designated research contact and confirmed secure channel for study-specific questions or documents. The next step is to send the research contact the accountability topics you need to verify.

For an accountability review, ask for the date range, product records, and document categories that will be discussed before the meeting. This allows the site and sponsor team to prepare the relevant logs, supporting documentation, and open discrepancy items through their established process. Keep study-specific records and shipment information within the designated research channel rather than sending them through consultation or general contact fields.

Sources: ICH — Efficacy guidelines, including GCP (E6)NIH — Grants & funding public hub

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