SOP for Related to Investigational Product

Receipt and Inventory of Investigational Product(s)

Upon receipt of the investigational product at the site, PI designated personnel should conduct the following activities:

1. Inventory: Confirm that the information on the packing record matches what has been shipped to the site (i.e., number of packages, quantity per package, size (if device), lot or batch numbers). Complete and return the form acknowledging receipt (if required by the sponsor), and file a copy of the form and courier airway bill(s) in the study files (if required by the sponsor).
2. Packaging: Check that the investigational product has been packaged to prevent breakage, contamination, and unacceptable deterioration during transport and storage.
3. Records: Document the receipt date, quantity, and lot numbers of all investigational product(s) received from the sponsor in the investigational product accountability record/log.
4. If IP is received outside the temperature range or is hampered, the IP shall be quarantined, and the sponsor representative shall be informed as soon as possible. All the above processes, discussions, comments, etc., shall be documented appropriately.
5. Remove and secure blinding envelope, if provided.

Storing the Investigational Product(s)

• Written information for handling the investigational product(s) should be received from the sponsor, including storage temperature(s) and acceptable range(s) storage conditions (e.g. protection from light) storage duration (e.g., expiry dates, re-test dates)
• The PI or designated personnel, as per the delegation log, shall handle the IP all throughout the duration of the study.
• PI-designated personnel will keep records of storage temperatures as required. The record should also clearly mention the site-specific holidays.
• Any deviation from the recommended storage conditions should be documented on the temperature log along with the comments mentioning the reason for such deviation, and such deviations would be immediately reported to the site monitor and sponsor.
• Temperature will be measured with a calibrated temperature monitoring device.

• Store the investigational product(s) in a secure environment (e.g., a room with locks) to restrict access to qualified and authorized personnel only. Confirm that doors to the storage units can be locked as required.
• When equipment (where IP or study-related material is stored) is not maintaining the desired temperature, IP should be immediately transferred to another calibrated piece of equipment, and the same should be notified to the site monitor. It should also be notified to the sponsor if specified by the sponsor.

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Preparation of the Investigational Product

• When required, IP needs to reconstitute at the site as instructed in the protocol.
• PI should identify qualified personnel to reconstitute the IP.
• When separate unblinded personnel are required to constitute the IP, it should be reconstituted in a separate place where confidentiality is maintained.
• IP will be reconstituted and handed over to the designated personnel who would be administering the IP. It would be handed over within time as instructed in the protocol.
• Transportation of IP from the reconstitution room to injecting room will be done at desired temperature and as instructed in the protocol

Dispensing the Investigational Product

• Before dispensing the investigational product, confirm that appropriate storage conditions are maintained
• The investigational product must be used only in accordance with the approved protocol.
• Complete the investigational product accountability or dispensing record each time the investigational product is dispensed.
• Provide each participant with the instructions on the proper use, handling, storage, and return of the investigational product(s). Document this discussion in the source documents.
• Assess participant compliance with the instructions at intervals appropriate for the research study as specified within the protocol.

Randomization Procedure

Follow the randomization procedures as described in the protocol. Retain all documents relating to randomization by external sources, such as an Interactive Voice Response System (IVRS).

Unblinding Procedure

• For blinded trials, confirm that the coding system for the investigational product(s) includes a mechanism that permits rapid identification of the product(s) in case of a medical emergency.
• Follow the protocol-specific requirements for unblinding the investigational product. Promptly document and explain to the sponsor any premature unblinding of the investigational product(s), such as accidental unblinding or unblinding due to a serious adverse event; the same also needs to be notified to the IEC.

Return or Destruction of Investigational Product

• At the conclusion of the study, or as participants complete the research study, all documentation regarding receipt, storage, dispensing, and return/destruction (if applicable) of investigational product must be complete and accurate and stored in the study files.
• Designated personnel will review the accountability records and conduct a final inventory and reconciliation and prepare for return shipment to the sponsor.
• The sponsor must provide written authorization for destruction of investigational product at the study site.
• If the product is to be destroyed at the site, the site must have the appropriate procedures, permits, and policies to do so. A copy of the destruction policy should be available, and a copy filed in the investigator study file.
• Provide the sponsor with documentation of destruction and copy to files. Return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirements).

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