MANAGING INVESTIGATIONAL PRODUCTS (IPs)
Purpose
To describe the process and requirements for the receipt. storage, dispensing, and return or destruction of investigational Product (IP) at the site.
Scope
This Standard Operating Procedure (SOP) will apply to all studies being conducted at SITE.
Any new trial which is initiated during the active period or the SOP will be covered under the SOPs unless otherwise indicated. The necessary study-specific SOP may be prepared.
Procedure
Prior to receipt of investigational Product (IP)/ Study Drug
• Pl must identify an area with restricted access and appropriate temperature control for IP storage. This area will be known as the 1P Storage Room '.
• Assign team members who would be responsible for IP receipt, storage, dispensing,
accountability and recording the temperature for the storage area and returning or destruction of the I P/ study drug.
• The person must be identified on the study delegation log.
Receipt of Investigational Product (IP)/ Study Drug
• Upon receipt of the IP shipment at the site, the ere /delegated member will unpack the IP box and check the IP inventory against the shipping form.
• Checking the inventory will include the following: o Checking the packaging numbers
o Unique Kit numbers/I P number
o Lot /batch numbers
o Number of IPs in the container (s)
o IP expiry date
• Any discrepancies (e.g. tampering/ breakage or the IP kit, mismatch in the number of kits temperature excursions, etc.) identified must be documented and informed to the sponsor/CRO point of contact immediately and seek advice for the next steps.
• Such IP must be stored separately and must be dispensed only after confirmation from the sponsor/CRO/designee. This must be done by the person designated for IP accountability.
• If the inventory matches the drug received, the pharmacist/delegated person will sign and date (note: mention logger temperature present in the IP container on the receipt form) on the shipping receipt or investigational Product Receipt Form. reply a copy to the sponsor. And file the original in the Trial Master File (SMF).
• Shipment inventory must be done as per the study-specific procedure (e.g. IYRS or IWRS. accountability log etc.)
• The IP must be immediately transferred to the designated storage area at the conditions mentioned in the protocol.
• The temperature of the storage area must be recorded with a calibrated thermometer for the temperature range once daily or as mentioned in the protocol. It is strongly recommended that accurate temperature must be recorded.
• If available maintain the hard copy or auto-generated temperature logger.
IP / Stud y Drug Storage
• Temperature of the IP storage area must be maintained on a 24-hour basis for recording temperature. The temperature will be recorded once daily or as mentioned 111 the protocol except on holidays and Sundays. The capture of minimum and maximum values or temperature will be recorded if only specified by the sponsor/CRO.
• In case a temperature excursion is noted, the CTC/designated study team member must inform Investigator and the following telephonically followed by email at the earliest:
o Inform the sponsor / CRO and document the same
o Try to identify the cause or temperature excursion
• Take remedial actions in consultation with the sponsor/CRO
• IP that has undergone a temperature excursion must be kept separately and must not be dispensed till a confirmation from sponsor/C RO is obtained i.e. the IP is " fit for use"
IP/ Study Drug Dispensing
• I P must be dispensed by the CTC/ delegated member to subjects randomized on the study after
fulfilling the eligibility criteria in accordance with the protocol.
• Upon dispensing the IP the CT C/delegated member must note the following in the source note and I P package:
o T ria l/ Stud y ID number (both source notes and IP package)
o Initial other subjects (both source notes and IP package)
o Date of IP dispensing (both source notes and IP package)
o Batch number and quantity of IP dispensed (in the source note)
o Expiry date (in the source note)
o This information must be captured in Real Lille basis on the IP stickers available on IP containers, in the subject source notes as well as in the Drug Accountability Logs.
• The CTC/delegated member will maintain a record of drugs dispensed to and retrieved from each subject. To accomplish this. the CTC/delegated member will use the CRF, if any, and only if provided by the sponsor/CRO.
• The CTC/delegated member will explain to each subject the drug accountability needs for
• the study (e.g., the need for the subject to return unused, partially used, and empty packages).
0 Requests for IP resupply must be done as per the study-specific procedures.
IP/ Study Drug Return
• The study subject will return all drug and study-related supplies to CTC/delegated member on the specified visit mentioned in the protocol.
• The CTC/delegated member will count the returned drug and compare this with the amount of drug expected to have been used since the previous study visit.
• CTC/delegated member must document IP returned by the subject in the subject's source file as well as in the drug accountability logs as per the study requirement.
• In case of missing IP or extra IP, the CTC/delegated member must obtain the information from the Subject and document the clarification provided in the source notes, drug dispensing log, and CRF. This documentation should be done on real title basis
0 The CTC /delegated member will keep the Drug Dispensing Log and the drug accountability CRF pages updated, regardless of when the monitor wi11 performs final accountability.
• The CTC/delegated 1nember will store the returned drug separately in a secure area until it is verified by the CRA/Monitor.
o Whether the drug is to be returned to the sponsor or destroyed on-site will be determined by the instructions in the protocol.
• The documentation of the destruction/ return must be maintained in the SMF.
Return of IP to Sponsor
• As specified in the protocol. the IP will be returned to the sponsor at intervals or at the end of the study. The CTC/delegated member will follow the protocol or other instructions from the Sponsor or CRO to decide whether empty containers must be returned.
• The CRA /Monitor will perform the independent drug accountability review and will seal the drug that needs to be shipped back to the Sponsor/CRO.
• The CRA/Monitor will arrange the preferred courier for the shipment of used and/or unused IP
back to the sponsor/CRO.
• The CTC will arrange for a gate pass for the shipment that needs to send back to the sponsor/CRO.
• Unless instructed otherwise by the CR/\ /Monitor. the CTC /delegated member will: o Perform an inventory or the drug supplies.
o Compare inventory with the study medication records.
o Document discrepancies in the CRF or in a memo to file.
o Complete the Drug Return / Destruction Form (in the presence or monitor) or a similar form provided by the sponsor or CRO.
o Include a copy of the signed and completed Drug Return Form with the drug shipment and place
the original in the study file.
IP Record Retention
At study completion, there will file all drug records with other regulatory documents in accordance with the record retention policy mentioned in the protocol.
Applicable staff
This SOP applies to those members of the study team involved in the process of receipt storage, dispensing, and return or destruction of investigational Product (IP). These include the following:
o Principal Investigator (Pl)
o Clinical Trial Coordinator (CTC)
o Pharmacist
o Research Nurse
o Support Staff
END OF THE DOCUMENT
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