North Shore LIJ Health System, Inc

North Shore – LIJ Health System, Inc.

SOP TITLE: TEST ARTICLE MANAGEMENT (For Clinical Research Sites)

SOP #:

Approval Date:

Site Implementation Date:

Prepared by:

Last Revised:

Effective Date:

OBJECTIVE: The objective of this Standard Operating Procedure (SOP) is to describe the management of test articles. “Test articles” includes investigational drugs and devices, including emergency use drugs and controlled substances.

RESPONSIBILITIES: 1. The PI and delegated staff must comply with all applicable federal and state statutes, rules and regulations and Health System policies regarding approval and use of test articles including procurement, storage, preparation, dispensation, administration, disposal, reporting and record keeping requirements. 2. The PI is ultimately responsible for the management of test articles used in clinical research investigation. 3. The PI will inform delegated staff of protocol amendments and any pertinent updates in study. 4. Blinded and unblinded staff must perform duties as described in delegation log to maintain blinding of the study. 5. Delegation of the investigational drug management to the Department of Pharmacy: . Study Feasibility: The PI and delegated research staff are responsible for notifying the Department of Pharmacy of any potential studies and providing necessary documents to secure resources and establish procedures. . Study Initiation, Conduct and Closure: The PI and delegated research staff are responsible for: o Notifying the Department of Pharmacy of any changes in study status (including approval, renewal, amendments, completion, closure and termination), o Providing 1) IRB approval and renewal letters, 2) an initial and updated lists of authorized Page 1 of 7 North Shore – LIJ Health System, Inc.

prescribers, 3) essential documents and their updated versions and 4) any applicable communications from the sponsors throughout the study conduct, o Notifying the pharmacist(s) of upcoming dosing schedules using and any changes in subject status AND o Providing the following documents for dose preparations in advance, if possible.  The first and signature page of signed informed consent form for each subject PRIOR to the first dispensation.  Prescriptions and drug orders signed ONLY by authorized prescribers for each study.  Any protocol-specific documents for each dispensation (e.g., randomization to treatment arm, dose assignment, assigned kit, bottle or vial numbers and subject weight or BSA) upon availability.

PROCEDURES: INVESTIGATIONAL DRUGS

Study Initiation . An investigational drug (Pharmacy) binder will be established for each protocol. . Establish protocol-specific storage compartments with adequate storage conditions.

Drug Procurement . The delegated staff will order investigational drugs according to the sponsor’s instructions. . The delegated staff will retain both blank and completed drug order forms for records.

Receipt of Drug . Upon the receipt of drug package, the delegated staff will verify the following information in the shipping document and confirm the receipt as instructed by the sponsor. o Protocol, sponsor and PI information o Subject information (for subject-specific investigational drug supply) o Drug name, dosage form and strength o Package size and quantity o Lot or batch number o Kit, bottle or vial numbers o Expiration or retest date o Temperature during transit o Damage and discrepancy . The delegated staff will retain the shipping documents and delivery or receipt confirmation in the investigational drug binder.

Drug Storage . The delegated staff will ensure the following storage conditions:

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o Security and safety  Limit access to investigational drugs by only authorized personnel.  Establish dedicated storage shelf, cabinet, refrigerator and freezer space separate from non- research drugs, other supplies and food.  Label storage compartments with protocol and drug information.  Store each drug, each dosage form, each drug strength and each lot under the same study in separate compartment.  Separate used, returned and expired drugs from working stock.  Establish safeguards such as caution labels for the same drugs used in multiple protocols. o Drug storage temperatures   

Drug Preparation and Dispensation . The delegated staff will follow protocol-specific instructions, site policies, procedures and any applicable regulations for preparation (including compounding and repackaging) and dispensation. . Only NYS licensed healthcare professionals authorized to handle drugs can be delegated for drug preparation and dispensation. . The PI is responsible for determining the risk level of preparing sterile investigational products and for ensuring adequate procedural and environmental quality practices for each clinical research protocol. . The staff delegated for drug preparation and dispensation will ensure that the subject has signed informed consent form (prior to the 1st dispensation and whenever the subject signs a revised informed consent form) and that an authorized prescriber has signed prescription, drug order or other forms as a record of investigator’s personal supervision over the drug dispensation. Any errors need to be corrected PRIOR to the preparation. . The delegated staff will complete and retain any protocol-specific documents for each preparation and dispensation. . Drug label should retain the following information: o ²Caution: New drug-limited by federal law (or US) to investigational use² o Study identifier (e.g., protocol number) o Prescription or drug order number o Subject name o Subject address or location in facility o Subject study identification number o Investigational drug name (or placebo) o Investigational drug dosage form and strength Page 3 of 7 North Shore – LIJ Health System, Inc.

o Dispensing quantity o Administration instructions including dose o Directions for storage and other relevant information o Preparation or dispensing date and time o Expiration date and time o Name of prescribing investigator o Name of preparing healthcare professional o Research site name, address and phone numbers

Drug Disposal . Ensure that subjects return any unused investigational drug supplies including empty containers to the research site. . The delegated staff will obtain and retain written procedures and approval for used, unused and expired investigational drugs PRIOR to their return to the sponsor or local disposal. . . The delegated staff will record the final disposition in drug accountability records and retain any other disposal records.

Drug Accountability . The delegated staff will record every drug transaction including, but not limited to, the receipt, preparation, dispensation, transfer, distribution, return from subjects, disposal, scheduled inventory verification, in a protocol-specific drug accountability record form. Complete all the information as required in each drug accountability record form. . The delegated staff will use separate drug accountability record sheet for each protocol, each storage location, each drug, each dosage form, each drug strength and each lot number. . The delegated staff will schedule periodic inventory verification to reconcile any discrepancies, secure sufficient supplies for upcoming subject visits and dispose of any expired drugs.

Drug Administration . A medication or an investigational new drug for research may be administered by: o A member of the full-time medical staff of the Health System; o A member of the voluntary medical staff and licensed independent practitioner; o PGY2 or higher resident or fellow physicians; and o Registered nurses, nurse practitioners and physician’s assistants under detailed written directions and supervision of the physician AUTHORIZED to prescribe the investigational drug(s) only after IRB approval has been granted for the protocol and administration. . Staff members responsible for administration need to be licensed in New York State to practice medicine and trained as required by each protocol. . Only individuals who are licensed by the State of New York to practice medicine will make medical

decisions regarding a clinical research subject’s care and treatment. . Staff members need to verify the investigational drug(s), the subject identification and other information specified in the NSLIJHS Policy PHT.401 Medication Administration and Monitoring Standard prior to drug administration. Two independent checks are recommended. . Unlicensed clinical research coordinators, PhDs and unlicensed clinically trained staff cannot dispense or administer a study drug. Non-clinical staff may, however, prepare documentation and paperwork for review and signature by licensed clinical staff.

Special Situations . Dispensing investigational drugs from automated dispensing machine (e.g., Pyxis) . Mailing investigational drugs . Re-labeling investigational products upon request from the sponsors . Transferring investigational drugs prepared in the Department of Pharmacy to research sites o Inform the research pharmacist of any upcoming dosing schedules in advance, if possible. o Upon arrival of the subject, the investigators, clinical research coordinator and other designee will complete procedures necessary to assess whether the study drug will be dispensed or administered. o If the subject is eligible to receive the study drug, the protocol-specific documentation is sent to the designated pharmacist (e.g., randomization assignment, weight communication form). o Confirm the receipt of the documents with the pharmacist and arrange the pick-up time. o At pharmacy, verify the prepared investigational drug and relevant information in labels, complete any documents to demonstrate chain of custody and immediately place the drug in a transport container , if necessary, with coolant packs and a temperature monitoring device. o Transport the prepared investigational drug directly to the research site without any other stops. . Procedure for individual patients in emergency settings (Expanded access emergency use; also known as compassionate use) The investigator will provide the following documents to delegated staff: o A grant from an FDA official, e.g., electronic communication. The FDA official may authorize shipment and use of the drug by telephone. o A signed informed consent form from the subject or legally authorized representative unless both the investigator and a physician not participating in the treatment use certify in writing that:  The subject is confronted by a life-threatening situation where the use of the drug is necessary and there is no alternative therapy to save the life of the subject; AND  Informed consent cannot be obtained from the subject or the subject’s legal representative. o Protocol or instructions for dose preparation o Prescription or drug order Page 5 of 7 North Shore – LIJ Health System, Inc.

NOTE: Emergency use is an EXEMPTION from prior review and approval by the IRB but the PI or physician must notify the IRB within 5 working days after the use of the investigational drug.

Controlled Substances . The research site will follow the Health System Policy GR050 Use of Controlled Substances in Research, other institutional policies and applicable regulations. . . Any discrepancy, loss or theft of controlled substances will be reported to the PI, Office of Research Compliance, Research/Administrative Director, and Corporate Security for investigation and required actions IMMEDIATELY.

Biological Agents . The research site will follow the Health System Policies and applicable regulations in conducting research involving recombinant or synthetic nucleic acid molecules and certain infectious and biological toxins or agents. .

INVESTIGATIONAL DEVICES

. The research site will follow the Health System Policy GR092 Handling of investigational devices, other institutional policies and applicable regulations. .

REFERENCES . NSLIJHS Policy GR092: Handling of Investigational Devices . NSLIJHS Policy GR049: Medications and Investigational New Drugs (IND) used in Clinical Research . NSLIJHS Policy GR050: Use of Controlled Substances in Research

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Approved: Date: ____/____/____