INVESTIGATIONAL PRODUCT ACCOUNTABILITY, STORAGE, DISPENSING, TRANSPORT AND RETURN

Transcription

1 Policy/ Procedure # INVESTIGATIONAL PRODUCT ACCOUNTABILITY, STORAGE, DISPENSING, TRANSPORT AND RETURN 21 Effective Date June 2018 Category Global Last Review/Revision March 2017 Sub-Category Research Standards Leader EVP, Chief Clinical Integration Officer POLICY STATEMENT: It is WellStar s policy to follow all federal and state regulations and Good Clinical Practice (GCP) guidelines regarding the proper handling of investigational product. PURPOSE: To define a process for receipt, storage, dispensing, transport, reconciliation and return or destruction of Investigational Product. DEFINITION(S): Clinical Trial Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or identify any adverse event to an investigational product(s) with the objective of ascertaining its safety and/or efficacy. Contract Research Organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor s trial-related duties and functions. Good Clinical Practice (GCP) An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Investigational Product (IP) - Any product (drug, device, or biologic) which has not received FDA approval or which was previously approved and is being evaluated for a new and different indication in humans, or which is not regulated by the FDA (such as vitamins or herbal supplements). Principal Investigator (PI) An individual who has the ultimate responsibility for oversight of all research he/she is conducting and is ultimately responsible for all communication with the IRB (via WRI s HRPP) regarding that research. The principal investigator accepts responsibility for training all personnel associated with the study in compliance with the human subject regulations of 45 CFR 46. Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable- knowledge. Sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. U.S. Food and Drug Administration (FDA) The federal agency responsible for the enforcement of federal regulations on the manufacture and distribution of food, drugs, medical devices, and cosmetics. WellStar Research Institute (WRI) - The department that serves to ensure that clinical research conducted at WellStar Health System is performed with excellence and in accordance with corresponding relevant laws, federal regulations, and guiding principles of research. EXCEPTIONS: None CARE SETTING VARIATION: CH DH KH PH WHH HOMECARE HOSPICE WMG LOCATION OF VARIATION: N/A Page 1 of 5

2 PROCEDURE: RECEIPT AND INVENTORY OF INVESTIGATIONAL PRODUCT 1.1 Receive Investigational Product in accordance with the Code of Federal Regulation and the requirements as set forth in the protocol and Clinical Trial Agreement. STEP ONE 1.2 Compare the packing slip to items received to ensure that the information on the packing slips match exactly with what has been received by the site. 1.3 Ensure the integrity of the shipment including temperature requirements. Amount Lot numbers /Serial numbers Quantity per carrier/container Temperature recording device 1.4 Bring any discrepancies to the attention of the sponsor promptly. 1.5 Complete acknowledgement of receipt form appropriately, if applicable, and return the form to the sponsor via fax/mail as per instructions. 1.6 Ensure that supplies required for blinding of the investigational product are available. 1.7 Log the new inventory into the Accountability Log. Retain a copy for regulatory files STORAGE OF INVESTIGATIONAL PRODUCT STEP TWO 2.1 Store Investigational Product in accordance with the Code of Federal Regulations and the requirements as set forth in the protocol and Clinical Trial Agreement. 2.2 Store Investigational Products in a secure environment with access limited to essential research personnel, and according to storage requirements detailed in the protocol or supplied by the Sponsor. Page 2 of 5

3 2.3 Store Investigational Product at the appropriate temperature and maintain a storage area temperature log, when appropriate. DISPENSING AND ADMINISTRATION OF INVESTIGATIONAL PRODUCT 3.1 Dispense Investigational Product in accordance with the Code of Federal Regulation and the requirements as set forth in the protocol and Clinical Trial Agreement. STEP THREE 3.2 Complete the Accountability Log when Investigational Product is dispensed. 3.3 Collect all used containers/ units, when appropriate. If any containers/units are missing, a memo to file shall be written to document the reasons. 3.4 Note any discrepancies (memo to file) between amounts used by subjects and amounts expected to be returned. 3.5 Ensure that an adequate supply of Investigational Product is available and initiate a resupply order if needed. 3.6 Investigational Product for outpatient use will be labeled as directed by study sponsor and any applicable state/federal regulations. Amount and lot/serial number dispensed Name of individual dispensing Investigational product Subject s initial Subject study number Date (and time, if appropriate) of dispensing Date (and time, if appropriate) of amount of Investigational product returned Amount of Investigational product dispensed 3.7 The subject will be instructed on proper use of the investigational product, potential side effects and precautions. 3.8 Investigational Product supplies shall be maintained within an appropriate expiration date. Page 3 of 5

4 3.9 If emergency breaking of the blind is medically necessary, document all circumstances appropriately FDA approved product used in a Clinical Trial will be dispensed and accounted for according to the study protocol Report any suspected adverse events associated with the Investigational Product to the sponsor, Principal Investigator (PI), research nurse coordinator, and Pharmacy (if applicable). Immediately. TRANSPORTING OF INVESTIGATIONAL PRODUCT 4.1 Transport investigational products from the storage area to the site of administration/ dispensing in appropriate packaging. STEP FOUR 4.2 Keep investigational product at the required temperature range as dictated in Investigator Brochure or Instructions for Use. 4.3 Chain of Custody of Investigational product must be maintained in the Accountability Log. 4.4 Any unused investigational product will be returned and recorded in the Accountability Log. RETURN/DESTRUCTION OF INVESTIGATIONAL PRODUCT Ensure that the investigational product is available for the monitor to inventory and prepare for return shipment to the sponsor or CRO. STEP FIVE 5.2 Investigational products may be destroyed on site per sponsor required instructions or Pharmacy policy. 5.3 The sponsor shall be provided with written documentation of the destruction of the investigational product. Page 4 of 5

5 5.4 A copy of the final disposition of Investigational Product will be maintained on site. RELATED DOCUMENTS Policy / Procedure Job Aids Related Medical Record Form(s) Form/Item # Regulatory Requirements Evidence Based Practice References 21 CFR 312, 21 CFR 812 This replaces all previous [SPP/APP/DPP] and all previous [SPP/APP/DPP] shall automatically terminate upon the effective date set forth above. Page 5 of 5