Purpose: To describe the requirements for managing IP at the clinical site

Transcription

1 Title: Investigational Product Management Topic: Management of IP Effective Date: March 16, 2016 Approved By: Rita Hanson, M.D. Senior VP/Chief Medical Officer Purpose: To describe the requirements for managing IP at the clinical site Scope: This procedure applies to IP used in any clinical trial/human research conducted by the Clinical Research Department at any Wheaton Franciscan Healthcare facility in Wisconsin or Iowa. Procedure: Study team members will comply with a site s specific IP management policy if there is an active policy at that site. If the active site policy does not include procedures in this policy, the study team will follow this policy to the extent that the procedure is not covered by the active site policy. IP management includes proper handling, storage, and disposition. Accountability The PI or designee must maintain appropriate records as follows: 1. Receipt of shipment(s) 2 Inventory at the site 3. Dispensation/use by each subject 4. Disposition return to sponsor or disposal. These records should include the following: a. Name of IP b. Dates c. Quantities d. Batch/serial numbers (or other identifying code) The PI or designee will not use IP past its expiration date (if applicable) and contact the study sponsor regarding any IP with imminent expiration dates. Storage Protocol defined storage of IP with respect to temperature, humidity, lighting, and other Standard Operating Procedures Version: February 2016 Page 1 of 12

2 environmental considerations will be followed. IP will be stored in a secure area with limited access, in accordance with applicable regulatory requirements. IP will be labeled in such a way that they are not dispensed to patients outside of the intended investigational protocol. Temperature logs will be maintained per the sponsor s protocol or authorization to use the site s temperature logs. Deviations from the storage temperature requirements for IP must be recorded and reported to the study sponsor. The affected IP will be quarantined until the study team receives instructions from the sponsor. Dispensation and Administration IP will be dispensed to subjects only by qualified investigators or qualified study team members. Drug, infant formula, food supplements or food fortifiers that are being studied will only be dispensed to the subject upon receipt of an authorized investigator s order. For NCI-sponsored Oncology trials, the pharmacist or coordinator will verify that the ordering investigator is part of the IRB-approved study team. The pharmacist or coordinator will also verify that the ordering investigator is registered and active with the NCI prior to filling an IP order by: 1. accessing and entering the last name and investigator ID number to confirm active registration, or 2. CTEP registration using ctepreghelp@ctep.nci.nih.gov. If the IP is not ordered by a NCI registered and active investigator, the order must be co-signed or re-ordered by an investigator who is actively registered. In the event the IP is not ordered by, or not co-signed by, a NCI-registered investigator, the IP should not be dispensed to the subject and a study coordinator should be notified. If more than one location will be used for IP storage or dispensation, the sponsor will be notified and the Form FDA 1572 or Investigator s Agreement should accordingly reflect all locations. The PI or designee will follow the clinical trial s randomization procedures, if any, and ensure that the code is broken only in accordance with the protocol. The PI or designee will follow the clinical trial s blinding procedures, if any. Any incidence of unblinding will be reported to the sponsor. The PI or designee will ensure that the IP is used only in accordance with the approved protocol. The PI or designee is responsible for educating each subject regarding the correct use of the IP as defined in the protocol. Standard Operating Procedures Version: February 2016 Page 2 of 12

3 Study team members will provide only IRB-approved patient education materials and/or IP administration information to subjects. The PI or designee will maintain prospective records of study materials returned by each subject. Compliance will be assessed by review of returned IP for each subject. Lost or unreturned IP will be documented in source documentation and in the IP accountability log(s). Controlled Substance If the IP is subject to the Controlled Substance Act, the PI or designee will take adequate precautions, including storage of the investigational drug in a double-locked, well-constructed cabinet or enclosure with limited access to prevent theft or diversion of the substance into illegal channels of distribution. Investigators or designees will comply with Drug Enforcement Agency (DEA) regulations in addition to the FDA regulations and will obtain DEA registration for the controlled substance(s), if required. IP Site Change If IP is transferred from one site to another, the PI or designee will record: 1. IP lot number (or other applicable study identifier) 2. Transfer date 3. Quantity transferred 4. Name of the person receiving the IP 5. If the IP is not transferred through a Wheaton pharmacy, document the name of the person transferring the IP. Disposition of IP At sponsor-authorized intervals throughout a clinical trial, and at the conclusion of a trial, the sponsor representative(s) will conduct final accountability and reconciliation prior to IP return and/or disposition if possible. Otherwise, IP will be returned to the sponsor or destroyed according to the sponsor s instructions. Should the sponsor not provide instructions for return and/or destruction, a study team member will follow the study site pharmacy s standard operating procedures for product destruction. Please see Pharmacy policy and Procedure for further description. Documentation All IP accountability must be accurately recorded and filed with other supporting documents in study binders. Study staff will document IP receipt, use, disposition, return, destruction and all other accountability procedures, as required by the FDA, on sponsor provided forms. If the sponsor does not provide forms for such documentation, study staff will use the logs provided in this SOP or similar documentation that has been approved by the sponsor. Standard Operating Procedures Version: February 2016 Page 3 of 12

4 Responsibility: The PI is ultimately responsible for all aspects of the clinical trial that she/he directs, including the management and accountability of IP. The PI is responsible for authorizing individuals who may prescribe and/or dispense IP as applicable. The PI may delegate some or all of their duties for IP management and accountability to qualified site personnel who act under his/her supervision. Regulations/Guidelines CFR Title 21; Record Keeping and Record Retention CFR Title Disposition of Unused Supply of Investigational Drug CFR Title Control of Investigational Drug CFR Title Investigator Record Keeping and Record Retention CFR Title Handling of Controlled Substances CFR Title , Subpart G - Reports and Record CFR Title Labeling of Investigational Devices CFR Title Records ICH GCP Consolidated Guideline - Part 4.6 Investigational Product ICH GCP Consolidated Guideline - Part 4.7 Randomization Procedures and Unblinding Version No. 1.0 New document created (3/2009) Revision Description 2.0 Revised 12/2015; Including title change from Investigational Agent Management to Investigational Product Management 3.0 Revised 2/2016 Standard Operating Procedures Version: February 2016 Page 4 of 12

5 Investigational Product (IP) Accountability Record Wheaton Franciscan Healthcare Investigational Product Accountability Name of Institution: Page No. : IP Name: Protocol No.: Protocol Title: Storage Area: Principal Investigator s Name: PI/Coordinator/Designee Signature and Date: Line No. Date Patient s Initials Patient s ID No. Lot, Serial, Model No. or Other Identifier Quantity Dispensed or Received Balance Forward Amount Unused or Expired Comment (e.g., dose, etc.) Recorder s Initials Balance Standard Operating Procedures Version: February 2016 Page 5 of 12

6 Storage and Access Plan for Investigational Products that are Controlled Substances Investigational Product: Sponsor: STUDY INFORMATION Protocol No.: Investigator: Site: Location of IP Storage STORAGE AND ACCESS PLAN Office address: Room: Type of cabinet/container for IP: Check to verify that IP cabinet/container is: securely locked substantially constructed List of all people who have access to the key (including PI, Wheaton Franciscan Healthcare associates, and others if applicable): Comments: Signature and date by the Director of Wheaton Franciscan Healthcare Research Department indicating that he/she has reviewed, verified, and endorsed the above plan: Director of WFH Research Department Date Signature and date by the PI or organizational official under whose controlled substance license the drug is shipped (if the latter, the person signing must be a licensed pharmacist who works for that organization) indicating that he/she has reviewed, verified, and endorsed the above plan: Principal Investigator or Licensed Pharmacist Date Standard Operating Procedures Version: February 2016 Page 6 of 12

7 IntraSite Transfer Investigational Product (IP) Form Wheaton Franciscan Healthcare Investigational Product Accountability INSTRUCTIONS FOR TRANSFERS: 1. Properly complete all sections 2. Type or print all information one transfer per page; one protocol per page 3. Enter signature of individual preparing IP and receiving IP 4. Pack the IP well to minimize breakage and leakage for transfers 5. All IPs must be transferred per sponsor specifications for handling/transport 6. Enclose the completed list with the IP IP Transferred From Name of Institution: Street Address City/State/Zip Code PI Name: IP Transferred To Name of Institution: Street Address City/State/Zip Code Protocol No.: Sponsor IP Name Quantity (include units) Lot/Serial No. or other Identifier Comments (dosage, etc.) Departure Date/Time: Departure Temp: Arrival Date/Time: Arrival Temp: Reason for transfer: Dispensing to active subject Return from subject : Additional Comments: If not transferring IP through a Wheaton pharmacy, document the name of the person transferring IP. Name: Title: LOCATION TRANSFERING IP: Signature/Printed Name Investigator or Preparer: Date: LOCATION RECEIVING IP: Signature/Printed Name Investigator or Receiver: Date: Title: Phone No.: Title: Phone No.: Standard Operating Procedures Version: February 2016 Page 7 of 12

8 Return Investigational Product (IP) to Sponsor Form Wheaton Franciscan Healthcare Investigational Product Accountability INSTRUCTIONS FOR RETURNS: 1. Properly complete all sections 2. Type or print all information one item, lot, or protocol per line 3. PI or individual preparing this form signs this form 4. Pack the IP well to minimize breakage and leakage 5. All IP may be returned via room temperature shipment unless otherwise specified, but must be transferred per sponsor specifications for handling/transport 6. Enclose this completed form with the IP Site Name: Site Address: Check here if a returned receipt/confirmation should be mailed to the above address. Otherwise provide fax number for return receipt: Protocol Name/No.: Site No: PI: Airbill No.: Address of Location Receiving IP: IP Name Quantity (include units) Lot/ Serial No. (or other ID) Strength, Dose or Description Signature and Title of Person Preparing IP for Return Signature and Title of Person Receiving IP Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired Reason for return: All subjects off treatment IP expired LOCATION RETURNING IP LOCATION RECEIVING IP Signature of PI or Preparer: Phone No.: Signature of Receiver Return receipt sent to site by mail or fax. Title: Date Returned: Title: Date received: Standard Operating Procedures Version: February 2016 Page 8 of 12

9 Investigational Product (IP) Destruction Record Wheaton Franciscan Healthcare Investigational Product Accountability Name of Institution: Page No. Protocol No. IP Name: Protocol Title: Principal Investigator Name: Personnel Authorizing Destruction/Return: Destruction Location/Return Destination: PI/Coordinator/Designee Sign and Date: Line No. 1. Date Dose, Bottle or Lot # Quantity Destroyed/ Returned Balance Forward Balance Recorder s Initials Standard Operating Procedures Version: February 2016 Page 9 of 12

10 TEMPERATURE MONITORING LOG IRB #: Study Name: Location of measurement instrument: Standard Operating Procedures Version: February 2016 Page 10 of 12

11 TEMPERATURE MONITORING LOG IRB #: Study Name: Location of measurement instrument: o F o C Temperature Date Initial Temperature Date Initial Standard Operating Procedures Version: February 2016 Page 11 of 12

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