AIDS CLINICAL TRIALS GROUP (ACTG)

Transcription

1 AIDS CLINICAL TRIALS GROUP (ACTG) Network Standard Operating Procedure Title Specimen Archiving Approval Process for ACTG Non-priority Protocols SOP number ACTG-145 Effective: 10/15/2018 Version 7.0 Last reviewed: 09/17/2018 Originator ACTG Network Coordinating Center Page 1 of PURPOSE This Standard Operating Procedure (SOP) describes procedures to be followed to identify specimens and acquire approval for specimen archiving from non-priority AIDS Clinical Trials Group (ACTG) protocols. 2.0 SCOPE This SOP directly affects all specimens collected and stored for ACTG protocols. Multiple groups within the ACTG are involved in the specimen archiving approval process including, but not limited to, ACTG protocol teams, Laboratory Science Group (LSG), Data Management Center (DMC), Repository Advisory Group (RAG), Transformative Science Group (TSG), and Scientific Agenda Steering Committee (SASC). 3.0 DEFINITIONS ACTG: AIDS Clinical Trials Group ACTG non-priority eligible studies: Protocols that have been concluded for 5 years or more, with analysis concluded, and are considered by the Scientific Agenda Steering Committee (SASC) and Transformative Science Group (TSG) as eligible for specimen archiving at the ACTG specimen biorepository and at the clinical research sites. ACTG concluded studies: Protocols in which the participants are off study, data entry screens are closed, and all analysis is concluded. Archiving: Identification, organization, and collection of specimens from ACTG nonpriority eligible studies to be stored at the Biorepository. Biorepository: Collects, processes, stores, and distributes biological specimens to support scientific investigations. DMC: Data Management Center Institutional Review Board (IRB): A group formally designated to protect the rights, safety, and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. LDM: Laboratory Data Manager LSG: Laboratory Science Group RAG: Repository Advisory Group, a cross-network oversight committee for site, laboratory, and biorepository specimen logistics. SASC: Scientific Agenda Steering Committee SDAC: Statistical and Data Analysis Center TSG: Transformative Science Group

2 Page 2 of RESPONSIBILITIES 4.1 Laboratory Science Group (LSG) The LSG generates an initial report of eligible studies. This list becomes the list of studies eligible for archiving, which is reviewed by the Repository Advisory Group (RAG). Sends Archiving Notification to the protocol chairs regarding what protocol (and what corresponding sub-studies) specimens have been recommended for archiving. Reviews and summarizes protocol chair responses and shares with the Data Management Center (DMC). Communicates with Transformative Science Group (TSG) for review and approval of specimen archiving plans (protocols with specimen types and time point selections). Notifies the Scientific Agenda Steering Committee (SASC) when TSG approval has been granted. Creates and tracks relevant specimen archiving documentation. Summarizes specimen archiving plans for approval by the Network Laboratory Center Principal Investigator. Provides network leadership with specimen archiving information as needed. 4.2 Repository Advisory Group (RAG) Reviews the list of protocols identified for specimen archiving. Discusses and resolves issues concerning archiving plans during monthly conference calls. 4.3 Data Management Center (DMC) Proposes specimen types and time points to be saved for each study that meets the criteria to be archived. Prepares and sends specimen shipping requests for sites to ship to the ACTG biorepository, and tracks the progress of those shipments. Prepares specimen destruction lists for the ACTG biorepository. 4.4 Protocol Chair(s) Grants permission to initiate the archiving process for the study by selecting one of the following archiving options: Allows all specimens to be destroyed Allows the DMC to select the specimen type and time points for archiving Requests specific specimen type(s) and/or time points for archiving 4.5 Statistical and Data Analysis Center (SDAC) Assigns a statistician, as needed, to work with the Laboratory Data Manager (LDM) to develop a list of specimens (i.e., participant identifiers and specimen dates) to be archived per study. 4.6 Transformative Science Group (TSG) The TSG reviews and provides written approval of specimen disposition plans (based on responses received from protocol chairs and input from the DMC and RAG).

3 Page 3 of 6 If concerns arise, the TSG will communicate with the RAG, via the LSG, to resolve any issues. 4.7 ACTG Biorepository Destroys specimens and consolidates inventory for archived studies. 5.0 PROCEDURES 5.1 LSG Generates List of Eligible Studies The LSG generates a list of non-priority studies eligible for archiving: protocols that have been concluded for 5 years or more, with analysis concluded, and are considered by the Scientific Agenda Steering Committee (SASC) and Transformative Science Group (TSG) as eligible for specimen archiving at the ACTG specimen biorepository and at the clinical research sites. 5.2 RAG Reviews and Approves List of Eligible Protocols The LSG sends the list of non-priority studies to the members of the RAG. If concerns arise, they are discussed during the monthly RAG conference call. The RAG chair provides written approval for the list of proposed studies for archiving to the LSG. 5.3 Archiving Notifications The LSG generates protocol archiving notifications and relevant specimen inventory reports for each study. Archiving notifications with the reports (generated from DMC portal) are sent to the protocol chairs (Appendix I - Sample Archiving Notification Template). Protocol chairs may decide to discard all specimens or choose to proceed with arching. 5.4 DMC Selects Specimen Types and Time Points If the protocol chairs choose to archive the study, the DMC will review their response together with the available inventory and propose an archive plan for each study. This includes the specimen types, time points, and number of aliquots to save (usually four or less). 5.5 TSG Approves Specimen Archiving Plans The LSG generates a summary for each TSG to review specimen archiving plans based on responses received from protocol teams and DMC input on specimens. (Appendix II - TSG Notification of Archiving Review and Approval Template). The TSG will provide concerns and/or approval for specimen archiving plans to the LSG. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the TSG (and protocol teams, if necessary). 5.6 SASC Notification The LSG will provide notification to the SASC of archiving plans (including DMC and TSG input) once TSG approvals are granted. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the TSG (and protocol teams, if necessary).

4 Page 4 of Final Archiving Approval The LSG will generate an Archiving Approval summary document for the Network Lab Center Principal Investigator to approve. This summary contains relevant information such as the date of initial RAG approval, list of protocols, protocol team responses, DMC selection of specimen types and time points, and TSG approval. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the Network Lab Center Principal Investigator. The Network Lab Center Principal Investigator provides written approval. 5.8 DMC Generates Shipment and Destroy Inventory Lists The DMC generates and distributes inventory lists for each clinical research site, which identify the specimens to ship to the biorepository. The DMC also generates and distributes an inventory list for the biorepository, which identifies specimens for long-term storage or destruction. When all specimens for a study have been shipped to the biorepository, the DMC will notify the LSG. The LSG will then inform the sites to destroy the remaining specimens for that study. Specimens that are testing remnants, located at closed or defunded laboratories, or collected from defunded international sites will not be requested for shipment and may be added to the Destroy Inventory list. 5.9 Regular Status Updates The DMC and biorepository destroy specimens and consolidate inventory for archived studies according to the DMC instructions. The DMC and biorepository will provide regular updates to the RAG and the ACTG Network Lab Central Principal Investigator Document Retention The LSG will store relevant documents and records in the ACTG portal for the RAG. Revision Summary Item Section Version Date Reason for Revision All sections 6.0 to 7.0 8/8/2018 All sections have been content updated to reflect the new process for specimen archiving and SASC directives on communication with the ACTG TSGs and SASC.

5 APPENDIX I SAMPLE ARCHIVING NOTIFICATION TEMPLATE Page 5 of 6 Date: Month Day, 2018 To: Protocol Chair, Protocol Co-Chair, and Protocol Vice Chair From: Grace Aldrovandi, MD, ACTG Laboratory PI Subject: ACTG XXX or A5XXX Protocol Archiving Notification The AIDS Clinical Trials Group (ACTG) Repository Advisory Group (RAG) has identified the protocol ACTG XXX or A5XXX (Full Study Title) as a candidate for archiving. As a study chair of the protocol, please complete the form by clicking the link below: rbodwcnref1zw/viewform. You will be asked to choose from the following options: 1) allow the remaining specimens to be destroyed, 2) allow the Data Management Center (DMC) to select the specimen type and time points, or 3) request specific specimen type(s) and/or time points to be archived. ACTG XXX or A5XXX has approximately ##### specimens in storage at the Biomedical Research Institute (BRI) Repository and ##### specimens in storage at the study sites. For additional information, refer to the attached specimen inventory reports. The completed form is due Month Day, After the due date, there is no guarantee that specimens will be saved in the repository for future use. If you choose to archive any specimens, your request will be sent to the Transformative Science Group (TSG) for review and approval. Please direct archiving questions to the RAG Coordinator, Heather Brand (hbrand@s- 3.com), and LDMS Project Coordinator, Alex Benns (benns@fstrf.org), at the DMC. Cc: Network Lab PI RAG Chair Sender Lab Science Group Manager FSTRF/DMC

6 Page 6 of 6 APPENDIX II TSG NOTIFICATION OF ARCHIVING REVIEW AND APPROVAL TEMPLATE Date: Month Day, 2018 To: TSG Chair, TSG Vice Chair, and NCC Coordinator From: ACTG Laboratory Science Group Subject: Please Respond: TSG Notification of Archiving Review and Approval Per the Scientific Agenda Steering Committee (SASC), as of July 10, 2018, the AIDS Clinical Trials Group (ACTG) Transformative Science Group (TSG) is being asked to review and approve the proposed specimen types and time points to be archived. The TSG can also choose to destroy all specimens for any of the protocols listed, or provide its own proposed specimen types and time points to be archived. The ACTG Repository Advisory Group (RAG) has identified the following protocols as candidates for specimen archiving. Please see the attached spreadsheet. We have separated the protocols by Responders and Non-responders (Protocol Chairs that have responded and not responded to the Protocol Archiving Notifications). TSG Chairs will choose one of the following selections for the Responders: 1) Approve Protocol Chair specimen types and time points to be archived. 2) Approve Specimen Destruction for all specimens. 3) Approve Data Management Center (DMC)-suggested specimen types and time points to be archived. 4) Have TSG give an alternative suggestion for specimen types and time points to be archived. TSG Chairs will choose one of the following selections for the Non-responders: 1) Approve Specimen Destruction for all specimens. 2) Approve DMC-suggested specimen types and time points to be archived. 3) Have TSG give an alternative suggestion for specimen types and time points to be archived. Please direct archiving questions to the RAG Coordinator, Heather Brand (hbrand@s- 3.com), and LDMS Project Coordinator, Alex Benns (benns@fstrf.org), at the DMC. Cc: Network Lab PI RAG Chair Sender Lab Science Group Manager FSTRF/DMC