AIDS CLINICAL TRIALS GROUP (ACTG)
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1 AIDS CLINICAL TRIALS GROUP (ACTG) Network Standard Operating Procedure Title: Development and Finalization SOP number ACTG-105 Effective: 07/28/2015 Version 17.0 Last reviewed: 07/09/2015 Originator ACTG Network Coordinating Center Page 1 of Purpose This SOP provides requirements for the development and finalization of a study protocol including identification of the sites at which the study will be conducted. 2.0 Scope and Policy 2.1 Scope This SOP applies to all ACTG studies and substudies and includes procedures from Concept Proposal (CP) approval through the distribution of the final protocol to appropriate sites. 2.2 Policy Team leadership: A single investigator should be appointed as the lead protocol chair if at all possible to ensure momentum. A junior investigator, with appropriate support, could be appointed a lead protocol chair. No more than three investigators (e.g., one protocol chair and two vice chairs to allow for mentoring of junior/international investigators) may be assigned by the Scientific Committee (SC) leadership to the team leadership unless approved by the Scientific Agenda Steering Committee (SASC). Substudies o Substudies that were not included in the original study proposal must be submitted as new proposals per the SOP ACTG-150, "Concept Proposal Submission and Review Process. o Approved substudies may be incorporated into an existing protocol document or developed as separate stand-alone documents depending on the status of the main study. If a substudy is incorporated into the main study, the team should make every attempt not to slow down the development of the main study. o A substudy chair and statistician must be assigned to oversee development and analysis of the substudy and may or may not be the same as those on the main study. Design changes o Significant changes in study design should be reported to the SC and SASC during development and prior to routine Stage 3 review. Reviews from SC and SASC on significant changes and team response to the reviews should be submitted to the CSRC within the CSRC submission package. All issues should be resolved at the time of the CSRC. o Major design changes may not be made after final team sign-off without resubmitting the protocol to the relevant SC, SASC, and Division of AIDS (DAIDS) Clinical Science Review Committee (CSRC) for reconsideration. Meetings and calls: Conference calls should be conducted in accordance with the ACTG conference call guidelines posted on the ACTG Website. Face-to-face
2 Page 2 of 10 meetings may be held at ACTG meetings or, if justified and approved by the ACTG leadership, they may be held at another appropriate venue or Web calls may also be conducted as warranted. Timelines (See Appendix I) development timelines should be monitored by the team and the assigned SC, with appropriate and concurrent investigator collaboration, to ensure that protocols are developed rapidly and efficiently. o Standard: Expected timeframe for the development and implementation of most ACTG studies. Deviations must be reported to the SC and SASC. o Expedited: SASC approval needed for this designation. Studies that propose to address a key and timely question in HIV pathogenesis and/or treatment and that will have a high impact and require evaluation within a stringent timeframe should develop using the expedited timeline. The question must be defined, focused, and limited in scope and complexity; proposing investigator(s) must be highly committed and have sufficient time, resources, and institutional support to realistically complete protocol development quickly. 3.0 Definitions 3.1 Concept Proposal (CP): Research proposal from ACTG or non-actg investigator submitted for approval to be developed as an ACTG protocol. 3.2 : chair(s), vice chair(s), statistician(s), and clinical trials specialist (CTS). 3.3 Core Team: plus other team members, as determined by team leadership, such as the data manager(s), laboratory data coordinator, laboratory technologist, DAIDS clinical representative, DAIDS pharmacist as appropriate, field representative, Community Scientific Subcommittee (CSS) representative, and specialist investigators as appropriate (eg, immunologist, virologist, pharmacologist, neurologist). 3.4 : Contributors to the development and oversight of implementation of the study protocol. Refer to Handbook for description of specific duties and roles. Team includes: Core Team Optional team members: industry representative(s), investigator(s), site investigator(s), consultants, and representatives from other NIH institutes or networks as appropriate 3.5 Handbook: Guidelines for protocol development and implementation of ACTG studies; found on the ACTG member website. 3.6 Scientific Committee (SC): Review committee that is either a Transformative Science Group (TSG) or Collaborative Science Group (CSG) or Subcommittee of a TSG. 3.7 Team Sign-off: Official approval of a draft and final protocol document signifying completion of all protocol sections, including the sample informed consent (SIC) form
3 Page 3 of 10 and any appendices or a study-specific Manual of Procedures (MOPS). 4.0 Responsibilities 4.1 SC and SASC Solicit, review, and prioritize protocols that address research questions within the ACTG scientific research agenda Evaluate financial, laboratory, personnel, and study participant resources and identify barriers to protocol development and implementation Replace protocol team members if they are not fulfilling their team responsibilities or protocol development progress is not timely At the time of concept proposal approval, determines whether the study should be site limited or open to all sites. Also determines whether non-actg Network sites may participate. (See ACTG SOP 159, Site Selection) 4.2 SC Assigns the protocol chair(s)/co-chair(s) and vice chair(s); provides guidance to protocol team Reviews and approves investigators added to the protocol team; ensures that the size of the team is appropriate Oversees protocol development and finalization; monitors progress and issues Reviews and coordinates study product and funding requests from team Conducts interim and final scientific protocol reviews Determines protocol disposition in the event that timelines have not been observed or due to a change in ACTG scientific priority Ensures that a protocol initiation review (PIR) is conducted (see ACTG SOP 124, Study Data and Safety Monitoring Review for details) 4.3 SASC Conducts interim and final protocol and budget reviews and gives final protocol approval Assesses the scientific priority of protocols in relation to the overall ACTG scientific agenda In consultation with the protocol team and SC, assigns a protocol type (eg, interventional vs. observational) 4.4 CSRC Conducts the review of DAIDS funded and sponsored clinical trials and other studies meeting DAIDS Review Criteria. The review is conducted to assess scientific merit, participant safety, and to identify any ethical and regulatory issues to be addressed. 4.5 Has primary responsibility for directing protocol development, ensuring accuracy, consistency, efficiency, and quality Ensures adherence to protocol timelines and tasks Writes protocol sections and/or assigns sections of protocol to be written by team members; conducts ongoing reviews of all protocol drafts Responds to SC, SASC, and CSRC protocol review comments Presents the protocol design during SC and CSRC review
4 Page 4 of 10 Makes final decisions for protocol content at final team sign-off, with input from SC and SASC Provide training and/or develop training materials 4.6 Completes writing assignments as designated and provides ongoing review of and input to protocol document Signs off on protocol and provides comments at designated development time points and within timeframe set by team leadership Assists in preparation for implementation of the study at sites 5.0 Procedures and Development Process (Timeline can be found in Appendix I.) STAGE RESPONSIBLE PARTY ACTIVITY Scientific Committee (SC) Initiation (Pre Stage One) Team Formation Stage One Initiation of Development Statistical and Data Analysis Center (SDAC) ACTG Network Coordinating Center Appoints or approves protocol chair(s) and vice chair(s) and team leadership Oversees protocol initiation, pharmaceutical contacts, approves timeline Assigns protocol statistician(s) Assigns protocol number and CTS CTS schedules initial team leadership conference call and develops initial timeline, development plan, and initial protocol draft from the concept proposal using the approved ACTG protocol template Discusses timelines and assignments Plans and develops initial drafts of protocol document Provides written responses to SC and SASC concept proposal review comments and addresses these in protocol development Prepares document for CSRC Early Draft review (includes background and rationale (including safety information), schema, study design, primary objectives, eligibility criteria, study intervention, proposed schedule of events, and statistical consideration, including endpoints) If applicable, initiates negotiations with industry for study agent provision and/or support for assays/procedures, etc.; informs SC of any discussion with industry regarding proposed support or any issues or delays with study agent procurement Adds specific team members as needed for early study development CSRC DAIDS Office for Policy in Clinical Research Operations Clinical Trials Agreement Team (OPCRO CTAT) Conducts early review; provides comments and a review decision, (Approved for continued development, approved for continued development and implementation without additional CSRC Review, decision deferred pending revision and resubmission, and not approved for further development). Initiates negotiations of clinical trials agreements (CTA) with industry collaborators at the request of the Study Team, if the industry collaborator will provide the study drugs Initiates negotiations of the Confidential Disclosure Agreements
5 Page 5 of 10 STAGE RESPONSIBLE PARTY ACTIVITY (CDA) with the Industry collaborators at the request of the Study Team Stage Two Completion of Development ACTG Network Coordinating Center ACTG Network Coordinating Center Community coordinator distributes draft protocol to members of clinical research site (CRS) Community Advisory Boards (CABs) for feedback after initial CSRC review submission (for limited site studies, protocol draft sent to appropriate CABs); CABs are expected to provide feedback within 30 days CTS sends site survey to all ACTG-affiliated CRSs as appropriate for site-limited studies Considers CSRC review comments Reviews timelines and goals with full team; identifies potential delays (and discusses strategies to solve them) in protocol development, keeps SC and SASC informed of delays Plans and assigns protocol writing tasks Ensures completion of all protocol sections by team members Determines when additional members are added to team based on stage of protocol development and contribution needed (Refer to Handbook for team member roles/responsibilities.) Reviews all protocol drafts and comments, arbitrates conflicting comments, and decides which revisions are to be incorporated into the next draft of the protocol document Requests, reviews, and approves protocol budget and justification prior to submission to SC Provides budget to ologists, if appropriate, and others designated by SASC Contacts DAIDS to initiate CDA when study treatment includes an unlicensed medication. This should occur as soon as the protocol number has been assigned. The investigator brochure (IB) must be available to DAIDS prior to submitting for CSRC review. CTS: Coordinates team calls/meetings as needed, schedules web or face-to-face meetings if appropriate (Note: Tasks may be completed via conference calls, web meetings, portal, and/or e- mail correspondence.) Prepares and distributes protocol drafts, and other supporting documents such as a MOPS Requests budget and funding request/justification upon completion of schedule of events Submits revised protocol and supporting documents to SC and SASC for reviews Monitors overall study development timeline, prompts the team about developmental milestones LOC Budget and Finance Team: Prepares protocol budget for team review and approval NCC Clinical Manager, Medical Editor: Conducts quality reviews of protocol and supporting documents. NCC Site Support Group and Laboratory Support Group: As applicable, work with sites to ensure their readiness to conduct the study.
6 Page 6 of 10 STAGE RESPONSIBLE PARTY ACTIVITY (Team + all other team members) Develops and completes all protocol sections and appendices as assigned Reviews each protocol draft and provides comments to the CTS as soon as possible after distribution of the draft Participates in conference calls or web meetings as needed to accomplish tasks Completes incorporation of approved substudies, as necessary Incorporates changes based on committee review comments and team member feedback Considers CAB feedback that CSS representative has collected Considers selection of participating sites (US and non-us sites). Completes Sample Informed Consent form Initiates laboratory processing charts (LPCs) and MOPS as required Data Manager Initiates draft study-specific case report forms (CRFs) Develops draft eligibility checklist and prescription file Selects appropriate generic forms As applicable, works with non-network sites to develop an Data Manager and Laboratory Data Coordinator SDAC Statistician(s) appropriate method for data transfer. Develops laboratory-related tracking and data transfer mechanisms (forms/electronic transfer) Completes section 9.0 draft (Statistical Considerations) Submits study for final SDAC internal review With input from the Medical Officer, confirms the form of an interim monitoring group (eg, DSMB, formal SMC, or protocol core team); outlines the monitoring plan in the protocol document Schedules initial DSMB review for studies to be monitored by NIAID DSMB Sign-off Stage Three Committee Reviews DAIDS Pharmacist SC and SASC: (See Appendix II) DAIDS CSRC (See Appendix II) Development and Implementation Subcommittee (PDISC) Completes section 5.0 draft (Study Treatment) Generates letter to pharmaceutical supporters providing estimates of study supply needs Notifies protocol chairs and CTS of any potential issues or delays Conducts complete review of protocol and supporting documents; incorporates all changes into document Drafts response letters summarizing the team response to all comments or required elements from previous SC, SASC, and CSRC reviews for submission with protocol for Stage 3 reviews Submits all documents for SC and SASC review Review and signs off on protocol budget Conducts final review of protocol, MOPS (if developed), and budget/funding request (SC and SASC) Ensures needed supplemental committee reviews are completed Addresses SC and SASC comments; then forwards revised protocol document and response letters for CSRC Review of Near Final Draft Conducts CSRC Review of Near Final Draft Reviews the draft protocol version that is sent for CSRC Review of Near Final Draft (and CRFs, if available) The PDISC leadership sends written comments to the Field
7 STAGE RESPONSIBLE PARTY ACTIVITY Representative within 2 weeks ACTG SOP Page 7 of 10 Stage Four Changes Final Team Sign-Off Finalization Regulatory Review DAIDS MO Final Sign-Off Outreach and Retention Subcommittee Chair ACTG Network Coordinating Center RSC and Regulatory Affairs Branch (RAB) and Team DAIDS Clinical Representative/Clinical Monitor (Medical Officer) CTS Develops study recruitment flyer Reviews draft CRFs and LPC Finalizes MOPS, if applicable Plans for acquisition and distribution of laboratory reagents Refines laboratory processing and shipping instructions Establishes and confirms laboratory data transfer mechanisms Determines whether participant education materials are needed Develops materials for protocol-specific web page (PSWP) If necessary, develops criteria for a written site implementation plan prior to site activation statistician notifies SC coordinator to schedule SMC protocol initiation review for studies monitored by an ACTG SMC Addresses comments from CSRC Review of Near Final Draft Incorporates changes based on PDISC feedback Makes changes to protocol, CRFs, LPC, MOPS, and randomization materials as needed Prepares response to the final committee review comments Reviews and signs off on final protocol draft Clarifies and finalizes issues arising prior to final protocol sign-off Ensures sign-off by all team members occurs within 1 week Decides on the inclusion of final comments into the protocol in collaboration with protocol team leadership Conducts quality review of protocol Submits REG version of protocol and MOPS to the Regulatory Support Center (RSC) for regulatory review (RSC may not review MOPS, but may submit it with the protocol to the Food and Drug Administration [FDA]) Sends Site Draft protocol (with SIC removed) to eligible sites so that they may begin preparations for protocol implementation RSC reviews REG version of the protocol and provides comments to DAIDS RAB RAB reviews RSC comments, provides additional comments as appropriate RSC compiles all regulatory comments and forwards to CTS RAB and RSC begin final assembly of Investigational New Drug (IND) application package for the FDA, if applicable Incorporates regulatory comments, as appropriate, into protocol and SIC CTS submits written response to REG comments with MO (medical officer) version of the protocol for MO sign-off Reviews MO version and signs off Incorporates MO comments into document Submits final protocol (with MOPS, if requested) to RSC
8 Page 8 of 10 STAGE RESPONSIBLE PARTY ACTIVITY As applicable, ensures that the Site Support Group is aware of any special requirements that must be met before sites can be activated (see SOP ACTG-154). DAIDS RAB Final Sign-Off Distribution RSC/RAB DMC ACTG Network Coordinating Center For IND study, submits to FDA along with IND package Informs CTS of date of FDA submission for IND studies Notifies CTS if study is determined to be non-ind Completes final review of LPC, MOPS, and CRFs Prepares for study opening (see SOP ACTG-153) Conducts final quality assurance of the CRFs and randomization materials Ensures that final protocol is posted to ACTG web page Notifies sites that protocol is available for downloading 6.0 References SOP ACTG-150, "Concept Proposal Submission and Review Process ACTG Template on the ACTG Member Website at» ACTG» Global Support Documents Handbook on the ACTG Member Website at» ACTG» Global Support Documents» Handbook: SOP ACTG-153, " Opening and Conduct SOP ACTG-154, Activation for ACTG Clinical Research Sites (CRSs) ACTG Conference Call Guidelines on the ACTG Member Website at» ACTG» About ACTG» Operating Policies» Guidelines SOP ACTG-159, Site Selection 7.0 Inquiries Questions and comments regarding this policy may be directed to the ACTG Network Coordinating Center at: ACTG SOP@s-3.com
9 Appendix I: Development Stages and Timeline ACTG SOP Page 9 of 10 Stage Milestones Standard Expedited Pre Stage One Stage One Initial Development Stage Two Completion of Development Sign-off Stage Three Committee Reviews (SC, SASC, others as needed) Changes CSRC Review Stage Four Changes Final Team Sign-Off Finalization Regulatory Review Changes DAIDS MO Final Sign- Off Changes RAB Final Sign-Off Distribution to Sites CP approved by SASC to first team leadership call First team leadership call to submission CSRC Early Draft Review Distribution of CAB draft to request for team sign-off Request for team sign-off to all comments incorporated All comments incorporated until SASC review complete SASC comments received to submission for CSRC review Submission for CSRC review to receipt of CSRC comments Receipt of CSRC comments to team sign-off start Team sign-off start to team sign-off complete Submit for REG review to REG comments received REG comments received to submit for MO review Submit for MO review to MO comments received MO comments received to submit to RAB Submit final to RAB to notified of RAB sign off Notified of RAB sign-off to distribution to sites 2 weeks 2 weeks 6 weeks 2 weeks 6 weeks 3 weeks 2 weeks 1 week 2 weeks 1 week 2 weeks 1 week 4 weeks 4 weeks 2 weeks 1 week 2 weeks 1 week 2 weeks 2 weeks 1 week 1 week 1 week 1 week 1 week 1 week 1 week 1 week 1 day 1 day
10 Version 16.0, TBD Page 10 of 10 Appendix II: Stage 3 Committee Reviews Stage 3 SC Review SC Ensures that secondary committee reviews required by the SASC are completed prior to assignment and scheduling of final SC review. These reviews should occur concurrently, if possible. SC Reviews near-final protocol as soon as possible after submission for review. The SC is provided with the protocol document, reviews and team responses, the budget and budget justification, and any request for use of Implementation Funds. Ensures rationale, study design, and objectives are still scientifically relevant and of high priority Ensures appropriate funding sources for evaluations and assays have been identified Ensures team s recommendation for central testing laboratories is justified; or recommends alternatives to the SASC. Recommends study disposition to the SASC. A point scale of 1-5 is used to determine the priority score for approval of protocols for implementation. A median score of 1.9 or below signifies approval, 2.0 and greater indicates an issue or issues exist which must be addressed prior to moving forward for final SASC review: 1 = outstanding, 2 = excellent, 3 = very good, 4 = good, 5 = fair Provides a written review to the SASC, specifying major and minor comments for the team to consider addressing as the protocol is being finalized. If the SC determines that the protocol requires significant revisions and/or received a score of 2.0 or greater, the SC will provide a written review directly to the team. The team must then respond to the review, and the SC will review the response and latest draft prior to SASC review. Stage 3 SASC Review Conducts final review of the protocol immediately after the SC review and determines on behalf of the ACTG Executive Committee whether the protocol should be implemented within the ACTG. Evaluates the scientific priority, rationale, study design, analysis, timeliness, feasibility, quality, and resource utilization and makes the final decision regarding implementation. Provides written comments based on its review (and the SC review) to the team, generally within 1 week, specifying major comments that must be addressed by the team and minor comments for the team to consider addressing as the protocol is being finalized. Stage 3 CSRC Review of Near Final Draft Conducts review of the Near Final Draft with all the sections completed, any changes required by the SASC and no plans to make major changes. Provides CSRC Review Decision (approved for finalization and implementation, decision deferred pending resubmission to the CSRC, not approved). Provides written comments to the team. All major comments should be addressed and a revised protocol document submitted for regulatory review or resubmitted for CSRC based on the CSRC Review Decision. If the protocol is approved from finalization and implementation or resubmitted to the CSRC for further consideration.
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