Definitions

Definitions for Corporate Clinical Trials Tracking System

Detailed definitions corresponding to the Center for Clinical Trials and Corporate Contracts (CCT) and University of Maryland Medical System (UMMS) steps specified for each project in the Corporate Clinical Trial Tracking System (CCTTS) are provided in the expandable sections below. Information about IRB states is covered in HRPP policies, SOPs and other documents. Please refer to CICERO and/or contact the HRPP with specific questions about IRB states.

The individual, specific steps for CCT and UMMS activities — explained below — are sequential and, therefore, reflect the relative stage of progression achieved within each process or an activity. For example, the CMS Device Approval steps occur progressively from “UMMS Input Required” through three intermediate steps (see below) until the final step “Approved.”

CMS Device Approval (UMMS steps)

UMMS Input Required: UMMS staff are reviewing the device protocol and related FDA correspondence provided by the sponsor to determine whether or not a CMS Device Approval is required.

Not Submitted, Awaiting IRB Approval: UMMS has determined that CMS Device Approval may be required and is preparing the required paperwork for submission to CMS. As IRB approval is a required component of the CMS Device Approval documentation, UMMS cannot submit the Device Approval application until IRB approval has been granted. At this point in the process, UMMS is awaiting written IRB approval.

Submitted: At this point in the process, the CMS Device Approval request has been submitted to CMS by UMMS. This request includes a copy of the written approval letter from the IRB.

Rejected: UMMS has received a formal rejection letter from CMS regarding the requested Device Approval. The clinical study cannot proceed in UMMS space without this approval. The study team and CCT are notified immediately by UMMS staff should a CMS application be denied.

Approved: UMMS has received a formal approval letter from CMS regarding the requested Device Approval. The clinical trial may proceed in UMMS space contingent upon completion of all necessary contracts, the CA, and budget. The study team and CCT are notified immediately by UMMS staff upon receipt of the CMS approval letter.

Study Feasibility Analysis (CCT steps)

CA Received by CCT: The Coverage Analysis (CA) performed by UMMS (or other site partners) has been received by CCT. CCT is currently reviewing the CA to identify specific cost elements attributed to the research components of the clinical protocol. CCT will complete its review of the CA within a few business days and begin developing an internal budget and/or total cost estimate for the study team.

Ancillary Service(s) Cost Requested by CCT: Using the CA as a guide, CCT has, at this point in the process, determined that one or more costs attributed to the research components of the clinical protocol are associated with Ancillary Services. Ancillary services include, but may not be limited to, IDS pharmacy, radiology, pathology, and other laboratory services that are required by the research protocol. During this time, CCT staff are corresponding with their counterparts in the IDS pharmacy, radiology, pathology, etc. The study team is notified should CCT encounter significant delays in the receipt of one or more ancillary cost estimates.

Internal Budget Development Progressing: This code indicates that the requested Ancillary Service(s) Costs have been received by CCT and CCT staff are in the process of developing the internal budget and/or cost estimate. Typically, CCT and study team staff require one to five business days to finalize the internal budget.

Internal Budget Proposed to Study Team: CCT has completed the Internal Budget and/or total cost estimate and provided documentation to the study team. The study team will, in turn, use the Internal Budget — in combination with enrollment projections, resource limitations, etc. — to determine the feasibility of pursuing the clinical trial opportunity.

Coverage Analysis (CA) (UMMS steps)

Request Received: UMMS staff have received a copy of the Clinical Trial Request Form from CCT. Receipt of the Request Form Questionnaire by UMMS staff is the initial step in development of the CA. Typically, the Request Form Questionnaire is received by UMMS within one business day of submission to CCT by the study team.

Information Requested: UMMS staff have reviewed the Request Form Questionnaire, compiled a list of study-specific information, documents and other input required to develop the CA, and submitted the list to the study team. At this point in the process, the study team should be collecting the requested information and providing it to UMMS. In most cases, UMMS completes its initial assessment and makes the information request within four business days of receipt of the Request Form Questionnaire.

Preliminary CA Issued: UMMS staff have received all of the requested information, reviewed and analyzed the information and protocol, and submitted an initial version CA to the study team for review. At this point in the process, the CA has been issued to the study team by UMMS and, upon review by the study team, UMMS and study team staff are working collaboratively to make modifications and improvements to the initial CA. The timeline goal for issuing the Preliminary CA — which is highly dependent upon receipt of requested information from the study team — is within four business days from the date of UMMS’s information request.

Final CA Issued: The Preliminary CA has been rigorously reviewed, analyzed and modified through collective efforts between UMMS and the study team staff. Subsequently, UMMS has developed and issued the Final CA to the study team and CCT. At this point in the process, budget development by CCT can begin in earnest. Typically, the Final CA is issued within four business days after issuance of the Preliminary CA — but is directly dependent upon study team response and cooperation.

Budget (External/Negotiated) (CCT steps)

CA Received by CCT: The Medicare Coverage Analysis (CA) performed by UMMS (or other site partners) has been received by CCT. CCT is currently reviewing the CA to identify specific cost elements attributed to the research components of the clinical protocol. CCT will complete its review of the CA within a few business days and begin developing an internal budget for the study team.

Ancillary Service(s) Requested by CCT: Using the CA as a guide, CCT has, at this point in the process, determined that one or more costs attributed to the research components of the clinical protocol are associated with Ancillary Services. Ancillary Services include, but may not be limited to, IDS pharmacy, radiology, pathology, and other laboratory services that are required by the research protocol. During this time, CCT staff are corresponding with their counterparts in the IDS pharmacy, radiology, pathology, etc. The study team is notified should CCT encounter significant delays in the receipt of one or more ancillary cost estimates.

Internal Budget Development Progressing: This code indicates that the requested Ancillary Service(s) Costs have been received by CCT and CCT staff are in the process of developing the internal budget. Typically, CCT and study team staff members require five business days to finalize the internal budget.

Internal Budget Proposed to Study Team: CCT has completed the Internal Budget and provided documentation to the study team. At this point in the process, the study team is reviewing and modifying the internal budget to reflect study team- and department-specific concerns including, but not limited to, resource limitations, enrollment expectations, etc. Study teams may make adjustments to the internal budget to ensure all anticipated UMB costs are covered AND that the budget will ultimately be acceptable to the sponsor. To keep the overall budget process moving on pace with the corresponding contract process, the study team should complete its review and modification of the Internal Budget within five business days.

Budget Negotiations Progressing: This code indicates that the study team and CCT have come to a mutual agreement with respect to the Internal Budget. At this point in the process, CCT has accepted the Internal Budget from the study team and proposed the budget (external) to the sponsor. Many clinical trial budget negotiations are completed within five to 10 business days. However, budget negotiations may involve: (1) multiple “cycles” of back-and-forth proposals and counterproposals and/or (2) significant deviations and changes from the UMB internal budget. Therefore, some negotiations may take up to 30 business days. The study team is notified should CCT encounter significant delays and/or other problems associated with the budget negotiation step.

Budget Final: This code indicates that CCT and the sponsor have reached mutual agreement on a final budget for the specific research protocol. The final budget is incorporated into the final contract and held until all of the following separate processes are complete: Budget Negotiation (CCT), Contract Negotiation (CCT), Facility Use Negotiation (UMMS), IRB Approval (UMB HRPP).

Two-Party Clinical Trial Agreement (CCT steps)

Draft Contract Accepted by CCT: This code indicates that CCT has received the draft contract provided by the sponsor and that CCT staff are in the process of redlining the document to accommodate UMB policies as well as state and federal laws and regulations. Typically, CCT requires five business days to redline the sponsor’s draft agreement and provide it back to the sponsor.

Contract Negotiation Progressing: At this point in the process, CCT staff and the sponsor are in the process of negotiating the terms of the contract. Many clinical trial contract negotiations are completed within 10 to 20 business days. However, because contract negotiations may involve multiple “cycles” of back-and-forth proposals and counterproposals, some negotiations may take up to 40 or 50 business days. The study team is notified should CCT encounter significant delays and/or other problems associated with the contract negotiation step.

Contract Execution Awaiting Other Required Components and Approvals: This code indicates that CCT and the sponsor have reached mutual agreement on a contract for the specific research protocol. The final contract and final budget are combined into a single document and held until all of the following separate processes are complete: Budget Negotiation (CCT), Contract Negotiation (CCT), Facility Use Negotiation (UMMS), IRB Approval (UMB HRPP).

Site/Facility Use Agreement (FUA) (UMMS steps)

Introductory Email Sent: At the outset of every clinical trial performed by UMB clinicians using UMMS space, UMMS equipment and/or other UMMS resources (e.g., IDS pharmacy), UMMS makes an initial determination, based on the protocol and the CCT Request Form Questionnaire, whether or not a UMMS Equipment and Facility Use Agreement (FUA) is warranted. Should UMMS determine that an FUA is required, UMMS sends an introductory email to the sponsor explaining: (1) why a UMMS Equipment and Facility Use Agreement (FUA) is required and (2) providing a WORD version of the required UMMS FUA template agreement for review and consideration by the sponsor. This code indicates that UMMS has made its initial determination and, if warranted, provided its introductory email to the sponsor. Typically, UMMS sends the introductory email to the sponsor within five business days of receipt of the Clinical Trial Request Form Questionnaire from CCT. Once the introductory email has been sent, UMMS is awaiting the initial response from the sponsor.

With Counsel: At this point in the process, the sponsor has responded with its first redline of the template provided by UMMS as part of the UMMS Introductory email. UMMS Counsel is reviewing the redlined document to determine those changes that UMMS can accept and those that it cannot accept as written by the sponsor. UMMS Counsel are charged with developing contracts that adhere to UMMS policies as well as State and Federal laws and regulations. Typically, UMMS Counsel requires five business days to redline the sponsor’s draft agreement and provide it back to the sponsor.

With Sponsor: This code indicates that UMMS Counsel has reviewed the sponsor’s initial redline of the FUA and responded with additional written modifications and/or rebuttals to the sponsor’s suggested language. At this point in the process, the FUA is with the sponsor and UMMS is awaiting a response. Many FUA negotiations are completed within 10 to 20 business days. However, because FUA negotiations may involve multiple “cycles” of back-and-forth proposals and counterproposals, some negotiations may take up to 40 or 50 business days. The study team is notified should UMMS encounter significant delays and/or other problems associated with the FUA negotiation step.

Signed/Fully-Executed: This code indicates that UMMS and the sponsor have reached mutual agreement on a FUA for the specific research protocol. The final FUA has been signed by UMMS and the sponsor and the agreement is in effect. Depending upon the sponsor’s requirements, the fully executed FUA may be (1) held as a stand-alone document or (2) incorporated as an addendum or attachment to the UMB-Sponsor Clinical Trial Agreement. In either case, the clinical trial cannot proceed until all of the following separate processes are complete: Facility Use Agreement negotiation (UMMS), Budget Negotiation (CCT), 2-Party Contract Negotiation (CCT), IRB Approval (UMB HRPP), CMS Device Approval (UMMS).

Three-Party Clinical Trial Agreement (CCT/UMMS steps)

Draft Contract Accepted by CCT: This code indicates that CCT has received the draft contract provided by the sponsor and that CCT and UMMS staff are in the process of redlining the document to accommodate UMB and UMMS policies as well as state and federal laws and regulations. CCT manages the back-and-forth with UMMS attorneys and UMMS staff involved in the contract negotiation process. Typically, CCT and UMMS require 10 to 20 business days to redline the sponsor’s draft agreement and provide it back to the sponsor.

Contract Negotiation Progressing: At this point in the process, CCT, UMMS, and the sponsor are in the process of negotiating the terms of the contract. Some three-party clinical trial contract negotiations are completed within 20 to 30 business days. However, because three-party contract negotiations often require multiple “cycles” of back-and-forth proposals and counterproposals, some of these negotiations may take up to 50 to 60 business days. The study team is notified should CCT and/or UMMS encounter significant delays and/or other problems associated with the contract negotiation step.

Contract Execution Awaiting Other Required Components and Approvals: This code indicates that CCT, UMMS, and the sponsor have reached mutual agreement on a contract for the specific research protocol. The final contract and final budget are combined into a single document and held until all of the following separate processes are complete: Budget Negotiation (CCT), Three-Party Contract Negotiation (CCT), IRB Approval (UMB HRPP).