Clinical Trial Workflow
Establishing a clinical trial at SBU requires the coordination of the efforts of several offices, including the PI’s office, Intellectual Property Partners(IPP), the Clinical Trials Office (OCT), Office of Sponsored Programs (OSP), Office of Grants Management (OGM), and the Office of Research Compliance (ORC).
When a PI receives a request from a sponsor to participate a clinical trial, s/he must evaluate the materials provided by the sponsor to determine if it is feasible to perform the work at SBU. If the sponsor requires that a confidentiality or non-disclosure agreement be in place before it will send the materials to the PI, the PI must work with IPP. If a CDA/NDA template is received from the sponsor, it must be forwarded to firstname.lastname@example.org with a copy to OCT and OSP.
Factors that the PI should consider in determining whether a trial can be successfully conducted at SBU include subject population, staffing, financial feasibility, and academic significance.
If a PI decides to proceed with a trial, the PI needs to simultaneously inform the other parties responsible for bringing the study to SBU:
- Send the contract, protocol and sponsor contact information to OSP via email@example.com or myResearch Agreements.
- Submit the protocol package to ORC.
- If the study is sponsor initiated, the PI sends the protocol, CTA and budget materials to Silvia Muniz in OCT. Investigator initiated studies are negotiated between PI/study coordinator and sponsor. OCT may be able to provide input.
- Once the budget is approved, OCT advises department PI/study coordinator and OSP. At that time, PI/study coordinator must route an internal myResearch Grants proposal for institutional approval to proceed with the trial. Proposal must include FINAL budget approved by OCT.
- If not already complete and if applicable, submit any applicable conflict of interest disclosures to ORC (attn.: Susan Gasparo).
The major tasks and the parties responsible for each are outlined below. In most cases, these tasks can be completed concurrently. Note that all the following tasks must be complete before the contract can be signed by the Office of Sponsored Programs.
The myResearch Grants proposal must be signed and routed electronically by the PI or authorized delegate for signatures by the departments and schools/colleges involved.
All investigators named in the proposal must have an up-to-date conflict of interest disclosure on file with ORC.
A fully approved myResearch application is needed in order for ORC to proceed with the internal review of the protocol and referral to Advarra.
Budgeting and budget approval
PIs/study coordinators must contact OCT in order to receive assistance with budget preparation and negotiation. https://osa.stonybrookmedicine.edu/octs/contact-us
Effective May 1, 2018 the Office of Clinical Trials fee charged to sponsors is $1000 per study. This fee does not apply to federally-funded studies or investigator-initiated studies (SBU investigators).
- To track all industry-funded clinical trials in order to assess the feasibility of the study and resources needed.
- To review sponsor proposed budget/payment terms.
Budgeting services include:
- Assistance with budget development,
- Billing compliance requirements: SOC vs research procedures,
- Cost analysis of study procedures to ensure Institutional costs are covered,
- Budget negotiations,
- Assistance with Clinical Trial Management System (CTMS) for more efficient study management
- To maintain a database of active trials to assist with subject recruitment.
- To match sponsors with investigators.
The OCT helps Industry sponsors and Contract Research Organizations (CRO) identify investigators with the research experience and expertise to conduct their clinical trials at SBM.
- To mentor new investigators and coordinators.
The OCT serves as the point of contact for questions related to clinical trials, assisting researchers, staff, and departments with expert resources for information on the conduct of clinical research. In addition, the OCT serves as a liaison to the Office of Research Compliance Sponsored Programs, Grants Management, and UH Finance Dept.
Please see CRRI-SBU Workflow document for information on workflow and communication.
Important for OSP: After the appropriate IRB approves the protocol, the PI should send a copy of the approved informed consent form to the Contracts/Clinical Trials Administrator in OSP. The Administrator will ensure that the terms of the contract are congruent with the approved informed consent form and will provide final consent. See workflow below:
Oncology Group: At the time of initial review, SBU coordinator will provide a draft consent to the Office of Sponsored Programs via email at firstname.lastname@example.org with “Attn: CT Administrator: ICF for subject injury review” in the Subject line. OSP’s consent on the subject injury compensation shall be provided as “final” during the initial ICF review. Any proposed sponsor changes to subject injury compensation that deviate from OSP’s approved version will be communicated back to OSP for additional approval. This step must be completed prior to submission to CIRBI.
Chesapeake IRB will provide its consent as a finalized document, ready for use (NO draft process) when issuing the approval notice for the study.
Non- Oncology Group: Chesapeake IRB staff will release the consent as a DRAFT when issuing the approval notice for the study. The approval notice will ask the SBU coordinator to forward the draft consent to both the sponsor and to the SBU’s Office of Sponsored Programs to ensure both parties accept the consent as written. The SBU coordinator will send the ICF to OSP via email at email@example.com with “Attn: CT Administrator: ICF for subject injury review” in the Subject line. OSP’s consent on the subject injury compensation shall not be granted until: 1) the clinical trial contract is finalized, or 2) the subject injury section is agreed upon during the negotiation of the contract, whichever occurs sooner. Should additional changes to the subject injury compensation be needed, the OSP CT Administrator will communicate with the SBU coordinator and revise the language accordingly. All requested changes should be approved by both the site and the sponsor prior to submitting to Chesapeake for review.
If no additional revisions are needed to the DRAFT ICF, the SBU coordinator sends a “Contact IRB” message through CIRBI to state the ICF has been accepted by both the sponsor and site – to include the SBU contracts office.
If additional revisions are needed, an ICF modification submission will be created in CIRBI and will state the proposed revisions have been accepted by both the sponsor and site – to include the SBU contracts office.
Chesapeake IRB will not process the requested changes without documented concurrence from all parties and will return the submission for clarification if not stated.
Changes will then be reviewed by Chesapeake IRB and the consent will be finalized and released.
Additional reviewer changes will be communicated to the SBU coordinator for approval prior to release
Office of Sponsored Programs
The Contracts/Clinical Trials Administrator in OSP reviews the contract, protocol, informed consent form and negotiates acceptable terms. The PI and department may be asked to approve unusual terms, such as publication timelines or IP restrictions. After the contract is finalized, a copy of the contract is sent to the PI for review and signature. The PI returns the contract OSP.
The Office of Sponsored Programs will sign the contract after all the following conditions are met:
- Protocol and informed consent form are approved by the IRB
- myResearch proposal is fully routed
- Contract fully negotiated
- Conflict of interest disclosure complete
After the fully signed contract is returned to OSP, an award/project number is assigned in ORACLE and sent to the PI and a copy of the agreement is uploaded to the myResearch Grants and Agreements portals.