Scientific Review and Monitoring Committee (SRMC) Policies and Procedures
SRMC Policies and Procedures V 11.0 | Sept. 5, 2025

For additional information regarding the Scientific Review and Monitoring Committee policies and procedures, please contact UFHCI-SRMC@cancer.ufl.edu.

1.0 Overview

A Protocol Review and Monitoring System (PRMS), as defined by the Cancer Center Support Grant (CCSG), must be utilized by a cancer center to fulfill the requirements for National Cancer Institute (NCI) designation.

NCI Guidelines for a PRMS include the following:

• A qualified committee of adequate size and with the breadth of expertise necessary to conduct a critical and fair scientific review of all institutional clinical cancer protocols;
• A committee with sufficient authority and processes for initiating, monitoring and terminating all cancer clinical research protocols in the institution(s) comprising the Center;
• Clear criteria and processes for scientific review, taking into account the rationale and study design, potential duplication of studies elsewhere, adequacy of biostatistical input, and feasibility for completion within a reasonable time;
• Adequate processes for determining the potential for accruing minority and underrepresented patients from the catchment area;
• Appropriate processes for ensuring prioritization of competing protocols from all sources and optimal use of the Center’s scientific resources;
• Robust criteria for monitoring trials to ensure they are making sufficient scientific progress; and
• Adequate and appropriate criteria and process for terminating trials that do not meet scientific goals.

The University of Florida Health Cancer Institute (UFHCI) incorporates the use of a two-stage review process to fulfill NCI requirements. Interventional studies are initially evaluated (first-stage) for feasibility in terms of accrual and available resources within their home Disease Site Group (DSG) and subsequently submitted (second-stage) to the Scientific Review and Monitoring Committee (SRMC) for review. When a new, interventional study is reviewed by a DSG, the group will identify if there are any currently active studies that could compete, identify resources needed (or lack thereof), and review for scientific soundness prior to SRMC submission.

The SRMC serves as the scientific merit and resource monitoring arm of the PRMS. The SRMC is charged with: 1) reviewing all new research studies and selected amendments for ongoing trials for scientific merit, methodology, validity of statistical analysis, potential feasibility based upon anticipated accrual goals; 2) ongoing monitoring of accrual to active interventional protocols to ensure that studies are adequately making progress towards their stated accrual goals and requiring corrective actions related to recruitment when necessary; 3) evaluating competing studies with overlapping eligibility criteria; and 4) establishing each protocol’s priority based on institutional priorities; 4) evaluating the potential and actual accrual of minority and underrepresented patients relative to the catchment area.The SRMC is also responsible for the ongoing annual scientific review of Cancer Institute protocols. Particular scrutiny in all areas is placed upon investigator-initiated clinical trials (IITs) for which no prior peer review has been conducted.

Mechanisms within the UFHCI SRMC ensure proper prioritization of studies within the site and the ability to monitor all cancer-related studies for expected progress relating to accrual goals and performance standards. The SRMC has the authority and charge to close any study deemed as not meeting the expected accrual goals or scientific standards laid out within the initial and ongoing approvals. These studies are then assessed for scientific merit, priorities, and progress through the SRMC. Protocols will not be reviewed by a UF Institutional Review Board (IRB) until SRMC approval has been received. The UF IRB will not release the approval letter for any cancer-relevant research prior to the study receiving final SRMC approval. The SRMC is not intended to duplicate, or overlap with, the responsibilities of the IRB. The committee is complementary to the IRB, and UF associated IRBs review all research involving human subjects to ensure that their welfare and rights are protected as mandated by federal regulations. Approvals must be obtained from both SRMC and IRB prior to commencing any research study.

Continuing reviews (CRs) are conducted independently by the SRMC at 6 or 12 month periods to affirm that accrual goals are being met and the scientific rigor is being upheld.

2.0 Scope of Application

All cancer-related studies conducted at the UFHCI or otherwise supported with institutional resources must be reviewed and approved by SRMC prior to initiation of the study. The University of Florida defines a “cancer relevant” study as one that; Specifies enrolling patients with a known or suspected diagnosis of cancer as part of the eligibility criteria; or includes research endpoints related to cancer, associated symptoms or established cancer risk factors (including smoking and tobacco-associated studies, surveys, hepatitis or HPV vaccines, etc.) or otherwise has a significant impact on cancer-related outcomes; or the local PI plans to exclusively enroll current, former or potential cancer patients into the study. Interventional studies, especially those that involve treatment, supportive care or diagnosis of cancer, must undergo full committee review while Non Interventional studies may qualify for expedited or administrative review. In addition, major amendments for all full committee studies must be submitted for review for the duration of the study’s active accrual period. Major amendments are further defined in Section 4.3.

Research studies that have already received peer review by an organization accepted by the NCI or by an NCI approved external PRMS do not require full SRMC committee review. Notable examples include the NCI’s National Clinical Trials Network (NCTN), Experimental Therapeutics Clinical Trials Network (ETCTN), and Blood and Marrow Transplant Clinical Trials Network (BMT CTN) sponsored studies. These previously reviewed studies still require entry into the UFHCI’s Clinical Trials Management System (CTMS) and expedited SRMC review to ensure feasibility, proper resource utilization, and that any competing trials have been appropriately prioritized. The UFHCI’s CTMS is OnCore.

The SRMC does not require review of cancer relevant studies that are considered non-human or are student led projects initiated to fulfill degree requirements. However, student projects that involve any level of UFHCI support, including Clinical Research Office resources, financial or other in-kind support, are subject to SRMC oversight.

For any study where cancer relevancy is not certain, clarification should be sought early within the study activation process. A senior leadership panel (comprised of the ADCR, AD CRO, Associate Director for Administration and UFHCI Deputy Director) will review and confirm PRMS classification and/or review requirements. Additionally, studies that are considered an expanded access study (EAP) will require DSG, ADCR and Associate Director of Administration endorsement to proceed with SRMC review. During this review, it will be confirmed if the study is determined cancer-relevant and/or confirmation of the SRMC classification status.

3.0 First Stage Review Process

The first stage of review within the UFHCI’s PRMS takes place within the Disease Site Groups (DSGs). DSG members come from and represent various academic and clinical departments that are engaged in cancer research. To ensure a multidisciplinary perspective, the DSG composition includes a broad range of specialties, including but not limited to basic science, medical oncology and hematology, pathology, radiation oncology, radiology, interventional radiology, laboratory research, surgery, and population-based science.

The first-stage review process does not require DSGs to review cancer-relevant clinical trials that are considered non-human or are student led projects initiated to fulfill degree requirements. However, cancer-relevant, interventional studies must receive DSG approval from the appropriate DSG before these studies can be submitted to the SRMC. An overview of the review processes are below.

3.1 Concept Enrichment Process

The UFHCI has a concept review process for all cancer-relevant IITs categorized as “interventional treatment” or otherwise involving investigational drugs, devices or medical procedures. This review, performed through the IIT Think Tank (I2T3), is mandatory for any IIT planning to utilize UFHCI resources, such as Clinical Research Office (CRO) study coordinator, data entry or Project Management Office (PMO) support. I2T3 review is also required for trials receiving UFHCI financial or other in-kind support. Concepts not meeting these specifications are exempt from this review but are encouraged to take advantage of the concept review process. The aims of this multifaceted concept review are to provide feedback to the study team and establish if the concept has preliminary scientific merit and fulfills the current needs for the DSG research portfolio and the UFHCI area prior to development into a full protocol. Protocols not having undergone prior concept review and approval often suffer significant setbacks during the development and implementation phases of the study. This concept review process enables institutional concepts, prior to development into a full protocol, to be reviewed for scientific merit and allows constructive feedback prior to significant investment of time and resources via the I2T3 mechanism. Concepts approved during this review, which have secured adequate support, are then sent forward for full protocol development. Approval during the concept review process does not guarantee ultimate approval by the SRMC.

Further details regarding the Concept Enrichment process can be found within the UFHCI Project Management Office I2T3 Concept Review Form document.

3.2 DSG New Trial Review

Upon availability of the full protocol, all interventional trials must be reviewed and approved by the primary DSG (see Appendix B) of record prior to SRMC submission. The PI and/or study team should submit necessary submission materials to DSG Support Staff at DSG-Support@cancer.ufl.edu. Upon intake of a new study, DSG Support Staff will confirm if the new study is disease specific or disease agnostic. The study will be forwarded to the appropriate DSG Research Leader for interest. If interest is confirmed, the DSG Research Leader for each group will determine if the study should be reviewed through an ad hoc review process or at the next scheduled DSG meeting. For studies reviewed through an ad hoc review process, the DSG Research Leader will identify key stakeholders from the DSG for the DSG administrator to contact for their vote. DSG meetings are administratively supported by the CRO and conducted either in person or via teleconference to review new and ongoing trials within the DSGs portfolio. These meetings occur no less frequently than quarterly. Ad hoc meetings may be called at the discretion of the DSG leaders to ensure protocol development or review is not impeded. During review of a new study or trial, attendance will be noted via meeting sign-in sheet or teleconference attendance. Prior to conducting the DSG (or ad hoc) meeting, a meeting agenda and meeting materials will be sent to the DSG members by CRO administrative staff. DSG portfolio reviews include ongoing trials, accrual status relative to stated targets, upcoming SRMC continuation reviews and address study specific items relevant to recruitment efforts and/or proposed changes to the study portfolio.

The DSG research leader must attest to the projected annual accrual, requirements for CRO resources, presence or absence of competing studies, and overall support from the group on the “DSG Submission Form” (Appendix E). In addition, a protocol flowchart that demonstrates where the proposed trial fits into the DSG’s active study portfolio must also be maintained in the CTMS by the DSG leader in conjunction with designated clinical research staff. When there are competing trials, the DSG leader is charged with determining if both studies can be open while achieving the defined accrual goals and must submit written justification for the proposed trial. The SRMC may consider competing studies when the proposed trials include 1) early phase studies, 2) there is an adequate patient population to meet both study enrollment expectations and/or any current competing studies are anticipated to complete accrual before the new trial is opened, or 3) studies that do not have completely overlapping eligibility criteria. In general, studies competing for the same patient population will be rejected by default in the absence of such justification provided by the DSG.

After review and discussion of a new trial, all key stakeholder members (identified by the DSG research leader) will cast their votes and have the opportunity to provide comments/feedback. Self-recusals for conflicts of interest are encouraged. Votes are compiled for the following decisions:

• Endorsement: The study is scientifically sound and fulfills a need in the current DSG research portfolio as well as in the UFHCI catchment area. After the study is endorsed, the DSG submission form will need to be completed and signed by the DSG Research Leader.
  • If the study has a primary DSG that is disease agnostic, such as the ETG or CCPS, and the study targets a patient population of another DSG, the other DSG will need to acknowledge this study via review by the acknowledging DSG leader(s).
  • All comments will be provided to the DSG research leader who can summarize or include them in their endorsement to SRMC and/or provide feedback to the study leadership team.
• Tabled: The PI and study team will need to make changes to address the concerns of the group. These concerns could include scientific validity or fulfillment of the DSG research portfolio and the UFHCI catchment area. Once revisions are completed, the DSG leader(s) will make the final decision. The minutes will be updated to reflect the final decision.
• Declination: The study is not scientifically sound and/or does not fulfill a need in the current DSG research portfolio as well as in the UFHCI catchment area. Once the study is declined, the study will not move past the DSG.
  • If the study team chooses to re-work the concept, or the protocol is substantially modified, a new review by the DSG will be needed in order to move forward.

Non-interventional studies are not required to be reviewed by a DSG prior to SRMC submission. The SRMC Administrator will confirm protocol prioritization for these studies.

4.0 Second Stage Review: SRMC Review Process

4.1 Protocol Prioritization

The SRMC will ensure the prioritization submitted by the DSG during the first stage review aligns with the overall priorities of the UFHCI. During the review process, all trials will be assigned a priority score which will be captured in the CTMS. The scoring system is based on protocol type, sponsorship, and potential for scientific impact. In general, institutionally sponsored or investigator-initiated trials are given the highest priority. Where both studies are assigned the same score (per Appendix C), the priority will be given to the study that has been activated the longest. Scientific merit will also be scored by the SRMC committee as part of initial review.

4.2 Submission Procedures

Prior to protocol submission to the SRMC, the PI reviews the study with their respective DSG for approval, if applicable. This initial review determines recruitment feasibility, prioritization and overall interest in the study design and content. Further instructions for study prioritization are described in Appendix C. After the initial review and approval by the DSG (completion of first-stage review), the protocol is then submitted to the SRMC.

As noted in Section 3.2, non-interventional studies are exempt from DSG review.

The SRMC submission deadline is at 12PM two weeks prior to the next scheduled SRMC meeting for all interventional IITs. For all other submissions, the deadline is 12PM one week prior to the next scheduled SRMC meeting, unless otherwise noted on the list of scheduled meetings and SRMC submission deadlines. A list of scheduled meetings and SRMC submission deadlines is available on the SRMC webpage. All submissions to the SRMC must be made via the ePRMS Console within the CTMS. Study staff may request SRMC submission assistance by emailing UFHCI-SRMC@cancer.ufl.edu.

Initial Submission

The PI or designee provides all necessary study documents to the SRMC through the CTMS submission console. The documents must include:

• SRMC submission form (Appendix F; interventional studies only)
• DSG submission form (Appendix E; interventional studies only)
• Complete study protocol with all appendices or investigational plan
• Investigator’s Brochure, if applicable
• Draft Informed Consent document (interventional IITs only)
• SRMC Pre-Review approval confirmation (interventional treatment and other qualifying IITs only; see section 3.1)
• Cellular Therapy/Apheresis form (qualifying interventional studies only) (Appendix N)
• Feasibility Assessment Reviewer Form (Appendix M; interventional studies only)
• Any other relevant or requested study documentation

Submission of Amendments/Revisions

The PI or designee provides all necessary study documents to the SRMC through the CTMS submission console. Note that submission of amendments/revisions is only required for studies initially approved (or that would have qualified) at SRMC as a ‘Full Review.” Amendments/revisions are only required to be submitted from the time of the initial SRMC approval until the study is permanently closed to accrual. The submission documents must include:

• Revised study protocol or investigational plan with tracked changes or revisions clearly marked
• Revised Investigator’s Brochure if applicable
• Revised Informed Consent document if applicable (interventional IITs only)
• Summary of Changes Form
• Any other relevant or requested study documentation

Submission of Continuation Reviews

The SRMC Administrator initiates all SRMC Continuation Reviews. Documents required include:

• Signed Protocol Activity Report form
• Corrective action plan (for studies not meeting accrual targets)
• Current Protocol
• Any other relevant or requested study documentation

4.2.1 Review Team

The SRMC Administrator, in conjunction with the Chair, will assign committee members to review each new study or revision. In general, reviewers are chosen based on the credentialing and expertise required to provide an in-depth review of the assigned protocol. All reviewers must be non-conflicted, as defined by holding an investigator-level role on the study. The number of reviewers and credentialing required for each type of study is noted below:

• BMSP
  • Type of study: UF interventional IIT
  • Reviewer quantity and type: Minimum of 6 including 2 primary reviewers (one who is a physician), 1 biostatistician, 1 feasibility, 1 COE, and 1 Community Scientist
• CCPSP
  • Type of study: UF interventional IIT
  • Reviewer quantity and type: Minimum of 6 including 2 primary reviewers, 1 biostatistician, 1 feasibility, 1 COE, and 1 Community Scientist
• BMSP
  • Type of study: Industry or Other Externally Sponsored Interventional Trial
  • Reviewer quantity and type: Minimum of 3 including 1 primary reviewer, 1 COE, and 1 feasibility 
• CCPSP
  • Type of study: Externally Sponsored Interventional Trial
  • Reviewer quantity and type: Minimum of 3 including 1 primary reviewer, 1 COE, and 1 feasibility
• BMSP/CCPSP
  • Type of study: NCTN, ETCTN or EPR Interventional and Non-Interventional Studies 
  • Reviewer quantity and type: Minimum of 3 including 1 primary reviewer, 1 COE, and 1 feasibility 
• BMSP/ CCPSP
  • Type of study: Prospective, Non-Interventional Studies
  • Reviewer quantity and type: 1 primary reviewer
• BMSP/ CCPSP
  • Type of study: Amendments/Revisions to Full Review Studies
  • Reviewer quantity and type: Minimum of 1. Physician review is required for amendments that alter the methods, procedures or study design, drug dosage or delivery, or eligibility of parent committee protocols. Biostatistician review is required for any changes that affect the statistical section of an interventional IIT protocol.
• Admin
  • Type of study: Retrospective, Non-Interventional Studies
  • Reviewer quantity and type: Administrative review only
• Admin
  • Type of study: IRB exempt studies
  • Reviewer quantity and type: Administrative review only
• Admin
  • Type of study: Expanded Access or Single Patient INDs
  • Reviewer quantity and type: Administrative review only* DSG, ADCR and Administrative Director endorsement required. 
• Admin
  • Type of study: Banks/registries
  • Reviewer quantity and type: Administrative review only

4.3 Review Types

Full reviews require a brief summary presentation by the Principal Investigator or their delegate during the specified SRMC meeting time laid out in the agenda. If a study team representative is not available, the study review may be reassigned to the next scheduled SRMC meeting by the SRMC Chair. All assigned reviewers are presented with the full study protocol, Investigator’s Brochure (if applicable), draft Informed Consent form and other supporting documentation (DSG approval, SRMC application, and any other relevant items). For initial reviews, a feasibility review and a COE review will be provided to the SRMC committee. Reviewers submit comments and recommendations where applicable. For IITs, statistical concerns are addressed by the assigned statistical reviewer. Reviewers submit a completed and signed review form to the SRMC Administrator prior to the meeting (see Appendices G – M).

Full reviews are conducted for the following protocol types:

• All UF sponsored Interventional Investigator Initiated Trials (IITs) that have not previously undergone external peer review by one of the NCI approved groups (see Section 2.0) or via a NCI-approved external PRMS.
• New industry, external academic or foundation-sponsored interventional cancer research studies that have not previously undergone external peer review by one of the NCI approved groups (see Section 2.0) or via a NCI-approved external PRMS.
• Continuation Reviews of interventional cancer studies that have not made adequate progress towards accrual goals.

Note for studies that have been IRB approved but never underwent an initial review by the SRMC (i.e., legacy studies), refer to Appendix P for the SRMC intake policy for IRB approved studies.

Expedited reviews of new studies must include the same documents as a full review but the reviewer is only responsible for confirming the DSG reviews regarding accrual, prioritization, feasibility and COE.

Amendments/revisions to applicable ongoing studies (see Section 4.2) that qualify for expedited review will be evaluated to ensure continued scientific merit.

Expedited reviews are conducted for the following submissions:

• NCI-approved National Clinical Trials Network and Experimental Therapeutics Clinical Trials Network studies.
• Other trials that have been peer-reviewed by one of the NCI approved groups (see Section 2.0) or via a NCI-approved external PRMS.
• Prospective, non-interventional studies (e.g. Observational or Ancillary/Correlative studies)
• Study amendments for protocols that were initially approved via a full committee review, which include: 1) addition/reduction of subject accrual goals; 2) changes in methods, procedures or study design; 3) modifications in drug dosage or delivery; 4) changes in exclusion or inclusion criteria; 5) addition of sub-site(s) for IITs; 6) change of Principal Investigator; or other major changes.
• Annual renewal of interventional cancer studies that have made adequate progress towards accrual goals.
• Legacy studies that would have initially met the criteria for a full review as described above. (If a study would have met the full review criteria when initially submitted, then subsequent amendments that meet the criteria above will need to be reviewed by the SRMC)

Administrative reviews are conducted on studies that do not qualify for full committee or expedited review. It is the responsibility of the SRMC Administrator to review the study to confirm that a study meets the criteria for administrative review. Studies that qualify for administrative review are exempt from further SRMC review. An approval letter is not generated for these study reviews. Administrative reviews are conducted for the following submissions:

• Continuation reviews for studies that have been suspended for ≥ 3 months during the review period
• Chart review studies (Retrospective and/or Prospective)
• Retrospective, Non-Interventional studies
• Tissue and/or data banks/registries
• Studies that meet criteria for IRB exempt status
• Expanded access studies (EAP). DSG, ADCR and Admin Director endorsement is required for these studies.
• Single patient INDs
• Studies meant to fulfill the degree seeking purposes of a student (that do not utilize CRO support)

Continuation reviews (CRs) are performed to assess study progress, monitor subject accrual, evaluate for continued scientific merit, and confirm prioritization.

• For non-rare, non-pediatric disease studies, initial CRs are conducted after a study has been activated (Status of “open to accrual” within the CTMS) for a total of six months and then, minimally, at 12-month intervals thereafter, on all full committee and expedited interventional protocols that are active with ongoing enrollment.
• For rare or pediatric disease studies, initial CRs are conducted after the study has been activated (status of “open to accrual”) for a total of 12 months and then, minimally, at 12-month intervals thereafter. Additionally, see Special Considerations for Pediatric Studies.

At CR, the committee will determine if there have been any developments affecting the study objectives or general study conduct. In addition, current accrual will be compared against initial accrual goals. If a study is shown to be below 50% of the target accrual for the reporting period, it will be the responsibility of the PI or DSG to give an explanation as to why it is below the target goal and provide a corrective plan of action (CAP).

CRs for protocols that have achieved the expected accrual goals at the appropriate intervals will be recognized in the SRMC meetings as having attained their goal and the study will have a status of approved until its next yearly evaluation. Protocols will continue to be evaluated against their declared accrual goals until the study is closed to further accrual. It will be the responsibility of the SRMC Administrator to notify the study team of an upcoming continuation review.

*Study accrual expectations were adjusted during the COVID-19 pandemic. See Appendix Q for additional details.

Chair reviews are conducted to ensure that proper correspondence has occurred for protocols that were previously approved with stipulations. The coordinator forwards all correspondence from the reviewers once the reviewer has confirmed if their initial stipulation(s) had been properly addressed.

The authority to provide the final approval lies with the Chair. Once the Chair approves that the proper review was conducted, the Administrator then notifies the PI and study coordinator with the appropriate approval letter. If applicable, the study is recorded as fully approved through prior stipulations on the next committee agenda. Chair reviews may also be conducted in situations where a study requires reclassification (i.e. downgrading of the data table 4 classification) or reassessment (risk level) subsequent to the initial review. These reviews result in the issuance of an updated approval letter reflecting the date of the chair review.

4.4 Possible Decisions

4.4.1 Full Review Decisions

After the assigned reviewers provide any concerns or recommendations for a study protocol, all voting members in attendance will cast their votes for the following decisions:

• Approval: The study is scientifically sound and acceptable as written. Full approval is given and the PI is notified.
• Approval with Stipulations: 1) the study is scientifically sound and acceptable if minor clarifications are provided. Full approval will be withheld until the necessary clarifications are made and approved by the SRMC Chair or Vice Chair, or 2) the study is scientifically sound and acceptable if the PI makes modifications to the protocol. Full approval is withheld until the protocol is revised to adequately incorporate the recommended modifications. The protocol must be re-reviewed and approved by the original SRMC reviewers or the SRMC Chair or Vice Chair.
• Tabled: The study requires significant modifications that must be re-reviewed by the SRMC full committee. All SRMC questions, concerns or requested clarifications must be included in the response along with any redlined study materials capturing cumulative updates within the response to the questions raised by the SRMC during its initial review. SRMC meeting deadlines will apply, as specified within Section 4.2.
• Disapproved: The study is neither scientifically sound nor ethical.

4.4.2 Expedited Review Decisions

Any review that is considered expedited as described in Section 4.3, and approved through its respective DSG, shall be reviewed for prioritization, potential for successful progress and scientific merit if applicable. Reviewers may recommend the following decisions to the SRMC Chair:

• Approval: The study is scientifically sound and is acceptable as written. Expedited approval is granted and the PI is notified.
• Approval with Stipulations: 1) the study is scientifically sound and is acceptable if minor clarifications or modifications are provided. Expedited approval will be withheld until the necessary clarifications are made and approved by the SRMC Chair or Vice Chair.
• Recommended for Full Committee Review: The study must be reviewed in its entirety by the full committee review. Requirements for full committee review as outlined in Section 4.2 then apply.

4.4.3 Administrative Review Decisions

Any review that is considered administrative as described in Section 4.3 shall be reviewed to ensure the study meets the criteria for administrative review. Reviewer(s) may recommend the following decisions to the SRMC Chair:

• Approval: The study meets the requirements for administrative review.
• Returned: The study does not meet the requirements for SRMC review or approval.
• Deferred: This decision type may only be used when a study has been suspended for a significant portion of time and no committee decision can be made until further information is available (i.e., the study is open to accrual long enough for a continuation review decision to be made).

4.5 Continuation Reviews

CRs will be performed for all interventional trials that are open to accrual. CRs are not required for noninterventional studies or interventional studies that are closed to accrual.

After the committee reviews the study accrual goals as compared to the confirmed subject accrual, one of the following decisions will be made:

• If a study is at less than 25% of its annual accrual goal (with at least one accrual) at 6 months, a justification for continued accrual and corrective action plan (CAP) must be submitted to the SRMC. This CAP must be generated by the study team in collaboration with the UFHCI CRO (as an investigator team resource) to help support recruitment.
• Upon acceptable review of the CAP by the SRMC, the study will be placed on probation and accrual activity for the first 12 months will be reviewed at the annual CR. Studies that are still under 25% of their annual target following this probationary extension will be subject to immediate closure to accrual.
• If a study is at less than 25% of its annual accrual goal at a subsequent CR, a justification for continued accrual and CAP must be submitted to the SRMC. This CAP must be generated by the study team in collaboration with the UFHCI CRO (as an investigator team resource) to help support recruitment. If the explanation and CAP is deemed satisfactory to the SRMC, the study may continue and be reviewed again in 6 months. Otherwise, the study may be subject to immediate closure to accrual.
• If accrual is greater than 25% but less than 50% of the study’s annual target during any review period, a justification for continued accrual and CAP must be submitted to the SRMC. This CAP must be generated by the study team in collaboration with the UFHCI CRO (as an investigator team resource) to help support recruitment. If the explanation and CAP is deemed satisfactory to the SRMC, the study may continue and will be reviewed again in either 6 or 12 months per the discretion of the Chair.
• Studies that have accrued greater than 50% of their annual accrual goal at the 6-month or annual CR will be granted expedited approval and will be reviewed again in 12 months and then annually. A feasibility assessment will not be required for studies at this time.
• If the study team is unable to resolve SRMC queries within 3 months of the queries being sent the study will be administratively disapproved.
• If there is no response from the study team within 1 month of SRMC queries being sent to the study team the study will be administratively disapproved.

An accrual is defined as a subject that has consented (or has enrolled via waiver of consent), has been deemed eligible and has been formally registered/randomized to the study. A subject is considered accrued when an On Study date has been entered in OnCore.

Protocol suspensions of ≥3 continuous months will be taken into consideration in scheduling CR reviews. The SRMC administrator can consider any time suspended and delay scheduling of a study’s continuation review as long as the study is reviewed at minimum once per calendar year. If a continuation review is scheduled and the study has been suspended at any time during the review period, the SRMC committee can take this into account and add the suspended time to any continuation decision. Any suspension must be noted in OnCore (via a “suspended” study status) and documentation of the enrollment hold provided (e.g. holds due to drug supply, financial limitations, interim analyses, etc.) at the time of CR. Protocols continuously suspended for greater than 12 months are subject to immediate closure by SRMC unless they qualify for special consideration as outlined below.

In addition to assessing the overall number of enrollments relative to target expectations, the demographics of the subjects enrolled (e.g., age, gender, race, ethnicity) will be reviewed at all interventional study continuing reviews.

4.5.1 Special Considerations

A modification to the above accrual and activation requirements will be made for studies that meet certain special considerations. Special consideration of accrual requirements will be given to rare disease studies, Phase 1 portion of trials where enrollment opportunities are limited and/or only intermittently available, national protocols where UF faculty serve in a leadership capacity as documented on the protocol cover sheet, IITs involving translation of UF science, and IITs accruing at affiliate sites where UF is the coordinating center. These special considerations of accrual requirements will allow a study to be open to accrual for up to 60 months for pediatric trials and 24 months for all other trials with a special consideration. If the study still has not accrued any study participants, the SRMC will terminate the study.

The SRMC, inclusive of COE and CRO, will make recommendations to enhance the absolute number and diversity of subject recruitment whenever possible.

Rare Disease Designation

UFHCI’s rare disease definition. The UFHCI defines a rare cancer as one with an incidence of ≤3 newly diagnosed persons out of a population of 100,000 persons per year (≤3/100,000 per year). Rare cancer definition can be assigned to clinical trials targeting specific mutations in non-rare cancers as long as the cancer specific mutation is diagnosed in <3/100,000 patients per year (<9,600 total patients per year in the U.S.). Incidence of mutation will be evaluated within individual tumor sites for disease agnostic studies. Patient factors such as stage, performance status, line of therapy or treatment modality are not taken into consideration when defining rare cancer trials. Rare disease designation will be confirmed by the committee. All pediatric oncology clinical trials will be considered rare disease studies.

Phase I Trials

Trials that are designated as Early Phase, Phase I, or Phase I/II may be granted an accrual modification. To be considered, these trials must be enrolling to the Phase 1 portion of the study. Such study phases typically have limited enrollment opportunities yet are high priority for the UFHCI and catchment area.

Trials designated as 1) rare disease or 2) Phase I at the time of SRMC review will be subsequently reviewed every 12 months after open to accrual. Rare disease or Phase I studies failing to accrue any subjects at 12 months will require a CAP. Studies may then be administratively closed at 24 months if there is still no accrual. A Phase I study accrual modification expires at the time of a SRMC continuing review when the study is no longer enrolling with limited slot availability (e.g., competitive cohort expansion phase).

If a study moves forward from a Phase I study to the Phase II portion of a study, the study is no longer considered a special consideration. Once the study re-opens to accrual during the beginning of Phase II, the study will proceed using the standard continuation review and zero tolerance requirements.

National Leadership Roles for Investigators

Trials where a Principal or Sub-Investigator is listed on the Protocol cover sheet as a study Chair or National Study Champion will be considered a special consideration. In addition, this will count for studies where a Principal Investigator (or sub-Investigator) is documented as being involved in the creation of a multi-site national study. These trials will be identified within OnCore under staff listing as well as requested confirmation on the SRMC submission documentation.

UF IITs

Trials that are UF IITs and are identified as involving UF translational science may be granted an accrual modification. To be designated as a UF translational study, a study, must test a scientific discovery originating at UF. Evidence of UF’s contribution to the discovery should be documented by a peer-reviewed publication when available; however, more timely discoveries may also qualify if supported by abstracts, conference presentations, patents, or other formal communications that provide sufficient scientific rationale for clinical translation. In addition, UF IITs that are accruing at affiliate sites where UF is the coordinating center may also be granted an accrual modification.

Master Protocols (to include “umbrella” and “basket” trials)

A Master Protocol is a type of study that serves as the “parent” protocol for either “umbrella” or “basket” type trials (defined below). The Master protocol will be opened as a separate study but will not have direct patient accruals. Rather, accruals are attributed to the specific companion (or sub) trials that open under the Master protocol. A basket trial is a study that evaluates a single treatment and/or biomarker on different cancer histologies which often share a common molecular alteration or mutation. These different cancers are placed in “baskets” that represent individual protocols. Umbrella trials test multiple therapies and/or biomarkers on a single cancer histology where each therapy/biomarker represents a separate protocol under the “umbrella” of the single cancer. Often the cancer being investigated has different mutations or molecular alterations that dictate groups and treatment received. Due to the specific nature of these trials, the Master trial will not undergo SRMC continuation review and may be exempted from early closure if patients are enrolled directly to the associated companion (or sub) trials.

Pediatric Trials

All pediatric trials will open to accrual in OnCore immediately after all activation activities are finalized. These trials will be reviewed within 12 months of opening to accrual and annually thereafter. The Zero-Tolerance Policy will be extended to 5 years and the study will receive a 12 Month Continuation review until the 4th year the study has been open to accrual. If the study has no accruals at the 4th annual continuation review, the study will receive a 12-Month Probationary Continuation. At the end of the 5-year open to accrual period, regardless of any suspended status time, if the study has still not accrued any subjects, the study will be subject to termination by the SRMC.

*Previously, studies fitting in this pediatric special consideration were placed in a policy known as Just-in-Time (JIT). As of Fall 2024, that policy was retired.

4.5.2 Zero-Tolerance Policy

A study which has zero enrollments after being open to accrual for 3 months has two options:

1. PI decides to close study immediately (diverting resources to another trial)
2. Study is administratively placed on probation for 3 months. If at 6 months after the open to accrual date, a study still has zero enrollments, it will be immediately closed to accrual by the SRMC (unless a special consideration or sufficient documentation for suspended status is provided).

There is a caveat for special consideration qualifying studies (see Section 4.5.1). The zero-tolerance policy allowance can be extended to a maximum of either 2 or 5 years after a study opens to accrual. If the study has zero enrollments at the end of the applicable pre-defined OTA duration window, it will be closed at the time of continuation review unless one of the following items are met resulting in a waiver.

4.5.3 Open to Accrual Deadline Policy

All studies approved via full committee or expedited review must open to subject accrual within one year (365 days) of the date of the final SRMC decision. Studies that do not proceed to the OTA status in the OnCore within this timeframe are subject to re-review by the SRMC.

If a study does not OTA within 12 months of an SRMC approval, the SRMC will administratively disapprove the study. At this time the PI can request an extension on the SRMC 12-month deadline.

4.5.4 CR Review Decisions

• 12 Month Approval: The study continues to be scientifically sound and is meeting or making adequate progress toward accrual goals.
• 12 Month Probationary Approval: The study continues to be scientifically sound; however, the study is not meeting the minimum accrual requirements. Revisions to the recruitment plan or accrual targets may be required. A corrective action plan must be generated by the study team in collaboration with the UFHCI CRO and COE (as an investigator team resource) to help support recruitment. This determination is reserved for studies receiving special considerations as described in previous sections.
• 6 Month Probationary Approval: The study continues to be scientifically sound; however, the study is not meeting the minimum accrual requirements. Revisions to the recruitment plan or accrual targets may be required. A corrective action plan must be generated by the study team in collaboration with the UFHCI CRO and COE (as an investigator team resource) to help support recruitment.
• Closure Required: Closure (or Closure to Accrual if patients remain on study or in follow up) may be required for studies that are no longer scientifically sound, or feasible, or have inadequate accrual for continuation.

4.6 Suspension or Closure Recommendation

The SRMC may make the decision to suspend or close a clinical trial depending on the significance of the following issues:

• No accrual during the first 6 months or chronic low accrual
• Amendments or developments that render the study no longer scientifically sound or feasible
• Recommendations from the DISC
• Upon request from the PI

Suspension or termination of a clinical trial is thoroughly deliberated and is based upon the continuation review guidelines in this manual (see section 4.5). If closure is required by the SRMC, the study status must be updated to “Closed to Accrual” within one business day of notification by the PI or designee. It is the PI’s responsibility to notify the IRB and any other regulatory authorities of a study that is closed by the SRMC and ensure that the OnCore status is updated accordingly.

4.7 Adjustments to Accrual Goals

Lowering accrual goals will be reserved for special cases. The SRMC may recommend changing the accrual goal if it is determined that the initial accrual goal was set too high. The study team may also request an adjustment to their original accrual goal at the time of CR. Requests to increase accrual goals may be considered for any type of study.

4.8 Decision Results Reporting

The SRMC will communicate the results of all reviews to the study team in writing. Decision letters will be sent electronically following meeting proceedings. Minutes from the SRMC meetings are recorded by the SRMC Administrator and approved into record by SRMC vote at the subsequent meeting. SRMC determinations may be modified upon further review or protocol understanding to alter the review classifications previously assigned during SRMC review.

4.9 Appeals Process

There is no appeal process. The PI and study team are able to provide perspective and dialogue to the SRMC through written or oral responses to reviewer questions or concerns and via a Corrective Action Plan prior to and during study review. All written SRMC decisions are final.

4.10 Consideration of Previously Closed Protocols

Protocols previously disapproved or terminated for poor accrual may be reconsidered by SRMC approval if appropriate protocol amendments have been made that address previously identified scientific issues or barriers to accrual. The PI must provide clear documentation on how the protocol amendments sufficiently address committee concerns. The opportunity for SRMC re-review is at the discretion of the ADCR. All studies authorized to move forward will be submitted as a new protocol.

5.0 SRMC Membership

The Director of the UF Health Cancer Institute appoints the chair of the SRMC. The Director, in consultation with the Chair of the SRMC and the UFHCI Associate Director for Clinical Research, appoints Vice Chairs, core, and administrative members of the committee. The Chair, Vice Chairs, and committee members represent various academic and clinical departments within the University of Florida that are engaged in cancer research. In selecting members, the UFHCI strives to engage faculty and staff with expertise in a broad range of specialty and treatment modality areas. Representatives include those from the fields of basic laboratory, clinical, cancer population sciences, and population-based science. Members of the committee come from the departments of medical oncology, bone marrow transplant, surgery, radiation oncology, neuro-oncology, pediatrics, radiology, nursing, pathology, pharmacy, public health, biostatistics, as well as clinical research staff and a Citizen Scientist. Having a diverse, multi-disciplinary committee affords the SRMC a satisfactory breadth of knowledge for the review of investigator-initiated and other studies proposed at the UFHCI.

Members are appointed for 3-year terms that are renewed at the discretion of the UFHCI Director. Members will receive an appointment letter and a copy of the UFHCI SRMC Policies and Procedures manual. Voting members include UFHCI biostatisticians, appointed representatives of academic units/departments/centers including a COE representative, and Community Scientists. Non-voting members include non-appointed clinical research staff representatives and the SRMC Administrator. At-large or additional ad hoc members with specific expertise not already present on the SRMC may be designated by the SRMC Chair as necessary.

6.0 SRMC Meetings and Administrative Coordination

The SRMC is comprised of two different panels (Biomedical Science and Cancer Control and Population Science) with differing specialists, but both fulfill the same function and comply with the same policies. The appropriate NCI guidelines apply to both the BMSP and the CCPSP. Each panel meets twice monthly for initial and continuing study reviews. Approximately one week prior to each panel meeting, reviewers from the committee will be assigned by the Chair or their delegate to review all necessary protocols. The number of reviewers assigned is based on study type and study sponsor (see Section 4.2.1), paying particular attention to assigning reviewers to topics most relevant to their field of expertise if possible.

Meeting agendas are sent out to Principal Investigators and committee members prior to each panel meeting. Overlapping participation between the SRMC membership and DSG leadership promotes consistency throughout the review process.

A research administrator is assigned to provide administrative support to the SRMC. The SRMC Administrator receives, tracks, and reviews all SRMC submissions for completeness. The SRMC Administrator also reviews study related information within the CTMS for accuracy. The Administrator assists the Chair with assigning reviewers for all accepted submissions, handles completed review forms and manages meeting agendas, documentation of meeting minutes and generation of formal review paperwork. In addition, the SRMC Administrator tracks committee member attendances, issues and closes queries in the CTMS, and generates reports for the SRMC Chair and UFHCI Director. The SRMC Administrator is responsible for maintaining all documentation related to SRMC reviews and actions within the CTMS in support of the UFHCI PRMS.

In addition to routine committee meetings, there is a SRMC Executive Committee that meets quarterly. This committee is comprised of the Chair, all Vice Chairs, SRMC Administrator, Associate Director for Clinical Research, Administrative Director of Clinical Research and other key members at the discretion of the Chair. This group reviews SRMC metrics and sets forth proposed revisions to SRMC policy and workflows to the full committee and addresses any unique needs of the individual panels.

6.1 Biomedical Science Panel (BMSP)

The SRMC Biomedical Science Panel (BMSP) reviews treatment studies that involve investigational drugs, devices, medical procedures, or tobacco cessation involving a drug or device. Members of the BMSP will either volunteer or be assigned for review based on need and availability from the relevant areas of expertise. These scientific themes are not exclusive, however, and decision as to review assignment will ultimately be decided by the SRMC BMSP Chair and Vice-Chairs. A Vice Chair executes the responsibilities of the Chair when the Chair is unavailable or as delegated by the Chair; when needed, another designated member may be requested to conduct these responsibilities. When a tie vote occurs, the Chair or Vice Chair, in the Chair’s absence, can cast the deciding vote.

Meetings may be conducted virtually or in person and are led by the BMSP Chair. Meetings may only start once quorum is met, which is defined as at least 6 voting members (i.e., appointed core committee members in attendance) including a minimum of one Chair or Vice Chair and one biostatistician.

6.2 Cancer Control and Population Science Panel (CCPSP)

The Cancer Control and Population Science Panel (CCPSP) reviews non-treatment studies that do not involve investigational drugs, devices, or medical procedures. Behavioral, communication, nursing, general population-science based studies that involve cancer as well as secondary analysis of patient data fall under the purview of the CCPSP. This panel provides appropriate expertise for the evaluation of protocols that focus on: implementation science, disparities, palliative care, communication/shared decision making, biomedical informatics, tobacco prevention or cessation not involving a drug or device, symptom science and self-management. These scientific themes are not exclusive, however, and decision as to review assignment will ultimately be decided by the SRMC CCPSP Chair.

Meetings may be conducted virtually or in person and are led by the CCPSP Chair. The Chair executes the Committee responsibilities or if the Chair is unavailable or conflicted, another member may be deputized to temporarily assume Chair responsibilities. Meetings may only start once quorum is met, which is defined as at least 3 voting members, (i.e., appointed core committee members in attendance) including a minimum of the CCPSP Chair (or a delegate approved by the SRMC and CCPSP Chair) and one biostatistician.

7.0 Assessment of Risk and Complexity for IITs

All protocols will be classified by the SRMC into one of the following general categories of risk at the time of initial review. Per 45 C.F.R. § 46.102(i), “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

For all local interventional investigator-initiated trials and other trials deemed by SRMC to be without an adequate data and safety monitoring board (DSMB), the SRMC will determine the appropriate level of monitoring required and refer such monitoring oversight to the UFHCI Data Integrity and Safety Committee (DISC). This determination will be made as a component of initial review and approval. This includes review of the protocol-specific data safety and monitoring plan provided in the protocol. Trials submitted without a satisfactory data safety and monitoring plan will not be approved. Study review frequency will be determined based upon the protocol’s phase, objectives, intervention under study, level of risk to subjects and overall complexity. The assigned level of risk will be reported back to the UFHCI DISC and the study PI by the SRMC Administrator. Please note that any Phase III study regardless of the level of risk requires oversight by DISC or an appropriate independent DSMB.

Level 1 – Low risk Investigator Initiated interventional trials.

• Diagnostic or screening trials involving minimal risk procedures
• Trials involving accepted doses of over-the-counter drug, or vitamins and supplements
• Behavioral or health services research (HSR) trials
• Trials involving diet or exercise involving minimal risk

Level 2 – Moderate risk Investigator Initiated or externally sponsored interventional (such as drug, biologic or device) trials using FDA approved or commercially available compounds or interventions.

• IND exempt phase II and III trials
• Trials involving delivery of radiation therapy
• Screening, diagnostic, behavioral, HSR, diet or exercise trials that involve invasive or greater than minimal risk procedures or interventions that ordinarily would be regarded as minimal or low risk but are being tested in a context where the risk might be perceived as higher.

Level 3 – High risk Investigator Initiated or externally sponsored interventional trials (such as investigator-sponsored INDs, Phase I trials, studies requiring biosafety approval, or other areas that may be designated by NIH as high risk). Note that a population science/behavioral type study (IIT Only) designated “multi-site” does not require a DISC Risk Level 3 if the study does not otherwise meet Risk Level 3 criteria.

• UF investigator as IND/IDE holder
• All Phase 1 Trials within the following categories: drug, device, bone marrow, and surgical trials
• Any UF trial that requires UF biosafety committee approval
• UF multisite interventional trials

Level 4 – Very high risk complex trials involving a higher risk to subjects and a high level of complexity (such as first in human or gene transfer studies).

7.1 DISC Monitoring Frequency

The SRMC will decide how often the DISC should review and assess study data as part of the trial specific monitoring plan generated at the time of initial SRMC review. The SRMC discusses the risk level assigned by the primary and secondary reviewers and determines the necessary intervals for the UFHCI DISC to review these studies. Upon initial DISC intake of the study, if the DISC disagrees with the SRMC-assigned risk level determination or monitoring requirements, a written correspondence will be submitted to the SRMC chair by the DISC chair (or designee). The SRMC chair may take such information under advisement and consider issuing a modification. However, all SRMC determinations regarding risk assessment and monitoring are otherwise final. The following are the recommended guidelines for how often the DISC should review studies according to the risk level assigned:

• Level 1: No routine monitoring required by DISC
• Level 2: Annual review by DISC
• Level 3: Semiannual review by DISC
• Level 4: Quarterly review by DISC

8.0 Responsibilities

8.1 SRMC Responsibilities

The SRMC has the responsibility to review all new cancer-related protocols. These reviews focus mainly on confirming scientific merit, methodology, prioritization, and accrual goal feasibility. The charge of the SRMC includes the following:

• Evaluate scientific merit and progression of studies
• Determine if study goals are aligned with the UFHCI scientific priorities and are feasible in terms of expected subject accrual
• Evaluate the accrual of minority and underrepresented patients relative to the catchment area
• Confirming risk levels relating to study design
• Approving, disapproving, or discontinuing studies

SRMC membership selection aims to include a diverse and extensive range of expertise across all areas of cancer specialties. This broad representation and communication between fields ensure that study protocols and progression are reliable, verifiable and of scientific merit.

8.2 SRMC Member Responsibilities

To promote consistency between every SRMC meeting, core members are expected to attend a majority of meetings held throughout the year. To be considered in “good standing” with the SRMC, all members (regardless of panel) must have an attendance level of at least 51%. In-person, videoconferencing, and teleconferencing will apply towards meeting attendance. Ad hoc committee members are not required but are encouraged to attend meetings.

Members are expected to complete accurate and in-depth reviewer assignments for protocols assigned to them by the SRMC Administrator. When assigned protocols are reviewed, members are responsible for ensuring enhancement of research quality with constructive criticism as needed. Members who are identified as a sub-investigator, other study personnel on a protocol or who self-declare a conflict of interest will be ineligible to vote or provide a review. Members who self-declare a conflict of interest for any reason will be noted by the SRMC Administrator. Their participation will be recorded as “abstain due to conflict”. Conflicted members who wish to remain during committee deliberations will be asked to abstain from making further comments on behalf of the principal investigator. Members who belong to the home DSG sponsoring the study but are not identified as having a conflict as noted above, or sub investigators providing clinical coverage without home DSG conflicts, can provide a scientific review (for example CTMS role: Doctor of the Day).

8.2.1 Protocol Reviewer Responsibilities

For studies meeting the criteria for full committee or expedited review, protocol reviewers will evaluate the SRMC submission form, clinical protocol, and any other relevant documents provided in the initial submission. When applicable, reviewers will present an assessment of the protocol and any recommendations for change. A recommendation for committee action is given by the reviewer as well. Primary, secondary and biostatistician reviewers are responsible for written reviews and comments on the following:

• Objectives: Are the objectives and endpoints of the protocol clearly defined? For interventional protocols, do the objectives measure the impact of the proposed intervention?
• Scientific Rationale: Does the protocol address relevant scientific questions?
• Scientific Impact & Merit: What is the project’s likelihood of having a sustained, powerful influence on the research field(s) involved?
• Study Design: Does the proposed protocol design address the protocol’s objectives and scientific rationale? Can the proposed objectives be met with available resources of the UFHCI? Can the objectives be met within an acceptable time frame? Does the study design include appropriate stopping criteria?
• Methodology: Are the methods in the protocol adequate to answer the questions addressed in the objectives? Are there resources available within the UFHCI to conduct these methods? For treatment intervention protocols, is there a description of the agent’s activity, dose delivery and scheduling, and dose modification criteria?
• Statistics: Is the statistical design clearly described, well-defined, and statistically sound? Are the accrual goals clearly stated? Is the sample size adequate to answer the specific objectives of the protocol? For qualitative studies, are appropriate analytical design and decision criteria included?
• Feasibility: Are there adequate institutional, financial, personnel and patient resources available?
• Community Outreach and Engagement: Is the study relevant to the catchment area? Does the study have the potential to accrue minorities and underrepresented populations relevant to the catchment area? Are there additional recruitment efforts that could be recommended?
• Data and Safety Monitoring: Does the protocol have an acceptable DSMP inclusive of any pre-defined stopping rules? For UF Interventional IITs and other Interventional studies, does the trial require DISC oversight and, if so, what level of risk should be assigned? All DSMPs must include the following: Description of oversight responsibilities, description of data and safety review processes, frequency of data and safety review, process for routine and serious adverse event reporting, and the process for determining if a study requires early stopping as applicable.
• Protocol Classification: Is the protocol and data table type correctly assigned within CTMS? Proper protocol classification is required to determine if the study meets eligibility criteria for full or partial academic points.
• Other: Are all other components (e.g., eligibility criteria, required biospecimens, timing of interventions, etc.) consistent with the scientific rationale and objectives of the study?

For National Cooperative Group Trials and Other Externally Peer Reviewed submissions that have been previously peer reviewed by an approved organization, the reviewer is responsible for confirming the DSG reviews regarding accrual, prioritization, feasibility and COE.

Primary Reviewer for Change(s) in Protocol: Reviewers are responsible for written review and comments regarding all changes in protocol. It should be noted that whenever a change is necessary to better protect research subjects, (for example, one that is the result of a toxicity or adverse event report) the IRB is obligated to approve or disapprove that change immediately and IRB continuation will not therefore be contingent upon SRMC approval. However, the investigator should understand that continuance of the study is dependent upon SRMC approval of the changes. The reviewer will provide a summary of the proposed change and make recommendations to the SRMC. Depending on the nature of the change, the SRMC may request that a biostatistician review the proposed revisions to the protocol.

Primary Reviewer Acceptance of Stipulations: If questions have been posed to the study team or stipulations have been recommended that prevent a clear approval or disapproval committee action, the reviewer raising these points will provide follow-up acceptance or comments of whether the information meets their needs to issue a formal recommendation. If a reviewer is unavailable to provide closure of such follow-up (i.e., vacation, medical leave), the Chair or a delegated Vice Chair may issue that response in their stead.

Community Outreach and Engagement Review (COE): The COE component of the SRMC review process is performed at the initial review of each interventional study (see 7.2.1). COE review encompasses study elements relative to the catchment area including aspects of inclusivity, impact and involvement. COE partners with a wide variety of community members and clinicians throughout the catchment area; their focus is collaboration with the communities that are served to help provide innovative research and healthcare services to those within our area. Their review also detects possible barriers to enrollment and identifies potential resources for recruitment.

The COE reviewer or their delegate will provide a written review. This review will be taken into consideration during the SRMC review.

As part of the COE review, the following protocol elements are taken into consideration relative to the catchment area:

• Inclusivity: Eligibility of participants relative to age, race, gender, ethnicity, etc. with particular focus on disparate or underrepresented populations.
• Impact: Targeted disease(s) or outcomes of importance to catchment area needs.
• Involvement: Assessment of potential recruitment barriers and identification of potential resources that may assist with overall diversity of participant participation.

COE catchment area impact score will be generated for each interventional trial using a rubric based upon key UFHCI catchment area priorities.

COE also participates in SRMC executive committee meetings where enrollment metrics and participant demographics are reviewed, helping to identify trends in enrollment disparities both at a trial and institutional level.

Feasibility Review: Feasibility review for successful deployment of the study will be conducted as part of the initial SRMC review for all interventional studies and continuation reviews where accrual is significantly underperforming (see 7.2.1). Feasibility review will be conducted by CRO staff or the study team familiar with protocol and institutional resource utilization and will be documented on the Feasibility Assessment Form. This review will be taken into consideration during the SRMC Committee review. The proposed study must be determined feasible to receive initial SRMC approval.

The UFHCI CRO assists study teams with determining local enrollment potential through centralized access to institutional databases including the Integrated Data Repository (using NIH funded i2b2 tool), tumor registry and other electronic datasets. Projected enrollment also takes into consideration historical enrollment to similar studies. As part of feasibility review, enrollment goals are better aligned based on patient population data.

Feasibility review for low enrolling studies at continuation review will be incorporated into the SRMC CAP. An ad hoc feasibility assessment may be conducted as part of a change review that impacts enrollment targets or institutional resource utilization. Any questions or comments related to any feasibility review will be provided to the study team.

Feasibility review assesses the following relative to successful protocol conduct:

• Accessible subject population and enrollment goal refinement
• Availability of adequate institutional and clinical resources (e.g., need for specialized equipment/processes, specialty providers or services, extended or after-hours support, special pharmacy or other ancillary department support, etc.)
• Compliance and regulatory requirement considerations
• Any additional resources that need to be considered prior to trial activation and/or continuation including community stakeholder involvement through COE

Cellular Therapy/Apheresis Review: An additional feasibility review done by the Cellular Therapy and Apheresis Group to ensure the availability of adequate Cellular Therapy and/or Apheresis resources and support to conduct the protocol.

9.0 Academic Research Consortium Program

At the request of a UFHCI Academic Research Consortium (ARC) member, the UFHCI supports our collaborating center(s) through the provision of ad hoc study reviews by the SRMC consistent with the UFHCI SRMC policies and procedures. Under the execution of a Confidentiality Agreement between UF and the partner organization requesting such services, the processes for application, review and decision rendering is similar, but will be outlined in an individual SOP. Of note, continuing reviews will not be undertaken and all recommendations by the SRMC are non-binding in these scenarios. Support of the UFHCI ARC in this manner will not jeopardize SRMC function, role or effectiveness otherwise. Submission processes, reviewer expectations and communication of non-binding recommendations are further described in the ARC SRMC SOP.

The exception to this will be UFHCI IITs that are proposed to be conducted at a UFHCI ARC site. In these scenarios, feedback will be solicited from the ARC site regarding feasibility. Continuing reviews, risk categorization and committee recommendations, including annual accrual monitoring, will be binding.