Process for submitting cancer related studies involving human subjects for review

As an NCI-designated cancer center, the CTRC at UTHSCSA is required to review and monitor all cancer-related studies involving human subjects at UTHSCSA and affiliated institutions, through our NCI approved Protocol Review and Monitoring System (PRMS). This is a university-wide requirement to maintain our NCI-designation and involves ALL cancer-related studies with human subjects at the UTHSCSA and other CTRC affiliated institutions, not just those that enroll patients at the physical CTRC location.


Our PRMS utilizes a series of committees for rapid review of protocols so that they can be submitted to IRB with minimal revisions required. Please use the Protocol Submission link on the right to begin a new protocol submission. Once completed, the protocol submission form will be directed to the appropriate Clinical Disease Site Team (CDST) for review and from there to the Operations & Logistics (O&L) committee and the Protocol Review Committee. Please see the links below for more information.


CDST

CDSTs determine whether or not an additional trial in a specific disease site should be opened by considering the following: open trials that may compete with this new study, and incidence rate of the disease and our patient population. Following review by the appropriate CDST, you will be notified of the results. If your trial is accepted the study will be submitted by the team to the O&L committee. O&L meets weekly or more often as needed and will address operational and logistical issues so that any issues can be addressed rapidly before submission to the Protocal Review Committee (PRC).

PRC

The PRC is responsible for scientific review and monitoring of trials. PRC has multiple forms of review (which type of review your protocol receives depends on the type of protocol and the complexity of the protocol). Protocols can be submitted for an IRB pre-review concurrently with PRC, but the IRB will not review until the PRC has approved the protocol. If you have questions about the PRC process please feel free to contact Ms. Melissa Nashawati (Nashawati@uthscsa.edu) or Dr. Susan Padalecki (southwell@uthscsa.edu). If you have questions about total accruals by race, ethnicity, and gender or questions regarding the checklist of investigator tools, please contact Monica Trevino at MAtools@uthscsa.edu.

Accrual Policies

Accruals are recorded for all patients that are consented and eligible to go on a trial.

Accrual Monitoring

Continuance of the protocol and access to CTRC shared resources require continued compliance with the requirements of all institutional committees (IRB, institutional research committees, etc.) and evidence of adequate subject accrual to the protocol. Responsibility for monitoring the due dates for protocol accrual progress and protocol amendment documents is the charge of the PRC Coordinator. A preset electronic query of the research data system facilitates this process. Accrual data is retrieved using IDEAS. Protocols are reviewed for accrual based upon the date of IRB approval.

Institutional (investigator-initiated) protocols are tracked for accrual monitoring every 6 months from the IRB approval date. All protocols are required to have the following elements both within the protocol itself as well as on the PRC face sheet:

  • Total accrual
  • Annual accrual
  • Length of study (time to total accrual)
  • Total accrual by race, ethnicity, and gender

At each 6 month junction of an investigator initiated protocol, a minimum accrual of 50% of the semi-annual accrual goal will be expected. If < 50% of the expected semi-annual accrual has not been achieved, the PI will be notified, asked to provide an explanation of plans underway to achieve the accrual goal. If, at the next review, < 50% of the expected accrual has again not been achieved, the PI will be notified of a pending study closure following review. If at the following review, < 50% of the expected review has not been achieved, the study will be closed. The PI, at this point, may appeal to the Cancer Center Director for a period of 6-12 months grace period, citing reasons for the lack of accrual and specific steps to be implemented to improve accrual. Regardless of the outcomes at any point, the every 6 month review will thereafter continue and, at a future point, the study may be recommended for closure by the PRC or Cancer Center Director for lack of progress of accrual. Scientific progress is monitored concurrently by the PRC using annual progress reports as well as literature searches as appropriate.

Industry, Cooperative Group, and Externally Peer Reviewed Trials are reviewed annually.

Failure of an investigator to comply with prestudy or interim estimates of protocol duration or with other committee stipulations may lead to review by the committee chair, submission of a cautionary memorandum to the investigator warning of possible committee proceedings for termination of the protocol, and notification of the IRB. Protocol accrual must meet estimates of progress established at the time of protocol approval. The PRC has clear criteria for determining whether ongoing research is making sufficient scientific progress, including adequate subject accrual rates. These include:

  1. Approval: Accrual goals have been met, the protocol continues to be scientifically relevant.
  2. Provisional Approval: Protocol accrual is less than 50% of annual target accrual, or data during the period of review call into question the need to continue the current protocol.
  3. Termination: The protocol has accrued less than 50% of the targeted accrual. The scientific question posed by the protocol has been answered or is no longer relevant.

Should the PRC determine that termination of a protocol is appropriate due to a lack of scientific progress; the PRC Chair will notify the PI, the IRB and the CTRC Director of this decision. The PI will be required to submit a final report to the IRB inactivating the protocol. A copy of the final IRB report should also be provided to the PRC.

Protocol Closure

PRC Criteria for terminating a clinical protocol

The PRC committee is empowered to terminate accrual to a clinical protocol and to bar access to the CTRC shared resources as related to the conduct of the protocol in question for the following reasons:

  1. Upon investigator request.
  2. For failure of the investigator to adequately comply with the committee's requirements for protocol approval (i.e. failure to respond to initial stipulations for approval; failure to respond to follow-up stipulations on annual review; failure to close a protocol when directed by the PRC, failure to provide annual accrual reports; failure to meet protocol-specified timelines and accrual goals).
  3. Upon achievement of protocol goals.
  4. Upon review of an amendment change that makes the science of the protocol questionable.
  5. Upon CTRC Director's request.

The Committee will utilize one of the following categories of protocol suspension or termination:

  1. Permanent termination.
  2. Temporary suspension until follow-up review. A protocol may resume with satisfactory response to committee concerns and stipulations.
  3. Probationary approval. The protocol may remain open with for a period specified by the Committee at which time mandatory review of protocol progress by the PRC must occur. The PI must submit a plan for adequate response to the concerns of the Committee within a 2-meeting period. If the PI fails to submit an adequate response, the protocol's status will be changed to temporary suspension to accrual until a response is submitted and reviewed by the PRC.

PRC termination actions are submitted in writing to the PI and are accompanied by notification to the IRB and the clinical affiliate institutions.