Internal Scientific Peer Review Committee
The Internal Scientific Peer Review Committee (ISPRC) reviews clinical oncology protocols conducted by UCLA Health Jonsson Comprehensive Cancer Center investigators. Drs. John Glaspy and Albert Lai serve as Co-Chairmen of the ISPRC. Under their direction, the committee reviews the required elements of the clinical protocol, statistical applications and other factors such as adequate research staffing, any competing trials, well-constituted data collection forms and utilization of other Cancer Center resources.
Meetings and FAQs
Meetings are held bi-weekly on Tuesdays. The deadline for submissions is two weeks prior to each meeting as noted in the ISPRC Meeting Schedule link above.
Submissions
The ISPRC provides initial review, protocol amendment review (including PI changes), continuing review and closure review.
Initial Review
- Instructions for Electronic New Study Submissions using CAFÉ (Comprehensive Ancillary Forms Engine)
- JCCC Protocol Review Processes Guidance (DSG-DSMB-ISPRC Protocol Review Flow)
The Cancer Center ISPRC New Study Submission application is submitted via the CAFÉ portal. Only electronic submissions are accepted.
Protocol Amendment Review
Studies Under UCLA IRB approval
Submit a webIRB Amendment application and CORA will be notified of your protocol amendment via an auto notification # 31 as long as the amendment trigger options are selected in the view amendment section of the webIRB amendment submission. See entry # 6 below to view the IRB Amendment Submission selections that trigger ISPRC notification #31 to [email protected].
Studies Under IRB Reliance Approval
Email the protocol amendment (clean and tracked) and a summary of changes to ISPRC via [email protected]. We then place the protocol amendment under ISPRC review and release correspondence or an approval.
Continuing Review
Annually, study are assessed by the ISPRC on their success with meeting their annual accrual targets provided in the initial ISPRC CAFÉ application. In the initial application, investigators indicate how many patients are targeted at UCLA and the total number of months accrual will be open (aka accrual duration). Studies that are not meeting their annual accrual target and are therefore not on track to meet their overall accrual target may be required to close the study.
Studies Under UCLA IRB Approval
Submit a Continuing Review (CR) application to the IRB in webIRB and notification #98 is triggered which alerts CORA that a study requires ISPRC CR approval
Studies Under UCLA IRB Approval with No CR required
Annually, based on the initial ISPRC approval date, these studies land on a report which alerts CORA that a study in this category requires ISPRC CR approval. No additional submission required.
Studies Under IRB Reliance Approval
Annually, based on the initial ISPRC approval date, these studies land on a report which alerts CORA that a study in this.
ISPRC Exemption
New studies that meet ISPRC exemption requirements are not subject to Full Board Review and are issued an ISPRC exemption letter after submission of the JCCC DSMB/ISPRC New Study CAFÉ application. Note that in order to access the JCCC DSMB/ISPRC New Study CAFÉ application, the study must be submitted to the IRB and have an OnCore record.
Exemption classification is determined by the ISPRC Co-Chairs or their qualified designee, based on the following criteria:
- Observational research, descriptive research, questionnaires and focus groups;
- Ancillary trials (i.e., pharmacokinetic research, pharmacogenetic research, and long-term follow up protocols);
- Correlative research: studies that use tissues (i.e., from an existing tissue bank, creating a tissue bank, genetic epidemiology, and collection of tissues for lab based trials (such as biomarker research) that pose no more than minimal risk to subjects;
- Studies with de-identified tissues;
- Treatment/management guidelines not asking a research question;
- Use and collection of de-identified (anonymized) human specimens, that pose no more than minimal risk to participants;
- Retrospective chart reviews and review of databanks.
Subject accrual will not be monitored by the Cancer Center for exempt protocols that fall into the following categories:
- Protocols only involving de-identified samples;
- Retrospective chart reviews;
- Tissue banking protocols that do not yet have a study endpoint or purpose.
Once a study has been deemed “exempt” it will not be re-reviewed by the ISPRC. The exemption letter may be provided to the UCLA IRB and the PI follows institutional policies for amendments and renewal.
Should there be an issue or question about the exemption status of a study, the ISPRC Administrative Director or the ISPRC Co-chairs and/or full committee reviews the study and determines the status. All exempt determinations must be made by the ISPRC.
Training
ISPRC submission training may be requested at any time through the Cancer Center's Clinical Research Unit Training unit at [email protected] (JCCC Quality Performance & Education).
Questions and ISPRC Submission Support
The Cancer Center's Clinical Oncology Research Administration (CORA) team supports administrative activities for the ISPRC. Any submission questions should be directed to [email protected].
Gina Santisaranyu
ISPRC Specialist, Clinical Oncology Research Administration
(310) 853-5845
Maggie Lindenbaum
Director, Clinical Research Support Services
(424) 440-0438