Activate a Study

Activation of a new study within the UCLA Health Jonsson Comprehensive Cancer Center requires study approval steps within the Cancer Center and Enterprise-wide. The guidance below provides insight into activation of cancer related interventional and non-interventional studies. Non-interventional studies include but are not limited to observational, ancillary/correlative, retrospective chart review, and specimen collection studies.

Cancer-Relevance

A study is cancer relevant if it is any of the following:

• Studies sponsored by the NCI either directly or indirectly; OR
• Studies with intent to treat, prevent, diagnose cancer or improve comfort/quality of life of cancer patients.Includes Epidemiologic/Observational/Ancillary-Correlative (e.g., Lab-based) studies that assess cancer risk, outcomes or therapy response; OR
• Studies with a focus on cancer; OR
• Studies with a subject population primarily made up of cancer patients
• Studies where theprotocol describe capturing a cancer diagnosis as a data point
• Studies where the inclusion criteria includes a cancer diagnosis
• Studies where the protocol objectives or aims have a cancer focus

If a study is any of the types described above, then the Cancer Center would consider this study cancer relevant and the study should be marked as a cancer study in the UCLA IRB's new study application and submit a JCCC New Study Application in CAFÉ.

To speak to someone about your specific study, email [email protected] and someone from the Cancer Center's Clinical Oncology Research Administration team will contact you.

New Study Intake Form to Initiate DSG Review

Study activation within the Cancer Center starts with Disease Site Group (DSG) review. To initiate a DSG review, ensure you have access to the protocol and submit a DSG Review Intake Form.

Only after approval by one of the Cancer Center's 15 Disease Site Groups, is the study eligible to submit a JCCC DSMB/ISPRC application in the CAFÉ portal.

JCCC DSG New Study Review Intake Form: Click here

New Study Application in CAFÉ to Initiate DSMB/ISPRC Review

The JCCC New Study application is submitted via the CAFÉ portal. A tip sheet to help you access and use the CAFÉ application is available here: Instructions for Electronic New Study Submissions using CAFÉ (Comprehensive Ancillary Forms Engine)

Important notes:

• The CAFÉ application can only be accessed from within the MEDNET network or via VPN.
• You login to the CAFÉ application with your AD credentials.
• A study must have an OnCore record before a CAFÉ application can be opened. If you have questions about your OnCore study record, email [email protected].

If you are unable to access the CAFÉ application, contact the Clinical Oncology Research Administration (CORA) at [email protected]. We are here to help.

Interventional Clinical Research Studies

Interventional Research are studies where participants are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed.

A study is interventional if the study is designed to alter treatment or intervention decisions, methods of diagnoses or act as an intervention.

JCCC DSG New Study Review Intake Form: Click here

JCCC DSMB/ISPRC New Study Café application: Click here

A detailed workflow for interventional clinical studies:

This schema above is provided to help visualize where the DSG review process might best fit into the Cancer Center's DSMB, ISPRC and enterprise-wide Study Activation Process. All activation steps are not included in this visual.

For Investigator- Initiated studies:

• The DSG has the ability to issue provisional approval with conditions for full approval in cases where a concept is accepted but the study requires revisions to the protocol, statistical analysis plan or some critical element related to study design or feasibility.

Non-Interventional Clinical Research Studies

All non-interventional clinical research studies, examples described below, require initial ISPRC evaluation, and therefore require the submission of a JCCC New Study DSMB/ISPRC CAFÉ application. In order to open a CAFÉ application, you must first submit the study at the IRB. See Important Notes below and this tip sheet.

Upon submission of a JCCC New Study DSMB/ISPRC Café application, non-interventional studies are reviewed by the ISPRC administrative unit and ISPRC Co-Chairs to determine if the study qualifies for ISPRC exemption. See ISPRC Exemption for more information.

Important notes:

• The IRB application can be submitted without an ISPRC exemption or approval notice uploaded.
• If you select Yes to Cancer Related in the IRB application, then 24-48 hours after you submit the study's IRB New Study application, the study should have an OnCore record automatically created.
• An OnCore record for a specific study is required in order to open a JCCC New Study DSMB/ISPRC application in the CAFÉ portal for that study.
• To troubleshoot CAFÉ portal access issues see this tip sheet.

Non-Interventional Clinical Research Studies (Observational)

Observational Research includes studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.

JCCC DSMB/ISPRC New Study Café application: Click here

Non-Interventional Clinical Research Studies (Ancillary/Correlative Study)

Ancillary Clinical Research Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study.

Correlative: Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc.

JCCC DSMB/ISPRC New Study Café application: Click here

Non-Interventional Clinical Research Studies (Retrospective Chart Review)

Retrospective Chart review studies are those studies that collect all study data from a review of existing records.

JCCC DSMB/ISPRC New Study Café application: Click here

For more information on how these terms are defined look here: cancercenters.cancer.gov/GrantsFunding/DataGuide