Research Group Review Information Summary for SRC
Protocol Title/Number:
If this evaluation refers to a local investigator-initiated study, PAGE 3 of this form should be also completed for submission to SRC.
Value of Trial for Patients / 1 / 2 / 3 / 4 / 5Little value / Moderate value / Very high value
Scientific Interest
/ 1 / 2 / 3 / 4 / 5No new science / Interesting / Novel and innovative
Potential Clinical Significance
/ 1 / 2 / 3 / 4 / 5Little/no significance / Advances research / Could change practice
Study Design / 1 / 2 / 3 / 4 / 5
Major flaws / Minor flaws / No significant flaws
Data and Safety Monitoring Plan / 1 / 2 / 3 / 4 / 5
Major flaws or gaps / Minor flaws or gaps / No significant flaws
Fit with Referral Profile / 1 / 2 / 3 / 4 / 5
Poor fit / Moderate fit / Excellent fit
Value Added By Consortium Participation
/ 1 / 2 / 3 / 4 / 5Low value added / Moderate value added / High value added
Anticipated Accrual*
/ 1Will be difficult to accrue / 2 / 3
Potential issues / 4 / 5
Accrual will be easy
Competing Trials in Consortium**
/ 1 / 2 / 3 / 4 / 5Multiple competing trials / Some competing trials / No competing trials
Feasibility
/ 1 / 2 / 3 / 4 / 5Not feasible as designed / Potential issues / No implementation issues
Enrollment of Underserved Populations
/ 1 / 2 / 3 / 4 / 5Low potential / Moderate Potential / High potential
* Please select the accrual track to follow, per the Low Accrual Policy:
CONVENTIONAL ALTERNATVE
Trials qualify for Alternative track based on the criteria below, please select that which is appropriate to this trial, and provide a thorough rationale in the comments section. Requests for alternative accrual track that do not have justification provided will default to the conventional track. The PI is requesting an alternative accrual review based upon (Select one):
Disease incidence is equal to or less than 6/100,000. Can be applied if the trial enrolls only pediatric patients.
Disease is of uncommon clinical presentation (e.g. uncommon clinical subtypes of more common cancers).
The trial involves narrow molecular subtypes.
Provide thorough rationale for the alternative accrual review request in comments section below.
The following disciplines participated in the evaluation of this protocol:
Medical Oncology / Yes, represented by: / No / N/A
Surgical Oncology / Yes, represented by: / No / N/A
Radiation Oncology / Yes, represented by: / No / N/A
Gynecologic Oncology / Yes, represented by: / No / N/A
Pathology / Yes, represented by: / No / N/A
Cancer Imaging / Yes, represented by: / No / N/A
Please check which of these Research Groups conducted the Research Group Review and is primary for this study:
Breast Oncology / Gynecologic Oncology / Immunotherapy / Neurologic Oncology / Sarcoma
GI Oncology / Head & Neck / Lung & Thoracic / Pediatric Oncology / Transplant
GU/Prostate / Hematologic Malignancies / RCC/Melanoma / Phase 1
If reviewed by more than one of these groups, please list the collaborating Research Group:
If other Research Groups may see eligible patients for this trial, please list:
Should network partners be invited to participate in this trial? / Yes / No
Disposition / Submit to SRC
Revise and Evaluate Again before Submission to SRC
Withdraw Protocol from Further Consideration
Comments for consideration by the SRC
(Please use this section to provide additional information including PROS and/or CONS regarding science, design, accrual, feasibility, etc.)
**For studies with competing trials, an explanation of how competing trials will be prioritized compared to this new trial must be included.
01200 Research Group Summary for SRC Form / Page 1 of 3 / Version: 05/08/2017
/ Clinical Research Support
Research Group Review Information Summary for SRC
01200 Research Group Summary for SRC Form / Page 1 of 3 / Version: 05/08/2017
/ Clinical Research Support
Research Group Review Information Summary for SRC
Signature / Printed Name / Date
Group Director (or Faculty designee***):
***If the study PI is also the Research Group Director, signature from a Research Group faculty member designee is required. The PI can sign the form only when there is no applicable Research Group as pre-approved by the CRS Medical Director.
Evaluation of Local Investigator-Initiated Studies
Protocol Evaluation by Research Group
01200 Research Group Summary for SRC Form / Page 1 of 3 / Version: 05/08/2017/ Clinical Research Support
Research Group Review Information Summary for SRC
1. Are the key outcome measures appropriate for the goals specified? / Yes / No
2. Is there sufficient background information to justify the drug, dose, schedule, etc., to be used in this study? / Yes / No
3. Is the study design appropriate? / Yes / No
4. Are the eligibility and exclusion criteria appropriate? / Yes / No
5. Is the time-frame projected for enrollment realistic? / Yes / No
6. Does the statistical section address the stated objectives of the study? / Yes / No
7. Are women, minorities and/or children properly considered for this trial? / Yes / No
8. Is the information stated in the consent form accurate and consistent with information in the Protocol? / Yes / No
9. If this protocol is intended for use as a multi-site trial, is all of the appropriate information included? (i.e., coordinating site, multi-center target, etc.) / Yes / No / N/A
10. If this is a phase I trial, are dose limiting toxicities, rules for escalation of dose, criteria for stopping the trial and defining the MTD (Maximum Tolerable Dose) clearly defined? / Yes / No / N/A
11. If this is a phase II trial, are the stopping rules necessary and appropriate?
i.e., do they clearly define the events to be monitored, the frequency of monitoring, and the threshold for stopping or modifying the trial? / Yes / No / N/A
12. If this is a phase III study, are plans for an interim analysis and/or monitoring by an independent DSMB necessary and (if present) is the membership of the DSMB appropriate? / Yes / No / N/A
13. Overall, is the study-specific plan for data and safety monitoring adequate? / Yes / No
14. If the study will not be monitored by an external group, is the monitoring risk level (high/medium/low) designated for the Consortium institutional data and safety monitoring plan appropriate? / Yes / No / N/A
01200 Research Group Summary for SRC Form / Page 1 of 3 / Version: 05/08/2017