There are two committees that provide review and approval prior to the activation of research studies. The Clinical Study Evaluation Committee (CSEC) provides scientific and feasibility assessment and the Institutional Review Board (IRB) conducts an evaluation for the protection of human subjects. Preparation of the CSEC and IRB applications can be done simultaneously; however, CSEC approval is required prior to submission of an application to the IRB. In this section we answer frequently asked questions (FAQ) and provide tips for creating a successful application to the CSEC and IRB.
Clinical Study Evaluation Committee
The mission of the CSEC is to provide a scientific and feasibility review of each study and to deliver feedback to investigators designed to improve the quality and impact of their project. A diagram illustrating the CSEC submission and review process can be found here.
Submitting a Study to the CSEC
To submit a study to the CSEC for review, please follow the instructions below:
- Complete Part A of the CSEC submission process by accessing the form here. Instructions for completing this portion of the CSEC application can be found here.
- Upon completing Part A, the CSEC will create a protocol application in eIRB and provide access for you to complete Part B. Instructions for completing part B of the CSEC application can be found here. In order for your submission to be considered complete, you will need to upload a completed PI Score and Signature Sheet.
- After Part B is complete, the study will be scheduled for CSEC review.
- While your study is undergoing CSEC review, you may begin completing the eIRB application. Please remember that changes should not be made to the Non-Technical Research Plan (NTRP), as these sections will be automatically populated upon CSEC approval.
CSEC Meeting and Agenda Closure Dates
The General CSEC meets weekly on alternating Mondays, Tuesdays and Thursdays. The Cancer CSEC meets every Thursday (except the 5th Thursday of the month). Meeting and closing dates as follows:
CSEC Frequently Asked Questions
How do I know whether my study requires review by the Clinical Study Evaluation Committee (CSEC)?
All research involving human subjects, with the exception of IRB exempt studies that do not require collection or processing of biological samples, require CSEC review and approval.
For assistance in deciding whether or not your study meets the requirements for an exemption determination, please refer to the Exempt Categories Decision Tool or contact the IRB at IRB@med.cornell.edu.
What is the purpose of the CSEC?
The CSEC has two main purposes:
- To review a study for scientific merit and feasibility.
- To provide an environment for input, guidance and mentorship amongst all faculty members who participate in clinical research.
How do I submit my study to the CSEC?
Submission to the CSEC is a two-part process.
First, complete Part A of the CSEC electronic application in REDCap by accessing the form here. If the study requires CSEC review, you will receive an email providing you access to complete Part B of the electronic application in REDCap. You will be required to upload the following supplemental documents within Part B:
- Protocol (if available)
- Informed Consent Form (Sponsor template is acceptable)
- Budget or memo stating there is no budget for unfunded studies
- Disease Specific Algorithm (An example of a Disease Specific Algorithm can be found here.)
- Completed PI Score and Signature Sheet
- Human Tissue Request Form
Submissions that do not include all required documents will be considered incomplete and will require updating and resubmission prior to CSEC review.
Upon completion of Part B, the study will be scheduled for CSEC review. You will receive an email notification confirming your study has been assigned to an agenda with meeting details.
What if I do not have a written protocol?
All sponsored studies and therapeutic Investigator Initiated Trials (IITs) must have a written protocol. A template for IITs can be accessed here.
A written protocol is not necessary if your study is a non-therapeutic investigator initiated study (i.e., chart review). Please do not complete the NTRP in eIRB and upload a copy of this information, as portions of the NTRP will be populated automatically in eIRB from the CSEC application.
What is a disease specific algorithm?
A disease specific algorithm is an illustration of the research studies that are active in your department, division or disease area. The algorithm should illustrate competing studies such as prioritization of studies aimed at the same patient population. If applicable, the algorithm should also illustrate how recruitment decisions will be made when enrolling to competing studies.
You can find an example of a disease specific algorithm here.
Where can I find the CSEC Submission forms?
How often do the CSEC meetings occur?
General CSEC meetings occur weekly. General Committee A meets on alternating Thursdays and General Committee B meets on alternating Mondays. Cancer CSEC meetings occur biweekly and occur on alternating Thursdays.
General and Cancer CSEC meeting dates can be found in the Researcher's Toolbox under CSEC Tools and Templates
Are PIs permitted to attend the CSEC meetings?
PIs are encouraged to attend CSEC meetings and participate in the discussion of their study. They may not vote on their study.
Are study coordinators permitted to attend the CSEC meetings?
Study coordinators are encouraged to attend CSEC meetings.
What happens after my study is reviewed?
In most cases, you will receive an email from a CSEC Administrator within 24 hours of the committee meeting providing you with the disposition of your study. There are three possible outcomes:
APPROVED: If your study is approved you will receive an approval letter from the CSEC and may submit your study to the IRB.
APPROVED WITH CONDITIONAL CHANGES: If your study is approved with conditional changes, you will be asked to provide a point-by-point response to the committee’s inquiries, comments or requests by email and to update Part B of your CSEC application in REDCap if necessary. Your responses will not need to be presented at a meeting and will generally be reviewed within 24 to 48 hours.
REVISIONS REQUIRED: If your study requires revisions, you will be required to make changes per the committee’s request to Part B of your CSEC application in REDCap, the study protocol and/or informed consent. You will need to provide a point-by-point response to the committee’s inquiries, comments or requests by email, as well as tracked changes versions of any revised study materials. Once complete, your study will be scheduled for a re-review at the next committee meeting.
How does submission to CSEC relate to my IRB submission in eIRB?
The CSEC application and the IRB application are two separate processes that may be completed concurrently.
Upon completing Part A of the CSEC submission process, a CSEC Administrator will create a protocol application in eIRB and will provide you with the IRB protocol number. If your study requires CSEC review, you will need to complete Part B in REDCap and may complete your IRB application in parallel. However, you cannot submit your study in eIRB without CSEC approval.
Portions of the CSEC application are populated in the NTRP section in eIRB. Any information you enter into these fields in eIRB will be overwritten by the CSEC to ensure information provided to the IRB has been reviewed and approved by the CSEC.
Is CSEC review going to delay IRB review and approval of my study?
CSEC review should not delay IRB approval timelines. You may complete the IRB application in eIRB while your study is under review by CSEC. In addition, portions of your CSEC submission will automatically populate the NTRP section in eIRB.
What documentation is needed to show an agreement with a collaborating department or division?
Any written documentation showing the agreement between the PI’s Department/Division and any collaborating Division(s)/Department(s) is sufficient (i.e., an email).
What number should I report when I am asked for the estimated number of subjects/cases to be accrued?
You should report the number of subjects, or cases you will feasibly enroll onto a study over a given time period, not including screen failures. This number is different than the expected enrollment asked for by the IRB. The IRB considers any subject that has signed consent to be “enrolled”. For example, if your study is a chart review, you should report the number of charts you expect to review.
Can multiple staff members have access to complete the CSEC application?
No, at this time only one administrative contact is able to complete Part B of the REDCap application. If you have additional questions or wish to change access rights, please contact the General or Cancer CSEC at GeneralCSEC@med.cornell.edu or CancerCSEC@med.cornell.edu.
My study is interventional, but not therapeutic. What should I select when asked for the study type?
If your study has an intervention but is not therapeutic, select “Therapeutic/Interventional Study.”
Does my study need biostatistical input?
An optimally designed study includes analyses and statistical data that are appropriately balanced in relation to the underlying hypothesis. It is strongly recommended that applicants consider biostatistical review and input prior to submission. All studies, including pilot and feasibility studies, must have a justification for the number of subjects/cases to be enrolled.
For short-term statistical assistance you may contact WCM's Biostatistics and Research Methodology Consulting Core by sending an email to Dr. Paul Christos firstname.lastname@example.org. For long-term collaboration, please contact Biostatistics and Epidemiology Division Chief Dr. Madhu Mazumdar email@example.com.
What is meant by "importance to PI or Department"?
“Why does the investigator want to pursue this particular study, and what is the importance to the scientific community?”
This question is aimed at the importance of the PI completing this study apart from the underlying scientific query. For example, it is important to the PI for national standing. All reasons explaining why the PI has a strong interest in pursuing the study should be identified.
What will the CSEC look for when reviewing my study?
The reviewer will assess the scientific soundness and feasibility of your study. You may reference the CSEC reviewer’s checklist utilized when evaluating your study here.
Who can I contact if I have additional questions?
What is meant by Study Indication/Population?
Study indication/population describes the disease that the study is treating or evaluating or the population the study aims to evaluate.
What is the estimated duration of accrual?
The estimated duration of accrual is the timeframe between the date of activation and the expected date of completion. For instance, if your study is a chart review that will evaluate 50 charts, you will indicate the estimated timeframe for evaluating 50 charts.