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UNC Scientific Review Committee Protocol Review Process

Study team develops study protocol, including statistical analysis plan

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Submit protocol through SRC portal

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SRC coordinator receives protocol, does pre-review for eligibility and completeness

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If protocol is ready for review, it will be scheduled for full SRC review at the next available SRC meeting

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If protocol needs revision, SRC coordinator will inform investigator and provide pre-review comments to be addressed

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SRC Full Committee Review—Committee will decide whether protocol needs revisions or is ready to proceed to IRB review

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Investigators provided with reviewer feedback and either proceed to IRB submission or submit revised protocol to SRC

1. Determine whether your study’s protocol needs review.

If the answers to any the following questions are yes, your study protocol most likely does not need SRC review.

  • Is this study an oncology study? (if yes, submit protocol to UNC Oncology Protocol Review Committee)
  • Is this study a minimal risk study? If you’re not sure, consult with the UNC IRB — they make the risk level determination for studies at UNC.
  • Has the study protocol been written by an industry sponsor?
  • Is this a multi-site, industry-sponsored study where UNC is not the primary clinical site?

Read “When is SRC Review Required” to get more details about which studies need UNC SRC review and why.

2. Use a UNC template to create a master protocol document (MPD) ready for SRC review.

Use one of UNC’s protocol templates. UNC has templates for several types of MPDs: NIH/FDA interventional studies, Registry Repository studies and observational studies as well as other types of studies. They are available on the SRC protocol page.

Prior to submission, make sure that the protocol document contains all of the required elements and has a detailed statistical analysis plan. Also make sure that the protocol lists all members of the study team including the study biostatistician.

  • Has the protocol been reviewed elsewhere? If yes, when, where and by what body?
  • Has the protocol been subjected to IRB elsewhere? If yes, when, where and by what body?
  • Industry sponsor? If yes, not eligible for SRC unless exceptional circumstances
  • Minimal risk? If yes, not eligible for SRC
  • Cancer study? not eligible for SRC
  • Multi site study? If yes, is UNC lead site?
  • Is UNC clinical site? Or data analysis/core services only?
  • Name all key personnel in study, including biostatistician

The protocol submitted to the SRC should be a step-by-step guide to the process and procedures that you will be using in your study. Think of it as an instruction manual for the study.

Grant applications tend to have a summary of the study protocol, but the master protocol document submitted to the SRC should be much more specific in terms of the logistics of the study including study visit schedules and a detailed statistical analysis plan.

If you have questions about study design and protocol writing, please contact the UNC SRC at src@unc.edu or schedule a consultation with NC TraCS protocol development consultation service.

While writing your study protocol, keep ClinicalTrials.gov registration and reporting in mind. Outcome measures and other elements of the protocol can be written to satisfy both SRC requirements and ClinicalTrials.gov requirements.

Your study may or may not need to be registered with ClinicalTrials.gov and may or may not have reporting requirements. More information about the ClincalTrials.gov requirements for a particular study can be found on the UNC ClinicalTrials.gov page.

  • Use one of UNC’s protocol templates.
  • Comments/tracked changes? If yes, provide a clean copy for UNC SRC review.
  • Make sure that the MPD contains a complete list of abbreviations.
  • All elements of protocol complete (based on OCT protocol template, as applicable)?
  • Page numbering/TOC correct?

3. Submit the protocol.

Submit your protocol as an MS Word document through the SRC portal. Sign into the portal using your UNC ONYEN and be sure to answer all of the questions on the submission form so that the SRC has the info it needs to start processing your request.

A protocol that is complete and contains all of the info that the UNC SRC needs to evaluate the scientific merit of the study will, in most cases, be able to get SRC approval within two weeks of submission. If protocol revisions or multiple revisions are needed, the length of time required to get the protocol approved by the SRC will increase.

Using UNC protocol templates and working with a biostatistician throughout the protocol writing process will reduce the likelihood that a protocol will need revisions.

If there is no biostatistician on the study team, consider using NC TraCS biostatistical consultations. NC TraCS also offers protocol writing assistance.

4. Pre-review

Once received, your submission will go through a pre-review process, to make sure that all required elements of the protocol are present.

If the submitted protocol needs editing or additional information, the SRC coordinator will contact the study contact person and let them know which elements of the protocol need updating prior to the protocol moving forward to full SRC review.

Once the protocol is revised the investigator will resubmit it for pre-review.

5. Full review

Once the protocol is ready for full SRC review, several reviewers will be assigned to the study: a primary reviewer, a secondary reviewer and a biostatistical reviewer.

The protocol is sent to all of the SRC members a week before the meeting where it will be reviewed.

During the meeting, the primary, secondary and biostat reviewers will present their comments about the protocol and then the entire SRC will discuss the protocol.

  • Background and rationale — literature review of this topic and explanation of how this study fills a gap in scientific knowledge
  • The study design is adequate to achieve study aims
  • The protocol has a complete statistical analysis plan
  • The protocol contains measurable study outcomes
  • Participant inclusion and exclusion criteria are clearly detailed
  • Details about patient visit procedures and timelines
  • MPD is detailed enough to be used as an operational manual for the study.

6. Feedback

Reviewer comments are compiled into summary documents which the SRC Coordinator sends to the study contact person(s) shortly after the meeting where the study is reviewed.

Along with the comments, the SRC Coordinator will notify the study contact whether the SRC has determined that the protocol is ready for IRB review or whether the SRC has determined that the protocol needs revision and resubmission to the SRC.

  • Need more biostat planning
  • Unclear study aims or outcomes
  • Need more background for the study
  • Need more detail about study design
  • Need reasoning for inclusion/exclusion criteria

7. IRB Submission

If protocol is ready for IRB review, the investigator submits the protocol along with SRC comments and approval email along with their IRB application.

For help finding answers for any additional questions, please contact the SRC Coordinator at src@unc.edu.