CORS Research Standard Operating Procedures

1. Expectations & Policies

Office Attendance & Remote Work

• Minimum 3 days per week in office — required for all fellows regardless of visa status (J1 visa compliance verified with GME)
• Maximum 2 days per week from home
• Remote access must be from a Cleveland-based location (cybersecurity compliance)
• Desk outside Dr. Holubar's office: search A30-262A Hotel Desk to reserve. Additional shared desk in the clinical fellows' room (next to Elissa, 2nd on the left)

Moonlighting (Gen Surg PGYs Only)

• Mandatory reporting of all moonlighting to Gen Surg PD
• One 12-hr call at Hillcrest per month required
• FV SICU at the discretion of the PI and trainee
• Don't let moonlighting interfere with research — it is a privilege, not a right

Monthly Reports

A monthly report will be requested to help support the numerous projects each fellow is working on. This helps identify areas needing improvement with feedback and input from PIs and the research team.

2. Research Analytic Staff

3. Biostats Support

The default should be Jennifer Sanchez and Dr. Li Tang for biostatistical support. See the Biostatistics Reference for methods guidance.

4. Data Resources

Local Databases

Curated National Data

* Annually updated Oct.   ** Runs 3 months behind

Patient-Reported Outcomes — Pouch QoL & Bowel Function

Patient-Reported Outcomes — Non-Pouch QoL & Bowel Function

5. How to Request Data

How to Request Data from the CORS Registry

1. Make a list of ICD-9 & ICD-10 (diagnosis) codes
2. Make a list of CPT (surgery) codes
3. Limit to a period of time (e.g., 2010–2020)
4. Consider how much additional chart review is needed
5. Consider how much follow-up time is needed (e.g., 5 years for oncologic outcomes)
6. Ask Jie Dai to query the CORS Registry to get case counts
7. May be done preparatory to research if you do not yet have IRB approval
8. After IRB approval, Jie will send data via JTool

6. How to Conduct a CORS Study

Step 1: Prepare — Research Your Topic in PubMed

Prepare a succinct 1-page summary which can be parsed into the background for the abstract and introduction of the manuscript:

• 1st paragraph — Define the disease/procedure and scope of problem/burden
• 2nd paragraph — What have we learned from the literature so far
• 3rd paragraph — How will we address the problem or knowledge gap; end with your scientific aim and hypothesis

Step 2: IRB Application

Write a 1-page protocol (hence the background literature review). What they really want is the list of exact variables you plan on collecting — in Word format, not Excel.

New IRB Study Flowchart

IRB: Studies Collecting New Variables

Aim: Reduce administrative burden of submitting new IRB applications for every retrospective chart review.

Solution: Construct disease-specific IRB-approved "Registries" and submit Appendix Amendments instead of new applications from scratch.

7. Processes & Forms

DDSI/CORS Research Policies & Forms

8. Meetings & Travel

Surgical Conferences

9. Authorship

ICMJE Criteria

The ICMJE recommends that authorship be based on all 4 of the following criteria:

1. Substantial contributions to conception or design of the work; or acquisition, analysis, or interpretation of data
2. Drafting the work or revising it critically for important intellectual content
3. Final approval of the version to be published
4. Agreement to be accountable for all aspects of the work, ensuring questions about accuracy or integrity are appropriately investigated and resolved

Contributors who meet fewer than all 4 criteria should be acknowledged, not listed as authors.

AI Use & Authorship (ICMJE Policy)

10. Altmetrics

Altmetrics are non-traditional bibliometrics proposed as an alternative or complement to traditional citation impact metrics (impact factor, h-index). They measure scholarly impact based on diverse online research output including social media, news media, and reference managers.

• Demonstrates both the impact and the detailed composition of impact
• Can be applied to: articles, people, journals, books, datasets, presentations, videos, code repositories
• Useful for: research filtering, promotion & tenure dossiers, grant applications, ranking newly-published articles

Learn more: Wikipedia — Altmetrics

11. Scientific Posters

• Always use a CCF Poster Template available pre-formatted to 4×6 from the Intranet under OnBrand
• Remember the audience will look at posters for seconds to minutes — briefly and concisely get your point across visually
• Avoid busy/crowded layouts with too many tables and figures

Poster Printing

Use the Lawson cost center for poster expenses.

12. Tables & Figures

CONSORT Diagrams

Every study should include a CONSORT-style flow diagram showing patient selection, exclusions, and final analytic cohort.

Figure Types

• Kaplan-Meier curves — survival analysis with number-at-risk tables
• Forest plots — subgroup analyses and meta-analyses
• Sankey diagrams — patient flow between treatment groups
• Waterfall plots — individual patient responses

Formatting Guidelines

• Figures should be high-resolution (600 DPI for TIFF)
• Use Arial font throughout figures
• Include clear axis labels, legends, and annotations
• Avoid 3D effects and unnecessary gridlines

13. Journals

Primary Target Journals

Abstract Submission Policy

14. Case Reports

• Case reports document rare conditions, unusual presentations, or novel treatments
• Follow the CARE guidelines for case report writing
• Target journals with dedicated case report sections
• Can lead to systematic reviews that aggregate similar cases

15. QI / IND / IDE

Quality Assessment & Quality Improvement Activities

QI/QA projects may not require full IRB review but still require proper documentation and oversight. Key distinctions:

16. Writing

Formatting & Reporting Numbers

• Follow journal-specific author guidelines for formatting
• Use AMA Manual of Style as default for medical manuscripts
• Report numbers consistently: spell out numbers below 10, use numerals for 10 and above
• Always include units for measurements and lab values
• Use en-dashes for ranges (e.g., 95% CI 0.51–0.76), not hyphens

CCF Writing Resources

The CCF Library offers writing support: CCF Writing Guide

AI Editing Tools

• Paperpal — AI editing tool with a generative AI writing feature (Co-pilot) which can be used for grants, not for publication
• AJE Curie — Professional language editing service

17. Reference Managers

Do not manually type references — this introduces errors and wastes time. Use your reference manager to insert citations and auto-generate the bibliography.

18. Resources

19. Lessons Learned — Real Examples