Eligibility LMS Module

eligibility

VICC - Clinical Trials Office

Content

1. What is Eligibility?

2. Overview of Eligibility Process

3. Submitting Initial Eligibility Requests

4. Inclusion & Exclusion Criteria

5. Final Eligibility Completion

6. Quiz

Our mission is to alleviate cancer death and suffering through pioneering research; innovative, patient-centered care; and evidence-based prevention, education and community activities.

Vanderbilt-Ingram Cancer Center, Clinical Trials Office

What is eligibility?

• In clinical trials, eligibility criteria are requirements that must be met for a patient to be included in a trial.
• Eligibility criteria for clinical trials are designed to ensure the safety of research participants and facilities, and to reflect the scientific objectives of a study.

What is eligibility?

• These criteria help determine clinical trial eligibility by utilizing protocol specific standards to:
• Determine the patient population of the study
• Isolate the potential effect of an investigational drug
• Ensure the trial is conducted safely

Overview of Eligibility Process

Step 1

Step 4

Step 5

Step 3

Step 2

Initial Eligibility Submitted (Allow 24 hours for follow-up).

Resolution of Eligibility Items/Updated Form emailed to Registrar Office by Clinical Staff Member.

Eligibility Review Completed by Registrar Office.

Patient screened for study.

Registrar Office Emails Initial Findings to Clinical Staff Member.

Overview of Eligibility Process

Step 6

Step 9

Step 10

Step 8

Step 7

Resolutions Confirmed as Adequate by Registrar Office.

Signature Page Signed by Registrar Office; emailed to Clinical Staff Member.

Complete!

Final Signed Form saved in Florence or emailed to Coordinating Center by Clinical Staff Member (Only if IIT study).

Final Eligibility Determination made by Investigator (marked as elig./not elig. on form and signed)

submitting initial eligibility requests

• Initial Eligibility Requests should be submitted via email to the Registrar Office at: viccctsrregistraroffice@vumc.org

• Please be sure to add any study backups to the email (if applicable)

• What to send?
• Completed/Signed Eligibility Checklist Form
• Any records not available in eStar (if applicable):
• Sponsor email communications/clarifications
• Outside medical records (not in media tab)
• Central lab tests Tissue Request Confirmation

Reminder:

• All requests have a 24-hour turnaround time.

• Requests should ONLY be marked as URGENT if needed the same day!

Don't forget to change the sensitivity label when including subject information!

eligibilty review - Oncore/florence

• Were consents uploaded into Florence?​
• Are the current form versions being used or have they expired? (OnCore Documents Tab)
• ​ Consent
• ​ Other consents (pre-screening, optional, HIPAA, etc)
• ​ Eligibility Checklist
• ​ Is the person who signed the eligibility checklist on the DOA? (Staff Tab)
• ​ Is the ICF note completed in Epic? Was contraception discussion noted?
• ​ Has the checklist been fully completed (no blanks, missing info, etc.)?

eligibilty review - medical record

• Pharmacy Medication Review​
• AE Review/Baseline Medical History
• ​ Procedures​
• Allergies​
• Notable Scans
• ​ Past Medical History​
• Cancer Diagnosis/Prior Treatment
• ​ Have all notes been signed (not in draft)?

Inclusion & Exclusion criteria

• Subjects must meet all inclusion criteria and none of the exclusion criteria!

• Any inclusion criteria must have verifiable documentation.

• Waivers to criteria are not allowed per Vanderbilt Guidelines.

Eligibilty dependent vs. independent

• Eligibility Dependent - directly impacts eligibility.
• ECOG Performance Status
• Life Expectancy
• Eligibility Labs (Hgb, AST/ALT, etc.) - must use most recent!
• Independent of Eligibility - findings will not change eligibility status.
• Correction of date
• Missed height
• Non-eligibility labs (LDH, Lipid Panel, etc.)

final eligibility completion

• Final eligibility is determined by the investigator. They must mark the participant as either eligible or ineligible and complete the final sign off on the checklist.
• After the investigator has signed and marked the participant as eligible/not eligible, file should be uploaded into Florence.
• For any ITT studies: please email final eligibility documentation to the Coordinating Center at: coordinating.center@vumc.org

final eligibility completion

• Final Signed Form must be saved in Florence or emailed to the Coordinating Center by Clinical Staff Member (ONLY if IIT study).
• When uploading to Florence, always use the naming convention: Subject ID_Eligibility_Study ID_Date_[Indicate Signer if Signatures on Multiple Documents]
• Only upload after final PI signature.
• If multiple forms, you may combine into a single PDF or upload as separate documents.

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eligibility quiz

Eligibility team

Holly McClellan - Manager

Shana Baughman

Allison Schanne

Questions? viccctsrregistraroffice@vumc.org

References

Duggal, M., Sacks, L., & Vasisht, K.P. (2021). Eligibility criteria and clinical trials: An FDA perspective. Contemp Clin Trials, 109, 106515. DOI: 10.1016/j.cct.2021.106515​ ​. National Institutes of Health (2022). NIH clinical research trials and you: The basics. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. ​ ​ U.S. Food & Drug Administration (2014). Basics about clinical trials: What are clinical trials? (Obtained October 2022). ​ https://www.fda.gov/patients/clinical-trials-what-patients-need-know.

NOTE: Date completed should be the date the criteria was done, not the date the checklist was completed.

If multiple labs are listed, please be sure that there is a result for each!

Always provide a detailed explanation - simple "Yes" or "No" answers are not acceptable.

When including a note as a Criteria Answer, please add the note type and date in eStar. For example: MD Note XX/XX/XX or Clinical Communication XX/XX/XX

NOTE: Please include TYPE of scan and date.