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Study Materials

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Study materials

Print the current study binder.

This page is the controlled source for the site binder. The versions listed here are the versions in force. Print from here rather than from a saved copy.

Binder Version21 August 2026
Sterling IRB ID16201
Protocolv1.4, 21 April 2026
Consent in ForceVersion 1.0; IRB-approved 27 Apr 2026
Patient Research Information (English)Patient Research Information (Spanish)Blank Consent Packet (reference)Back to Clinical Research
Before you print

Consent only on the version issued here.

If you believe a newer consent form exists — someone mentions it, emails it, or you see one elsewhere — stop and call before consenting anyone. A version is only in force once it appears on this page or has been issued into your binder in writing by the Principal Investigator.

Replacing a versionPrint the replacement, remove and destroy the superseded copy, and file the new one in the same section. A superseded consent left in a binder will eventually be used.
Amendment pendingAn amendment is currently with the IRB covering Spanish-language support, consent administration by clinical staff, and additional data sources. Pending is not approved.
Print settingsUS Letter, single-sided. The complete binder prints in tab order. Extra copies of the consent template and the patient information sheets are worth having on hand.
Complete binder

Site 01 — Pupila Eye Care (Houston and Sealy). Includes the cover, the document register, the operations manual, imaging and export procedures, and the full IRB-approved set.

Download Complete Binder (PDF)
Working documents

Individual documents.

00 — Binder Cover1 page. Front sleeve insert. Not a numbered tab 01 — Start Here3 pages. Binder contents and what is live 02 — Document Register and Version Control3 pages. What is in force today, the replacement procedure, and the signable acknowledgement 03 — Site Operations Manual11 pages. The document the site works from every day 04 — Topcon Maestro Imaging Protocol7 pages. Acquisition standards — dilation, minimum image set, quality 05 — SOP-003, OCT Export and Imaging Data Handling16 pages. The controlled export procedure. Where anything disagrees with it, SOP-003 governs 08 — Retinal Imaging Modalities1 page. For explaining the imaging to a patient who asks
Not yet approved

Draft — pending IRB approval.

These sheets are part of the amendment currently with the IRB. They are provided for site familiarity only. Do not distribute them to patients until written approval is issued.

06 — Patient Research Information (English)2 pages. DRAFT — pending IRB approval. Not for patient distribution 07 — Patient Research Information (Spanish)2 pages. DRAFT — pending IRB approval. Not for patient distribution
Section 06 — the approved set

IRB-approved materials. Approved versions only.

These are the only documents that may be used to consent a patient or to obtain a records authorization.

09 — IRB Protocol v1.47 pages. The approved protocol. The study you are participating in 10 — Consent Form Template (APPROVED)6 pages. The consent form in force. Use this one 12 — Medical Release Form (APPROVED)2 pages. Approved authorization for release of medical records
Questions

Route research questions to the investigator.

Please do not answer research questions from your own knowledge, however reasonable the answer seems. Sai Chavala, MD — Principal Investigator — schavala@gmail.com, 214-233-6170.

Back to Clinical ResearchResearch Page