SpectOcular
Secure operations

Google Drive Pilot Handoff

Restricted implementation page for SpectOcular research personnel. Enter the access code to continue.

Print / wet-sign pilot architecture

Use Google Drive under BAA as the interim system of record.

The website remains the branded front end for staff. For the pilot, OD/site staff print the populated packet, obtain wet-ink signatures, scan the packet, upload it to restricted Google Drive, and update the restricted master linkage sheet.

Recommended pilot path

Google Drive with BAA + wet signatures.

1. Populate formsAuthorized page creates a printable packet using the existing source documents and entered data.
2. Wet-sign and scanPatient and site/consentor sign on paper. Staff scan as a single PDF.
3. Upload + logUpload PDF to restricted Drive and update the Master Linkage sheet.

Signed packets folder

Store scanned PDFs only in the restricted signed-packet folder. Use file name: SubjectID_YYYYMMDD_signed-packet.pdf.

Download upload checklist →

Master linkage database

Use the restricted master linkage Google Sheet to map Study Subject ID to patient identifiers. Do not store this in the same folder as de-identified exports.

Download Google Sheets template →

No-PHI notifications

Central review alerts should include Subject ID only. Do not include name, DOB, MRN, signed documents, or medical information in email notifications.

Download Google Drive SOP →
Google Drive security requirements

Before storing PHI.

BAA confirmedGoogle Workspace BAA must be signed and applicable to the services used before storing PHI.
2-Step VerificationRequire 2SV for all users with access to PHI; use named-user sharing only.
No public linksDo not use anyone-with-link access for PHI folders, sheets, or signed packets.
Separate linkage keyKeep master linkage separate from de-identified image/model-development exports.
If Google Drive is not enough

Fallback options, in order of regulatory strength.

1. TCU REDCap

Best scalable research path if available, especially for audit trail, alerts, consent status, and role-based access.

2. REDCap Cloud / validated eClinical platform

Commercial fallback for regulated clinical research workflows.

3. DocuSign Life Sciences / Part 11 module

Strong for FDA-facing electronic signatures, but still needs a master linkage/database system.

4. Dropbox Sign with BAA

Possible HIPAA e-signature option, but less ideal for subject IDs and master linkage.

Implementation checklist

Before go-live.

Open Print & Wet-Sign WorkflowFront-end packet generator for staff use.Clinical Research ParticipationSecure patient/staff research overview page.Master Linkage Google Sheets TemplateUpload/convert this XLSX to Google Sheets in the restricted folder.Master Linkage CSVBackup CSV for import or manual copy/paste.