PI Governance SOP

1. Purpose and Scope

This Standard Operating Procedure governs the use of the ATLAS platform (Adherence Tracking and Longitudinal Assessment System) for multi-site medication adherence data collection in research studies. It covers workspace setup, role assignments, data collection procedures, quality assurance, and export protocols.

This document is intended to accompany the study's primary IRB protocol as a technical appendix describing the digital data collection platform. It does not replace the protocol itself.

Applicable study types

• Cross-sectional adherence surveys using the MMAS-8
• Longitudinal adherence tracking with repeat assessments
• Multi-site comparative studies with institutional sub-cohorts
• Quality improvement projects using adherence data for clinical decision support
• PEACS validation studies using the Predictive Emergence framework

2. Instrument Overview and Licensing

MMAS-8R

The Morisky Medication Adherence Scale, 8-item revised version (MMAS-8R) is a validated self-report instrument for measuring medication adherence. It is the intellectual property of Dr. Donald E. Morisky (© TX 8-632-533). Use on ATLAS is governed by a licensing agreement between the study institution and Adherence Inc.

Every workspace key issued through ATLAS includes a Letter of Permission specific to the named PI, institution, and study title. This letter must be retained in the study's regulatory binder and submitted with ethics applications.

PEACS v2.0

The Predictive Emergence Assessment for Clinical Services (PEACS v2.0) is a three-dimension instrument developed by Philip Morisky, Founder of Adherence Inc., based on the Theory of Predictive Emergence (DOI: 10.5281/zenodo.18209699). It is available on the PI and Institution tiers. PEACS data is collected at the same session as the MMAS-8 and stored in a separate data node.

Instrument validation status

The MMAS-8 has been validated in over 3,000 published studies across 100+ countries. The MMAS-8R administered through ATLAS uses the original validated wording. The ATLAS platform itself has been used in institutional research at the University of Nicosia, Democritus University of Thrace, NUST Oman, and multiple clinical sites in Italy (SIMAT partnership).

3. Site Setup and Workspace Key Assignment

PI workspace (master key)

The PI receives a PI-tier workspace key (format: PI-[INST]-XXXX-2026) upon purchase at keys.adherence.cc. This key provides access to the full ATLAS dataset including all sub-site data, the multi-site dashboard, bulk upload, and IRB-grade export.

Site coordinator workspaces

Each data collection site should have its own workspace key (typically Researcher tier). This allows:

• Site-specific data isolation — each coordinator sees only their site's patients
• PI-level oversight — the PI's key sees all sites in aggregate
• Audit trail — each submission is tagged with the submitting workspace key

Contact info@adherence.cc to provision sub-site keys under your PI key. Provide: site name, coordinator name, coordinator email. Sub-site keys are issued as Researcher tier at a discounted rate for multi-site studies.

Setting up a new site

4. Role Hierarchy and Access Controls

5. Data Flow and Storage

Collection path

1. Patient opens ATLAS (directly or via shared link) on a device provided by the researcher
2. Patient reads and accepts digital consent
3. Patient completes MMAS-8 (and PEACS if included in protocol)
4. Submission is transmitted over TLS 1.3 to Google Firebase Realtime Database (Iowa, USA)
5. Record is tagged with the researcher's workspace key as institution_code
6. Record is immediately visible in the researcher's dashboard
7. If score is below threshold, Sentinel alert is written to Firebase alerts/{workspace} node

Data isolation

Each workspace key creates an isolated data namespace. A coordinator with key RES-SITE1-XXXX-2026 can only see records tagged with that key. The PI with key PI-INST-XXXX-2026 can see records tagged with either the PI key directly or any child workspace registered under it.

Data elements collected

6. Data Collection Procedures

Standard procedure — researcher-administered

1. Researcher logs into ATLAS with their workspace key
2. Researcher enters the Patient ID in the SDOH fields before initiating assessment
3. Researcher selects the patient's preferred language
4. Researcher either: (a) hands device to patient for self-completion, or (b) reads questions aloud and records answers
5. Patient submits assessment
6. Researcher notes Patient ID in their paper or electronic CRF
7. Researcher reviews result on dashboard and documents any Sentinel flags

Procedure for patients using their own devices (remote collection)

1. Researcher generates a direct assessment link: atlas.adherence.cc?key=[WORKSPACE-KEY]&pid=[PATIENT-ID]
2. Link is shared with patient via email, SMS, or patient portal
3. Patient completes assessment independently
4. Result appears in researcher's dashboard under the specified Patient ID

Deviations from protocol

Document any departure from this SOP in your study's deviation log, including: assessments completed without Patient ID assignment, technical failures requiring manual re-entry, or patients who completed assessment in incorrect language. These should be noted but do not invalidate the data.

7. Quality Assurance

Weekly data review

The PI (or designated data manager) should review the dashboard weekly during active collection to:

• Confirm expected submission volumes across sites
• Review Sentinel alerts for clinically urgent cases
• Check for duplicate Patient IDs (same patient submitted twice)
• Verify geographic distribution matches enrollment plan

Identifying and handling duplicates

The Active Patients table can be searched by Patient ID. If the same Patient ID appears more than once with the same timestamp, this may be a duplicate. Contact info@adherence.cc to review and remove confirmed duplicates from your dataset.

Data completeness monitoring

The export CSV includes a timestamp column. Use this to verify all sites are submitting data within expected windows. Gaps may indicate technical issues, coordinator absences, or site-level protocol deviations that require follow-up.

8. IRB-Grade Data Export

The PI tier includes IRB-grade export headers — additional metadata columns added to the CSV that are not present in the standard Researcher export.

Additional IRB export columns

Export procedure for study closeout

9. Escalation Matrix

10. IRB Submission Language

Methods section — data collection platform

Ethical considerations section

Data management plan section

11. Required Citations and Acknowledgements

MMAS-8R — required citation in all publications

Required acknowledgement footnote

ATLAS platform citation

PEACS — if used in study

12. SOP Amendments

This SOP should be updated when any of the following occur:

• A new version of the ATLAS platform introduces materially different data collection procedures
• The MMAS-8R license terms are amended by Adherence Inc.
• IRB conditions require modification to collection procedures
• A new data collection site is added to the study

All amendments should be dated, versioned, and re-signed. Previous versions should be retained in the study regulatory binder. Notify info@adherence.cc of any material amendments to ensure platform support is aligned with updated procedures.