Studies / Admin / Tenant config
X Pharma · Admin

Tenant admin

Thin config for this client org — modules, branding, SSO, connectors. Do not gold-plate.

Tenant overview

Active
Tenant
X Pharma
Plan / SKU
Mock Shells + SCE core
Dedicated VPC
Stub · us-east-1
Environments
3 · Dev / QC / Prod

Org ID ten_x_pharma · created 2026-03-12 · region AWS first

Module flags Feature flags
Spine
Tenant, SSO, study, layout map, and Part 11 audit are always on — not toggled here.
Mock Shells
Standalone SKU · shell catalog, generate Word/RTF, human lock
Metadata
Optional · Mock Shells spreadsheet specs for SAS macro automation (safety tables, etc.). Off = hide Metadata UI for this tenant.
Extract data
Pull / register data from elluminate & uploads · under File Explorer
File Explorer
Study folder browser · houses Extract data
Compute
Job submit + logs · off in this example tenant
Tracker
TLF & dataset statuses · check-out / Send to QC
Generate PDF Package
PDF / RTF bundle assembly · opened from Tracker (not main nav)
Define
Optional · CDISC Define-XML 2.0/2.1 for SDTM/ADaM · generate from metadata + specs · human approve before publish
Copilot
Governed suggestions only · attaches to enabled modules
Audit
Module UI for trail browser · append-only log is spine
Branding Tenant chrome
SSO · SAML / OIDC Stub · not wired
Stub
Fields for IdP setup only. Day-one auth is local/dev login; SAML/OIDC lands later.
Connectors · elluminate Stub · demo
Demo
Connect SPHERE to the customer’s eClinical Solutions elluminate tenant. SAS and primary study files stay on elluminate. This stores API credentials and sync mode for Data Hub / Tracker path awareness.
Recommended UX: users open SPHERE in the browser inside the elluminate remote desktop, so program paths and SAS stay in that environment. Local laptop browser also works if the network can reach SPHERE HTTPS.
Tracker review flow Per tenant
Order
When optional roles are on, records move Primary → QC → Stats → Released to MW (Released to MW is the final stage; without the MW stage, records end at Approved). Primary (production programmer) and QC are always in the path. Program files are editable only in In dev and Revise; all other stages are read-only.
Production programmer (Primary)
Always on · owns In dev and Revise (only editable stages)
QC programmer
Always on · In QC review (read-only programs)
Statistician
Optional · inserts In Stats after QC
Medical writing
Optional · inserts In MW after Stats (or after QC if Stats is off)

Programs folder layout

How editable vs read-only program files are stored for this tenant.

No check-in / check-out. Editability follows stage: Dev & Revise only. History + restore backend is under Version control.

Program version control Per tenant
History
History + restore in In dev and Revise. Snapshots on save, handoff, restore, and promote. Same UX either backend — this toggle only chooses where snapshots live.

Storage backend for this tenant. Default is Local history. Enterprise GitHub is a stub in this demo.

Users & roles
Name Email Role Status Last active
J. Patel j.patel@xpharma.example Programmer Active Today · 4:48 PM ET
M. Chen m.chen@xpharma.example Reviewer Active Today · 4:12 PM ET
S. Ortiz s.ortiz@xpharma.example Programmer Active Tue · 5:30 PM ET
A. Rivera a.rivera@xpharma.example Admin Active Mon · 10:02 AM ET
R. Nguyen r.nguyen@xpharma.example Reviewer Invited —

Roles: programmer · reviewer · admin. Invite is stub — SSO will map groups later.

Teams
ACL
Teams are used for folder access on the study file share (Box/WatchDox-like). Grant a team View or Edit on a folder in Files → Manage access; permissions inherit down the tree. v1 = View | Edit only.
Team Members Used for Status
Stats programmers J. Patel · S. Ortiz · +2 Folder ACL Active
QC reviewers M. Chen · R. Nguyen Folder ACL Active
Study leads A. Rivera · +1 Folder ACL · View Active

Stub only — membership sync from SSO groups later. Same teams appear in Files Manage access picker.

Study layout Tenant template
Lock
Base tree is {study folder}/data/raw | sdtm | adam | programs | tlf | logs | docs. Admin may add / remove / rename template subfolders from that base — not free-form chaos. Every new study gets this tree; in this demo, Save layout re-renders every study's folder path from its compound / protocol / deliverable metadata.
Programs
Editable vs read-only program files: choose single programs/ or dev / qc / prod subfolders under Tracker workflow. Split mode: programs/dev (editable) + programs/qc (QC copies) + programs/prod (approved, read-only).
Study folder hierarchy · applies to every new study in this tenant

Save updates the tenant template for new studies only. Apply is a separate, explicit action (stub).

Compliance

Audit retention
7 years
Append-only · exportable · immutable log lives with the spine
E-sign
Not in v1 Later
Approve / freeze in Tracker stays human-gated; Part 11 e-sign badge lands after MVP
Thin
IQ/OQ kit and security questionnaire answers live outside this screen. Admin stays configuration-only.

Audit

Tenant + study

Audit trail

Part 11–style timeline · append-only · includes locks and rejected Copilot suggestions

Event timeline Immutable log
  • Today
    4:48:02 PM ET
    Job started · JOB-1842
    Programs adam_adae.R, tfl_14_1_1_demog.R submitted by J. Patel. Runtime R 4.4.1.
    ComputeActor · J. Patel
  • Today
    4:12:19 PM ET
    Shell locked · 14.1.2 Baseline characteristics
    Human lock by M. Chen. Prior status In review → Locked. Edit and Copilot overwrite blocked. Reason: “SAP-aligned; biostat sign-off complete.”
    LockActor · M. Chen
  • Today
    2:40:07 PM ET
    Copilot suggestion rejected · Mapping Assist
    Suggestion ID MAP-992: AE.AETERM free-text → preferred term dictionary. Rejected by J. Patel. Comment: “Keep manual MedDRA coding workflow for this cut.”
    Copilot rejectActor · J. Patel
  • Yesterday
    6:05:41 PM ET
    Snapshot ingest complete · Raw
    Label “EDC cut 2026-08-28”. Mapping package study default v1.4. Checksum recorded. 38 domains mapped, 2 pending.
    IngestActor · System
  • Yesterday
    4:15:33 PM ET
    Copilot suggestion accepted · TLF Assist
    Footnote text applied to draft shell 14.1.2 from SAP 9.2. Shell remained Draft; no lock performed by Copilot.
    Copilot acceptActor · M. Chen
  • Yesterday
    11:20:12 AM ET
    Job complete · JOB-1839 · adam_adsl.R
    Output ADaM.ADSL written. Tracker status → QC. Duration 00:06:18.
    ComputeActor · Compute
  • Tue
    5:30:44 PM ET
    Copilot suggestion rejected · Mapping Assist
    Suggestion ID MAP-971: CM route code → SDTM CMROUTE. Rejected by S. Ortiz. Comment: “Vendor codes already normalized upstream.”
    Copilot rejectActor · S. Ortiz
  • Tue
    3:18:02 PM ET
    Shell saved · 14.3.1 Adverse events — overview
    Draft update by J. Patel. Columns and footnotes revised. Generated Word shell artifact stored.
    Shell editActor · J. Patel
  • Mon
    10:02:55 AM ET
    Dataset locked · ADSL
    Human lock by J. Patel after QC pass. Downstream TLF programs may reference locked ADSL.
    LockActor · J. Patel