WHIM-001 v2.1 · Coordinator · Enrolling

WHIM: Whole Health in Menopause

Study workspace · all sites · blinded to participant identity

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Site

Arm

IRB, registration & consent

ClinicalTrials.gov

NCT06120451

IRB

IRB #2026-0148 · approved 2026-01-14

Consent

Electronic consent · WHIM-001_ICF_v2.1.pdf (v2.1)

Reporting windows

SAE 7d · reportable AE 10d · major deviation 10d

IRB documents

WHIM-001_IRB_approval.pdf· IRB approval letter
WHIM-001_protocol_v2.1.pdf· Approved protocol

eConsent

Preview participant signing flow →

Study machinery

Arms & courses

Interventionn = 19
4-session WHIM group program starting at week 0.
Course: WHIM — Women's Health in Menopause
Waitlist controln = 18
Usual care, program offered after week 8.
Course: Usual care · WHIM offered after week 8

Changing an arm's course is logged.Course library

Phases

No phases — participants go straight to arm assignment. Add a phase for run-in periods, washouts, or lead-ins.

Phase dates anchor like timepoints: wave groups share one start date; individual participants get their own Day 0.

Mode switching

Switch automatically when a phase endsParticipants follow the course interface set for each study phase — for example Measures only during a run-in, then whatever the next phase sets. Like moving a group program to alumni.Allow manual override by the study teamCoordinators can change a participant's course interface by hand from the participant record. Both settings can be on at once.

After the last phase — arm assignmentWith automatic switching on, the course interface becomes this when the final phase ends and the arm is assigned.

Automatic rules run unless a coordinator has set a manual override on the participant.

Blinding

As PI you can blind or re-blind any facet at any time. Every change is logged.

Upcoming windows

T0 · Baselineweek 0 · ±7d · MRS, HFRDIS, PHQ-8, PROMIS Sleep
T1 · Mid-programweek 2 · ±5d · MRS, SUS
T2 · End of programweek 4 · ±7d · MRS, HFRDIS, PHQ-8, AIM, IAM, FIM, SUS
T3 · Follow-upweek 8 · ±10d · MRS, HFRDIS, PROMIS Sleep

Team & access

Dr. Whitfield
Principal Investigator · All sites
Dr. Ramos
Co-Principal Investigator · Site 02
K. Lee
Research Coordinator · All sites
J. Alvarez
Facilitator · Site 01
M. Osei
Observer (IRB monitor) · All sites, read-only
ends 2026-09-30
T. Nakamura
Research Coordinator · Site 03
invited

Exports & audit

Last export

2026-08-21 14:02 · All sites · T0–T2 · De-identified · 1284 rows

Export centre →

Recent audit trail

Exported de-identified T0–T2 dataset (CSV)
Dr. Whitfield · 2026-08-21 14:02
Marked WHIM-021 consent as pending re-signature
Coordinator (K. Lee) · 2026-08-20 09:41
Edited T1 assessment window (5 → 7 days)
Dr. Ramos · 2026-08-19 16:15