CASE STUDY · TMU JIRB

11 Years of Continuous Compliance —
TMU's Digital IRB Governance Journey

Since 2015, Harasoft's IRB platform has served the TMU Joint IRB (serving TMU and its three affiliated hospitals); TMU Hospital, Wanfang and Shuang Ho have maintained AAHRPP Full Accreditation for 11 years. From 4-generation form coexistence (paper-grade evidence preservation) to 13 scheduled batch jobs — deep compliance is not a slogan, but 11 years of practice.

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11yr
AAHRPP
Full Accreditation
TMU's three hospitals, since June 2015[1]
2nd in
Taiwan
to receive AAHRPP
TMU Hospital, March 2014[2]
48/ year
IRB committee meetings
4 committees × monthly[3]
Customer

TMU Joint Institutional Review Board

The TMU Joint IRB (TMU-JIRB) reviews once on behalf of all three affiliated hospitals — TMU Hospital, Wanfang Hospital and Shuang Ho Hospital. TMU's affiliated hospitals are also one of eight lead-review hospitals under Taiwan MOHW's c-IRB joint ethics review mechanism for multi-center drug trials[5].

TMU
Taipei Medical University
TMU Hospital
University-affiliated
Wanfang Hospital
Taipei Municipal
Shuang Ho Hospital
MOHW affiliated
11-Year Outcomes

Not just stable — publicly verifiable international accreditation

Public sources for the numbers and facts below are listed in the References at the end of this page.

11 yr
Continuous AAHRPP Full Accreditation
Three hospitals fully accredited since June 2015[1]
2nd in Taiwan
Hospital to receive AAHRPP
TMU Hospital, March 2014 (after NTU Hospital)[2]
Only one (2015)
in Taiwan at the time with all affiliated hospitals accredited
TMU Hospital (Mar 2014), Wanfang & Shuang Ho (Jun 2015)[1]
48 / year
IRB committee meetings
4 committees × monthly schedule[3]
1 university + 3 hospitals · 4 committees
One university, three affiliated hospitals
TMU-JIRB, TMU-JIRB A, B and C — four independent committees; handles MOHW c-IRB submissions[4]
Core Differentiator

Paper-grade evidence preservation — 4 generations side by side

When new versions ship, old cases are not retroactively overwritten. Like paper records: old wine in old bottles, new in new — never mixed.

2015
Generation 1
First system launch
2018
Generation 2
Revised in response to regulatory changes and review practice
2020
Generation 3
Further revised in response to regulatory changes and review practice
2023
Generation 4
Includes CSN module
Why this design matters

Most IRB systems use schema migration when upgrading forms (add column / rename / re-render). It's cheap and easy to maintain — but the exact form a PI saw and signed years ago is no longer reproducible.

Harasoft uses parallel version tables. 4 generations of forms are independently preserved. A 10-year-old case can still be reconstructed in its original submission state, supporting:

  • ICH E6(R3) Annex 1 §1.5 (R2 §3.4) — IRB/IEC records
  • AAHRPP Element II.5.A — the IRB/EC maintains a complete set of materials relevant to the review
  • Regulations for Organization and Operation of Human Research Ethics Review Board, Art. 16 — review records retained for three years after project completion

Want a similar IRB governance platform
for your hospital or university?

Harasoft delivers IRB system implementation end-to-end: requirements, configuration, AAHRPP preparation, go-live, and ongoing maintenance — backed by 11 years of real deployment.

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References

  1. TMU Three Affiliated Hospitals All Achieve AAHRPP Full Accreditation — TMU Newsletter, 2015-07-23
  2. TMU Hospital becomes the 2nd hospital in Taiwan to receive AAHRPP Full Accreditation — TMU Newsletter, 2014-04-22; verifiable at AAHRPP — Find an Accredited Organization
  3. TMU Office of Human Research — TMU-JIRB board meeting schedule 2026 (4 committees, each meeting monthly): ohr.tmu.edu.tw/en/jirb/236
  4. TMU Office of Human Research — IRB Administrative Staff (includes c-IRB case management): ohr.tmu.edu.tw/en/jirb/178
  5. Center for Drug Evaluation (CDE) — c-IRB lead review hospitals (8 hospitals; updated 2025-11-07): cde.org.tw/cirb/1402/64839/simpleList

Public sources for the numbers, accreditation years, and structural facts cited above are listed here. Published 2026-05-01.