CASE STUDY · TMU JIRB

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

Since 2015, Harasoft's IRB platform has supported the Taipei Medical University one-school-three-hospitals consortium in maintaining AAHRPP Full Accreditation for 11 consecutive years. From 4-generation form coexistence (paper-grade evidence preservation) to 13 daemons standing 24×7 watch — deep compliance is not a slogan, but 11 years of practice.

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

TMU Joint Institutional Review Board

The TMU Joint IRB (TMU-JIRB) is one of Taiwan's MOHW-recognized central IRBs (c-IRB). A single review can be accepted simultaneously by all three affiliated hospitals — among the few c-IRBs in Taiwan operating at scale.

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

All numbers and facts below are backed by publicly verifiable third-party sources.

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
in Taiwan with all affiliates accredited
All three hospitals received Full Accreditation[1]
48 / year
IRB committee meetings
4 sub-committees × monthly schedule[3]
4 hospitals + 4 sub-committees
One-school-three-hospitals
TMU-JIRB / A / B / C; c-IRB structure
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
Human Subjects Act updates
2020
Generation 3
GCP / ICH revisions
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, satisfying:

  • ICH-GCP §4.9 — Records and Reports: review records preserved in original state
  • AAHRPP Element II.2.D — Documentation of Reviews: what the reviewer saw, is preserved
  • Taiwan Human Subjects Act §18 — Records preservation obligation

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 — IRB Meeting Schedule (public): ohr.tmu.edu.tw/zh-Hant/jirb/52

All publicly verifiable numbers, accreditation years, and structural facts cited above are backed by third-party sources. Published 2026-05-01.