Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Example ResearchStudy: JPMA0001 Provided Example - Japanese Language

Page standards status: Informative

Language: en

Profile: M11 Research Study Profile

M11 Research Study Extension

  • originalProtocol: Protocol Not Amended
  • versionDate: 2026-01-14

Narrative Elements: Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)

identifier: Sponsor Identifier/JPMA001 (use: usual, )

version: 2.0

title: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験

Labels

-TypeValue
*Short title2型糖尿病患者への投与

status: Active

phase: Phase III Trial

Recruitments

-Eligibility
*Group Japanese Protocol from Vulcan UDP Eligibility Criteria