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2026-07-20
Application Forms
Department：TMU-JIRB
New application
*For the sake of confidential issues, the English forms are not published. 
If you're TMU's international student or faculty and need to submit a study, please contact us by email (tmujirb@gmail.com) to request.

TMU-JIRB Primary Review documents list
File Name Language Explanation
Application form
(Required)
Form060		 English
  1. PI’s name must be identical spelling with the name in the system.
  2. Please fill out the form. If not applicable, please fill in N/A with a short description.
  3. Please edit the version and date on the top, like Version1.0/20260101.
  4. Point 3: the date must in the future tense.
  5. All the team members (include Principal Investigators, Co-Investigator, Investigator, and Study members) should be listed in the application form.
  6. If the venue is outside TMU system, point No.18 need to write the venues for study execution also need to write the PI’s institution.
  7. Point 29(1): participants number need to write the range, if the number is fixed, please fill the same number in both field.
  8. According to the Civil Code of Taiwan, individuals reach adulthood at 18 years of age. Minors between the ages of 7 and 17 (inclusive), as well as individuals under an order of assistance, have limited capacity to make juridical acts. Therefore, if the minimum age of the person to be included is under18, then "child/minor" should be checked in point 29(10), and the reason for inclusion and additional protective measures should be explained. Point 33 should also be checked and filled in.
  9. Point 30A, please describe the handling and preservation of the data/ specimen during and after the end of the study, including the depositary, location, retention period and destruction. (According to consensus of cIRB, the data maximum preservation period is 25 years, and the specimen remains intact for 20 years. If you need to retain the data and specimen beyond the aforementioned limits, please explain the specific reasons and describe the associated management mechanisms.
Information on the PI
(Required)		 English
  1. PI’s curriculum vitae, training record/certificate on Good Clinical Practices (GCP) (6 hours of training within the one year on human trials, human research, research ethics and research regulations).
  2. For human trials under The Regulation of Act for Medical Care, Taiwan item #8, the record/certificate should reach at least 30 hours of training on human trials and 9 hours on medical ethics. If the trial involved somatic cells or gene therapy, 5 hours on relevant issues are required.
  3. For human trials under the Medical Device Clinical Trial, item#5, PI should be a physician holding a valid practicing license and with at least five years of clinical practice experience. (However, for clinical trials publicly announced to pose no significant risk in accordance with the proviso of Article 37, Paragraph 1 of the Regulations for Good Clinical Practice for Medical Devices, the PI may be a professional healthcare personnel in the category of teachers/specialists who holds a professional certificate issued by the central competent authority and has actually engaged in related professional work for at least five years.) The PI must submit certificates of 30 hours of clinical trial-related training completed within the past 6 years, which must include at least 9 hours each in medical device clinical trials and medical ethics.
  4. If using the Ministry of Health and Welfare’s continuing education credit, please mark the course name.
  5. If PI is not affiliated with TMU system, please refer to the announcement on entrusted reviews for further instructions (https://ohr.tmu.edu.tw/en/jirb/202).
Information on the co-PI and/or other study members
(It’s essential if there are Co-PI and/or other study members in this study)		 English The research team includes the members who participate in the trial / study, such as research nurses, research pharmacists, research Medical Laboratory Scientist, research assistants, etc.
 
  1. Co-PI’s curriculum vitae, training record/certificate on Good Clinical Practices (GCP) (6 hours of training within the past one year on human trials, human research, research ethics, regulations on medical research, or patient safety).
  2. If the PI is recruiting cases out of the place which he/she serves, at least one co-PI affiliated with the site needs to be included so that the research is under proper oversight. Applications violating this requirement will not be reviewed by TMU-JIRB.
  3. The regulation for TMU faculty members conducting trial/research in TMU-affiliated hospitals. Affiliated hospitals are obligated to protect the rights and ensure the safety of trial participants. Therefore, affiliated hospitals should include at least one member to help the research.
*If using the Ministry of Health and Welfare’s continuing education credit, please mark the course name
     
Protocol
(Required)
Form059		 English
  1. We does not mandate the use of TMU-JIRB’s protocol template. However, it’s recommend that the protocol clearly and specifically describe the study procedure, inclusion/exclusion criteria, inform consent, risk, data/specimen handling and preservation. 
  2. Please edit the version and date on every page in the document.
  3. If amend the document need to re-edit the version and date.
Chinese abstract of the Protocol
(Required)
Form057		 Chinese
  1. This document (計畫書摘要) is essential and the only one which must be in Mandarin (Chinese), please fill in the content use Traditional Chinese characters. (Only item 12~14 should write in English.) 
  2. Please edit the version and date.
  3. Point 11 upload documents just support JPG, JPEG, PNG.
Informed consent form
(Required if ICF is the informed consent procedure in this study))
*templates of ICF: Form049, 051, 054, 056
*application form of waiver of consent or waiver of ICF:
Form106, 107, 108, 109		 English
  1. We have 4 ICF templates.
  2. If you apply to waiver of consent or waiver of consent form, please fill out item32 in Form060 and specify further explanation.
  3. Please choose one of them to fill and edit the version and date.
  4. If ICF templates is not suitable for the study, please upload to the“案件其他相關附件” field.
Case Report Form
(Questionnaire)
(Required)		 English
  1. We do not provide a format for the case report form. Please design a form (or questionnaire) to show what information/column you will collect from participants.
  2. Please edit the version and date on every page in the document.
  3. If the study is data analysis please provide the code-book to review.
Expedited review
Form027		 English This form is required if applying for expedited review. TMU-JIRB will make the final decision whether or not the application can be expedited.
Checklist of Exemption
Form093		 English This form is required if applying for exemption review. TMU-JIRB will make the final decision whether or not the application can go for exemption review.
DSMP/DSMB Form
Form096		 English This form should be filled out when the study/trial has either a data safety management plan (DSMP) or data safety management plan (DSMB).
Declaration Form of Significant Financial Interest and Non-Financial Interests (Study Team)
(Required)
Form104		 English PI and Research team members should sign and fill out the form online.
(disclosure period is the past 12 months)
Statement of Review Fee (Required)
Form101		 English Please confirm the funding source and confirm if you have made the review fee payment.
Study Site Agreement Form
Form053		 English  This form should be filled out and signed by the head of the institution and stamped with the institution's official seal if your study site is outside the TMU system.

Please contact: Tsang, Oi-Ki-Camil
Email: camiltsang@tmu.edu.tw

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