| File Name | Language | Explanation |
| Application form (Required) Form060 |
English | Please fill out the form. If not applicable, please fill in N/A with a short description. |
| Information on the PI (Required) |
English | 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). 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. (If using the Ministry of Health and Welfare’s continuing education credit, please mark the course name) |
| Information on the co-PI (Required if there are Co-PI’s in this study) |
English | 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). For human trials under the regulation of Medical 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. 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. 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) |
| Information on the research team (Required if there are research assistant in this study) |
English | Curriculum vitae, training record/certificate on Good Clinical Practices (GCP) (6hours of training within the past one year on human trials, human research, research ethics, regulations on medical research, or patient safety). 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. (If using the Ministry of Health and Welfare’s continuing education credit, please mark the course name) |
| Protocol (Required) Form059 |
English | We have not set a defined protocol format; however, we recommend including components that are included in the reviewers’ report. Please edit the version and date. |
| Abstract of the Protocol (Required) Form057 |
Chinese | Please provide a Chinese abstract according to the Ministry of Health and Welfare’s format along with a study flow chart. Abstracts of other formats can serve as an attachment. Please edit the version and date The document is the only one that must be in Chinese. |
| Informed consent form (Required) *templates of ICF: Form049, 051, 054, 056 *application form of waiver of consent or waiver of ICF: Form106, 107, 108, 109 |
English | We have 4 ICF templates and also provide application form of waiver of consent or waiver of ICF if necessary. Please choose one of them to fill and edit the version and date |
| Case Report Form (Questionnaire) (Required) |
English | We do not provide a format for the case report form. If such a form is required by the trial/research, please design a form accordingly for review. If your study does not have a case report form, please describe why not; don’t just write “Not Applicable”. (Please edit the version and date) |
| 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. (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 |
