We will inform you about the matters that the principal investigator or the principal investigator is required to report to the Minister of Health, Labor and Welfare and the Accredited Clinical Research Review Board.
To the teachers of Teikyo University Hospital (main hospital)
The reports from the researchers at this hospital to the managers (hospital directors) of the implementing medical institutions are also posted on the website of the Clinical Trials Secretariat of the Clinical Trials and Clinical Trials Management Center. See also here.
To teachers of Teikyo Teikyo University Chiba Medical Center, Teikyo University Hospital, Mizonokuchi, and other medical institutions
For reports to the manager (hospital director) of the implementing medical institution to which you belong, please follow the prescribed procedures within each institution.
Notification of change in implementation plan after the start of research
(1) When making changes to the implementation plan, the principal investigator or principal investigator shall submit the changed implementation plan to the Minister of Health, Labor and Welfare after being reviewed and approved by the Accredited Clinical Research Review Board. Is stipulated. (2) When a minor change is made to the implementation plan, the content shall be notified to the Accredited Clinical Research Review Board within 10 days from the date of the change, and the content shall be the same within 10 days from the date of the change. Is stipulated to be notified to the Minister of Health, Labor and Welfare.
(1) Change of implementation plan
(2) Minor changes to the implementation plan
Content / scope
Changes in matters related to the progress of clinical research
Changes to matters other than the progress of clinical research
Change of name of person engaged in clinical research (Those that do not involve changes in those engaged in clinical research)
Changes due to changes in area names or lot numbers
When the Principal Investigator or Principal Investigator becomes aware that the clinical study is incompatible (incompatible) with the case or research plan, (1) Report to the manager of the implementing medical institution It is obligatory to do. If any of the nonconformities are found to be particularly serious, (2) Promptly request deliberation from the Accredited Clinical Research Review Board After listening to the opinions of the committee, (3) Report to the manager of the implementing medical institution It is stipulated to do.
◆ About nonconformity
Nonconformity means non-compliance with rules, research plans, runbooks, etc., falsification of research data, and falsification. A serious nonconformity is one that affects the human rights and safety of the subject of the clinical study and the reliability of the progress and results of the study. For example, non-compliance with selection / exclusion criteria, discontinuation criteria, concomitant ban therapy, etc., and those that did not comply with the research plan due to other medically unavoidable reasons in order to avoid urgent danger to the subjects of clinical research. Does not include.
(1) Report format to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
Promptly request the accredited clinical research review board for deliberation after it is found.
(3) Report format to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
Hear the opinions of the Accredited Clinical Research Review Board and submit it when the review result notification is issued.
Report of diseases / defects during research
If the principal investigator or the principal investigator encounters any of the diseases / defects shown in the following tables (Tables 1 and 2) that are suspected to be caused by the clinical research during the clinical research, they will be included in the table. It is obligatory to (1) report to the administrator of the implementing medical institution and (2) report to the accredited clinical research review committee within the indicated deadline. In addition, it is also obligatory to report to (3) the Minister of Health, Labor and Welfare (the contact point is PMDA) for serious unpredictable ones. Even if the cause of the outbreak of illness is not clear, please report it as the first report within the following deadline as far as it is known. In this case, please report the detailed factors as a follow-up report immediately after that (the follow-up report does not have to be within the following deadline).
(1) Report format to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
Unified Form 8_Pharmaceutical Disease Report * Regarding reports of diseases that need to be reported to the Minister of Health, Labor and Welfare, when reporting to the Accredited Clinical Research Review Committee, it is permissible to report to the committee in Attachment Form 2.
Attachment Form 2-2_ Disease Report (Medical Device) * The disease reporting service to the Minister of Health, Labor and Welfare is available from jRCT (Clinical Research Implementation Plan / Research Outline Disclosure System). After logging in with your jRCT account, please use this service from the disease report at the bottom of the page.
(Table 1) In the case of clinical research using pharmaceutical products
Research category
Predictability
Severity
Deadline
Unapproved or Drugs that are not indicated Research to use
can not predict
death
May lead to death
The 7th
Predictable
death
May lead to death
15th day
can not predict
Hospitalization or extension of hospitalization
hindrance
May lead to failure
Serious illness according to the above
In later generations Congenital illness or abnormality
15th day
Already approved Research using pharmaceuticals, etc. (Unapproved or not applicable Other than research using pharmaceutical products)
It doesn't matter
Death (* excluding infectious diseases)
15th day
Unpredictable occurrence
Occurrence of health hazards, Or there is a risk of expansion
Hospitalization or extension of hospitalization
hindrance
May lead to failure
Serious illness according to the above
In later generations Congenital illness or abnormality
15th day
Predictable
30 days
can not predict
Diseases caused by infectious diseases, etc.
15th day
It doesn't matter
Death from infectious disease
Hospitalization or extension of hospitalization
hindrance
May lead to failure
Serious illness according to the above
In later generations Congenital illness or abnormality
15th day
(Table 2) In the case of research using products such as medical devices or regenerative medicine
Research category
Predictability
Severity
Deadline
Medical device or Research using products such as regenerative medicine
can not predict
Hospitalization or extension of hospitalization
hindrance
May lead to failure
Serious illness according to the above
Congenital illness or abnormality in later generations
30 days
Predictable
◆ About diseases
Diseases, etc. are diseases, disorders, deaths, or infectious diseases that are suspected to be caused by the implementation of clinical research. Adverse events for which a causal relationship with ongoing clinical research cannot be ruled out, including abnormal laboratory test values and various symptoms. (Infectious disease refers to cases where it is suspected that a pathogen is mixed into a drug, etc. from a biological raw material or material in a biological product. In addition, virus markers such as HBV, HCV, and HIV become positive. Is also subject to infectious disease reporting.)
◆ About defects
Regarding test equipment, it means that the condition of the test equipment is not good in terms of quality, safety, performance, etc., such as damage and malfunction, regardless of which stage of design, delivery, storage, or use. .. For products such as regenerative medicine, it refers to the effects of a wide range of illnesses such as dysfunction and side effects of cells on the human body, regardless of whether it is manufactured, sold, distributed or used.
◆ About forecast
can not predict Those that cannot be predicted from the package insert of the drug used in the relevant clinical study or the precautions on the container or encapsulation.
Predictable Those that can be predicted from the package insert of the drug used in the relevant clinical study or the precautions on use described in the container or encapsulation.
◆ Disease reporting flow
Periodic report during research
It is stipulated that the principal investigator or the principal investigator must report the implementation status of clinical research and the occurrence of diseases, etc. every year from the date of submission of the implementation plan to the Minister of Health, Labor and Welfare. (Example: If the research started in June 2018, the report will be made from June 2018 to May 2019 by August 2019).
(1) Report to the administrator of the implementing medical institution, (2) Report to the Accredited Clinical Research Review Committee, and within one month from the date when the Accredited Clinical Research Review Committee gives its opinion (3) ) It is obligatory to report to the Minister of Health, Labor and Welfare.
(1) Report format to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
Every year from the date of submitting the implementation plan to the Minister of Health, Labor and Welfare, within 2 months after the expiration of the period
(3) Report form to the Minister of Health, Labor and Welfare
Within one month from the date when the Accredited Clinical Research Review Board stated its opinion
Research discontinuation report
When a clinical research is discontinued, the principal investigator or principal investigator is required to notify the Accredited Clinical Research Review Committee and notify the Minister of Health, Labor and Welfare within 10 days from the date of discontinuation. I am. In addition to notifying the Accredited Clinical Research Review Board, please also report to the administrator of the implementing medical institution.
Notification to the Accredited Clinical Research Review Board
Report form to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
When a clinical study is discontinued, within 10 days from the date of discontinuation
Summary report at the end of research (research completion report)
The principal investigator or investigator (1) Primary endpoint report within one year from the end of the primary endpoint data collection period, (2) Summary of summary report / summary report within one year from the end of the collection period of all data It is stipulated that each should be prepared and reported to the Minister of Health, Labor and Welfare after hearing the opinions of the Accredited Clinical Research Review Board. In addition, please prepare the summary report and the summary of the summary report in an arbitrary format.
Request for deliberation to the Accredited Clinical Research Review Board
Notification / report to the manager of the implementing medical institution
Please report to the administrator of the implementing medical institution using the format specified in each implementing medical institution. At Teikyo University Hospital (main hospital), please use the following format.
