医学情報・医療情報　UMIN

FAQ -
Examples of answers to frequently asked questions about the UMIN Clinical Trials Registry (UMIN-CTR)

Free Word Search

About Free Word Search Specifications

Keywords are not case sensitive. Also, it does not distinguish between full-width and half-width.
The following search methods can be used. The search conditions will be applied in order from the first entered keyword.

AND Search
Results Includes all entered keywords
Method Enter "space" between keywords
Example UMIN　ID　Register
OR Search
Results Includes any of the entered keywords
Method Enter "space", "OR", and "space" between keywords
※"OR" is a half-width uppercase letter
Example Registration　OR　Submission
NOT Search
Results Does not include the entered keyword
Method Enter "-" before the keyword you want to exclude
※"-" Is a half-width uppercase letter
Example Password　-Abstract

FAQ list

1. The Registration Process - What is needed to register?

2. UMIN-CTR Operating Policy

1.

What kinds of clinical trials does UMIN-CTR accept?
2.

Does UMIN-CTR accept registrations of observation research?
3.

Who can register a clinical trial?
4.

Can a clinical trial be registered, even if it has already been registered with another clinical trial registration organization?
5.

Is there a deadline for the registration of new clinical trials? For example, should registration take place before assembling patients, before acquiring consent from the first patient, at or before the onset of patient enrollment, or before intervention on the first patient?
6.

Can clinical trials that are already underway be registered?
7.

Can clinical trials be registered if they have already been completed?
8.

What needs to be done after a clinical trial is registered?
9.

What is the procedure when the UMIN Center contacts the submitting organization or individual every 6 months for updates to trial information?
10.

Is action by the submitting organization or individual required every 6 months, even if no changes to the information are necessary?
11.

Once every 6 months, the UMIN Center confirms with the main Institutional Review Board (IRB) overseeing the trial that the trial is actually in progress. How is this confirmation made?
12.

Can the contact information for the IRB and the individual responsible for the research be the same?
13.

When I clicked the Confirmation and Response URL, one of these errors was displayed:

・"The URL does not exist."

・"You do not have authorization to access the file."
14.

How is the validity of the registered trial information confirmed?
15.

Can the information of a formally-registered clinical trial be changed?
16.

Is it possible to see past trial information?
17.

Are all updates to information made public?
18.

Will all inputted information be made public?
19.

I have registered a clinical trial, and been issued a trial ID by UMIN. If I do not make the trial public, have I still registered the clinical trial?
20.

Maximam tree IRBs can be registered. Are to which e-mail for confirmation of registered data sent?

3. About the Collected Data Items

1.

What types of data items are required for input?
2.

How much detail is required in the information? Some data items relate to information crucial or otherwise important to writing papers. There are items for which I do not want to include very much data.
3.

[Classification by Specialty] I am trying to register a clinical trial evaluating health foods. What should I select under "Classification by Specialty"?
4.

[Condition] [Classification by Specialty] I am trying to register a pharmacological test trial with healthy adult subjects. What should I select under "Classification by Specialty" and "Condition"?
5.

My trial does not specify an upper or lower limit for "Age".
6.

[Developmental Phase] Is the specification of a 'phase' necessary for trials which are not connected with companies?
7.

[Age] [Gender] [Key Inclusion Criteria]

'Age' and 'Gender' are separated from 'Key Inclusion Criteria' as independent items. Can age and gender be included under 'Key Inclusion Criteria'?
8.

[Principal investigator, research contact person, contact of organization sending information]

Principal investigator, research contact person, contact of organization sending information, Are these Mandatory field? Are you going to open all of the information?

(In particular, the phone number is opened, detrimental to business inquiry comes as a medical consultation, I will in trouble.)
9.

[Organization sending information]

Is the name of the individual submitting information required?
10.

[Phone number for Submitting Organization, Point of Contact, Lead Researcher]

Is it possible to input an extension number?
11.

[Sponsors][ Funders]

How should sponsors and funders be entered in the registration?
12.

[IRB Approval Date] [Anticipated Registration Start Date] [Anticipated Trial Start Date] [Last Follow-Up Date] [Date of Closure to Data Entry] [Date Trial Data Considered Complete] [Date Analysis Concluded] All of these dates may be difficult to input at the beginning of the trial.
13.

What should be entered as the "Date of disclosure of the study information"?
14.

[Date of disclosure of the study information]

The clinical trial information has been entered. When I later try to register, I'm unable to go from the "Form Selection and Data Confirmation" screen to the "Final Confirmation of Data" screen. When I first entered the information all of the "Input Completion Status" fields were blue, but now the "Input Completion Status" of the "Management Information" is red.
15.

[URL Releasing Results] [Results]

How should I input the results?
16.

[Classification by malignancy] Which should we choose "Malignancy" or "Others" while our trial include patients with malignancies and other diseases.

4. Using the System

5. Relationship with ICMJE and WHO

6. Other

1.The Registration Process - What is needed to register?

  • 1.1）

    What is the process for registering trial data with UMIN-CTR?

  • 1.2）

    How long does it take for information about a clinical trial to be made public after a new UMIN ID is acquired?

    • In ordinary cases, 1 to 10 days are needed to issue a UMIN ID. Because there are no penalties for unused UMIN IDs acquired "for the purpose of registering clinical trials with UMIN-CTR", we encourage you to apply for a UMIN ID early.
      UMIN IDs may only be issued in 2-3 days in cases classified as 'urgent' "due to the immediate registration of first examinations" and "for the purpose of registering the clinical trial with UMIN-CTR". If a UMIN ID is needed urgently, please mark the application as "Urgent" on the registration form.
      Registration and publication of trial information is normally completed in approximately 20 minutes. Please take note of the following to ensure smooth processing:
      1. Prepare necessary information in advance (Preparation File)
      2. Confirm the procedure in advance using the Test UMIN-CTR System. (The system uses the same program as the actual system, and has been put in place for test and practice purposes.)
  • 1.3）

    Is there a fee for registering clinical trial information with UMIN-CTR?

    • No fee is required for registration, or to search trial information. UMIN is supported by the Japanese Government, and nearly all services are provided free of charge.
  • 1.4）

    What must be prepared before registering a clinical trial?

    • Some medical journals have policies regarding the registration of clinical trials, when clinical trial results are submitted for publication. Please ensure that the UMIN-CTR operating policy and positioning match the policies of the journal to which you are submitting. The UMIN-CTR operating policy can be found here.
      UMIN-CTR has specified a minimal set of data required for registering clinical trials. Registrations will not be accepted unless all of these required items are completed. Please confirm in advance what data is required.
      International agreements regarding clinical trial registration systems are under development. As a result, clinical trials conducted in countries where the primary language is other than English must be published some types of data item in English. UMIN-CTR requires also English data for all text input items, and we recommend advance preparation of English information.
      The information necessary for registering clinical trials with UMIN-CTR can be prepared using this Preparation Worksheet Excel File.

2.UMIN-CTR Operating Policy

  • 2.1）

    What kinds of clinical trials does UMIN-CTR accept?

    • UMIN-CTR can accept all clinical trials, including those conducted by pharmaceutical companies. "Clinical Trial" is defined as any test involving some kind of 'intervention' to human research subjects. 'Interventions' include medical products and tools, surgical procedures, food products, and education programs.
  • 2.2）

    Does UMIN-CTR accept registrations of observation research?

    • Yes, observation research can be registered. The current system has been constructed primarily to register clinical trials involving interventions, due to the added complexity needed to be fully compatible with data item necessary to register observation research. As a result, not all sections of the system are fully suited to observation research. However, observation research can be registered using the following modifications to the registration process.
      ・At the "Trial Design" input screen, select "Observation" under "Basic Items."
      ・Also at the "Trial Design" input screen, leave "Trial Design" and "Intervention" blank. ("Trial Design" and "Intervention" are only needed to register clinical trials involving interventions.)
      ・Under "Other Related Information" at the "Progress and Conclusion" input screen, enter information regarding causes and results to be investigated the relevance, specify whether the study is prospective or retrospective, and give details of the sampling method (for example, if a random sample or case-controlled sample was used.)
      Please contact the UMIN Center for clarification regarding any part of the registration process.
      Future plans for the system include updates to make it fully compatible with observation research.
  • 2.3）

    Who can register a clinical trial?

    • Any researcher conducting a clinical trial can register. Pharmaceutical companies and other for-profit organization can also register, as can researchers based outside of Japan.Responsibility for registering clinical trials lies with the pharmaceutical company requesting the trial (for trials conducted by pharmaceutical companies), or with the researcher in charge (for all other types of clinical trials.)
      The actual registration process can be also undertaken by the office overseeing the research group.
      The actual submission of data is generally performed by the pharmaceutical company requesting the trial (for trials conducted by pharmaceutical companies), or by the office overseeing the research group (for all other types of clinical trials.)
  • 2.4）

    Can a clinical trial be registered, even if it has already been registered with another clinical trial registration organization?

    • Yes, trials registered with other organizations can be registered with UMIN-CTR.
      However, the pre-existing trial ID and the name of the organization issuing the ID must be entered under "Trial IDs Issued by Other Registering Organizations."
      This information is necessary to enable identification and tracking of a clinical trial. Entering "Trial IDs Issued by Other Registering Organizations" establishes a connection to pre-existing registration records, and clarifies that both registrations refer to a single trial.
  • 2.5）

    Is there a deadline for the registration of new clinical trials? For example, should registration take place before assembling patients, before acquiring consent from the first patient, at or before the onset of patient enrollment, or before intervention on the first patient?

    • The BMJ and journals affiliated with the ICMJE include registration of a trial at or before the onset of patient enrollment as one of the conditions of paper selection. UMIN-CTR recommends that trials be registered to meet this condition.
      Meanwhile, in order to accommodate the publication of information for the greatest number of clinical trials, UMIN-CTR will accept registrations for trials after this deadline.
      However, UMIN-CTR cannot take any responsibility for the outcomes of trials (for example, if a paper based on registered trial research is not accepted due to the timing of trial registration) registered after the onset of patient enrollment. Responsibility for the trials rests solely with the organizations or individual researchers conducting the trials.
  • 2.6）

    Can clinical trials that are already underway be registered?

    • Yes, clinical trials that are in progress can be registered.
      To the best of our knowledge, the following journals have policies regarding the registration of clinical trials. These deadlines will be of use for registration of clinical trials in progress. (Deadlines may change, and those planning to submit papers are encouraged to confirm this information with each journal.)
      BMJ and Journals Affiliated with the ICMJE:
      Trials already in progress must be registered by September 13, 2005.
      Anteriosclerosis, Thrombosis, and Vascular Biology; Circulation; Circulation Research; Hypertension; Stroke:
      These journals support ICMJE guidelines.
      Archives of Dermatology:
      This journal supports ICMJE guidelines.
      Journal of the American Society of Nephrology; Nephrology, Dialysis, Transplantation; The American Journal of Transplantation; The American Journal of Kidney Diseases; Kidney International; Transplantation:
      Trials undertaken from before January 2006 must be registered by April 1, 2006.
      UMIN-CTR encourages the registration of trials to meet the above conditions. Meanwhile, in order to accommodate the publication of information for the greatest number of clinical trials, UMIN-CTR will accept registrations for trials after this deadline. However, UMIN-CTR cannot take any responsibility for the outcomes of trials (for example, if a paper based on registered trial research is not accepted due to the timing of trial registration) registered after the onset of patient enrollment. Responsibility for the trials rests solely with the organizations or individual researchers conducting the trials.
  • 2.7）

    Can clinical trials be registered if they have already been completed?

    • Yes, completed trials can be registered.
      For completed trials, please enter as much information as possible under "URL Releasing Results" and "Results". If results cannot be entered for reasons related to publication, please enter the data as soon as publication has been confirmed.
      In cases where results are presented at conferences before papers have been published, we recommend that you enter the name of the conference at which the results were presented under "Results". If results are presented at a conference before publication, the "Publication of Results" field should be marked as "Published." The name of the registering organization and trial ID will be necessary for publication of the results of a clinical trial in a journal requiring trial registration. The receiving journal may confirm registration information for the trial with UMIN-CTR. If the place of initial presentation is not clearly marked as a conference, the paper may come under suspicion of multiple submission.
      When possible, please include a direct link to the paper under "URL Releasing Results". (The viewing page will allow direct access to this URL.)
      A summary of research results can be entered in text format under "Results."
  • 2.8）

    What needs to be done after a clinical trial is registered?

    • After a clinical trial is registered, please ensure that the information is updated to reflect any changes in the trial.
      Information must be updated in the following cases:
      - Changes to the trial protocol.
      - Changes to the status of progress of the trial (eg. In the case where patients are no longer being collected since the target number of patients was assembled.)
      - Publication of research results after the conclusion of the trial. (Please add a summary of research results and publication information.)
      Please update trial information as soon as possible. If information cannot be updated in a timely manner, UMIN-CTR will contact the submitting organization or individual to update the trial information once every 6 months.
  • 2.9）

    What is the procedure when the UMIN Center contacts the submitting organization or individual every 6 months for updates to trial information?

    • Every 6 months from the formal registration of a trial, UMIN will send an e-mail with the subject "UMIN-CTR Request for Update/Confirmation of Registration Data" to the e-mail address for the submitting organization or individual.
      This e-mail will include the trial name and ID, as well as the following 2 URLs. Please access the appropriate URL and make any necessary changes. The procedure will also be explained in the update/confirmation request e-mail.
      ・If data updates are needed:
      - Click the "Data Update URL" and access the "Form Selection and Data Confirmation" screen. Update and submit any information in the same way as for a normal data update.
      ・If no data updates are needed:
      - Click the "Confirmation and Response URL" and access the "UMIN-CTR Confirmation and Response" screen. Enter the name of the organization and individual confirming the data, and press 'Send."
      The procedure will be complete when the response receipt screen is displayed.
      In order to ensure that trial results are published correctly, the system will continue sending periodic request e-mails to the submitting organization or individual until suitable data (place of publication and summary of results, etc.) is entered into the "URL Releasing Results" and "Results" fields.
  • 2.10）

    Is action by the submitting organization or individual required every 6 months, even if no changes to the information are necessary?

    • Yes. Even after the trial has been registered, the organization or individual is responsible for the registered information. The organization or individual should confirm whether no changes are necessary, or if updates are not being made in a timely manner.
      Every 6 months after the formal registration, UMIN will send an e-mail with the subject "UMIN-CTR Request for Update/Confirmation of Registration Data" to the e-mail address for the submitting organization or individual. Please follow the procedure in the e-mail and submit the"Confirmation and Response".
  • 2.11）

    Once every 6 months, the UMIN Center confirms with the main Institutional Review Board (IRB) overseeing the trial that the trial is actually in progress. How is this confirmation made?

    • Every 6 months after the formal registration, UMIN will send an e-mail with the subject "UMIN-CTR Request for Confirmation of Progress of Clinical Trial" to the e-mail address for the IRB registered with UMIN-CTR.
      This e-mail will include the trial name and ID, as well as the following 2 URLs. The e-mail requests confirmation at the Confirmation and Response URL. The procedure is also be explained in the confirmation e-mail.
      ・Data Update URL:
      - Current information for the clinical trial can be viewed.
      ・Confirmation and Response URL:
      - This will access the "UMIN-CTR Confirmation and Response" screen. Enter the name of the organization and individual confirming the data, and the status of the trial, and press 'Send."
      IRBs functioning as Central IRBs must report the overall status of the trial.
      The procedure will be complete when the response receipt screen is displayed.
      The above e-mail will also be sent by 'cc' to the submitting organization or individual. The submitting organization or individual may respond in place of the IRB. The first response received from either the IRB or the submitting organization or individual will be accepted. (The group or individual submitting later will be notified that confirmation and response has already been received by UMIN.)
      Confirmation e-mails will be sent periodically to the IRB until the trial has been completed.
  • 2.12）

    Can the contact information for the IRB and the individual responsible for the research be the same?

    • For research registered in the clinical trial registry, we recommend that the contact information for the lead researcher and the IRB be different, so that viewers of the information (including referees and editors), or other researchers with concerns or questions regarding the handling of human subjects can contact the IRB that evaluated and approved the research directly.
      In addition, viewers of the information may doubt whether independent third-party evaluation of human-subject research was completed if both sets of contact information are identical.
      Considering the above points, final judgment on this matter rests with the lead researcher.
  • 2.13）

    When I clicked the Confirmation and Response URL, one of these errors was displayed:

    ・"The URL does not exist."

    ・"You do not have authorization to access the file."

    • Your mail application may be automatically inserting line breaks, splitting the URL and breaking the link to the appropriate page.
      Copy the URL into a word-processing program and remove the line breaks to correct the URL.
  • 2.14）

    How is the validity of the registered trial information confirmed?

    • Confirmation is made in 2 ways:
      1.Consistency check of the registered information.
      a.Automatic data checks are used where possible.
      b.Information is confirmed by the submitter when the information is submitted.
      The automatic data checks are supplementary measures, and final responsibility for the information lies with the organization submitting the information and conducting the trial.
      2.Confirmation of the actual progress of the trial.
      a.Requests for data updates (changes to the status of the trial) are sent to the submitting organization.
      b.Requests for status updates are made to the main IRB overseeing the trial.
      An additional method to confirm that trials are actually in progress is to audit a sample of trials. The validation of registered information improves the quality of clinical trials, and is extremely important. While UMIN is not able to address all aspects needed to ensure validation of the data, it will be an issue of ongoing consideration.
  • 2.15）

    Can the information of a formally-registered clinical trial be changed?

    • Yes, the information can be changed.
      UMIN-CTR maintains a record of updates made to formally-registered trial information. The record of updates is vital to maintaining transparency, and fulfilling the objectives of a clinical trial registry. When the registry is searched and the detailed information for a trial displayed, the "Display History" button will show past information (those published only) for that trial.
      In addition, those organizations or individuals submitting information, or those authorized to update trial information can use the "Display History" button on the "List of Registered Clinical Trials" screen to display all past information.
  • 2.16）

    Is it possible to see past trial information?

    • Yes. Anyone can search for a particular trial, and use the "Display History" button on the detailed trial information screen to show all past public information for that trial. In addition, those organizations or individuals submitting information, or those authorized to update trial information can use the "Display History" button on the "List of Registered Clinical Trials" screen to display all past information.
  • 2.17）

    Are all updates to information made public?

    • Yes. After formal registration has been completed, all information is made public. The record of updates is vital to maintaining transparency, and fulfilling the objectives of a clinical trial registry. After registration, all changes, including minor corrections to spelling are publicly viewable. However, the update history is not available to the general public before registration is complete. We recommend that you ensure all information is accurate before completing registration. Even after all the input forms have been completed, the registration information will not be public until the submit button on the final confirmation screen is pressed. You may leave the registration in this state until the next day when another confirmation will be made before submitting the information. Similar to printed material, once published the information cannot be withdrawn.
  • 2.18）

    Will all inputted information be made public?

    • Inputted information related to the clinical trial, especially the minimum data set determined by the WHO, will be made public. Some data only used internally by the UMIN Center, including those related to management (eg. Data about the organization submitting the information) will not be made public.
      In the future, the system will be updated to allow some types of information (trial name, primary outcomes, secondary outcomes, intervention, target sample size) required for registration to be kept private. Guidelines from the WHO meeting regarding clinical trial registration allow for these types of data to be kept private.
  • 2.19）

    I have registered a clinical trial, and been issued a trial ID by UMIN. If I do not make the trial public, have I still registered the clinical trial?

    • The ICMJE defines "Clinical Trial Registration" as "Publication of the content of a clinical trial prior to registration of the first examination."Note that "published" for UMIN-CTR corresponds with the "registration" according to the ICMJE.
  • 2.20）

    Maximam tree IRBs can be registered. Are to which e-mail for confirmation of registered data sent?

    • All three IRBs.

3.About the Collected Data Items

  • 3.1）

    What types of data items are required for input?

    • For details, consult this Preparation Worksheet Excel file.
      In summary, the required data items consist of:
      - Data required by the ICMJE statement.
      - Data for the purpose of education (mainly information related to trial design)
      - Data related to analysis of the current status of the clinical trial.
      - Data required for managed (data used for contact by the UMIN Center.)
      UMIN-CTR has specified a minimal set of data required for clinical trial registration. Registrations will not be accepted unless these required items are completed. Please confirm in advance what data is required.
      The information necessary for registering clinical trials with UMIN-CTR can be prepared using this Preparation Worksheet Excel file.
      On the input screens, required items are highlighted in light pink. Non-required and other data fields are highlighted in light blue.
  • 3.2）

    How much detail is required in the information? Some data items relate to information crucial or otherwise important to writing papers. There are items for which I do not want to include very much data.

    • However, if too much content is presented without a sufficient amount of detail, the registration system will be unable to fulfill its objectives. This may also invite concerns when any papers are published. Please carefully consider the need to publicize information against the need to maintain privacy.
  • 3.3）

    [Classification by Specialty] I am trying to register a clinical trial evaluating health foods. What should I select under "Classification by Specialty"?

    • Please select the specialty which best matches the target population for that food (the condition of the intended population). If no category fits, select "Not Applicable."
  • 3.4）

    [Condition] [Classification by Specialty] I am trying to register a pharmacological test trial with healthy adult subjects. What should I select under "Classification by Specialty" and "Condition"?

    • [Condition] For clinical trials involving healthy individuals, select the appropriate category based on what kind of the condition or state of the target population are finally intended to be applied. Note that these descriptionsare not intended to present the condition of the participants of the study.
      If healthy adults are the participants in the trial, enter "Healthy Adults" under "Key Inclusion Criteria."
      Under "Classification by Specialty", select the specialty which best matches the target population.
  • 3.5）

    My trial does not specify an upper or lower limit for "Age".

    • Under "Age", select "Not Applicable." Leave the corresponding entry fields for age and boundary symbol blank. An error may result if any extraneous data is included
  • 3.6）

    [Developmental Phase] Is the specification of a 'phase' necessary for trials which are not connected with companies?

    • For trials which are not connected with companies, the phase should still be entered if the research group uses the concept. If 'phase' is not applicable, or if no selection fits, select 'Not Applicable."
  • 3.7）

    [Age] [Gender] [Key Inclusion Criteria]

    'Age' and 'Gender' are separated from 'Key Inclusion Criteria' as independent items. Can age and gender be included under 'Key Inclusion Criteria'?

    • The 'Age' and 'Gender' items are used for searching the clinical trials, and must be entered as independent items. Age and gender can also be included under "Key Inclusion Criteria". In such cases, the age and gender must be consistent with those entered as independent items.
  • 3.8）

    [Principal investigator, research contact person, contact of organization sending information]

    Principal investigator, research contact person, contact of organization sending information, Are these Mandatory field? Are you going to open all of the information?

    (In particular, the phone number is opened, detrimental to business inquiry comes as a medical consultation, I will in trouble.)

    • Contact information is handled as follows: [Point of Contact]
      UMIN Center will not ordinarily contact the principal investigator. However, this information is necessary in case journal editors need to make contact regarding trials. So contact information is mandatory.
      [Principal investigator]
      Name of principal investigator individual in charge of the clinical trial.(Input : Mandatory・Open)
      The organization and division of principal investigator(Input : Mandatory・Open)
      Address: Address of the organization of principal investigator(Input : Mandatory・Open)
      Phone Number: Phone number of the organization of principal investigator(Input : Mandatory・Open)
      e-mail: e-mail address of principal investigator(Input : Mandatory・Open)
      [Contact person for general public]
      The point of contact is for members of the general public who view the clinical trial information.
      The contact person can be input if needed for the convenience when you have the asking.
      The organization and division:The name of the organization and division to receive inquiries from the general public(Input : Mandatory・Open)
      Contact person:The name of the individual who will receive inquiries from the general public(Input : Mandatory・Open)
      Address、Phone Number、e-mail address、URL:At least one must be entered as a method of contact from the general public(Open)
      Address of the division of contact from the general public(Input : Mandatory・Open)
      Phone Number of the division of contact from the general public (Input : Mandatory・Open)
      E-mail of the division of contact from the general public(Input : Mandatory・Open)
      [Organization sending information]
      The organization sending information's information is used for contact related to clinical trials by the UMIN Center.
      The UMIN Center requires all the information for the submitting individual is for contact, and to verify the organization's existence.
      Person sending information:Name of the individual submitting information related to clinical trials. (Input : Mandatory・Closed)
      Organization and Division Name: The organization and division of the submitting individual.(Input : Mandatory・Closed)
      Address and Phone Number: Address of the organization of the submitting individual.(Input : Mandatory・Closed)
      E-mail: Individual e-mail address of the submitting individual, or the e-mail address of the organization.(Input : Mandatory・Closed))
  • 3.9）

    [Organization sending information]

    Is the name of the individual submitting information required?

    • The Person sending information's information is used for contact related to clinical trials by the UMIN Center.
      The UMIN Center is mandatory all the information for the submitting individual is for contact, and to verify the organization's existence.
      Person sending information: Name of the individual submitting information related to clinical trials. (Input : Mandatory・Closed.)
      Organization and Division Name: The organization and division of the submitting individual. (Input : Mandatory・ Closed.)
      Address and Phone Number: Address of the organization of the submitting individual. (Input : Mandatory・Closed.)
      E-mail: Individual e-mail address of the submitting individual, or the e-mail address of the organization. (Input : Mandatory・Closed)
  • 3.10）

    [Phone number for Submitting Organization, Point of Contact, Lead Researcher]

    Is it possible to input an extension number?

    • Yes, an extension number can be entered. Please use the following format to input the phone number. 0xxx-xx-xxxx (ext. xxxxx) ((Area Code including 0) + Phone Number + (ext.
      Number); there is no space between the external phone number and the internal number (ext.xxxxx).
  • 3.11）

    [Sponsors][ Funders]

    How should sponsors and funders be entered in the registration?

    • The definitions are as follows:
      [Sponsor]
      Definition: An organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.
      [Funders]
      Definition: An organization other than the primary sponsor, providing research funding or research materials, such as drugs to be tested.
      An organization that provides funding, or materials, drugs, or staff is usually
      classified as a secondary funder. If no funding or materials are provided, and the organization is involved in joint research, the organization is classified as a secondary sponsor. In general, an organization is not a secondary sponsor if it is a simply a testing facility, while a companies providing medical supplies in the clinical trial lead by physicians are secondary funders.
  • 3.12）

    [IRB Approval Date] [Anticipated Registration Start Date] [Anticipated Trial Start Date] [Last Follow-Up Date] [Date of Closure to Data Entry] [Date Trial Data Considered Complete] [Date Analysis Concluded] All of these dates may be difficult to input at the beginning of the trial.

    • Please enter 'Year' and 'Month' for each of these dates (the database will add the day (1st) automatically). A best estimate should be entered for any dates that cannot be determined definitively at the time of application. These dates can be added or revised later, as they become available.
      When first registering trial information, it is not necessary to enter the Date of Closure to Data Entry, Date Trial Data Considered Complete, or Date Analysis Concluded. These dates can be entered when the progress of the trial enters the "Trial Cancelled" or "Trial Complete" phases. At these phases, the dates will become required, and estimates should be entered if specific dates cannot be determined.
  • 3.13）

    What should be entered as the "Date of disclosure of the study information"?

    • The following guidelines should be used to set a date of disclosure of the study information:
      For trials still to be begun: The date of disclosure is generally set as the date of registration, or the anticipated trial start date.
      For trials already in progress or completed: The date of disclosure is generally set as the date of registration. (In either case, if information can be made public right after registration, please set the date of publication to the date of registration.)
      Clinical trial information will not be made public until the desired date of publication. Because there are no restrictions on the desired date of disclosure, the date can be set after the completion of the trial. However, it should be recognized that doing so is contrary to the goals of the registry system.
      When clinical trial information is made public, the desired date of disclosure will be displayed as the "Publication Date". When there is a large difference between the registration date and the disclosure date, a clear rationale is needed. For example, when submitting a paper, an inquiry from a journal editor may result in a paper being rejected if a reason for the difference is not clear.
  • 3.14）

    [Date of disclosure of the study information]

    The clinical trial information has been entered. When I later try to register, I'm unable to go from the "Form Selection and Data Confirmation" screen to the "Final Confirmation of Data" screen. When I first entered the information all of the "Input Completion Status" fields were blue, but now the "Input Completion Status" of the "Management Information" is red.

    • When clinical trial information left in an 'in progress' state is re-opened for editing, and the original desired date of publication has passed, it is necessary to change the desired date of publication to the registration date or later. When the date is changed, the "Input Completion Status" of the "Management Information" will change to blue, and the button to allow final confirmation of data should be displayed.
  • 3.15）

    [URL Releasing Results] [Results]

    How should I input the results?

    • URL Releasing Results: When possible, please enter direct links to the URLs for articles or releasing results. (The viewing screen will allow direct access to the URLs entered in this field. URLs can be entered in the 'Results' field, but these will not be directly linked.) Results: A summary of results can be entered in text format. If results have been presented at conferences, the name of the conferences should also be entered.
      In cases where results are presented at conferences before papers have been published, we recommend that you enter the name of the conference at which the results were presented under "Results". If results are presented at a conference before publication, the "Publication of Results" field should be marked as "Published." The name of the registering organization and trial ID will be necessary for publication of the results of a clinical trial in a journal requiring trial registration. The receiving journal may confirm registration information for the trial with UMIN-CTR. If the place of initial presentation is not clearly marked as a conference, the paper may come under suspicion of multiple submission.
  • 3.16）

    [Classification by malignancy] Which should we choose "Malignancy" or "Others" while our trial include patients with malignancies and other diseases.

    • Please choose "Malignancy" if health condition(s) or problem(s) studied in your trial include malignancy.

4.Using the System

  • 4.1）

    What is the process through which clinical trials are registered?

    • A UMIN-CTR application number is issued when the trial name, shortened trial name, and trial world region are entered. After the application number is issued, other necessary information about the trial should be entered. There are 4 input screens for this inputting process. As each input screen is completed, an automatic data check will be performed. If any errors are found, the necessary data corrections are made. Once all of the data checks are cleared, all of the required data has been entered, and the submitter has confirmed the information, UMIN-CTR will issue a trial ID. Until a trial ID is formally issued, the trial will not be officially registered, even if the application has been tentatively received.
      The date on which the trial ID is issued will be the date of registration. The trial can be withdrawn if the trial is tentatively registered. However, if a trial CANNOT be withdrawn once formally registered.
  • 4.2）

    A clinical trial should have been registered, but has not been made public.

    • There may be tworeasons for this.
      1. There may have been an error in the desired date of publication that was entered; the date entered may be further in the future than intended.
      -> Confirm the "Date of disclosure of the study information" in the registration, and correct as needed.
      2. The registration process may have stopped before formal registration.
      -> A registration has not been formally completed, even if all required data has been entered, and all "Input Completion Status" fields under the "Form Selection
      and Data Confirmation" screen are blue, unless the "Input Confirmation Button" on the same screen is pushed, and the "Transmit" button is clicked on the final confirmation screen. Once the data is registered with UMIN-CTR, a formal trial ID will be issued (the screen will display the trial ID.)
      Until a trial ID is formally issued, the trial will not be officially registered, even if the application has been tentatively received. The date on which the trial ID is issued will be the date of registration.
      3. Registration was only performed on the test system.
      -> Please note that a registration on the test system will not be recognized as a formal registration.
  • 4.3）

    The person who first registered the clinical trial will be retiring (or transferring.)

    What should be done in order to update the clinical trial information?

    • Please set a person who has responsibility for the clinical trial information and who has a UMIN ID as an 'editor'.
  • 4.4）

    A trial was input in error. Can it be deleted?

    • The trial can be withdrawn if its registration is still 'in progress'. The trial can be deleted from the "List of Clinical Trial Registration In Progress". However, a trial cannot be withdrawn once it is formally registered. Please confirm the registration information adequately before formally submitting a trial.
  • 4.5）

    Are there any things to be aware of with regard to inputting data?

    • 1. Usable characters: The following half-width characters can be used in English input fields.
      0-9 a-z A-Z - ^ ? , . / < > ? _ ; : ] + * } @ [ ' { ! " # $ % & ` ( ) = ~ |
      2. In large input fields, such as Narrative Objectives 1, Outcomes, Interventions,
      3. Content: The ICMJE Editorials presented in May 2005 remark that the reliability and value of each data item in the registration can be factors in whether a paper is accepted. The responsibility for the content of the registration lies with the research sponsor and the information-submitting organization.
  • 4.6）

    Update registration information

    • 1. to UMIN-CTR. 'Updating your registered trial information' < login
      2. The relevant exam 【Modify】 < Click
      3. Administrative Information【Continue】 < Click
      4. The bottom of the page Date of disclosure of the study information < Changes to dates after today 【Continue】 < Click For update completion by clicking on the [Send] as the transition to the confirmation screen.

5.Relationship with ICMJE and WHO

  • 5.1）

    Is UMIN-CTR recognized as a clinical trial registry system by ICMJE?

    • UMIN-CTR has been recognized by the ICMJE as an "acceptable registry" UMIN-CTR appears as an 'acceptable registry' in the FAQ on the ICMJE site. At a minimum, a paper should be received for consideration by an ICMJE-affiliated journal, if the corresponding trial is registered by the appropriate deadline with UMIN-CTR.
      From before its formal establishment, UMIN has corresponded with the main ICMJE-affiliated journals to introduce UMIN-CTR, to increase awareness of UMIN-CTR. In January 2006, formal notification was received from the ICMJE that UMIN-CTR had been recognized as an 'acceptable registry.'
      The WHO is developing the International Clinical Trials Registry Platform (ICTRP) project in order to collect various clinical trial registry systems throughout the world under fixed standards as "member registries" and "associate registries. " The project will also issue unique trial recognition numbers, to allow unified searching of clinical trial information from around the world. The standards of the WHO system are under development to facilitate acceptance of papers by the ICMJE. The ICMJE has recognized the WHO's ICTRP project activities.
      UMIN-CTR is planning to participate as a 'member registry.'

6.Other

  • 6.1）

    Will the registered clinical trial information be used for purposes other than general publication?

    • The information will be used to analyze the current status of clinical trials globally.
  • 6.2）

    What kind of data backup procedures does UMIN use?

    • Data is fully backed up once each week (Saturday). Incremental backups are performed on each weekday.
  • 6.3）

    What means the number of "Studied searched" in the "Search Clinical Trials" page?

    • It's the total number of trials completely registered and formally disclosed.
  • 6.4）

    I got UMID ID and registered my research, but not be able to find out it online. How should I do ?

    • Your Date of disclosure of the study information may be in future.
      so please revise your date form today(Japan time).

      http://www.umin.ac.jp/ctr/index.htm < click
      Registering and updating trial information
      Updating your registered traial information. < click

      When still you can't find it.
      Please tell us your UMIN ID and your name with the page's screenshot.