Data Submission Application Procedure | Contents

Detailed Procedure for the Data Submission Application and the Data Update Application

IMPORTANT

If you are replacing or adding data governed by the same Policy as data you have already submitted (i.e., data derived from the same informed consent explanation document, consent form, and research plan), this is a Data Update application.
If you are registering data under a different Policy, or applying for the first time, this is a new Data Submission application.
If you are providing data derived from human-derived specimens that clearly fall outside the scope of the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" — namely, specimens or information whose academic value is already established, that are widely used for research purposes, and that are generally available — you may submit a signed "Simplified Review Request for the Data Submission Application (free format)" from the principal investigator in place of the head of institution's research authorization document (approval notice, etc.).
You can apply for data with different access levels (unrestricted access, controlled-access) in a single application.

Creating a Data Submission Group:

After logging in to the application system, select [Create Group] from the menu on the left side of the screen.
Enter the group name, group description, and select Data Submission Group as the group type, then click [Save].
Add members to the Data Submission Group you created:
- Click [Invite Member] on the [Members] tab.
- Enter the institutional email address or the DDBJ account of the principal investigator, the applicant, and the data upload contact.
- Clicking [Invite] sends an email to the invited member.
- Once the member accepts the invitation following the instructions in the email, they are registered as a member of the group.
Grant PI privileges to the principal investigator for the Data Submission application:
- Only members with Owner privileges can make this change.
- If the principal investigator for the Data Submission application is the one who created the group, no change is needed, since they are already PI/Owner.
- Select the radio button next to PI for the relevant member, then click [Change Owner/PI].

Updating DDBJ Account Information:

The following information is required: name, institution, department, job title, and phone number in Japanese; and address, institution, department, and job title in English.
- Applicant information is automatically carried over from your DDBJ account into the system, so you must add this information to your DDBJ account registration.
After logging in to the application system, click [DDBJ Account] under "Application List" in the upper right of the screen.
After updating your information, click [Update Profile].

Submitting a Data Submission Application:

After logging in to the application system, click [Submit a Data Submission Application].
Select either "Application from within Japan" or "Application from outside Japan", then click [Start New Application].
Fill in the required fields on the application form and attach the necessary documents:
- Select the Data Submission Group.
- To change the principal investigator, edit the registration information of the Data Submission Group.
- The head of institution is the person who authorizes execution of a research plan approved by the ethics review board. Enter the information of the person currently holding the position designated as "head of the research institution" in the review result notice or equivalent document.
- For the research title, enter the title exactly as it appears in the research plan that received ethics review board approval and head-of-institution authorization.
- When attaching documents, specify at least one file type.
On the "Summary" page, check the entered information for errors, then click [Submit].

Submitting a Data Update Application:

After logging in to the application system, click the relevant [J-DS number] from the "Data Submission Application List".
Select "Data Update Application", click [Start Application], and create and submit the application form:
- For "Research Content (subjects, methods, ICD-10 disease classification code)" and "Data Type and Volume (data type, format, file format, total data volume)", enter only the information relating to the data being added in this application.
- Create the "Detailed List of Files to Be Updated or Added" and attach it in the application system:
  - Enter one row per file.
    - For data additions, columns B, E, F, and H–K are required.
    - For replacements, columns G and L are also required in addition to B, E, F, and H–K.
- If ethics-related documents such as the research plan have been updated, attach those as well.