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GaP FAQ Archive [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2009-.

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GaP FAQ Archive [Internet].

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Revise, Amend, and Update Existing Application

Rejected or Revision Requested Data Request

Some of my data requests are rejected and others are requested for revision by the DAC(s). How can I revise and resubmit them?

If your dbGaP data request is rejected or requested for revision by the DAC, you can revise and resubmit the project that contains the requests through your dbGaP account.

1.

First of all, you need to read the comment regarding the rejection made by the DAC. The comment is included in email that notifies you about the rejection. The DAC comment is also stored as the processing history of the data request. To find it, go to “My Requests” tab and click on the “Processing History” link from the “Actions” column of the request. The popped up window of processing history page includes all the DAC comments.

2.

Before making any changes, check the status (under “My Requests’ tab) of you data request to see if it is under “SO review” status. If so, the request needs to be recalled from SO first, and this is how to make recall.

3.

The simplest way to revise a project is to go the “My Projects” sub-tab and either click on project title or click on the “revise project” link from the “Actions” column of the project. The link leads you to the project page, from which you can make any necessary revision and reselect datasets through appropriate sub-tabs, and finally resubmit the project.

4.

Please note that you need to reselect the disapproved datasets from the “Choose datasets” sub-tab before moving forward. It is suggested to use “Next” or next equivalent buttons to go through all steps of web-forms before resubmitting the revised project.

More details about how to revise and resubmit an existing project can be found from here.

After the revision is submitted, all data requests under the project, except already approved ones, will be under “SO review” status. Please check (under “My Requests” tab) to make sure that the status is indeed changed. The SO will be informed by an automatically generated email to review the revised project. You may want to directly contact the SO to expedite the process if you haven’t heard anything for too long.

Once SO approval is done, the data requests will be again in queue for DAC review. Please directly contact the DAC for an update if the approval process takes too long. Here is how to find the DAC email address.

(08/02/2012)

Revise Data Access Request

How to make changes to my existing dbGaP project?

A dbGaP data application is organized by project. A project could contain multiple data requests from one or more dbGaP studies. Any changes to the application have to be made at project level, which means that even the changes may only be related to one or some of the data requests under the project, the entire project has to be revised.

Most steps of project revision are simply repeating of those in new project creation. Revised and resubmitted project will go through the SO review and subsequently be in queue for DAC review again.

Please note that approved the data requests will stay as approved during the re-review process, unless the revision is ultimately rejected by the DAC(s).

The following are some common situations where revision and re-submition of a completed project are needed:

a.

Change user profile

Note: the profile items include phone number, position/title, and user address. PI’s email can only be changed directly through the eRA.

b.

Change project information or data use statement.

c.

Change collaborator or IT director.

d.

Change Signing Official (SO).

e.

Data request is rejected or sent back for revision by the Data Access Committee (DAC).

f.

Add or delete datasets from project.

g.

Add or update IRB documents.

The following is a detailed instruction.

Log on to the dbGaP Authorized Access System as a Principal Investigator (PI).

Go to “My Projects” tab if you are not already there.

Note: If any data request under the project is currently under SO review status, the project has to be recalled from SO first before the revision can be made. The status of data request can be found under “My Requests” tab and here is how to recall a project from SO.

Go to project page by clicking on the “revise project” link from “Actions” column of the project that needs to be revised. Another way of getting to project page is to simply click on project name under “My Projects” tab.

If the “revise project” link is not in the “Actions” column, it may suggest that the year-end renewal date of the project is approaching or passed. In this case, you should instead click on link named “renew project” to start the project renewal process. Please see here for more about it.

Research Project

Make necessary changes to the information presented on the page. This may include data use change, new information related to revision and update etc. The change of the Signing Official (SO) can also be made on this page.

Collaborator

Change internal and external collaborators information if necessary. For external collaborators, the information of related dbGaP requests should be included. Please see here for more about it.

IT Director

Change IT director information if necessary.

Choose Datasets

You can add datasets not currently included in the project at this step. You may have to reselect the rejected datasets in the project if you want to include them again.

To navigate through hundreds of datasets listed on the page, it is suggested to search using web browser’s search function (Control-f) to find related datasets. For example you will find Framingham datasets by searching for “phs000007” (no quotes) or by “Framingham”.

If any datasets are selected, use “Add Selected and Continue” button to move to next step.

You would need to go through rest of steps listed below) without skip and finally re-submit the project.

Confirm Datasets

Review DUC

Review DUL

Review Applications (& Electronic Signature)

The detailed description of steps can be found in the creating a new project section..

The submission will go to SO for re-review and an automatically generated email notification will be sent to the SO. If approved by the SO, the data requests will be in queue for DAC review again. You will be notified once the requests are approved by the respective DAC.

(12/11/2013)

Recall is required before Making Changes to Project under SO Review

I am not able to make changes to my project that has data requests under SO review. What do I need to do?

If a project contains any data request under “SO review” status, in order to make change to the project, the PI will need to either contact the SO with a request to return the application for revision or use the link named "Recall from SO" to withdraw the application from SO review queue. The following is how to make the recall.

1.

Login to the dbGaP Authorized Access System.

2.

Go to "My Projects" page (this is default page you are presented upon login).

3.

Click on the link named "Recall from SO" link in the Action columns of the project. You should be redirected to the step “5. Review Applications” sub-tab of project page. .

4.

Click on "Recall Application" button. A text box for a comment should be displayed.

5.

Enter the comment and click "recall application" button again.

6.

At this point, you are ready to make necessary revisions or reselect datasets through respective sub-tabs, and finally resubmit the project to SO for review again. Please see here for a more detailed instruction of how to revise your project.

(08/06/2013)

Changing Signing Official

How to change the Signing Official (SO) designated to my dbGaP project?

If any of the data requests in the project is under the “SO review” status, you need to recall the project from the SO. Please see here for more details.

After being recalled from SO or if the Data Access Request has been completed and approved by current SO, you can change the SO of your project by the following steps:

1.

Log into the dbGaP Authorized Access System. Click on “My Projects” tab if you are not on “My Research Projects” page.

2.

For the project to which you need to change the SO, click on the project name, or from the “Actions” column of the project, click on the “revise project” link. This will take you to the project page.

3.

Click on “Research Project” sub-tab and choose from the list of SOs of your organization registered with eRA Commons.

4.

Go through all rest of steps and submit the change.

The new SO will be informed to review submitted request.

It often happens that the new SO intended to be designated for the project is not found from the SO list registered by PI’s organization in the step 3 described above. In this case, the PI’s organization will have to first register the new SO with eRA Commons before the PI could make the SO change. Please beware that any changes made to the eRA system may take one or two days to become effective in the dbGaP system. Please contact the eRA administrator of your organization or visit the eRA Commons website for more about how to add an institutional SO. The eRA Commons How To and FAQ sites are often found to be useful.

(08/02/2013)

Changing PI for Project

How to change the PI of an existing project?

The only way of transferring a project from current to a different PI is to close out the current project and start a new one by the new PI (see here for more about project closeout). It may be helpful to directly contact the Data Access Committee (DAC) that approved the requests to see if there is an expedited review for the situation. (07/31/12)

Transferring Data Request to a Different Institution

I am about to leave my current job and start a new one in a different intitution. Can I transfer my approved data requests to the new institution?

The Signing Official (SO) and IT director of PI’s institution are ultimately responsible for enforcing proper data use and data security. The dbGaP data applications therefore are not transferable to different institution. Prior to leaving current institution, the PI needs to close out current dbGaP project and file a new application with the new institution (see here for more about project closeout). It may be helpful to directly contact the Data Access Committee (DAC) that approved the request to see if there is an expedited review given the situation (09/23/2011)

Adding New Lab Members from Same Institution

I have new people in my lab that arrived after I received approval for the data sets I requested. How do I amend my data access request to include them?

The degree of detail for your list of collaborators is decided by your DAC reviewers, but generally speaking, a “collaborator” is meant to include staff with an official appointment at your institution, and not supervised students.

The step-by-step process for adding collaborators to a Data Access Request is as follows:

1.

Navigate to "My Projects" page in the dbGaP authorized access system.

2.

Click on the "revise existing request form(s)" link, for the project to which you need to add personnel (the link is located below the title of the project).

3.

Select Step 2a (Collaborators) from the grey tabs at the top of the page.

4.

Enter the name(s) and contact information for your new lab member(s) and press "Save" or "Next" button

5.

Use the "Next" button at the bottom of each succeeding page until you get to Step 6.

6.

At step 6, re-submit your application

Please see here for more about collaborators (06/21/2011)

Requested Wrong Data Sets

Can I remove previously selected dataset from my project?

You are able to delete unwanted dataset included in your project before the data access request is approved by the Data Access Committee (DAC). The dataset is no longer removable from the project once it is approved for access. Please refer to project revision section at here for more details. (08/07/2013)

Change User Profile

How do I change my dbGaP account user profile?

The user profile of PI’s dbGaP account can be changed through “My Profile” tab. Please note that the field value of the fields with grey background is automatically filled in by pulling in the information from PI’s eRA account. These fields include first, last names, and email address. The eRA account information can only be changed directly through the eRA system. Please visit eRA commons website for information. The eRA Commons How To and FAQ sites are often found to be useful.

Please beware that any changes to an eRA account may take one to two days to be propagated from eRA to dbGaP system. You may have to wait long enough before trying to login to the dbGaP system again.

(08/02/2012)