NICHD Data and Specimen Hub (DASH) Tutorial
This User Tutorial provides an overview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) and describes its features and functionality.
This tutorial contains step-by-step instructions for navigating the NICHD DASH system. You may also refer to the Frequently Asked Questions (FAQs) page for additional information, or you may ask specific questions through the Feedback page if they are not addressed in either the tutorial or FAQs.
NICHD DASH is a centralized resource for researchers to store and access data from NICHD-funded research studies to use for secondary research. It serves as a mechanism for NICHD-funded extramural and intramural investigators to share de-identified research data from studies in accordance with the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy.
By supporting data sharing through NICHD DASH, NICHD aims to accelerate scientific findings and improve human health.
NICHD DASH is a free public resource designed for the scientific research community.
The NICHD DASH website, https://dash.nichd.nih.gov/, is compatible with the following Internet browsers:
- Google Chrome
- Internet Explorer 10 or 11
- Mozilla Firefox
Create an Account
You do not need to create an account to browse or search for study data stored in NICHD DASH; however, you do need an account to submit or request study data and download study documentation. Creating an account will allow the NICHD DASH Administrator to communicate with you about your data submissions and requests.
The registration process differs for NIH email account holders and individuals that do not have an NIH email account as described below.
1. Registration with NIH Credentials
If you have the NIH Enterprise Directory (NED) credentials or a PIV card, you can register for an NICHD DASH account using those credentials:
- Access NICHD DASH using one of the compatible browsers listed in Access.
- Click on the "Sign Up/In" button located at the top right of the homepage.
- Select "Login using NIH Credentials" on the login screen.
- You will be directed to the NIH login page. You can login using your NIH Enterprise Directory (NED) User ID or your PIV card. Complete the required fields, click "Save" to save your login information and then click "Next."
- On NICHD DASH "User Agreement" page click the "I Agree" checkbox at the bottom of the page after reviewing the Terms & Conditions and then click "Register." The system will create your DASH NIH account and you can now login from the DASH homepage.
2. Registration for Individuals without an NIH Email Account
If you do not have NIH credentials, you may register for NICHD DASH using a Non-NIH email address.
- Access the NICHD DASH using one of the compatible browsers listed in Access.
- Click on the "Sign Up/In button" located at the top right of the homepage.
- Click the “Sign Up” button.
- On the "Create an NICHD DASH Account" page, complete the requested information. Required fields are marked with an asterisk and must be completed. Click "Next" when finished.
- When selecting your institution, you may choose from a dropdown list, or, if your institution is not listed, you will need to add your institution. Be sure to complete all required fields about your institution, which are marked with an asterisk.
- Clicking “Next” will take you to the NICHD DASH User Agreement page. Click on the “I Agree” check box after having read the Terms and Conditions to accept the Agreement, and click “Register” to submit your registration.
NOTE: When you are selecting your institution, if you don't see your institution in the dropdown list, you can select "Click here to add an institution" and populate your institution information. If you are from an institution that is outside of the United States, field options will change when you select your country.
NOTE: If at any point you wish to change the information you provided on the previous screen, select “Back” to revisit the "Create an NICHD DASH Account" page. Please ensure you use the “Back” button located at the bottom of the page (below the “Register” button), and not your browser’s back button.
After you submit your registration, you will receive a confirmation email within one business day. Please click on the confirmation link in the email to verify your registration. You will then be able to log into NICHD DASH with the email address and password you provided during registration. If you do not receive a confirmation email within 24 hours please contact the DASH administrator at SupportDASH@mail.nih.gov.
3. Login to Your Account
Perform these steps to log in to your NICHD DASH account:
- Access NICHD DASH using one of the compatible browsers listed in Access.
- Click on the "Sign Up/In" button located at the top right of the homepage.
- If you registered with a non-NIH email address, enter the email and password that you used to register in NICHD DASH, and click "Login." If you do not remember your password, click “I Forgot my Password.” You will be prompted to enter the email address associated with your account, and the DASH Administrator will email you a link to reset your password.
- If you registered with an NIH account, select "Login using NIH Credentials." Log in using your NIH Enterprise Directory (NED) credentials or your PIV card.
Browse Studies/Search Data
You may browse and view information about studies and data archived in NICHD DASH without creating an account. This section outlines how to do so.
1. Browse/Search Options
You can search for study items archived in NICHD DASH in several ways from the NICHD DASH homepage:
Option 1: Menu Bar – Explore DASH Catalog
Option 2: Menu Bar – Find Study Data
Option 3: Search Bar – Keyword Search
Option 4: Recently Submitted Studies
Option 1: Menu Bar - Explore Study Catalog
Click on “Explore DASH Catalog,” located on the navigation bar at the top of the NICHD DASH homepage. You will be directed to the “Browse Catalog of Studies” page, where you can browse studies, and filter by topic, study type, and life stage.
Clicking on a study title on the “Browse Catalog of Studies” page will take you to the “Study Overview” page. The Study Overview page displays the study description, descriptive documents, study schema (if provided by study submitter), study timeline, study population, and subjects by sex/life stage/ethnicity/race/location.
Option 2: Menu Bar - Find Study Data
Click on “Find Study Data,” located on the menu bar at the top of the NICHD DASH homepage. You will be directed to the search page where you can search for specific study items. See the Filter Your Search section for further information about refining and filtering your search.
Option 3: Search Bar - Keyword Search
Enter only one keyword in the search field (bar), located below the video on the NICHD DASH homepage, and click on the magnifying glass icon. You will be directed to the "Find Study Data" page populated with your search results. If you wish to add additional keywords, you may add them one at a time in the search bar at the top left on the NICHD DASH "Find Study Data" page. See the Filter Your Search section for further information about refining and filtering your search.
Option 4: Recently Submitted Studies
Recently submitted studies are featured at the bottom on the NICHD DASH homepage. Click on any study in the “Recently Submitted Studies” listing and you will be directed to the "Study Overview" page of the study you selected. The "Study Overview" page displays the study description, descriptive documents, study schema, study timeline, study population, and subjects by sex/life stage/ethnicity/race/location.
2. Filter Your Search
You can filter and refine your search results displayed on the NICHD DASH "Find Study Data" page using the Search Bar/Keyword search or the Topic/Study/Dataset/Document Filter:
Option 1: Search Bar - Keyword Search
Enter only one keyword in the search field (bar), located on the left of the "Find Study Data" page, and click on the magnifying glass icon. To refine your search, enter additional keywords one at a time in the search bar and click on the magnifying glass. The NICHD DASH search page will be populated with your search results.
Option 2: Topic/Study/Dataset/Document Filter
Located on the left, below the search bar are additional filters you can use to narrow your search:
- Click ">>" icon to the right of the "Topic," "Study," "Dataset," or "Document" filter bars to expand the list and view available options. The number to the right of the topic name indicates the number of items related to that subject.
- Click a subject to select it. You may select multiple subjects.
- It is possible to drill deeper into some filters. In the example below, the “Study” filter bar has filters below it, such as: “Clinical Research Network Name;” “Study Name;” “Study Type;” “Enrollment Start;” “Enrollment End Dates;” “Data Collection Start Date” and “Data Collection End Dates.” Click the “>>” icon to the right of the filter description to view the options for that filter. In the example below, the user clicked the “>>” icon for Study, then clicked the “>>” icon for “Study Type.” There are additional options to choose from in the example below: “Clinical Trial – NIH defined” and “Other Types of Clinical Research.”
3. View Your Results
Search results are displayed on the right side of the “Find Study Data” page based on the criteria and filters you selected.
For each result item, you can view additional information by clicking on “Show Details,” located at the bottom left of each result item. Once you have clicked on “Show Details” click “View the Study Page” to view information about the study to which this item belongs. You will be directed to the “Study Overview” page that displays information such as the study description, descriptive documents, study structure, study timeline, study population, and subjects by sex/life stage/ethnicity/race/location.
NOTE: Click on the study name (above the item name) to jump directly to the "Study Overview" page.
NOTE:To deselect all filters, click on “Remove All Filters” located at the top of the “Find Study Data” page. To remove individual filters, click on “x” next to each filter located at the top of the “Find Study Data” page.
4. Limit the Number/Sort Search Results
You can choose the number of results to be displayed on a single page (e.g., 10, 20, or 50) and/or the criteria for sorting the results (e.g., item title, item category, or study name). Choose the desired options using the dropdown boxes located at the top of the “Find Study Data” page.
Request Data from NICHD DASH
You must have an active NICHD DASH account and be logged into the system to request data from DASH. You may request data from any study archived in DASH. Please consult the Data Request Checklist before requesting Data. You will be required to submit the following:
- Data Request Form signed by the Data Requester,
- NICHD DASH Data Use Agreement signed by the Data Recipient and the Authorized Organization Representative (AOR) from your institution. Please see the NICHD DASH FAQs for additional information on the AOR.
- Institutional Review Board (IRB) approval, if required for the requested study data (as shown on the "Study Overview" page)
NOTE: If you are interested in obtaining datasets from multiple studies, you will need to submit a separate Data Request Form, NICHD DASH Data Use Agreement, and IRB approval (if applicable) for each study.
1. Add to Your Cart
You can add data to your cart from either 1) the "Find Study Data" page or 2) the "Study Overview" page.
Option 1: From Find Study Data Page
After conducting a search, you can click on the check box next to a study item and then click “Add Selected Items to Cart." You can select multiple check boxes to add multiple study items to your cart. The study item will update to inform you that it is “In Cart” and requires request.
Option 2: From the "Study Overview" Page
Each study has a "Study Overview" page, which is accessible from any of the Browse/Search methods outlined previously. When you are on the "Study Overview" page, click on “Add Study to Cart” located below the study name. This will add all items associated with that study to your cart.
You can continue exploring data after adding items to your cart. You can click "My Cart" on the top navigation bar to view all the items you have added to your cart. From the “My Cart” page, you can remove items previously added to your cart.
From the “My Cart” page, you can remove items previously added to your cart by clicking on the “Delete from Cart” button in the bottom right-hand corner, under the study name.
2. Complete a Request
After you have added study items (datasets or documents) to your cart, you can start the data request process by following the instructions below.
- Click on "My Cart" located at the top right of the menu bar.
- The study items you have added to your cart are be grouped by study. Click on "Request Access" to initiate the data request.
- A "Getting Access to Study Items" pop-up window will provide guidance on how to access study items. Click on “Continue” in the pop-up.
- If you have previously submitted a request, you will see a pop-up that asks if you would like to use information from previous requests. If you select “Yes,” the General, Request Information, and Affiliates sections will be pre-populated with your information from the previous request you select from the drop down list..
- Complete the Data Request process. The left-hand navigation pane will show you the various sections you will need to complete to request data from NICHD DASH. All fields marked with an asterisk (*) are required and must be completed to move on to the next page. The "General" page of the online Data Request will be prepopulated with the information you provided when you created your NICHD DASH account. Review the information and then click “Next.”
- The "Study Information" page of the online Data Request process requests information about the research study for which you will be using the data. Complete required fields marked by an asterisk (*).
- The “Funding Information” section of the “Study Information” page asks you to indicate your funding source, which can be NIH intramural, NIH extramural, or other. You will also be asked to include the funding institution, funding type and the identifying number attached to that funding type.
Select your funding source. A dropdown list appears to select the funding institution. If the funding institution for this project is not listed, click “Click here to add new funding institution” and complete the required fields.
Select the funding type, enter the “Identifying Number” for your funding, and click on “Add Funding Information.”
If you select “Other” for the funding source or funding type you must specify the type of funding source or funding type in the required field.
If your study has multiple funding sources and/or multiple identifying numbers, please make a new funding information entry for each funding source.
- The Principal Investigator (PI) section asks for information about the PI for your study. If you are the PI, click on “Use information from my registered account.” The PI must register as a user in NICHD DASH. They must also be registered under the same institution as the person requesting NICHD DASH data for a study. If you are not the PI, select a registered user from your institution from the dropdown list. If the PI has not already created an NICHD DASH account, please ask him or her to do so, and return to this section to complete your request. There is a “Save” button located at the bottom of every page so that you can return to your request and edit it.
- The "Authorized Organization Representative (Institutional Business Official)" section requests the name and contact information for the Authorized Organization Representative from your institution. NIH defines the Authorized Organization Representative as "the individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards." Please see the NIH Grants Glossary page for additional details. This is the person from your institution with the authority to sign your Data Use Agreement. The Authorized Organization Representative does not need to be registered in DASH. However if they are a registered user and you enter their registered email address, the system will automatically populate the appropriate user information.
- Click "Next" when complete. This will save your work and move to the next page. You may also click on "Save" to save completed sections without leaving the page.
- Affiliates are other researchers, programmers, analysts or anyone from your institution that will access the data being requested from NICHD DASH. You must report all affiliates of your study. They must be registered users in NICHD DASH from your institution and will be bound by the Data Use Agreement. If no Affiliate access is needed, select “No” and then click "Next."
- If affiliates from your institution will be using the data, select "Yes." Select your affiliates from the dropdown list and click on the "+Add an Affiliate" button. You may select more than one affiliate.
- Affiliate names will appear below in the dropdown list. To remove an Affiliate, click on the "x" to the right of the name.
- When you have finished adding Affiliate names click “Next.”
- Read the information on the “Generate Package” page, and then click “Confirm and Generate Package.” The system will generate a data request package and send it to you via email. This package includes your DASH Data Request Form, and Data Use Agreement that require signatures from you and your Authorized Organization Representative.
- Please review all documents in the Data Request Package prior to requesting appropriate signatures from your institution. The requester is responsible for coordinating with all parties involved and collecting all signatures required to complete the data request.
- To upload the package after obtaining all necessary signatures, scan your documents and log back in to the NICHD DASH system. Click on “My Cart” at the top of the NICHD DASH homepage to begin. Next to the requested study, click “Upload Package.” You will be directed to the “Upload” page.
- Click “Choose File” and select the appropriate file from your computer to upload. Each required file must be uploaded separately. In the example below, two of the three required documents have been uploaded.
- Once you have uploaded your documents, click "Next" to move to the "Data Request Submission" page. Then click the "Submit" button to submit your request.
- Your data request will be reviewed by the NICHD DASH Data Access Committee and possibly by a study-specific approval entity such as the Steering Committee of the study you requested. You will be notified via email if any updates or additional information are needed for your request. You will be notified by email if your request is approved or not approved. You may also check on the status of your data request at any point from your cart.
NOTE: You may start and stop this process at any time, and resume at the section where you left off. Be sure to click “Save” at the bottom of the window you are working on so your work is available when you return.
NOTE: Affiliates are individuals within the same institution as the Recipient, for whom access to Data is required to carry out the Research Plan. Collaborators are individuals collaborating with the Recipient, requiring access to the Data, and who are employed by a different institution than the Recipient. Collaborators must submit their own data requests.
NOTE: All affiliates must be pre-registered in DASH for their name to appear in the dropdown list. If you are unable to select an affiliate, save your work by clicking on the “Save” button and return to this page when your affiliates have registered. Do not continue to the “Generate Package” section until you have completed this section, as you will not be able to add affiliates once your package is generated.
NOTE: Do not make changes to or add information in the Data Request Package you receive. If you make any changes to your data request (e.g. adding or removing affiliates) after the system has generated the package, your request package will be invalidated, and you will need to generate your request package again. If there are changes to the request, login to NICHS DASH, make the changes to your Data Request and generate a new Data Request Package.
Manage Approved Study Data in NICHD DASH Workbench
After you have received notification from the NICHD DASH Administrator that your data request has been approved, you will be able to manage the data associated with your requests in the NICHD DASH Workbench. You can access your Workbench by logging in to NICHD DASH and clicking on the Workbench icon located on the top menu bar of NICHD DASH. Note that your Workbench will be empty until after you submit a data request and your request is approved.
The Workbench has three sections: “Inbox,” “My Approved Items,” and “DUA Management”. Some studies have cart-level approval, meaning you will be granted access to only the specific study items (documents, datasets, images, etc.) you have requested. Once your data request is approved, these specific items you have requested will be available in your “Inbox” for download.
Other studies have study-level approval. Upon approval of your data request, you will have access to all study items (documents, datasets, images, etc.) for the study and not just the items you specifically requested. These study items will be displayed on the “My Approved Items” section. The specific items you have requested will be available in your “Inbox” for download. Later, if you are interested in other items from the approved study, you will be able to move data to your Inbox and download them without going through the approval process.
The “DUA Management” section is where you will be able to manage your Data Use Agreements you executed with NICHD for your data request/s. You will see all DUAs you have executed with NICHD and will be able to download and modify affiliates.
Your Inbox function is similar to that of an email inbox. Once your data request is approved, the specific study items you requested are delivered to your Inbox where you may select individual items and perform actions on them. You may:
- Download selected items from your Inbox to your computer.
- Remove (archive) selected items from your Inbox. Removing a study item from the Inbox will not remove it from the “My Approved Items” section, where all approved items will continue to be available.
When you click “Download” a pop-up window will inform you that your download is being prepared. Large downloads can take up to 15 minutes. The pop-up will inform you when your download is ready.
2. My Approved Items
“My Approved Items” always displays all study items that you have access to for the study that has been approved by the NICHD DASH Data Access Committee irrespective of the level of approvals (cart-level or study-level). You may move items from your Approved Items page to your inbox for download.
A grey check box means the item is already in your Inbox
3. Data Use Agreement Management
- All your NICHD DASH Data Use Agreements (DUAs) are grouped by request and arranged chronologically on the “DUA Management” page of your Workbench. You can download copies of your DUAs, and view their expiration dates.
- You can also add and remove Affiliates for a study on the DUA Management Page. First, scroll to a DUA. Then click the “Actions” button, and click “Modify Affiliates.”
As per the NICHD DASH Policy, data submitted to NICHD DASH must be stripped of the 18 HIPAA identifiers and coded,
with keys to the codes retained by the submitting institution(s). NICHD has developed
Data De-identification and Coding Guidance for investigators to utilize when preparing data for submission to NICHD DASH.
All data submissions to NICHD DASH must be accompanied by the following:
- An Institutional Certification from responsible institutional official(s) of the submitting institution stating that an Independent Review Board (IRB) and/or Privacy Board, as applicable, has approved submission of the study to NICHD DASH and that the identities of research participants will not be disclosed to NICHD.
- Required study documentation which ensures meaningful use of the data and prevents misuse, misinterpretation, and confusion.
Submitting study data to NICHD DASH includes the following major steps:
- Complete online required information about the data (such as general information about the study and the investigator(s), policy compliance, and data distribution instructions)
- Upload compliance documentation (such as Institutional Certification)and descriptive documents (such as study protocol, code books, etc.) into NICHD DASH
- Annotate and prepare your study data for submission to NICHD DASH. You will be provided with a downloadable Data Preparation Tool (DPT) to assist you with offline annotation and preparation of your data.
- Upload your study data to NICHD DASH via secure data transfer methods
1. Who May Submit
All investigators (extramural and intramural) who have studies funded by NICHD are encouraged to submit their studies to NICHD DASH. To submit studies to NICHD DASH, you must be registered and logged into your NICHD DASH account.
2. Required Documents for Submission
Submission of data to NICHD DASH must be accompanied by the following documentation:
Institutional Certification: This is an administrative compliance document and will not be provided to DASH users.
Submitters must provide an Institutional Certification from the responsible Institutional Official(s) of the submitting institution stating that they approve submission to NICHD DASH and that
the identities of research participants will not be disclosed to NICHD. The template for the Institutional Certification is available under the DASH Resources Tab.
The Institutional Certification must assure that:
- The data submission is consistent with all applicable national, tribal, and state laws and regulations, as well as institutional and study policies;
- The appropriate research uses of the data and its limitations that are consistent with the informed consent documents are delineated during the process of data submission to NICHD DASH
- The investigator will inform the NICHD DASH if data needs to be removed from NICHD DASH for any reason, such as change in informed consent; and
An IRB and/or Privacy Board (as applicable) has reviewed and verified that:
- Data sharing via NICHD DASH does not conflict with the informed consent of study participants from whom the data were obtained
- Data has been de-identified in accordance with NICHD DASH Policy, and
- Data were collected in a manner consistent with 45 CFR Part 46.
Descriptive Documents: These documents ensure meaningful use of the data and are provided to the users who are interested in requesting your study data from NICHD DASH. Four documents, listed below, are required and the rest are optional:
- Study Protocol (required)
- Codebook/Variable Dictionary (required)
- Data Collection Instruments (required)
- De-Identification Methodology (required: for guidance on de-identification, refer to Guidance for Data De-Identification and Coding)
- Data Collection Methodology (optional)
- Data Analysis Plan (optional)
- Manual of Operations (optional)
- Study Manual (optional)
- Project Summaries (optional)
- Summary Statistics (optional)
- List of Publications (optional)
3. Navigating through NICHD DASH Submission
Once you have started the submission process, please navigate using the NICHD DASH navigation buttons and NOT your browser buttons.
There are two ways to navigate among pages in the NICHD DASH submission process. The figure below shows a sample submission information page. On the lefthand side of the page is a Navigation pane, and at the bottom of the page are blue buttons: "Previous," "Save," and "Next," depending on the section you are in.
NOTE: Using your Internet browser's "Back" button will take you out of the NICHD DASH submission process. This will cause you to lose any information that you have not saved. To avoid this, please use the navigation pane provided and click "Save" often.
The left-hand navigation pane shows each of the major submission steps. If you have not completed a section, it will appear in nonbolded grey text. Sections that are completed are shown in bolded black text with a check mark to the right. The section you are currently working on is shown in bolded blue text with an arrow mark to the right.
You may return to any section that you have already completed by clicking on the section name.
At the bottom of each page, there are blue navigation buttons labeled "Previous," "Save," and "Next."
Use the blue "Previous" and "Next" buttons to navigate between pages—to move forward to the next page or to return to a previous page to make additions or corrections. Do not use your browser's "Back" button, or you will exit the submission process and may lose your work. The "Save" button will save completed sections of the page without leaving the current page.
4. Start a New Submission
Follow the instructions below to submit your study to NICHD DASH. You may save your work at any point during the submission process and resume later. Note that only completed sections within a page will be saved. To access ongoing study submissions, click on the "Submissions" button on the top menu bar of NICHD DASH and select "Manage Submissions" from the dropdown list. For more information, see "Tracking your Submission" via the "Manage Submissions" Dashboard.
NOTE: You must de-identify all your study data prior to initiating submission.
- Click on the "Submissions" button on the top menu bar of NICHD DASH, and select "Submit Study."
- You will be directed to the "Study Submission Overview" page, where you can download a submission checklist to help prepare your study for submission.
- Click the "Start Submission" button. You will be directed to the "General - Part 1" page.
5. Submission – General Part 1
In the following steps, you will provide information on the "General - Part 1" page regarding the study you are submitting.
- Fill in the “Study Name” and “Abbreviation” fields with your study name and abbreviation, respectively.
- Select whether the study is a "Single Site" or "Multi Site."
- From the dropdown menu, select the “NICHD Division/Branch/Center” that sponsored your study.
- If applicable, select the “Clinical Research Network Name” from the dropdown menu.
- Provide Point of Contact (PoC) information. The PoC should be a person who can be contacted long-term about any study questions or concerns.
- If you are the PoC, check the box labeled “Use information from my registered account.” NICHD DASH will autocomplete the PoC with your information (i.e., the person logged into the system at the time).
- If you enter the email address of a registered User in the “Email Address” field, NICHD DASH will autocomplete the PoC information associated with that email address.
- If you enter an email address and the fields do not autocomplete, fill in the remaining fields. NICHD DASH will store this information, based on the email address, for future submissions.
- Select your institution from the dropdown list. If you do not see your institution, select the "Click here to add your institution" link, and fields will appear for you to add your institution.
- To add your institution, complete all the required fields denoted by an asterisk for your institution and division. This will make your institution available for future submission.
- Select "For Profit" or "Not For Profit."
- Complete information about the School/Division/Center. If you click “Use my institution Name” or “Use my institution address,” these fields will autocomplete.
- Click "Next." You will be taken to the "General - Part 2" page.
6. Submission – General Part 2
In the following steps, you will provide information about the Principal Investigator (PI) for this study.
- Indicate the study PI:
- If the Study PI is the Point of Contact defined on the previous page, select "Point of Contact."
- If you are the Study PI, select "Submitter."
- If the Study PI is neither the PoC nor the submitter, select "Other," and fields will appear for you to enter additional information.
- Additionally, you may provide Data Center Principal Investigator or Co-Investigator information (optional). Click on "+Add Co-Investigator" if you need to add additional names. Click on "Remove Co-Investigator" to remove an entry.
- Click "Next" to save your work and continue to the next page.
7. Submission – Policy Compliance
The "Policy Compliance" page contains regulatory questions regarding your study. These fields are all required, and you may provide a narrative explanation if necessary.
- On the "Policy Compliance" page, answer the regulatory questions by selecting "Yes" or "No" for each question. If you select "No," provide an explanation in the space provided.
- Click "Next." You will be taken to the "Study Information" page.
8. Submission – Study Details
In the following steps, you will enter a study description that includes a narrative description, dates, keywords, funding information, and additional details. Secondary researchers will be able to use this description to get a better idea of your study and ensure that it is the correct one for them to request.
The Study Information section requires you to enter a narrative description of your study, enrollment start and end dates, and data collection start and end dates.
- Provide a narrative study description including the study objective.
- Enter enrollment start and end dates and data collection start and end dates in yyyy-mm-dd format.
- Enter keywords by typing in the keyword one at a time and clicking "Add Keyword" after each entry.
- Add topics by selecting a topic from the dropdown list and clicking "Add Topic." This list is generated from the NICHD A to Z Health and Human Development Topics.To remove keyword(s) or topic(s), click on the “x” next to the keyword or topic.
- Select “Yes” or “No” to reflect whether you are submitting all the data from your study to DASH. If you answer “No,” additional fields will open asking you to provide details about why you are not providing all study data.
In the "Funding Information" section, identify the funding source and additional identifying information.
- First, select "Funding Source." If you select "NIH Intramural" or "NIH Extramural," you will see a dropdown list of NIH institutions.
- Select your institution from the dropdown list. If your funding institution is not "NIH Intramural" or "NIH Extramural," select “Other” and then select from the drop-down or click on the corresponding link to add the institution.
- Select your funding type.
- If you select "Grant" or "Contract," to provide the grant or contract identifying number in the "Identifying Number" field. Then click on “+Add Number.” If you need to remove a number, click on the “x” next to the number you wish to remove.
- If If you select "Other," you must provide information in the "Please specify" input field, which will appear.
In the "Research Details" section, you will add your clinical research type.
- Select your Clinical Research Type from the dropdown list.
- Enter URL links for your study website, ClinicalTrials.gov entry, and/or dbGaP entry, as applicable. You may also provide up to five links to publications associated with this study. If there are additional study publications you would like to provide, you can upload a list of publications on the descriptive documents page.
- Click on "Next." You will be taken to the "Study Population" page.
9. Submission – Study Population
The "Study Population" page will allow you to enter information about the different population groups of your study. Not all population information is required but you are encouraged to be as specific as possible so that others can better understand your study.
- Enter the total number of research participants from your study into the "Total Population" field.
- Add a description of your total population into the "Total Population Description" field.
- Provide a breakdown of study participants by sex. Enter the population by sex in the "Males," "Females," "Unknown," and "Undifferentiated" fields.
- Provide a breakdown of study participants by "Life Stage," as defined by NICHD Pediatric Terminology.
- Provide a breakdown of study participants by ethnicity (Hispanic, Non-Hispanic, or Unknown).
- Provide a breakdown of study participants by race. The most recent standards for race definitions
can be found through the U.S. Department of Health and Human Services
Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status
Provide a breakdown of study participants by location. Select a location from the dropdown list and click on "+Add Location." For international studies, click on "Click here for International Study Locations (by Country)." A second data entry box will appear and you will then be able to add subjects by U.S. or International location. using the appropriate data entry box.
10. Submission – Data Distribution
In the following steps, you will enter data distribution information, including acknowledgementinstructions for users of your study data.
- Answer all the "Yes/No" questions related to study data distribution (please note that all fields are mandatory):
- In Question 1, please mark whether you require additional approvals for access to your data beyond the approvals made by the NICHD Data Access Committee. If you select "Yes", a new field will appear for details.
- In Question 2, please mark whether there are any limitations to the use of the data. If you select "Yes", a new field will appear for details.
- In Question 3, please mark whether a requester of your data will need approval from his or her Institutional Review Board before access to your study data can be granted.
- Provide instructions for how you wish your study to be acknowledged by researchers who use your study data.
- Click "Next."
11. Supporting Documents – Compliance
In the following steps, you will upload required and optional compliance documents.
- Upload yourInstitutional Certification. This is a required field.
- Click on the "Upload" button, select the signed Institutional Certification saved on your local computer, and click "OK." Your document title will appear on the page to verify it has been uploaded.
NOTE: Institutional Certification is an administrative requirement for submitting studies in NICHD DASH and is not made available to other users.
- Upload optional documents. You may include additional Compliance documents if applicable.
- Click on the "Upload" button, search for your document, and click "OK." If there is a problem with your document, you will see an error message when you move to the next step.
- Click "Next."
12. Supporting Documents – Descriptive
The following steps allow you to upload descriptive documents associated with your study. Descriptive documents include study protocol, codebook/data dictionary, data collection instruments, and data de-identification methodology. The descriptive documentation will be available and viewable by any registered NICHD DASH user without approval from the NICHD DASH Data Access Committee. Verify that all descriptive documents have been properly de-identified before uploading into NICHD DASH.
The following documents are required—see the "Required Documents for Submission" section for additional information:
- Study Protocol
- Codebook/Variable Dictionary
- Data Collection Instruments
- De-identification Methodology
NOTE: PDF documents are preferred over .DOC or .DOCX; however, all are accepted, including .RTF and .TXT files.
- For each document, click on the "Upload" button, search for your document, and click "OK." If there is a problem with your document, an error message will be displayed when you move to the next step.
- Optional documents may be uploaded in the same way. Note that all descriptive documentation will be available to registered users without approval from the NICHD DASH Data Access Committee.
- Click "Next."
NOTE: Descriptive documentation will be available and viewable by any registered NICHD DASH user without approval from the NICHD DASH Data Access Committee. Any study documentation that should be limited to approved data users should not be uploaded in this section but should be included with your data submission package that will be sent directly to NICHD DASH Administrator (see Data Preparation below).
13. Data Preparation
The NICHD DASH system allows researchers to search for data based on annotated study content. The Data Preparation Tool (DPT) is a downloadable application that you can use offline to prepare your data for submission. It allows you to organize and annotate your study datasets, images and documents. When using the DPT offline, you can save your work and return to it later.
NOTE: All your data must be de-identified prior to performing data annotation (for de-identification guidance, see "Required Documents for Submission").
Follow the steps below to prepare for annotation:
- Ensure all your data (datasets, images, and documents) are de-identified and saved in a single, easy-to-find location on your computer. Include the descriptive documents that you have already uploaded.
- If you are logged out of NICHD DASH at this stage, you can return to this step of study submission by logging into NICHD DASH and clicking on the "Submissions" button located on the top bar of the homepage. Select "Manage Submissions." You will be directed to the "Submission Dashboard" page displaying your study submissions. Click on the study that you wish to annotate, and navigate to the "Data Preparation" page.
- Download DPT for Windows or for Mac OS X by clicking the appropriate download button.
- Open and run DPT. For step-by-step instructions on how to use DPT for preparing your data, annotating data files and uploading data to DASH, see the DPT section below.
- Guidelines for de-identifying your data are available at Guidance for Data De-Identification and Coding
- Datasets and images should be in a format that can be easily accessed by others. For example, if your datasets were created using a statistical software package such as SAS, please also provide your datasets as .CSV files.
- If you provide .SAS files, consider providing them as .SAS transport files (.XPT files) so that SAS users working in different environments can import your files into their SAS application. You will need to encode .XPT files using utf-8.
- In your documentation, please provide the version of the statistical software package that you used to create your datasets and the imaging software used to create your images.
- You are required to include a "De-identification Methodology" document that explains how your datasets and/or images were de-identified.
- For documents, .PDF files are preferred but all formats are accepted including .DOC, .DOCX, .RTF, and .TXT.
14. Complete Submission
You are now ready to complete the submission of your study.
- First, verify the completeness and accuracy of your submission. This is another opportunity to ensure your data are completely de-identified. Click “Study Preview Page.” After verifying the accuracy and completeness of the information provided on the “Study Preview Page,” click “Submit.”
- You have submitted your study. You will receive an email confirmation from NICHD DASH Administrator that your submission has been received.
15. Tracking your Submission via the "Manage Submissions" Dashboard
You are not required to submit your study in one sitting; you can save your work and resume it later.
To access your ongoing study submission, log into NICHD DASH, click on the "Submissions" button on the top menu bar of
the NICHD DASH homepage, and select "Manage Submissions" from the dropdown list.
A list of your study submissions will appear, along with a status column and "action" buttons.
The studies you have started to submit or have already submitted will be displayed under one of the following statuses:
|Initiated||The Submitter has initiated a new submission.||You have started a submission but have not clicked "Next" for the first time in the submission process.
Actions you can take: You can resume your submission by clicking on the "Resume" button from the "Manage Submissions" dashboard at any time while your study is in the "Initiated" status.
|In Progress||The Submitter is in the process of entering information in the submission steps.||You started a submission and are in the process of submitting but have not completed the submission.
Actions you can take: You can resume your submission by clicking on the "Resume" button from the "Manage Submissions" dashboard at any time while your study is in the "In Progress" status.
|Submitted||The Submitter has clicked "Submit" in the Complete Submission step.||You have submitted all documents, files, and information for the study.
Actions you can take: None. You can no longer make changes to your submission; it is now under review by a NICHD DASH Curator.
|Approved||The appropriate NICHD Division/Center Director or Branch Chief has approved the study submission.||Your study has been approved and loaded into NICHD DASH. It is now available in NICHD DASH for other researchers to perform searches and request data from your study.
Actions you can take: None.
|Not Approved||The submission was not approved.||
You should have received an email from the NICHD DASH Administrator stating the reason why your study was not approved.
Actions you can take: You can click on the "Edit Submission" button in the "Manage Submissions" dashboard to revise your submission by entering correct information or replacing documentation and/or data.
Data Preparation Tool
The Data Preparation Tool (DPT) organizes study items (e.g., datasets, documents, and images) associated with
your study and allows you to annotate these items prior to uploading them into NICHD DASH. DPT is a standalone application
that you can download to your computer and use offline. Once you have begun to organize your study items, you can
save your work at any time and return to it later.
DPT automatically categorizes study items and generates annotation templates in Microsoft Excel, generating one template for each category. You will be asked to approve the categorizations or make the appropriate changes. You will then be instructed to review and provide key information (annotations/metadata) about your data, such as dataset type, format, and document type. Once you have saved your completed annotation templates, DPT will create a .zip file. DPT also requires you to construct a hierarchal structure or schema for your study. Your files are encrypted prior to uploading them into NICHD DASH.
At any time, if you need help, click on the question mark (?) at the top of the screen and the following Help screen will appear.
1. Prepare for Annotation
NOTE:Ensure that all your data have been de-identified prior to beginning the annotation process(for de-identification guidance, see the "Required Documents for Submission" section).
After de-identifying your data, follow the steps below:
- Ensure that all your data (datasets, images, and documents) are de-identified and saved in a single, easy-to-find location on your computer.
- If you are logged out of NICHD DASH at this stage, you can return to this step of study submission by logging into NICHD DASH and clicking on the "Submissions" button located on the top bar of the homepage. Select "Manage Submissions." You will be directed to the Submission Dashboard displaying your study submissions. Click on the study that you wish to annotate, and navigate to the Data Preparation page.
- Download and install DPT from the "Data Preparation" page.
- Open and run DPT.
After opening DPT on your computer, you will see the DPT dashboard, which displays a list of all the studies you have annotated or are currently annotating via DPT. You can save your work and revisit it later by clicking the "Resume" button on the main dashboard.
- To start annotating a new study, click the "Add Study" button in the lower left-hand corner.
- To resume a previous annotation, click the "Resume" button to pick up where you left off.
NOTE:For step-by-step instructions within the DPT, click on the "?" button at any time.
3. Add Study
After clicking on the "Add Study" button on the DPT Dashboard, a pop-up window appears:
- Enter the name of your study in the "Study Name" field. You do not need to use the complete study name—an abbreviated study name will help you remember what data you are submitting. The abbreviated study name is strictly internal to help you manage your data submission and will not be accessible to end users or the NICHD DASH Data Curator.
- Make sure you have saved all items (datasets, documents, images) associated with your study in a single, easy-to-find folder on your computer. Click the "Browse" button next to the "Data Location" field, search for the folder, and click "OK."
The “Workspace Location” is where DPT will store your annotation work. DPT generates templates that you will then use to annotate your data. Indicate where you would like these templates to be saved on your computer by clicking “Browse” and choosing a folder on your computer. DPT will then generate a sub-folder titled “DPT_Annotations_[Study Name].” This sub-folder will contain your templates and a Study Schema you may choose to create using DPT.
NOTE: Your “Workspace Location” folder must be completely separate from your “Data Location” folder. Please make sure that you specify two distinct folders. They may both be contained within the same parent folder (e.g. the “My Documents” folder) but the “Data Location” folder cannot be a subfolder within the “Workspace Location” folder or vice versa.
Click the "Add to List" button to start the annotation process. You will be taken to the "Categorize Files" page, where you
will be able to view your study files. If there are errors in your entry, you will see error messages in the pop-up window.
4. Categorize Files
Each item is assigned to a category (e.g., dataset, document, or image). Each category has a different set of annotation properties (metadata) that are associated with it. DPT analyzes your study items and automatically assigns a category based on the file extension. You can either approve the category automatically selected by DPT for your items or select a different category from the dropdown list.
- Select a folder on the left-hand side of the page; the items in that folder will be listed to the right. DPT will have performed a first pass at categorizing your items based on the file extension.
- Check to see that each item is appropriately categorized. For example, an .xlsx file will be categorized as a dataset but may be a document. Use your knowledge of the study data to ensure proper categorization. To recategorize an item, click the dropdown list aligned to that item.
- Every categorization must be approved; click the "Approve" checkbox for each item to confirm categorization. You can also click
the "Approve All" button located at the top-right hand side of the page to approve all categories for the items in the selected folder.
- Click on “Save” to save your work or “Next” to save and continue. If an item has not been categorized and approved, you will see an error message when you attempt to continue. You will not be able to move forward until all study items have been categorized and approved.
- Once all your items are categorized and approved, click the "Next" button, and the tool will create Microsoft Excel spreadsheets (one for each category) and take you to the “Generate Templates” page.
- Be aware that you cannot recategorize your items once you click “Next.” To recategorize your items, you will need to start a new submission in DPT.
5. Generate Templates
DPT generates annotation templates in Microsoft Excel based on the categories that were selected in the previous step; one template will be generated for each category of study items (datasets, documents, and images). For example, all your documents will be referenced in the DocumentTemplate.xlsx spreadsheet. You will be able to annotate your study items in these templates.
- Indicate if you are submitting any biospecimen information with this study.
- Click on the Generate Templates button.
- When you click on "Generate Templates," DPT will show you the location of your templates and remind you to annotate your study items. Templates are provided in Microsoft Excel format. A link for Excel is provided on the “Generate Templates” page.
- You may select "Go To Workspace" from here and be taken to your workspace location to annotate your study items. Or, if you have already completed your study annotations, you may click on "Annotations Completed." Do not click on "Annotations Completed" until you have competed your annotations.
6. Annotate Templates
You should annotate your study offline and do not need to open DPT. Templates are provided in Microsoft Excel format. A link for Excel is provided on the “Generate Templates” page. Follow the steps below to annotate:
- Find your templates. They have been saved by DPT to your computer in the "Workspace Location" you specified
in the "Add Study" section.
- Open your templates and enter descriptions/annotations associated with each item. Each row in the template represents a study item. Item names are shown in the first column; other columns are for properties that can be assigned to your items.
- Some columns in each spreadsheet will have a dropdown list with annotations you can select to describe your data. If an appropriate descriptor is not available in the dropdown list, you can choose "Other" and enter a new descriptor in the next column.
- You can drag and drop information from row to row. This is especially helpful when you have many similar items.
- Be sure to annotate all templates and pay particular attention to the required fields. The required fields are labeled as such in the column headings. The more descriptions/annotations you provide, the easier it will be for others to find your data in NICHD DASH.
- Save your work; do not "save as" a new file name or save your templates in a different location.
7. Validate Templates
Once you have completed your annotations, return to the "Validate Templates" section in DPT.
- Click on the "Validate Templates" button.
- During validation, DPT checks that you have entered information in the required fields of your templates.
- If you have not entered all the required information, you will receive the following error message:
DPT will help you locate missing values by generating a table with columns labeled "Source", "Column", "Row", "Error Description", and "Solution."
- Return to your templates. It may take a few attempts to fill out all your templates correctly. Complete the changes and save.
- You will either receive a “Validation Success” message or a message detailing a list of errors.
- Continue correcting any errors using Microsoft Excel and click "Re-Validate" until there are no more errors, and then click "OK."
8. Create/Edit Schema
The “Create/Edit Schema” page allows you to build a study schema that will be displayed on the “Study Overview” page associated with your study. The study schema provides an outline of the main headings and/or data collection points in the study (e.g., interview visits, sample collections, and laboratory tests). These will be organized hierarchically, and there can be as many levels as necessary in the hierarchy.
You are providing a schematic representation of the main elements of your study as outlined in your study protocol. You can decide what
events, levels, headings, and data collection points work best to describe your study data collection process. If you have previously created
a study schema and saved it as a JSON file, you can upload it to DPT by clicking on the "Load Schema" button.
When you click "Start New Schema," a default outline will appear:
You can use the outline provided or start your own using the instructions below.
Add a Heading (e.g., event/data collection point/etc.)
- Click on the "Add Heading" button to add a heading. Name your heading in the "Name" box (e.g. "Enrollment Visit 1").
- You can describe the heading in more detail in the description box. Add as many headings as you wish.
Add a Sub-Heading (e.g. data collected)
To add sub-headings to your main heading, select your main heading in the box on the right then click on "Add Sub- Heading." Fill in the name and description as above.
Remove a Heading or Sub-Heading
To remove a heading, select the heading you wish to delete, then click on the "Delete Heading" button.
If you want to delete the entire schema, click on the "Delete Schema" button. This will allow you to start over.
If the selected heading you wish to delete has one or more sub-headings, DPT will warn you that deleting the main heading will cause its corresponding sub-headings to be deleted.
Click the "Save" button at any time to save your work and return to it later.
9. Create Submission Files
The following steps will guide you through generating your submission files.
- Click on the "Upload Submission" button. You will be prompted to enter the location for your encrypted submission files. Click “Browse” and select the desired location. Click “Encrypt Files” to create a set of encrypted submission files in the specified location.
- A message will appear prompting you to ensure you are connected to the internet for the upload process. Click “Continue” once you have confirmed you are connected to the internet.
- You will be prompted for your NICHD DASH email account and password. Enter your credentials and click “Login.”
- Select the study you want to encrypt and upload. Click “Choose Study”.
- You are given one last chance to review your submission request. Review the study selected and the item name. Click “Upload Submission.”
- The upload status will be displayed in a pop-up window.
- A message will appear informing you that the upload was successful after the upload is complete. The uploaded annotation and data files can now be submitted from the NICHD DASH website. Login to the website and complete the submission process described in the Submission Section
NICHD welcomes feedback on NICHD DASH to inform future improvements to the website.
- Click on the "Feedback" widget on the left side of the NICHD DASH homepage. If you are not logged into NICHD DASH, you will be required to provide your email address, title, first name, last name, and middle initial to submit feedback. If you are logged in, your information will be populated automatically.
- Select type of feedback and section to which your feedback relates from the dropdown boxes.
- Enter your comments in the Comments field.
- Click on "Submit Feedback." You will receive an email confirmation from the NICHD DASH Administrator upon receipt of your feedback.
The following resources may be helpful when using NICHD DASH. You may access all of them by selecting "Resources" on the top menu bar of the NICHD DASH homepage.
1. NICHD DASH Policy
NICHD DASH Data Archive Policy Statement provides an overview of the data archive component (not the specimen archive component) of NICHD DASH that is available to house research data from NICHD funded research studies when such data are ready for sharing as per NIH policies. This Policy Statement also serves to inform investigators about how to submit data to, and request data from, NICHD DASH.
2. DASH User Agreement
During registration, users are required to agree to the Terms and Conditions of the NICHD DASH User Agreement.ions of the NICHD DASH User Agreement.
3. Data Request Checklist
The Data Request Checklist provides guidance on information required for submitting a request for data.
4. DASH Data Use Agreement
All data requests for studies stored in NICHD DASH must be accompanied by an NICHD DASH Data Use Agreement (DUA) signed by the Data Recipient (Lead Investigator) and the Authorized Organization Representative. To protect and promote the confidentiality and privacy of the individuals whose data have been deposited into NICHD DASH, NICHD requires all requesters of such data to sign and agree to the terms of the NICHD DASH DUA as a condition of access. A requester who is granted access to NICHD DASH data is expected to adhere to the specifications of the DUA.
5. DASH Data Preparation Tool
The NICHD Dash Data Preparation Tool is available for download for Windows and Mac OS X.
The Institutional Certification Template provides guidance to investigators on submitting an Institutional Certification from responsible Institutional Official(s) of the submitting institution certifying that they approve submission to the NICHD DASH and that the identities of research participants will not be disclosed to the NICHD DASH. l not be disclosed to the NICHD DASH.
7. Guidance for Data De-Identification and Coding
The Guidance for Data De-Identification and Coding provides general guidance to investigators on de-identification and coding of data that will be submitted to NICHD DASH.
8. Links to Other Archives
This is a list of NICHD studies that are available in other archives.
9. Frequently Asked Questions (FAQs)
The FAQs aims to provide answers to various questions that users may have about NICHD DASH and supplements the NICHD DASH Policy and the NICHD DASH User Tutorial.
The NICHD DASH Tutorial is available for download as a PDF here: NICHD DASH Tutorial [803 kB]