Preparing for Data Submission

Before you’re ready to submit data, there are several initial steps you need to complete: assign roles, gain the necessary permissions and certifications, organize your project outputs, and submit data sharing documentation. Read about each step below.

Assign roles

Each data contributing team should have people in these roles:

• Grant PI (also may be called team lead)—this person authorizes the activity of the study

• Data liaison—this person will be the main contact with the AD-DCC (AD Data Coordinating Center)

• Data uploader—this person is responsible for assembling the required metadata and uploading the data and metadata to Synapse, and therefore, they must be familiar with with R, Python, or the Command Line in order to use the Synapse API clients

If appropriate, the data liaison may also be the data uploader.

Gain the necessary permissions and certifications

1. Become a Synapse Certified User by passing the certification quiz. This is required to upload data and therefore must be done by the data uploader.

2. It is recommended to have a signed Data Use Certificate (DUC) in place to be able to use the AD Knowledge Portal data resources, and download previously contributed files that may be relevant to the data contribution process

Organize your project outputs

1. For each AD Knowledge Portal funded grant, the grant PI must fill out a Project Attachment (see below) in order to inform the AD-DCC of your data generation plan, team members, and data contribution roles.

2. The AD-DCC will schedule a call with the grant PI and the data liaison to review data contribution expectations and provide information on the available resources.

Submit data sharing documentation

The grant PI will be contacted by our Governance team with information on how to submit data sharing documentation. This consists of:

• a Data Transfer Agreement and

• one or more Project Attachment(s)

Reference the graphic below for an explanation, followed by more detailed information on each type of documentation.

Complete a Data Transfer Agreement

Before data upload begins, a Data Transfer Agreement (DTA) must be in place between the data contributing institution and the data host (Sage Bionetworks). This agreement serves as a general understanding of data provider and recipient rights and responsibilities and needs to be signed by a Signing Official. This does not need to be done if Sage already has a DTA with your institution, or if your grant stipulates data sharing through the AD Portal. The AD-DCC will establish if this is the case before this request is made.

Submit (one or more) Project Attachment(s)

A Project Attachment (PA) must also be submitted to help inform about the specific data being contributed. This must be completed for each research project from which an investigator is contributing data to the AD Portal, and requires the signature of the research project PI. The PA should be completed even if a DTA or equivalent are already in place. The Project Attachment will include information on:

• species from which the biospecimens were obtained

• if human, details about the cohort

Summary of what needs to be signed

To determine what you need to sign, consider the following questions:

1. Is any of your data considered sensitive or HIPAA-limited?

2. Was this data generated under a grant funded through an NIA-supported AD Knowledge Portal program, or is it being contributed through the CDCP (Community Data Contribution Program)?

Data Transfer Agreement (DTA)

• If your data is generated under a NIA AD Portal grant, it contains language requiring that you submit your data to an NIA-approved repository—in that case, this qualifies as a DTA

• If you are submitting data through the CDCP, you will need a DTA signed by a signing official at your institution.

If you need a DTA, please contact the Access & Compliance Team here for additional support.

Project Attachment (PA)

• The project attachment describes the data you will contribute.

• If your data is HIPAA-limited, your attachment must be signed by an institutional official

• If your data is submitted through the CDCP, your attachment must be signed by an institutional official

Here’s an example PA

Consider the table below for a summary of documents and signatures needed based on your situation.

Overview of responsibilities by role

The following table provides an overview of what each role is responsible for doing/providing.