Prior to data being submitted to the PD-DOC as a Linked Database, conference calls will be arranged with PD-DOC personnel and the site’s or study’s Database Manager, Coordinator, and PI. We will discuss their resources and data management expertise and the options for study documentation, de-identifying the database and transferring the data.
Outlined below are the steps to prepare a Linked Database to be submitted to the PD-DOC for posting on the PD-DOC website:
1. Study PI should review PD-DOC policies and register on the PD-DOC
website.
2. PD-DOC staff obtain contact information for study PI, Chief Biostatistician,
and Database Manager.
3. Study PI and PD-DOC personnel work together to obtain appropriate permissions to share the Linked Database.
4. Study PI/staff and PD-DOC staff discuss what data from the database are or are not appropriate for sharing (e.g. derived variables, text fields).
5. Study PI/staff provide PD-DOC Project Manager with the required supporting documents below to be posted on the PD-DOC website:
a. A copy of the IRB approved Informed Consent document (not posted).
b. Protocol Synopsis
e. Annotated case report forms (optional)
f. NINDS Human Genetics Repository (at Coriell) Dataset containing study subject and the matching de-identified Coriell NINDS IDs if applicable.
h. Permission from the journal(s) to link to corresponding published paper(s) on the PD-DOC website. The actual link should be provided when possible. As a reminder, manuscripts generated from NIH-funded studies should be made publicly available on PubMed Central no later than 12 months after the official date of publication. See the PubMed Submission Process for more information.
The PD-DOC staff are available to answer questions and offer assistance while preparing supportive documentation.
6. Study Database Manager sends sample data from the Linked Database to PD-DOC Lead Statistical Programmer to verify compatibility.
7. Database is de-identified by either the study PI’s staff or the PD-DOC staff. If the study PI prefers the PD-DOC to carry out the de-identification procedures, then a Business Associate Agreement (BAA) will be obtained (available through the PD-DOC).
8. Discussions will occur on the best method to transfer the DB to the PD-DOC. Once the database has been submitted to the PD-DOC, the confidential
PD-DOC ID’s are assigned by the PD-DOC Lead Statistical Programmer.
9. PD-DOC Lead Statistical Programmer will create instructions for users to download the Linked Database from the PD-DOC website.
10. Once all required elements for a Linked Database are provided, reviewed, and considered complete, the supporting documentation and Linked Database will be posted on the PD-DOC website. Linked Databases are currently made available as SAS transport files only.
Note: NINDS has indicated that NINDS-funded principal investigators of clinical or translational research studies in Parkinson’s disease or a related parkinsonian disorder will satisfy NIH requirements for data sharing if they comply with the process for public sharing of data as a Linked Database on the PD-DOC website.