DS002 - Project Director Request for National Database

DS002 TBIMS Project Director Request for National Database
Review Committee: Research Effective Date: 11/22/2008
Attachments: None Revised Date: 6/16/2023
Forms: DS002F - Project Director Request for National Database FORM Reviewed Date: 12/7/2019

Introduction:

The TBIMS National Database is available to currently funded TBIMS Project Directors upon request for internal purposes only (e.g., exploring study/analysis ideas, program evaluation, et cetera). In order to track release of the National Database and protect the use of the database, this procedure and request form were developed.

Purpose:

To establish a procedure for currently funded TBIMS Project Directors to request the multicenter TBIMS National Database for internal use, without having to submit an internal notification and DSF101 - Internal Use TBIMS National Database Notification Form.

Scope:

All TBIMS and TBIMS Follow-up Centers, NDSC.

Responsibilities:

All TBIMS and TBIMS Follow-up Centers, NDSC will abide by this procedure.

Procedural steps:

  1. This procedure is for TBIMS Project Directors to request the TBIMS NDB for internal purposes only. For dissemination of any information contained in the multicenter TBIMS NDB beyond the requesting Center TBIMS staff, refer to SOP DS001 - Access to the TBIMS National Database.

  2. The TBIMS National Database containing all centers’ data is updated on a quarterly basis on the following dates: January 15th, March 31st, June 30th, September 30th.

  3. The currently funded TBIMS Project Directors are the only persons who may request a copy of the National Database using this procedure. Project Co-Directors may also request a copy if prior arrangements are made in writing between the Project Director and the NDSC.

  4. The Project Director (or Co-Director) may not release the National Database to anyone other than those involved in his/her TBIMS project.

  5. The Project Director (or Co-Director) will assume responsibility for the protection of the data and release of the National Database to his/her TBIMS staff.

  6. In order to receive a copy of the National Database using this procedure, DSF002 – TBIMS Project Director Request for the National Database Form and Data Use Agreement must be completed and signed by the TBIMS Project Director, and sent via email, to the NDSC at tbimsdata@craighospital.org.

  7. The version of the National Database available is that which does not contain Protected Health Information (PHI).

  8. If a TBIMS wishes to receive a version of the National Database containing PHI defined as those variables in a limited dataset, those specific variables must be requested on the DSF002 – TBIMS Project Director Request for National Database Form and Data Use Agreement.

  9. The NDSC will track requests for the National Database.

  10. The National Database will be posted in a secure directory in the members only section of the NDSC website and will require security authentication to the website in order to be downloaded.

Training requirements:

None

Compliance:

All TBIMS requestors of the National Database must comply with this procedure.

References:

None

History:

Date Action
11/22/2008 Database Request Form Transferred to SOP template
12/12/2008 Approved by SOP Committee, Planning Committee and Project Directors
07/07/2014 Reviewed and approved.
06/12/2015 Updated NIDRR to NIDILRR
12/07/2019 Reviewed and updated to coincide with SOP 602f
2/18/2021 Updated procedure to differentiate from internal notification and include data use agreement as part of the request
6/16/2023 Renamed procedure as TBIMS Project Director Request for National Database and Data Use Agreement and clarified DUA for this specific data request purpose.

Review schedule:

At least every 5 years.