Standard Operating Procedures

The NIDILRR priority requires the NDSC to develop and revise standard operating procedures (SOPs) that provide guidance for TBIMS Center operations. Formally implemented by the NDSC in 2008, these documents describe the regularly occurring operations of the TBIMS for data collectors, researchers, analysts, data managers, and the NDSC. Having such SOPs increases the likelihood that operations are carried out consistently and systematically across all TBIMS Centers, serves as training documentation for new TBIMS staff, and preserves an historical record of how and why processes have changed during the lifecycle of the project.

To make it easier to search within all SOPs at once, during the 2021-2026 grant cycle the NDSC combined all SOPs into a single indexed PDF. The NDSC also restructured the SOPs to align with the workflow of the NDSC and the TBIMS Centers, organizing them into the following five major chapters which correspond to the elements of the data lifecycle.

Indexed, searchable document that contains all Standard Operating Procedures

If you open the document and show the document outline, you will see that there are 5 major chapters included in the PDF

Data Aquisition

  • Identification of Subjects
  • Sampling for NDB Enrollment
  • Guidelines and Strategies for TBIMS National Database Recruitment & Consenting
  • Guidelines for Medical Record Abstraction and Record Requests
  • Guidelines for Collection of Follow-Up Data
  • Guidelines and Strategies for Maximizing Follow-Up
  • Handling Unexpected Events at Follow-up

Data Processing

  • Quarterly Submission Process for Data Center
  • Quarterly Submission Process for TBIMS Centers
  • Editing, Entering, and Submitting Old Data
  • Obtaining and Coding Cause of Death in the TBIMS National Database
  • Notification of Staff Changes

Data Quality

  • Data Quality Guidelines and Principal Investigator Verification of Compliance
  • Performance Target Monitoring
  • Prevention and Investigation of Possible Falsification of Data
  • Resolving Data Collection and Coding Questions
  • Methods for Locking and Unlocking Records

Data Sharing

  • Access to the TBIMS National Database
  • TBIMS Project Director Request for National Database
  • Submission of TBIMS Data to FITBIR
  • Non-TBIMS Collaborative Relationships
  • VA PRCs Collaborative Relationships
  • Follow-up Centers Collaborative Relationships
  • Access to TBIMS Module Project Datasets

TBIMS Operations

  • TBIMS Data Collection Integrity Pledge
  • Implementing Changes to the National Database
  • TBIMS Committees, Modules and Special Interest Groups, and Election Process for Committee Chairs and Co-Chairs
  • Procedure for Creating and Changing SOPs
  • Branding and Authorship of Manuscripts and Other Products Using Data from the TBIMS National Database, Archived Module Datasets, and Ongoing TBIMS Module Studies
  • Adding Affiliate Hospitals to a TBI Model System