DA008 - Handling Unexpected Events at Follow-up

DA008	Handling Unexpected Events at Follow-up
Review Committee: Data	Start Date: 12/03/2008
Attachments: None	Last Revised Date: 12/1/2009
Forms: None	Last Reviewed Date: 2/11/2020

Introduction:

The TBI model systems strive to ensure a continuity of process for addressing unexpected events occurring during follow-up data collection (FORM 2) for the TBIMS National Database.

Purpose:

To have a procedure in place for data collectors to provide assistance for interview participants, as appropriate, if unexpected events arise during follow-up data collection.

Scope:

Current TBIMS and Longitudinal follow-up centers that are collecting follow-up data for the TBIMS National Database.

Responsibilities:

In the process of gathering follow-up data for NDB cases, participants may describe a physical or emotional condition that could have immediate or emergent consequences, such as (but not limited to) comments reflecting a desire for harm of self or others. In such situations, appropriate steps should be taken to guard the health and welfare of the research participant and others, as needed.

Procedural steps:

Each center must establish a procedure for data collectors to employ in this situation to ensure that appropriate assistance is available to the data collector and to the research participant. The specific steps taken may be different from center to center based on the services and staff available.

Training requirements:

Each center is responsible for training data collection personnel regarding the procedure.

Compliance:

During site visits, NDSC staff will confirm that the procedure exists and that staff have been trained regarding the procedure. There is no need to file the procedure with the NDSC.

References:

None

History:

Date	Action
12/03/2008	New SOP drafted by Data Committee
08/13/2009	Approved by Data Committee
09/01/2009	Approved by SOP Committee
12/01/2009	Revisions recommended by Data Committee and approved
01/18/2010	Approved by SOP Committee
09/08/2014	SOP Reviewed
02/11/2020	SOP Reviewed

Review schedule:

At least every 5 years.