Researcher General Information

Researchers can work with the Registry in a variety of ways including obtaining data and/or samples from the Registry and requesting help recruiting for their studies and clinical trials.

Researchers must submit an application including information about:

• who is conducting the study
• who is sponsoring the study
• the study objectives and procedures
• Institutional Review Board (IRB) approved recruitment materials
• proof of IRB approval (e.g., an IRB approval letter)

Following submission, ATSDR will review the application for completeness and relevance to Registry participants. It will then be evaluated by an external expert panel. ATSDR will not consider any research that does not have IRB approval and an FDA IND or IDE number for an investigational test article, if applicable.

The Registry Web portal provides a tool for researchers to track the status of their applications. ATSDR estimates the approval process could take up to 60 business days from the receipt of a complete application.

If your application for data and/or samples is approved, there will be some additional requirements, e.g., signing a Material Transfer Agreement (MTA) you must complete before you can receive the approved data and/or specimens. You will also be required to submit an annual updates about your project. Annual Update Form.

For questions about how you can work with the Registry, please contact us at 1-877-442-9719 or by email at
ALS Research (Monday through Friday; 8am to 5pm ET).

Research Notification Requests

ATSDR has developed a research notification tool that will allow persons with ALS (PALS) enrolled in the National ALS Registry to find out about new studies and clinical trials for which they may be eligible. Email notification will be sent to PALS who have agreed to receive notifications about related studies. ATSDR will email the research notifications and study details to PALS based upon the eligibility criteria defined for each study.

Benefits of the research notification tool for researchers include:

• shorter recruitment time
• increased study sample size
• increased geographic diversity
• free service

Researcher Biorepository Requests

ATSDR has developed an online tool for researchers to request samples from the National ALS Biorepository. The samples come from PALS enrolled in the National ALS Registry and, when available, can be linked to epidemiological data (e.g., smoking history, residential history, occupational history, and history of military service) collected by the Registry. ATSDR would like to invite researchers to apply for samples and data collected from PALS.

In addition to the standard review, ATSDR will also review the application for sample availability and appropriateness of sample use. For more information on the types of samples available, please review Part B and C of the application form.

For more information about biological samples and tissues available please call the National ALS Biorepository at 1-855-874-6912. (Monday through Friday 8:30am to 5pm ET).

Researcher Data Requests

Researchers may request Registry data for their own research studies. These data are collected in the risk factor modules. Some data requested may not be available because, for example, it could be used in conjunction with other data to identify a participant. For more information on the types of data collected by the Registry, please review Part D of the application form. Prior to submitting a data request, please contact the Registry in order to determine which data are available.