Sabai IRB Resources

Sabai Institutional Review Board’s (IRB) mission is to protect the rights, safety and welfare of human research participants who participate in research studies.

IRB Guidance
Institutions
Investigator Guide
Short Form Consents
Investigator Training
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Sabai IRB provides exemplary client support to researchers for all phases of research; along with Quality, Timeliness and Subject Matter Expertise.

Key features of MySabai Portal include:

  • Ability to track the progress of a study or site submission through IRB review process
  • All study documents (and site submissions) can be submitted online and are available 24/7
  • Copy feature for quicker submission next time

IRB Forms

Note: Submission forms are only available in the Online Portal. Guidance for completing online forms is available below.

Exempt Project

Use this form to submit an Exempt Determination for IRB review.

GUIDANCE

Multisite Initial Protocol Application

Sponsors of multi-site studies use this form to submit a new master protocol for Initial Review.

GUIDANCE

Single Site Application

Use this form to submit a new protocol for single site Initial Review.

GUIDANCE

Site Application

Use this form to add an Investigator/site to a multisite protocol that has already been approved by Castle IRB.

GUIDANCE

Single Patient Expanded Access Application

Use this form to submit an application for single patient expanded access/compassionate use.

GUIDANCE

MySabai

Note: Submission forms are only available in the Online Portal. Guidance for completing online forms is available below.

Add or Remove Contacts

Use this form to add or remove contacts.

GUIDANCE

Add Translations to an Active Study

Use this form to add translation(s) to an active study.

GUIDANCE

Amendment

Use this form to submit a change in PI, research, study materials, etc. This can be at the master level or site level.

GUIDANCE

Closure Form

Use this form to submit a closure for a site or master protocol.

GUIDANCE

Reportable Events Form

Use this form to submit a reportable event on an active study.

GUIDANCE

Retrieve Approval Letters & Documents

Click link for guidance on how to access approval letters and approved study documents.

GUIDANCE

Submit a New Contact Form

Use this form to submit a new contact form.

GUIDANCE

IRB Services Include:

Sabai IRB Services follows US DHHS and FDA Regulations, the Belmont Report, ICH GCP and NIH Guidelines as well as local/state laws.

  • Multi-site and Single Site/Investigator studies in pharma, device/human factors, biotech, social-behavioral, natural history, registry and investigator-initiated projects
  • Single Patient Expanded Access/Compassionate Use
  • Exempt Determination reviews
  • Initial Review, Continuing Review of Research, On-Going reviews, including Amendments and Safety Reporting
  • Determinations of what is/is not research requiring IRB review
  • Informed Consent Form Pre-Review/Consultation and development
  • Translation Services
  • Generic Materials
WHAT SETS US APART

What Our Clients Say

"Christine was very patient with our questions and did a great job explaining and helping the site learn—[made] the process incredibly seamless and we look forward to our next project together."

Dakota Gaines CenExel

"Many thanks for your excellent service. [You’ve] been the easiest and most collaborative and communicative IRB to work with. Hoping to cross paths again!"

Gina Gorgone Simone Sr. Project Leader, Emmes

"The best vendor I have ever worked with."

Associate Director of Clinical Operations Merck

"We love you guys."

Research Safety Associate Director over Biosafety University of California-San Diego

"Accelerated our timelines and beat our projections for our sponsor, with the added complexity of IBC on top of IRB regulatory."

Study Start-Up Director MedPace CRO

"Every time I interact with your team I walk away with a smile. For Shield, Heidi has been my lifesaver: pragmatic, understanding, and action-oriented. I have come to her feeling overwhelmed and unsure of how to tackle complex issues, and within the span of a single call she develops a plan and I am able to walk away with 1000 pounds lifted off my shoulder."

BSO Pharmaceutical Company

Contact Sabai

For prospective and current participants, sponsors/CROs, researchers or others who wish to discuss problems, concerns, questions, or who wish to obtain information, or offer input about each IRB, please contact us at:

SABAI IRB

16150 Main Circle Drive, Suite 100, Chesterfield, MO 63017

1-888-442-2472
ClientServices@sabaiglobal.com
irbteam@sabaiglobal.com

companies and concerns

Any person with concerns regarding the conduct of Sabai is encouraged to contact officials through the following means:

1-888-442-2472
Contact Sabai

www.lighthouseservices.com
Contact the Compliance Hotline

833-370-0002
Toll-free English speaking

800-216-1288
Toll-free Spanish speaking