Institutional Review Board Forms Submission Checklist

We encourage you to answer the following questions and make use of this checklist before submitting any documentation to DCH IRB office.

Have you included a cover memo of submission (DCH IRB format) signed by investigators, advisors?
If not exempt, have you used the DCH template for your consent form with the appropriate header and version date?
Does your research require the use of supplemental materials? If so, have you included them with your submission?
Does your research include Non-English speakers? If so, have you translated the consent form, surveys and questionnaires? Have you included a letter certifying the translations?
Have you checked the spelling, grammar and consistency of your submission?

Exempt Review	YES	N/A
(1) Copy of the Protocol
(1) Copy of questionnaires and/or surveys
(1) Copy of any proposed advertisement/recruitment materials
Expedited Review	YES	N/A
(1) Waiver of Consent
(1) Cover memo of submission
(1) Copy of the Protocol
(1) Copy of the Consent, Assent, if applicable
(1) Copy of questionnaires and/or surveys
(1) Copy of any proposed advertisement/recruitment materials
Full Board Review	YES	N/A
(20) Cover memo of submission
(20) Copies of the Protocol
(20) Copies of the Consent, Assent
(20) Copies of any proposed advertisement/recruitment materials
(20) Copies of the Investigators brochure and package inserts
(1) Copy of the wallet ID card, if required
(20) Copies of Conflict of Interest and Financial Disclosure form, if applicable
(20) Processing Fee Waiver Request/Payment Receipt whatever is applicable
Amendments/Revisions	YES	N/A
(20) Copies of the Amendment/Revision
(20) Copies of Updated Consent and Assent forms
(20) Copies of any new or updated materials
(20) Payment Receipt (for company-sponsored studies)
Continuing Reviews:	YES	N/A
(20) Copies of Annual Report form(updated project summary, summary of serious adverse events and unanticipated problems)
(20) Copies of the current consent and assent forms
(20) Copies of DSMB result if applicable
(20) Copies of any new or updated materials
(20) Payment Receipt (for company-sponsored studies)
Local Adverse Events YES N/A
(1) Copy of Adverse Event Reporting form (one event per form)
(1) Copy of any new or updated materials
Non-Local Adverse Events	YES	N/A
(1) Offsite Adverse Event Reporting From (multiple events may be submitted on one form)
(1) Copy of new or updated materials

How to Reach Us

The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.

Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466

Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000

Institutional Review Board Forms Submission Checklist

How to Reach Us

Institutional Review Board

For Patients and Parents

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