Forms

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Required Submission Forms for Standard IRB Reviews

Investigator Submission Form
Investigator Agreement to Terms
Investigator Conflict of Interest Form
Sponsor Submission Form
Sponsor Agreement to Terms
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Additional Forms

Continuing Review Form

The continuing review form provides Pearl IRB the information needed to ensure the study is on track.

Download Continuing Review Form

Unanticipated Event Form

Unfortunately, unanticipated events occur.  These need to be reported promptly to Pearl IRB using this form.

Download Unanticipated Event Form

Study Closure Report

Congratulations on completing your study! The study close out form will ensure Pearl IRB has the required information to close out your study.

Download Study Closure Report

Exemption Determination Submission Form

Research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) [federally funded projects] and 21 CFR 56.104(d) [FDA regulated studies]. An applicant may apply to Pearl IRB for an exemption determination. A Pearl IRB Exemption Determination Submission Form and a copy of the final study protocol should be submitted prior to Pearl IRB’s review of an exemption determination request.

Download Exemption Determination Submission Form

Human Subject Determination Form

If you are unsure if your project involves research with human subjects, please consult with IRB staff who can provide a determination.

Download Human Subject Determination Form

Recruitment Material Submission Form

If you are ONLY submitting advertising/recruitment materials, the sponsor or designated CRO/representative needs to fill out this form. If you are submitting advertising/recruitment materials as a part of a larger IRB submission, do not fill out this form.

Download Recruitment Material Submission Form

ClinicalTrials.gov Required Information

To assist our clients in meeting the reporting requirements for ClinicalTrials.gov we have developed a guideline to help you comply. Please review the guide and don’t hesitate to contact us with any questions.

Download ClinicalTrials.gov Required Information

Submission Guide and Policies

The Pearl IRB Submission Guide and Policies document is provided to introduce Pearl IRB, the board membership, types of reviews conducted, preparation for the IRB review, the review process, possible outcomes of the reviews, and closeout procedures.

This information is provided in order to ensure an efficient and streamlined process while working with Pearl IRB to complete the review process.

Download Submission Guide and Policies