Forms

See below for links to our forms:

Submission Guide and Policies: All new, and perhaps, returning clients should start by reading this first. 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 given to benefit all visitors that would need to know about Pearl IRB to complete the review process.

 

Required Submission Forms for Standard IRB Reviews

Investigator Submission Form: The site needs to fill out this form to ensure Pearl IRB has all the information needed to initiate the review process.

Investigator Agreement to Terms: The site needs to fill out this form to ensure Pearl IRB has all the information needed to initiate the review process.

Investigator Conflict of Interest Form: The site needs to fill out this form to ensure Pearl IRB has all the information needed to initiate the review process.

Sponsor Submission Form: The sponsor or designated CRO/representative needs to fill out this form to ensure Pearl IRB has all the information needed to initiate the review process.

Sponsor Agreement to Terms: The sponsor or designated CRO/representative needs to fill out this form to ensure Pearl IRB has all the information needed to initiate the review process.

 

Additional Forms

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

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

Study Closure Report: Congratulations on completing your study!  The study close out form will ensure Pearl IRB has required information to close out your study.

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.

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.

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.

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 here and don’t hesitate to contact us with any questions.

All forms  and documents should be submitted via our online portal Egnyte.

For EGNYTE web upload instructions click here.