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