FREQUENTLY ASKED QUESTIONS


PRINCIPAL IRB FAQS

Q. How do I submit a study to Principal IRB?

 At Principal it is our goal to make your study submission as seamless and simple as possible. Please visit SUBMIT A STUDY to get started.

 

Q. How often does Principal IRB meet?

PIRB meets weekly and can accommodate any deadlines you may have. Simply submit your study documents via   LAUNCH  one week prior to the meeting date.  

 

Q. How do I securely submit documents online to Principal IRB?

Principal has a secure digital platform for submission of your sensitive study documents. Our platform is fully CFR 21 Part 11 compliant.  
Please CONTACT US to gain access to   
LAUNCH.

Q. What is the submission deadline for a new study?

Your Single Point of Contact at Principal will provide your specific submission deadlines. Be sure to include all items listed in the Submission Checklist to ensure your study will be reviewed.

 

Q. What is your turnaround time?

PIRB reports all board decisions within 2 business days of the board meeting. Documents will be sent electronically.

 

Q. What should I do when I need my consent revised?

Consent revisions may be submitted electronically. Please clearly indicate all changes and include a cover letter explaining the rationale for change.

 

Q. What is HIPAA?

HIPAA stands for Health Insurance Portability and Accountability Act of 1996. It is also referred to as The Privacy Rule. 

 

Q. As an investigator, what do I need to do to be HIPAA compliant?

If you as an investigator are considered a HIPAA covered entity, you will need to ensure that you have measures in place to maintain the privacy and confidentiality of protected health information. The HIPAA Authorization Form may be found on LAUNCH.

 

Q. What are Principal’s requirements for reporting adverse events?

Principal IRB follows all guidelines in reporting adverse events and unanticipated problems as set forth by the OHRP. For detailed guidelines please CLICK HERE.

 

Q. What Protocol Deviations must Principal require to be reported?

Protocol Deviations, which in the view of the sponsor or investigator may affect the rights, safety and welfare of human research subjects must be reported to PIRB. 

 

Q. How do I renew IRB approval for a study?

A Continuing Review Form must be completed and submitted along electronically with a copy of your most recently approved consent form. This form may be found on LAUNCH.

 

Q. How do I submit a Protocol Amendment?

Protocol Amendments should be submitted with a cover letter signed by the investigator. A summary of changes should also be included to facilitate board review. Clearly indicate if a consent change is needed.

 

Q. How do I request a revision of the consent form?

Subject Informed Consent Revisions should be submitted with the changes clearly indicated. A cover letter signed by the investigator, with the rational should be included with the submission. 

 

Q. Will a Sponsor/ CRO receive an approval letter?

The original determination letter will be sent to the investigator; however, PIRB will be happy to send copies to the Sponsor or CRO upon request.

 

Q. What is Principals’s policy for reporting IND Safety/ Med Watch reports?

IND Safety/ Med Watch reports should be submitted to PIRB within 5 business days of receipt. All reports will be acknowledged and sent back to you electronically.

 

Q. If I have questions about an existing study, is there someone I can contact?

Your assigned SINGLE POINT OF CONTACT  will be happy to assist you with any questions or concerns you may have. 

 

Q. How will I be notified that my submission is complete?

You will be sent an email that your submission packet has been received by PIRB. If there is missing documentation, you will be contacted immediately. Otherwise you should expect your site to be reviewed within 7 business days.

 

Q. What can an IRB review by Expedited Review?

See Federal Register Notice November 9th, 1998. This information can provide you with guidance for determining if your submission meets expedited review criteria.  Appendix D Page 1-8

 

Q. Do you need approval for telephone scripts?

Yes, you need approval on all study related materials.

 

Q. Is Principal IRB accredited? 

Principal IRB is currently seeking IRB accreditation thru AAHRPP Association for the Accreditation of Human Research Protection Programs.

 

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