FAQ’s
Q. How often does your IRB meet?
Our IRB meets 4 times a week (Monday, Tuesday, Wednesday, and Friday) except when conflicted with holidays. Click here for our current meeting calendar.
Q. Has your IRB ever been audited by the FDA, OHRP, or any other government agency?
Chesapeake IRB has been audited by the FDA four times: 1998, 2000, 2004, and 2009. There were no significant findings in any of the audits and no FDA 483s were issued.
Q. What type of research and therapeutic areas can your IRB review?
Our IRB oversight has included all phases of clinical research including Phase I-IV IND studies, IDE studies, NIH/Federally funded research, social science and behavioral studies, registry studies, retrospective chart reviews, and investigator initiated studies.
Q. Is your IRB Accredited?
Yes. Chesapeake IRB is the only independent IRB to receive full accreditation simultaneously from both the Association for the Accreditation of Human Research Protections Programs (AAHRPP) and Partnerships for Human Research Protections (PHRP). (As of today, only AAHRPP exists). CRRI also received Full Re-accreditation in 2010 without any delays.. This “seal” of commitment to excellence accrues to the subjects participating in research and to our clients for whom we serve as a risk management partner.
Q. Are there deadlines for submissions?
There are no deadlines for submissions.
Q. What is the review timeline for submission of a new protocol?
Once your submission is complete, IRB review will occur within 5 business days. You will receive the IRB’s determination within 1-2 business days.
Q. What is the review timeline for submission of an additional investigator for a previously approved protocol?
An investigator’s submission is reviewed within 24 hours upon receipt of a complete submission. One to two days after review, you can expect the outcome of the review.
Q. Does Chesapeake IRB require qualifications of sub-investigators and personnel involved in the informed consent process plus the respective 1572 to be submitted?
No. Chesapeake only requires information on the principal investigator of the study and does not need 1572 information.
Q. What documents are needed for initial site submissions?
A site application needs to be completed through our 21 CFR Part 11 Compliant CIRBI website at www.cirbi.net. In the application, there will be areas where you can upload attachments, including the CV of the principal investigator and any FDA findings within the past 5 years which are required as part of the submission. There are other places where you can upload SOPs, site specific informed consent form language, and any other supporting document that may aid in the IRB’s review.
Q. What are the costs associated with IRB review?
Q. How are investigators, CROs, and Sponsors informed of approvals or requests by the IRB?
Any time approval information is posted or there are additional requests from the IRB, you will be prompted by email notifications sent from our CIRBI website.
Q. Will the IRB provide hardcopies of documents?
No. All IRB documentation is electronically available through our 21 CRF Part 11 compliant CIRBI website at www.cirbi.net
Q. Is Chesapeake IRB registered with the Office of Human Research Protections and FDA?
Yes. Chesapeake’s registration number is 00000790.
Q. How do I submit information to Chesapeake IRB?
Chesapeake IRB is a paperless IRB. All submissions, from the beginning of the study to the termination of a study, need to occur through our 21 CFR Part 11 compliant CIRBI website at www.cirbi.net
Q. Do I have a point of contact for my study?
Yes. Chesapeake IRB has a dedicated Project Coordinator assigned to all your studies to ensure that any questions you have are rapidly addressed.
Q. I have questions about your online submission management system, CIRBI?
