Principal Investigators/Study Coordinators/Regulatory Coordinators:
Welcome to the Centra IRB Web Page!
To the right of the page are forms necessary for approval from the Centra IRB. Below are brief descriptions of the documents.
The Centra Policy and Procedure Manual is revised annually. There are numerous documents: one is with the IRB manual and the rest of the documents are the Appendices.
The IRB meets monthly (usually the 3rd Tuesday of each month). The deadline for applications are due to the IRB secretary 14 days prior to the next meeting. (Example: Meeting is scheduled for Tuesday, February 19; all applications are due by Tuesday, February 5, 5:00 pm.) If the submission does not make this deadline the application will be placed on the next scheduled meeting (Example: Tuesday, March 19.)
Forms can be emailed to the IRB secretary (firstname.lastname@example.org). Electronic signature are acceptable.
Appendix C Form 1 is for the initial application. This will need to be completed and any pertinent documents should accompany it when submitted. Pertinent documents include the protocol, Investigators Brochure, Informed Consent Form, survey document, etc. The principal investigator and/or study coordinator will need to attend the initial meeting and present the study to the IRB.
Federal Regulations/Centra IRB Policy and Procedures require at least annual renewal/update by the expiration date. Renewal/update/closure forms will be sent to you prior to the scheduled review.
If you are seeking a waiver of jurisdiction to another IRB of record plese see below.
Appendix D Form 2A 2B is for an annual renewal, update or closure of the study. The principal investigator and/or study coordinator may be required to attend the meeting; however, usually a phone number to contact the PI or SC for any questions is sufficient.
Appendix E Form 3 is for any modification to the study.
Appendix F Form 4 is for quarterly/biannual report required by the IRB.
Appendix G Form 5 is a Waiver of Authorization is for need access to and use only the minimum amount of Protected Health Information (PHI) necessary to review eligibility criteria and contact potential subjects complete this form.
Appendix H Form 6 is a Exempt Research Checklist. The ERC is to determine if your research requires submission of a full/initial application to Centra IRB. The IRB Exempt committee will review this application.
Appendix I Form 7 is a HIPAA Authorization. Each participant will need to sign this form if your study will use Protected Health Information (PHI).
All applications include a Conflict of Interest Disclosure Form.
The IRB secretary's email address is email@example.com and the phone number is (434) 200-4513.
We look forward to working with you in your study.
IRB Executive CommitteeDean Gianakos, MD, Chair; Amanda Keith, PharmD, BCPS; Vice Chair; Beth Burgess, IRB Secretary
Waiver of Jurisdiction