NUMBER / DATE / AUTHOR / APPROVED BY / PAGE
HRP-020 / 10/18/2011 / C. Pettengill / K. Blank / 1 of 2
1 PURPOSE
1.1 This procedure establishes the process to triage information submitted to the IRB.
1.2 The process begins when any communication is received by the IRB.
1.3 The process ends when an IRB staff member determines the appropriate action for the received information.
2 REVISIONS FROM PREVIOUS VERSION
2.1 None.
3 POLICY
3.1 Contact information is maintained in the InfoEd System.
3.2 Protocol history is maintained in the InfoEd System.
3.3 The list of protocols is maintained in the InfoEd System.
3.4 Receipt deadlines are maintained in the InfoEd System.
4 RESPONSIBILITIES
4.1 IRB staff members carry out these procedures.
5 PROCEDURE
5.1 Date stamp information received by mail.
5.2 Print information received by email.
5.3 If the submission includes new or modified contact information, create contact information or update the contact information.
5.4 If the information represents a request to withdraw from consideration a new protocol or modifications to an approved protocol with a status of “Submitted” or “Modifications Required to Secure Approval”
5.4.1 Add an entry to the protocol history.
5.4.2 If the status was “Modifications Required to Secure Approval,” update the item’s receipt deadline as received.
5.5 If the information represents a request for an approval or determination (approval of new research, continuing review of research, modification to previously approved research, request for study closure, or a determination whether an activity is exempt Human Research or is not Human Research):
5.5.1 If the submission is a new protocol, make a new entry in the list of protocols.
5.5.2 If the submission is a new protocol in follow-up to an emergency use of a test article in a life-threatening situation, update the item’s receipt deadline as received.
5.5.3 Add an entry to the protocol history to indicate the current status of the protocol.
5.5.4 Follow “SOP: Pre-Review.”
5.6 If the information represents a response to modifications required to secure approval:
5.6.1 Update the item’s receipt deadline as received.
5.6.2 If the submission includes a new or modified contact, make a new entry in the contact information.
5.6.3 If the item is a new protocol in follow-up to an emergency use of a test article in a life-threatening situation, update the item’s receipt deadlines as received.
5.6.4 Add an entry to the protocol history to indicate the current status of the protocol.
5.6.5 Follow “SOP: Modifications Required to Secure Approval.”
5.7 If the information represents a prior notification of an emergency use of a test article in a life-threatening situation:
5.7.1 Add an entry to the protocol history.
5.7.2 Have a Designated Reviewer follow “SOP: Emergency Use of a Test Article Review.”
5.8 If the information represents a five-day notification after an emergency use of a test article in a life-threatening situation:
5.8.1 Add an entry to the protocol history.
5.8.2 Check for the item in the receipt deadlines and if present, update the item’s receipt deadline as received.
5.8.3 Have a Designated Reviewer follow “SOP: Emergency Use of a Test Article Review.”
5.9 If the information represents a notification of completion of required training, update the item’s receipt deadline as received.
5.10 If the information represents an investigator’s request to continue subjects in expired research:
5.10.1 Add an entry to the protocol history.
5.10.2 Have a Designated Reviewer follow “SOP: Expiration of IRB Approval.”
5.11 If the information represents an item that does not fit into the above categories:
5.11.1 Add an entry to the protocol history.
5.11.2 If the information represents a question, concern, or complaint:
5.11.2.1 Document the nature of the question, concern, or complaint and the contact information of the person contacting the IRB.
5.11.2.2 Answer any questions that are basic or general in nature. For more complicated questions, tell the person that you will call/email him/her once you have been able to find additional information. If necessary, consult with the Associate Director or Director, Human Research Administration to identify the best course of action for the question, concern, or complaint.
5.11.3 Follow “SOP: New Information.”
5.12 Upon completion follow “SOP: IRB Records.”
6 MATERIALS
6.1 InfoEd System
6.2 InfoEd System.
6.3 InfoEd System
6.4 InfoEd System
6.5 SOP: Emergency Use of a Test Article Review
6.6 SOP: Expiration of IRB Approval
6.7 SOP: IRB Records
6.8 SOP: Modifications Required to Secure Approval
6.9 SOP: New Information
6.10 SOP: Pre-Review
7 REFERENCES
7.1 None