An unanticipated problem is any event or information that was unforeseen and indicates that the research procedures caused harm (including physical, psychological, economic, or social harm) to participants or others or indicates that participants or others are at increased risk of harm than was previously known or recognized.
Events that meet the definition of an unanticipated problem
must be reported to COMIRB within
5 days of their occurrence. Click
here for a list of reportable problems.
Events that do not meet the definition of an unanticipated problem may be reported in summary form at continuing review, but need not be reported using the Unanticipated Problem Form. External safety reports and adverse events should be reviewed by the local PI prior to submission to determine whether the event meets the definition of unanticipated problem. For further guidance in reporting external events (events at an non-affiliated institution), refer to the
Safety Report Decision Tree.
Please click the accordion folder below for information on how to submit an Unanticipated Problem Report:
Unanticipated problems are first reviewed by a COMIRB chair. The chair may note the report, require minor modifications, or defer the report to the Full Board for review. The investigator will receive notification of the chair's decision. If the report is deferred to full board the investigator must respond to any questions raised by the chair, and (for paper submissions) submit the appropriate number of submission packets for Full Board review.
1. Complete the Unanticipated Problem Form. The description of the problem must be described in sufficient detail for the reviewer to fully understand the nature of the event, and its relatedness to the study. (Please note that if you plan to submit electroinically, this form is built into the submission process; however, only certain submissions can be made electronically. Please see Step 3 below to find out if you can submit electronically.)
2. Compile supporting documents, including, but not limited to:
- Communication from the sponsor (if applicable)
- IND Safety reports (if applicable)
- Revised Investigator Drug Brochure or Package Insert (if applicable)
- DSMB / DMC / Safety Officer reports (if applicable)
- There is currently no fee for review of unanticipated problems.
3. Submit the materials to COMIRB. Please note that if your protocol was originally submitted for Full Board review, but has since been moved to Expedited review, your ability to submit via ePaper depends upon the Panel you’re originally submitted to (i.e. where your protocol "lives"). Please click here for instructions on how to find out where your protocol "lives": your protocol lives either with the Exempt/Expedited Team or on a Full Board Panel.
Once you have confirmed where your protocol "lives", please click the appropriate Panel title below for submission instructions and the number of submission packets required.
All submissions for Expedited protocols submitted for can be submitted using both paper and ePaper through the eRA(InfoEd) system, if they were originally submitted to COMIRB for Expedited review.
Please note that if your protocol was originally submitted for Full Board review, but has since been moved to Expedited review, your ability to submit via ePaper depends upon the Panel you originally submitted to (i.e. where your protocol "lives"). Please click here for instructions on how to find out where your protocol "lives". If your protocol still "lives" at the Full Board Panel, please close this accordion folder and click the appropriate Panel name from the accordion files below.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
- If you are submitting a paper submission packet, submit one copy of all documents to COMIRB (please submit to the Anschutz Campus unless you are located on the Downtown Campus):
- Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
- Downtown Campus
1380 Lawrence Street Building [LSC], Room 300
Campus Box 120
Denver, CO 80204
Phone: 303-315-2732
All UAP submissions to Panels A or B can only be submitted in paper. They cannot be submitted using ePaper through the eRA(InfoEd) system.
- Please submit one submission packet that includes a copy of each relevant document to:
- Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
All UAP submissions to Full Board Panel C can be submitted using both paper and ePaper through the eRA(InfoEd) system.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
- If you are submitting a paper submission packet, please submit one submission packet that includes a copy of each relevant document to:
- Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
All UAP submissions to Full Board Panel D can be submitted using both paper and ePaper through the eRA(InfoEd) system.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
- If you are submitting a paper submission packet, please submit one submission packet that includes a copy of each relevant document to:
- Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
All UAP submissions to Panel S Full Board can be submitted both in paper and electronically through the eRA(InfoEd) system using ePaper.
- Click here for instructions on how to submit using ePaper through the eRA(InfoEd) system. We strongly suggest that you attend our weekly training course before attempting to
make a submission electronically. Click here to sign up for the course.
- If you are submitting a paper submission packet, please submit one submission packet that includes a copy of each relevant document to:
- Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
- Downtown Campus
1380 Lawrence Street Building [LSC], Room 300
Campus Box 120
Denver, CO 80204
Phone: 303-315-2732
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