Incident Involving Potential Risk to Research Subjects Or Others

COMMUNITY MEDICAL CENTERS

INCIDENT INVOLVING POTENTIAL RISK TO RESEARCH SUBJECTS OR OTHERS

REPORTING FORM

Note: Form must be submitted to the IRB Office at within 10 calendar days.

Study Title:
IRB Approval #: / Date Form
Completed:
Person Completing Form: / Subject ID #:
Principal Investigator: / Date of Protocol
Violation or Incident:

Check all that apply:

Type of Incident:

[ ] Enrollment of ineligible subject

[ ] Eligibility criteria exception approved by the Sponsor post-enrollment

[ ] Screening procedure/lab work required by protocol not done

[ ] Screening or on-study procedure/lab work done outside the protocol required

time frame

[ ] On-study procedure required by protocol not completed

[ ] Failure to follow approved protocol/study procedures

[ ] Implementation of a study procedure not approved by the IRB

[ ] Implementation of unapproved recruitment procedure

[ ] Incorrect research treatment or intervention given to subject

[ ] Failure to follow data and safety monitoring plan

[ ] Use of unapproved, expired, or incorrect version of consent form

[ ] Failure to report serious unanticipated problems involving risk to subjects or others

[ ] Failure to obtain informed consent prior to initiation of study procedures (if not waived by IRB)

[ ] Insufficient documentation of informed consent including signatures of subject (or legally

authorized representative), investigator and/or person obtaining consent

[ ] Breach of confidentiality

[ ] Research-related concern or complaint received

[ ] Unanticipated problem involving risks to subjects or others

[ ] Other:

Please provide explanation for each event in the Narrative section below. Attach supporting documents if applicable.

Narrative (all narratives must include brief responses to the following five questions):
1. How did the incident happen?
2. What are the consequences of the event (if any).
3. What was done in response to the violation or incident occurring?
4. What measure(s) have been taken to assure that the violation or incident does not happen again?
5. Has the violation or incident been resolved? Please explain:
Is a study protocol or informed consent document modification needed? [ ] Yes [ ] No
If yes, please attach modification:

Consequence/Action Taken (may check more than one response):

[ ] Study treatment/interventionhas been permanently stopped

[ ] Study treatment/interventionhas been temporarily stopped

[ ] Approved study data analysis plan modified

[ ] Sponsor or cooperative group Study Chair notified (whichever is applicable)

date:

[ ] Other regulatory agency notified. Specify:

[ ] Other:

Other comments (optional):

I certify that the information provided above is an accurate description of the event.

Principal Investigator:

Printed name Signature/Date

Version date 01Sep2016