Download COMIRB Safety Report Policy - University of Colorado Denver

UNIVERSITY OF COLORADO DENVER
Colorado Multiple Institutional Review Board
FWA: 00005070
13001 E. 17th Place, Suite N3214
Campus Box F490
Aurora, CO 80045
Office: 303-724-1055
Fax: 303-724-0990
Management of Safety Reports – COMIRB studies only
I. SCOPE
This SOP applies to all protocols reviewed and approved by COMIRB.
II. PURPOSE
The purpose of this SOP is to outline the process for review, submission, and retention of all
IND safety reports received by the PI of a currently approved study.
III. BACKGROUND
All IND safety reports received by the PI must be reviewed, submitted and retained in a
regulatory compliant and consistent format. This policy was written in order to facilitate this
process.
IV. ACCOUNTABILITY
A. The PI is responsible for:
1. Reviewing all safety reports received and determining if the event occurred on a
study that is also being conducted at UCD or an affiliate.
2. Submitting and retaining all SRs received according to policy, as outlined in section
VI of this policy
B. The Principle Investigator has the responsibility for reviewing all safety reports that
involve an unanticipated event occurring on a study also being conducted at UCD or an
affiliate for which he/she is the PI.
V. DEFINITIONS
A. Acronyms
PI – Principle Investigator
N/A – Not Applicable
SOP – Standard Operating Procedure
SR – Safety Report
MFR# - Manufacturer Number
COMIRB – Colorado Multiple Institutional Review Board
Revised 4-20-2010
Downtown Campus
Denver, Colorado
Anschutz Medical Campus
Aurora, Colorado
UCD AMC – University of Colorado Denver Anschutz Medical Campus
UCD – University of Colorado Denver
UCH – University of Colorado Hospital
VAMC – Veteran’s Affairs Medical Center
DHMC – Denver Health Medical Center
CPC – Colorado Prevention Center
IB or IDB – Investigator’s Brochure or Investigational Drug Brochure
IND – Investigational New Drug
B. Definitions
1. Unanticipated Problem Involving Risks to Participants or Others
(Unanticipated Problem): 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.
2. Adverse Event: Any unfavorable and unintended sign (including abnormal
laboratory finding), symptom, or disease temporally associated with the use of a
medical treatment or procedure, regardless of whether it is considered related to the
medical treatment or procedure (attribution of unrelated, unlikely, possible, probable
or definite).
3. Unanticipated event: Any adverse experience where the nature, severity or
frequency is not identified in the investigational brochure, described in the
application form or detailed in the consent form.
4. Possibly related: In the opinion of the PI, the adverse event is unlikely to be
related to the study intervention, drug or device.
5. Probably related: In the opinion of the PI, there is a reasonable probability that
the adverse event is related to the study intervention, drug or device.
6. Related to the research: An event is “related to the research procedures” if in the
opinion of the principal investigator, it was more likely than not [probably] to be
caused by the research procedures or if it is more likely that not [probably] that the
event affects the rights and welfare of current participants.
7. Internal event / problem: An occurrence involving research subjects enrolled in a
project approved by COMIRB and directed by a principal investigator employed by
the University of Colorado at Denver Anschutz Medical Campus (or affiliate site) or
one whose project is under the purview of the COMIRB).
8. External event / problem: An occurrence involving research subjects enrolled in
multi-center research projects that do not fall under the purview of the COMIRB (i.e.
sites other than UCD, UCH, VAMC, DHMC, CPC).
9. Prompt Reporting: Reportable events must be submitted to COMIRB within 5
working days of the event or knowledge of the event.
VI. POLICY
This policy will be used by all Principal Investigators and their research team when reviewing,
submitting, and retaining SRs received by UCD or affiliate PI. Note: All SRs do not need to be
reported within 5 days even if it involves a death. Reporting is based on section VII and the
appendixed flow diagram.
VII. PROCEDURES
A. IND SR (for a drug or device) is received by the PI.
1. PI or research team receive SR via direct mail from sponsor or coordinating site.
B. PI or research team review SR and determine if the report relates to the approved study
at UCD or affiliate.
1. Is UCD or affiliate is an external participating site? YES, then:
a. Is the event unrelated to the study treatment?
i. Yes. The report is filed in a protocol or drug specific binder and kept by the
PI.
(i) An updated IB is submitted to COMIRB upon receipt
b. Is the event expected or unexpected and possibly related to the study treatment?
i. Yes. These reports are evaluated for increased frequency and/or severity
(i.e. trends) by:
(i) Investigator’s Brochure
(ii) DSMB or safety officer
(iii) PI or research team
ii. Are there increased frequency and/or severity concerns?
(i) Submit aggregate data report (from DSMB, IB) to COMIRB once available.
c. Is the event unexpected and probably/definitely related to the study treatment?
i. Yes. The report is submitted to COMIRB within 5 days of research team’s
first knowledge of the report as an unanticipated problem.
(i) If the investigation involved a drug: relationship to event can be based on
sponsor’s documentation
(ii) If the investigation involved a device: the PI or research team must
determine relatedness/expectedness
2. Is UCD or affiliate an external participating site? NO, then:
a. The report is reviewed by the PI or research team to determine if this is
significant new information. Yes, then:
b. The report is submitted to COMIRB within 5 days of research team’s first
knowledge of the report as an unanticipated problem
c. The report is filed in a protocol or drug specific binder
d. All revised IBs will be submitted to COMIRB
VIII.
APPROVAL
This section contains the signatures of the staff approving the SOP.
Alison Lakin
Date: 03.01.10
Director, COMIRB