[Insert Hospital Name]
[Insert
Hospital
Logo]
Clinical Safety
Policies and Procedures
Title:
SERIOUS ADVERSE EVENTS
INVOLVING RESEARCH
STUDY PATIENTS
I.
No.
Page:
Origination Date:
Effective Date:
Retires Policy Dated:
Previous Versions Dated:
Hospital Governing Board
Approval Date:
CQ-2.030
1 of 6
07-01-11
xx-xx-xx
xx-xx-xx
xx-xx-xx
xx-xx-xx
SCOPE:
This policy applies to _________________________________ [insert hospital name] (“Hospital”).
II.
PURPOSE:
The purposes of this policy are to (a) clarify and delineate the responsibilities of Principal
Investigators with respect to reportable events involving research study patients; (b) provide a
system for promptly reporting and investigating serious and/or unexpected adverse events
involving research study patients; (c) comply with the requirements of the institutional review
board and applicable federal and state law and the standards of applicable accrediting
organization as they relate to reporting of adverse events involving research study patients, and
(d) describe the procedure surrounding alerting key personnel of a serious adverse event.
III.
DEFINITIONS:
A.
“Serious Adverse Event (SAE)” means any adverse experience of a patient
participating in a research study that results in any of the following outcomes:
death, a life-threatening experience, inpatient hospitalization or prolongation of
existing hospitalization, a persistent or significant disability/incapacity, or a
congenital anomaly/birth defect. Important medical events that may not result in
death, be life-threatening or require hospitalization may be considered a serious
adverse event when, based upon appropriate medical judgment, they may
jeopardize the patient or subject and may require medical or surgical intervention
to prevent one of the outcomes listed in this definition.
B.
“Unexpected” means an adverse drug or device experience that has not been
previously observed.
C.
“Unexpected Adverse Event ” is any adverse experience associated with the
study drug or study device in which there is a reasonable possibility that the
experience may have been caused by the study drug/device for which the nature
or severity of is not consistent with the current investigator brochure.
Additionally, an event is characterized as an Unexpected Adverse Event if an
investigator brochure is not required or available and there is the possibility that
the nature or severity of the experience is not consistent with the risk information
described in the general investigational plan or elsewhere in the current
application.
[Insert Hospital Name]
[Insert
Hospital
Logo]
Clinical Safety
Policies and Procedures
Title:
SERIOUS ADVERSE EVENTS
INVOLVING RESEARCH
STUDY PATIENTS
IV.
No.
Page:
Origination Date:
Effective Date:
Retires Policy Dated:
Previous Versions Dated:
Hospital Governing Board
Approval Date:
CQ-2.030
2 of 6
07-01-11
xx-xx-xx
xx-xx-xx
xx-xx-xx
xx-xx-xx
POLICY:
Principal Investigators are responsible for reporting SAEs to all relevant parties as required by
law/regulation/accreditation and for providing updated information to those same groups. The
Hospital will process SAEs affecting its patients through its reporting, investigation and analysis
processes.
V.
PROCEDURE:
A.
Reporting
1.
In research studies, the Principal Investigator (PI) is responsible for
reporting SAEs, including completing all required SAE forms. The form
can be a sponsor designated form to use for SAEs or the FDA Med Watch
form. The PI is responsible for contacting the Hospital for copies of all
pertinent records needed to complete the SAE forms. SAEs must be
reported to the study sponsor, the Hospital’s designated Institutional
Review Board and the Hospital’s Risk Manager or Patient Safety Officer
within 48 hours of knowledge of the event.
2.
If a research patient experiences an SAE that results in a patient
hospitalization or an SAE that occurs during a Hospital encounter the PI
must complete an initial SAE report form as well as a final SAE report
which contains all treatment given for that event through resolution of the
event. If the event is not resolved at discharge, the PI will be responsible
to timely complete another SAE (Med Watch) form that will detail when
the event has resolved and address the causality of the event if not
indicated in the initial SAE form. These reports must be submitted to the
study sponsor, the Hospital’s designated Institutional Review Board, and
the Hospital’s Risk Manager or Patient Safety Officer.
3.
The Risk Manager or Patient Safety Officer shall follow the CQ-2.008
Event Reporting Policy, CQ-2.010 Sentinel Event Response and Reporting
Policy and CQ-4.007 Conducting a Root Cause Analysis Policy for proper
reporting and investigation of adverse human subject outcomes, including
notifying Tenet Corporate Patient Safety and Clinical Risk Management.
The Risk Manager or Patient Safety Officer also shall ensure the patient is
identified as a research patient in all relevant systems, including PBAR
and eSRM.
[Insert Hospital Name]
[Insert
Hospital
Logo]
Clinical Safety
Policies and Procedures
Title:
SERIOUS ADVERSE EVENTS
INVOLVING RESEARCH
STUDY PATIENTS
4.
B.
No.
Page:
Origination Date:
Effective Date:
Retires Policy Dated:
Previous Versions Dated:
Hospital Governing Board
Approval Date:
CQ-2.030
3 of 6
07-01-11
xx-xx-xx
xx-xx-xx
xx-xx-xx
xx-xx-xx
a.
The patient’s PBAR account shall be flagged as a research account.
The patient consent and the contract will determine who is
responsible for payment of the medical treatment provided as a
result of injury incurred due to participation in the clinical study.
The PBAR Patient Inquiry function will display the appropriate
research flags on the first screen after keying the account number.
Report any necessary updates to the Hospital’s Director of Patient
Access.
b.
Check “yes” to the question in e eSRM “is this a clinical research
patient” and notify Tenet Patient Safety and Clinical Risk
Management.
Tenet Patient Safety and Clinical Risk Management shall alert the Clinical
Research Review Committee of the event. The SAE occurrence shall be
added as a discussion item at the next scheduled Clinical Research Review
Committee meeting if the SAE has an attribution of possibly, probably, or
definitely related to the study drug or study device and resulted in the
death of a patient at a Tenet facility.
Auditing and Monitoring
Tenet’s Quality Management Department will audit adherence to this policy
during the Comprehensive Clinical Audits. Tenet’s Audit Services Department
also will audit adherence to this policy.
C.
Responsible Persons
The Risk Manager and Patient Safety Officer are responsible for ensuring that all
individuals adhere to the requirements of this policy. If the Risk Manager and
Patient Safety Officer are unable to create adherence to this policy, they shall
immediately report the non-adherence to this policy to the Hospital Compliance
Officer.
D.
Enforcement
All employees whose responsibilities are affected by this policy are expected to
be familiar with the basic procedures and responsibilities created by this policy.
Failure to comply with this policy will be subject to appropriate performance
improvement pursuant to all applicable policies and procedures, up to and
including termination. Such performance improvement may also include
[Insert Hospital Name]
[Insert
Hospital
Logo]
Clinical Safety
Policies and Procedures
Title:
SERIOUS ADVERSE EVENTS
INVOLVING RESEARCH
STUDY PATIENTS
No.
Page:
Origination Date:
Effective Date:
Retires Policy Dated:
Previous Versions Dated:
Hospital Governing Board
Approval Date:
CQ-2.030
4 of 6
07-01-11
xx-xx-xx
xx-xx-xx
xx-xx-xx
xx-xx-xx
modification of compensation, including any merit or discretionary compensation
awards, as allowed by applicable law.
VI.
REFERENCES:
- CQ-2.008 Event Reporting Policy
- CQ-2.010 Sentinel Event Response and Reporting Policy
- CQ-4.007 Conducting a Root Cause Analysis Policy
- Clinical Research Policy Manual
- Office for Human Research Protections Guidance on Reviewing and Reporting Unanticipated
Problems Involving Risks to Subjects or Others and Adverse Events
July 18, 2011
To:
Distribution List
From:
Kelvin A. Baggett, MD
Chief Medical Officer
Subject:
Policies Related to Clinical Research Program
Today we are publishing two model policies related to our clinical research program, CR-2.00
Facility Research Committee and CQ-2.030 Serious Adverse Events Involving Research Study
Patients. Tenet’s Management Quality, Compliance and Ethics Committee has approved the both
policies with the expectation that they be sent to the appropriate hospital committees and
departments for approval and adoption. To access the policies on the Monitor page of eTenet,
click here (eTenet login required).
Please click here (eTenet login required) for a brief video from Laura Rice, Director of Clinical
Research, explaining why the policies are important and how they support our mission of quality.
Purpose
The primary purposes of both policies are to ensure we have the proper information flow and
responsiveness when participating in clinical research activities. CR-2.00 Facility Research
Committee sets out the expectations for how each facility will review each proposed study. Each
facility must have a multidisciplinary Facility Research Committee to review all proposed
studies. The Facility Research Committee structure ensures each study is evaluated for
operational and financial impact in all affected areas. CQ-2.030 Serious Adverse Events
Involving Research Study Patients describes the reporting responsibilities and requirements
when study patients experience unexpected or unfavorable events. Principal Investigators are
responsible for reporting all serious adverse events to the study sponsor, Institutional Review
Board and the Facility’s Risk Manager. The Risk Manager is responsible for ensuring the events
are reviewed according to the standard processes outlined in CQ-2.008 Event Reporting Policy,
CQ-2.010 Sentinel Event Response and Reporting Policy and CQ-4.007 Conducting a Root
Cause Analysis Policy.
Click here to access the policy redline for CR-2.00 Facility Research Committee through
eTenet’s Policy Central (eTenet login required).
Responsible Person
The individual directly responsible for the implementation of the revisions to CR-2.00 Facility
Research Committee is the Hospital’s Clinical Research Coordinator. The individual directly
responsible for the implementation of CQ-2.030 Serious Adverse Events Involving Research
POLICY FLASH: Policies Related to Clinical Research Program
July 18, 2011
Page 2 of 2
Study Patients is the Hospital’s Risk Manager. The Hospital A-Team will support both positions
in implementing and complying with these policies.
Hospital Action on the Policy
Your Hospital Compliance Officer will include these policies on the agenda for the next Hospital
Compliance Committee meeting. At that time, the Research Coordinator and Risk Manager
should be prepared to present their policies and the Hospital’s implementation plan as well as
discuss the Hospital’s plan for monitoring adherence to the policies following implementation
and thereafter. Implementation of these policies should take place within 60 days of the date of
this memo.
Whenever possible, adoption of these model policies in their entirety is preferred; however, we
recognize that hospitals may have existing policies that address this subject. If this is the case,
compare the policies and modify your existing policies to include all components of these
models. Any additions or modifications to the model policies must be approved by Laura Rice,
Director, Clinical Research and Sarah Campbell, Director, Policies and Procedures Management,
as required by Regulatory Compliance Policy COMP-RCC 4.47 Clinical Research Review
Committee and Associated Compliance Requirements.
Also, because CQ-2.030 Serious Adverse Events Involving Research Study Patients is
considered a patient safety policy, it should be sent to Governing Board for approval and
adoption.
Please contact Laura Rice with any questions. Her telephone number is 469.893.6760 and her
email address is laura.rice@tenethealth.com.
Training
No additional training is required for these policies.
Auditing
Tenet’s Quality Management Department will audit adherence to the CQ-2.030 Serious Adverse
Events Involving Research Study Patients policy during the Comprehensive Clinical Audits.
Tenet’s Audit Services Department will audit adherence to both policies.
Thank you for your compliance with these important policies.
Email Distribution:
Hospital A-Teams
Clinical Research Coordinators
Risk Managers
Directors of Clinical Quality Improvement
Directors of Health Information Management
Hospital Chief Medical Officers
Regional Leadership
Email ccs:
Management Quality, Compliance and Ethics Committee
Senior Compliance Staff
Clinical Quality Department
Regional Counsel
Regulatory Counsel
Regional HIM Directors
Audit Services