A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
Phase: PHASE4
Conditions: Pain, Acute
Sponsor: University of California, San Francisco

 
 
Study Title: 
 
ID: 15-18354 
    Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion 
for Epidural Analgesia in Abdominal Surgery. 
 
 
NCT Number: NCT03307174 
 
Document Approval Date: 7.30.2018 
 

Study Application (Version 1.12)
1.0
General Information
*Enter the full title of your study:
A prospective, randomized analysis of epidural anesthesia using programmed intermittent 
epidural boluses versus continuous epidural infusion in patients undergoing abdominal surgery.
 
 
*Enter the study number or study alias
PCEA with PIEB versus CEI 
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add Department(s)
2.1 List the departments associated with this study. The Principal Investigator's department 
should be Primary.:
Primary 
Dept?
Department Name
UCSF - 
 - Colorectal Surg. MB
742524
UCSF - 
 - M_Anesthesia
127037
UCSF - 
 - CANCER CENTER GYN ONCOLOGY
707137
UCSF - 
 - CANCER CENTER URO SURGERY
707131
UCSF - 
 - CANCER CTR GI SURGICAL ONCOLGY
707143
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Behrends, Matthias, MD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Aleshi, Pedram 
 Other Investigator
Chen, Lee-Lynn 
N

 Other Investigator
Haight, Matthew J 
 Other Investigator
Latronica, Mark 
 Other Investigator
Naidu, Ramana K 
 Co-Principal Investigator
Sarin, Ankit, MD, MHA 
 Other Investigator
Siegmueller, Claas 
 Other Investigator
Su, Po-Yi Paul 
 Co-Principal Investigator
B) Research Support Staff
Clelland, Elle N 
 Study Coordinator
Delgado, Adrian C 
 Study Coordinator
Ladd, Michael J 
 Study Coordinator
3.3 *Please add a Study Contact:
 
Su, Po-Yi Paul 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s):
 
Gropper, Michael Allan, MD, PhD 
Department Chair
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions - Updated 2015
(Note: You must answer every question on this page to proceed.)
4.1  
: 
* PROJECT SUMMARY
 
(REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
  
Abstract, paste it here:  Click on the orange question mark to the right for more detailed instructions.
Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor 
epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia  can 
improve pain control thus reducing the amount of local anesthetic required as well as improve patient 

satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus 
of epidurals compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our 
goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a 
surgical patient population. We plan to enroll patients already undergoing surgery under the enhanced 
recovery after surgery (ERAS) pathways. ERAS pathway surgeries include colorectal, gynecologic, surgical 
oncology to name a few. The primary endpoints of the study will be the total local anesthetic consumption 
and total opioid consumption as surragate markers for the quality of epidural anesthesia.  Secondary 
endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension .
4.2  
: 
* HUD DEVICE (REQUIRED) Does this application involve a 
 (HUD):
Humanitarian Use Device
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  
: (Click the Help link for definitions and guidance): 
* TYPE OF RESEARCH
 
(REQUIRED)
Biomedical research 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is mainly social
/behavioral but also involves specimen collection or blood draws to look at biological measures) 
4.4  
 
* SUBJECT CONTACT:
 
(REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
Does your protocol involve any radiation exposure to patients/subjects 
* RADIATION EXPOSURE: 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-guided biopsy, 
EITHER
standard care
 
OR
research
radiation therapy, or nuclear medicine including PET, MUGA or bone scans): (REQUIRED)
  Yes   
  No
4.6  
 
* RISK LEVEL: 
 
(REQUIRED) What is your estimation of the risk level, including all screening 
procedures and study activities 
:
(Help Text updated 9/13)
Minimal risk 
Greater than minimal risk 
4.7  * REVIEW LEVEL: 
 
(REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.11  
 
* CLINICAL TRIAL:
 
(REQUIRED) Is this a clinical trial? According to The World Health Organization 
 
(WHO) and the International Committee of Medical Journal Editors (ICMJE) a 
is:
 
clinical trial
Any research study that prospectively assigns human participants or groups of humans to one 
or more health-related interventions to evaluate the effects on health outcomes.
ICMJE requires 
 of a clinical trial in a public database (such as ClinicalTrials.gov) prior to 
registration
 
enrollment, for eventual publication of results in member biomedical journals.
Public Law 
Guidance: 

110-85 requires that all investigators who perform an 
 must ensure that the 
applicable clinical trial
  
trial is registered on a government web site called 
.
ClinicalTrials.gov  The FDA requires registration 
for “applicable clinical trials,” defined as follows:
For any trials of drugs and biologics: controlled clinical investigations, other than Phase 1 
investigations, of a product subject to FDA regulation.
For trials of biomedical devices: controlled trials with health outcomes of devices subject to 
FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.
For additional information on the 
 registration process at UCSF and the definition of 
ClinicalTrials.gov
a clinical trial for purposes of registration, visit the ClinicalTrials.gov section of the UCSF Clinical 
Research Resource HUB.
 Yes   
 No
Clinical Trial Registration
"NCT" number for this trial:
Pending
If you don't yet have the NCT#, type 'Pending.' 
4.12  
 
* CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
4.13  
: 
* INVESTIGATOR-INITIATED
 
(REQUIRED) Is this an investigator-initiated study:
 Yes   
 No
4.14  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR approval 
for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
4.15  
 
* STEM CELLS: (REQUIRED) Does this study involve 
(including iPS cells and adult 
human stem cells 
stem cells), gametes or embryos:
No 
Yes, and requires CHR and GESCR review 
Yes, and requires GESCR review, but NOT CHR review 
4.16  
 
 
* FINANCIAL INTERESTS: (REQUIRED) Does the Principal Investigator and/or one or more of the 
 
key study personnel have 
 related to this study:
financial interests
  Yes   
  No

5.0
 Funding
5.1  
FEDERAL FUNDING: 
* 
(REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
  Yes   
  No
5.2  
Is this project linked in any way to the Department of Defense (DoD): 
* DoD INVOLVEMENT: 
(REQUIRED)
  Yes   
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
NOTE: It is no longer necessary to add the A or the P Number. iRIS now 
allows you to link the proposal to the study (see below)!
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution
Contract 
Type:
UCSF RAS 
"P 
number" 
or 
eProposal 
number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
No Sponsor has been added to this IRB Study
If the funding is coming through UCSF and you don't know the A 
or P number,  you can search the eProposal side for the contract 
or grant (this does NOT replace adding the sponsor by name 
above):
Project Status
Proposal Number
Project Title
Principal 
Investigator
No Projects are Linked to this IRB Study
Other Funding Sources and Unfunded Research - Gift, 
Program, or Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES

UCSF (including Laurel Heights and all the other sites outside the main hospitals)
Parnassus
Mission Bay
China Basin
Mount Zion
Helen Diller Family Comprehensive Cancer Center
Langley Porter Psychiatric Institute
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno Community Medical Center
Gallo
Gladstone
Jewish Home
Institute on Aging (IOA)
SF Dept of Public Health (DPH)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
UCSF Bakar Cancer Hospital
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes   
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 
 units or utilize 
:
Services (CRS)
CRS services
  Yes   
  No
6.6  * MULTI-CENTER TRIAL:
 
 (REQUIRED) Is this a multicenter research trial? By multi-center trial, we 
mean a study where the protocol is developed by an industry sponsor, consortium, a disease-group, 
etc., who then selects sites across the nation or in different countries to participate in the trial. The 
local sites do not have any control over the design of the protocol. 
  Yes   
  No
6.7  
Check all the other types of sites not affiliated with UCSF with which you are 
OTHER SITE TYPES: 
cooperating or collaborating on this project:   Do NOT check any boxes below if this is a 
multi-center clinical trial, UCSF is just one of the sites, and neither UCSF nor its 
affiliates are the coordinating center.

Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.10  
Does this application include a request to rely on an a central IRB 
* RELYING ON AN EXTERNAL IRB: 
(other than the NCI CIRB) or an external IRB (UC, commercial, or institutional): 
 
(REQUIRED)
  Yes   
  No
7.0
 Research Plan and Procedures
7.1  This new consolidated section requests information about:
Hypothesis
Aims
Study Design
Background and Significance
Preliminary Studies
Procedures
Statistical Methods
References
Later sections include:
Drugs and Devices
Sample Size, Eligibility, and Subjects
Recruitment and Consent
Risks and Benefits
Data and Safety Monitoring Plan
Confidentiality, Privacy and Security
Financial Considerations
Qualifications of Personnel
Other Approval and Registrations
7.2  
Describe the hypothesis or what the study hopes to prove 
:
HYPOTHESIS: 
(Help Text updated 9/13)
Null hypothesis: There is no difference in total local anesthetic and opioids required when comparing 
patients receiving epidural anesthesia using either programmed intermittent epidural boluses or continuous 
epidural infusions following abdominal surgery.
7.3  
List the specific aims:
AIMS: 
The aim of this study is to prove the superior efficacy of programmed intermittent bolus administration of 
epidural medications compared to traditional continuous infusions in providing adequate post-operative 
analgesia and patient satisfaction in a surgical patient population.
7.4  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
This is a prospective, randomized controlled study of programmed intermittent bolus administration of 
local anesthetic in epidural anesthesia compared to traditional continuous infusions for patients 
undergoing surgery as part of the enhanced recovery after surgery pathway.

 
As part of the UCSF Enhanced Recovery After Surgery (ERAS) pathway, all patients  routinely treated with 
thoracic/lumbar epidural anesthesia for post-operative analgesia. The planned investigation does not 
change is approach, but compares solely two different modalities how epidural medications are 
administered. The study ends when the catheters are removed which is most often on  post-operative day 
two, but can be later in case the patient may still benefit from epidural anesthesia.
During the duration of the treatment with epidural anesthesia, enrolled patients will be randomized to 
receive either programmed intermittent bolus or continuous epidural administration of the local 
anesthetic ropivacaine (0.0625%) with fentanyl (2ug/ml). In addition to this maintenance administration 
of local anesthetic, the patient are also also able to apply additional (demand) boluses of epidural 
medication by pressing a button. This technique, called patient- controlled epidural anesthesia (PCEA), is 
routinely used in all patients with epidural catheters and allows patients to receive additional medication in 
the event they experience discomfort. If the patients have still pain not covered by epidural anesthesia, 
they have access to additional RN-administered opioid pain medication. The normally used drugs for such 
treatment are oxycodone p.o. and hydromorphone i.v. However, other opioids could be used in this 
context and all opioid use would be quantified using a  conversion to oral morphine equivalents. The 
primary outcomes of the study will be the total amount of local anesthetic administered and opioid 
requirements (oral morphine equivalents). Secondary outcomes arede: numeric pain rating scores (should 
not be different as patients have access to additional analgesic medication), number of patient attempts to 
trigger additional PCEA boluses, overall patient satisfaction assessed through validated questionnaires, and 
incidence of hypotension.
7.5  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):
If this is a first in humans study, please summarize the safety data from the 
animal studies. For pediatric drug or device studies, please identify if this is the 
first study in pediatric populations.  
Programmed intermittent bolusing of epidurals have been shown in the labor analgesia setting to have 
significantly decreased in total local anesthetic consumption as well as significantly higher overall patient 
satisfaction scores as compared to traditional continuous infusions. Whether these observations apply to 
post-surgical analgesia settings and post-surgical populations have yet to be elucidated.  Addressing the 
aforementioned question is of clinical importance as this may represent an avenue for the improvement of 
post-surgical analgesia that is not dependent on the use of opioid based approaches.  The planned 
investigation would be the first study to investigate the use of programmed intermittent bolusing of 
epidurals in surgical patient populations and in surgical 
analgesia.                                                                                                                                           
                                           
7.6  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
Prior studies in the use of programmed intermittent epidural bolusing has been in the labor anesthesia 
literature.  Wong et al (2006) showed in a randomized controlled trial that there was significantly less local 
anesthesia consumption, less requirement for manual rescue bolus, and higher satisfaction scores in the 
programmed intermittent epidural bolus group compared with the continuous infusion group.  Since then 
numerous other randomized controlled trials were conducted in laboring women and a meta-analysis 
conducted in 2013 by George et al further supported the observation of less local anesthetic usage and 
higher maternal satisfaction score in the programmed intermittent bolus group.
7.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Observation
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Administration of contrast agent
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-guided 
biopsies, DEXA scans, MUGA or PET scan)

Biopsy conducted solely for research purposes
Use of placebo
Sham surgical procedure
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, etc.)
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Social media-based research activities
None of the above
7.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
For clinical research, list all study procedures, tests and treatments 
required for this study, including when and how often they will be 
performed. If there are no clinical procedures, describe the research 
activities.
 
If some of the activities would occur even if the person were not in the 
study, as in the case of treatment or tests performed for diagnostic 
purposes, clearly differentiate between those activities that will be 
done solely for research purposes and those that are happening as part 
of routine care.
 
Examples may include:
additional scans outside standard clinical diagnosis or monitoring
additional biopsies to collect tissue for research
extra clinic visits
extra lab tests not required for clinical care
If you have a procedure table, attach it to the submission with your other 
study documents.
All study participants will complete a questionaire that includes their pain history, an anxiety and 
depession questionaire (Hospital Anxiety and Depression Scale) and the WHO Disability Assessment 
Schedule 2.0 (WHODAS 2.0). Patients will be block randomized to the programmed intermittent bolus 
group or continuous infusion group.  As part of the existing ERAS pathways, all patients will receive a 
thoracic/lumbar epidural catheter prior to their scheduled surgical procedure depending on the anticipated 
surgical incision site. Both groups will receive the same standard concentration of local anesthestic 
(0.0625% ropivacaine) and opioid (fentanyl 2ug/mL) based epidural mix. A total of 8mL of the epidural 
mix will be adminstered every hour either as a continuous infusion (8mL/hr) or programmed intermittent 
epidural bolus (4mL bolus every 30 min) based on the study participant's randomization. The epidural will 
be started in the OR, prior to the end of the surgical procedure  at the discretion of the intraoperative 
anesthesia provider.
The clinical  investigator who enrolled the patient will write the epidural infusion orders. A PACU nurse will 
be programming the pump following hospital policies.  The attending in the acute pain service will be 
informed about the enrollment of the patient in the study to ensure the pain service has all the information 
needed to ensure the best pain control to the patient in accordance with the study protocol. The display of 
the pump will be covered with a removable cover to make sure that the patient  will stay blinded about the 
treatment group. The epidural pumps will subsequently be managed by the acute pain service, not the 
study investigators. The study protocol allows the reduction of epidural flow rates from 8ml to 6ml/h (from 
4ml q30 to 3 ml q30 min in the bolus group) in case of hypotension.
 
Patients will have the option to administer patient controlled epidural analgesia (PCEA) in addition to the 
basal rate. For continuous epidural infusion group, they can receive additional 2ml every 15 minutes (lock 
out period) for a total of 16ml/hr (8ml/hr from continuous infusion and up to 8ml from PCEA). To match 
the total epidural volume in the programmed intermittent bolus group, they can receive additional 2ml 

using a lock out period of 10 minutes. Because 4ml of epidural is bolused every 30 min and a PCEA bolus 
cannot coincide with the basal bolus doses, the shortend lock out period is necessary to make sure the 
patient can still receive the same four additional 2ml PCEA boluses as the continuous infusion group.
 
In addition, patients will be able to receive additional physician manual boluses, IV opioid medications 
from nursing staff, adjunct medications as per standard UCSF ERAS protocol.  Hypotension and itching are 
some common adverse reactions to epidual analgesia; we will treat and document these episodes as per 
prexisting UCSF acute pain service epidural protocol.
 
Outcome measures will be total local anesthetic use (charted by nursing staff each shift as part of routine 
care), numeric rating scale (charted by nursing staff as part of routine care), total PCEA button presses 
(recorded on epidural pump),  anxiety and functional measures (WHODAS2.0, brief pain inventory, HADS 
survey) to be measured on post operative day 1 and 2.  Incidence of hypotension (charted by nursing staff 
as part of routine care).
7.10  
: To what extent, if any, do the planned research procedures differ 
STANDARD CLINICAL PRACTICE
from the care that people would otherwise receive at this institution or the study site if not being 
done locally:
 
The proposed study tries to maintain the care that patients would otherwise receive at UCSF.  The 
differences would be in the use of randomized assignment to programmed intermittent bolus of epidural or 
continuous epidural infusion.  As a measure of the efficacy of the different study arms, additional 
questionnaires, interviews listed below differ from standard clinical practice.
 
All other anesthetic interventions, including the placement and use of an epidural catheter, the monitors, 
safety parameters, availability to pain physicians, supplemental pain medications are consistent with 
existing standard clinical practice.
7.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
A brief validated questionnaire (WHO diability assessment schedule 2.0; hospital anxiety and depression 
score; brief pain inventory) will be adminstered at the time of enrollment into the study. During each 24-
hour period that the patient has the epidural in place, an abbreviated brief pain inventory (abbreviated to 
the inpatient population) will be administered. At the end of the study, prior to discharge, the patients will 
be handed another questionaire to assess the quality of pain control and patient satisfaction using the 
expanded brief pain inventory.  All the aforementioned surveys are previously published and validated 
questionnaires.
 
 
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after completing the 
study application. Published instruments should NOT be attached.
7.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.): (REQUIRED)
  Yes   
  No
7.25  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
The study is designed as a prospective, randomized, two treatment parallel study.  
All patient description as well as outcome variables will compared between groups using appropriate tests, 
including  standard unpaired t-test for continuous variables, chi square tests for categorical variables, and 
ANOVA for variables with repeated measurements. Post hoc test will be applied if appropriate to assess for 
statistically significant differences between the two groups.  
7.26  
(a separate bibliography can be attached 
REFERENCES: List only the 5-10 most relevant references 

for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus 
continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor 
outcome. A randomized boule-blind study in nulliparous women. Anesth Analg. 2011;113:826-31.
 
George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusion for 
labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013;116:133-44.
 
Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth 
Pain Med. 2002;27:150-6.
 
Kang S, Jeon S, Choe JH, Bang SR, Lee KH. Comparison of analgesic effects of programmed intermittent 
epidural bolus and continuous epidural infusion after total knee arthroplasty. Korean J Anesthesiol. 2013;
65:S130-1.
 
Taboada M, Rodriguez J, Bermudez M, Amor M, Ulloa B, Aneiros F, et al. Comparison of continuous infusion 
versus automated bolus for postoperative patient-controlled analgesia with popliteal sciatic nerve 
catheters. Anesthesiology. 2009;110:150-4.
 
Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of 
programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth 
Analg. 2006;102:904-9.
 
Wong CA, McCarthy RJ, Hewlet B. The effect of manipulation of the programmed intermittent bolus time 
interval and injection volume on total drug use for labor epidural analgesia: a randomized control trial. 
Anesth Analg. 2011;112:904-11.
8.0
 Drugs and Devices
8.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
 Yes   
 No
8.2  
List the drugs or biologics that will be studied:
LIST THE DRUGS/AGENTS: 
View 
Details
Drug Name
FDA Approved
A new drug or a 
new use of 
approved drug:
IND Number
Trade Drug 
Name: NAROPIN
Generic Drug 
Name:
ROPIVACAINE 
HYDROCHLORIDE 
MONOHYDRATE
Investigational 
Drug Name:
Yes 
No 
 
Trade Drug Name:
NAROPIN 
Generic Drug Name:
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE 
Investigational Drug Name:
 
Identify the name of the 
manufacturer or source of 
investigational drug/biologic:
 
Is the drug supplied at no cost?
Yes  
Is the Drug FDA Approved:
Yes  
Is this a new drug or a new use of 
an already approved drug
No  

Is an IND necessary
No  
IND Number
 
Who holds the IND:
N/A  
IND details:
 
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
 
Are you currently using this IND 
in another research project?
No  
If yes, list the IRB Number(s):
 
Will the investigational pharmacy 
be dispensing?
No  
If the source is not a FDA licensed 
facility, provide details regarding 
the purity, quality, stability and 
sterility of the investigational drug
/biologic:
 
Trade Drug 
Name: FENTANYL
Generic Drug 
Name:
FENTANYL 
CITRATE
Investigational 
Drug Name:
Yes 
No 
 
Trade Drug Name:
FENTANYL 
Generic Drug Name:
FENTANYL CITRATE 
Investigational Drug Name:
 
Identify the name of the 
manufacturer or source of 
investigational drug/biologic:
 
Is the drug supplied at no cost?
Yes  
Is the Drug FDA Approved:
Yes  
Is this a new drug or a new use of 
an already approved drug
No  
Is an IND necessary
No  
IND Number
 
Who holds the IND:
N/A  
IND details:
 
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
 
Are you currently using this IND 
in another research project?
No  
If yes, list the IRB Number(s):
 
Will the investigational pharmacy 
be dispensing?
No  
If the source is not a FDA licensed 
facility, provide details regarding 
the purity, quality, stability and 
sterility of the investigational drug
/biologic:
 

8.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
  Yes   
  No
8.6  
: Is this an expanded access or compassionate use protocol, meaning the 
* EXPANDED ACCESS
primary purpose is to dignose, monitor or treat a patient's condition, rather than the collection of 
safety and efficacy data of the experimental agent or device: (REQUIRED) 
  Yes   
  No
9.0
 Sample Size and Eligibility Criteria
9.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
120
 If there are multiple participant groups, indicate how many people will be in each 
group:
9.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
Based on labor analgesia literature, the median local bupivacaine dose per hour of analgesia was 10.5mg
/hr with 95% confidence interval of 9.5 - 11.8mg/hr compared with continuous infusion group of 12.3mg
/hr with 95% confidence interval of 10.5 - 14.0mg/hr.  We expect similar effective size (0.6).  With a 
power of 80% and accepting an alpha error of 0.05, we need 44 patients in each group.
 
In order to compensate for incomplete data collection, we estimated a total of 120 patients, 60 patients in 
each group should be enrolled.
9.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
9.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)

Children / Minors
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
9.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, providers, 
administrators, students, parents, family members, etc.):
Patients age 18 years of age or older, American Society of Anesthesia physical classification I - III, 
scheduled for abdominal surgery with epidural anesthesia as part of the perioperative treatment 
plan. Surgery at UCSF Mission Bay hospital.
9.8  
 List any exclusion criteria (e.g. reasons why someone would not be included in 
EXCLUSION CRITERIA:
the study):
Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such 
as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic 
deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each 
day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 
consecutive days prior to surgery, patient refusal.
9.9  
Do any study activities take place on patient 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
 
care units: (REQUIRED)
 Yes   
 No
Attach a letter of acknowledgement for the study from the involved 
patient care manager. If you don't know who the patient care manager is, 
click 
 to send an email to the nursing group.
here
10.0
 Recruitment and Consent
10.1  
 
What kinds of methods will be used to identify potential participants for 
* RECRUITMENT METHODS: 
recruitment (check all that apply): (REQUIRED)
Medical records review
Recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials you will 
provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social media, 
presentation of the study at community events/media, etc.)
Online recruiting tool such as TrialSpark
CTSI Recruitment Services unit
Other method (describe below)

* Provide details about the other recruitment methods: (REQUIRED)
We will plan to screen eligible patients based from their encounters with the anesthesia Prepare 
appointment as part of their preparation for upcoming surgery.  We will recruit them at that time or 
contact them after they have been identified.  Additionally, patients can also be identified by using the 
surgical scheduling board for specific procedures.
10.2  * SEARCHING OF MEDICAL RECORDS: (REQUIRED)
Whose patients are they:
Investigators' own patients or patients seen within the same practice
Patients not under the care of the investigators
How and by whom will records be accessed and searched (check all that apply):
Self-search in APeX or other medical records source
Self-search using UCSF's Research Cohort Selection Tool
CTSI Consultation Service Recruitment Services
UCSF Academic Research Services (ARS)
University of California Research Exchange (UC ReX)
Other method (describe below)
10.3  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Eligibility will be determined after patients undergo a pre-operative anesthesia evaluation by a nurse 
practicioner or anesthesia provider prior to surgery.  This appointment varies from a few days to a few 
weeks before the scheduled operation.  Eligible paitents will be identified by anesthesia providers involved 
in the study.
10.4  
Who initiates contact (check all that apply):
INITIATION OF CONTACT: 
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
10.5  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study Documents 
section of the Initial Review Submission Packet Form. If potential 
participants will initiate contact, attach the telephone screening script 
that will be used to provide more information about the study and 
determine if callers are eligible to participate.
10.6  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?

If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
Patients eligible for this study will be informed of the study by an anesthesia provider participating in the 
study after their initial pre-operative anesthesia evaluation, but prior to day of surgery.  Patient who meet 
the inclusion and non-inclusion criteria will receive a phone call from one of the study investigators 
explaining the study prior to the day of surgery.  The consent form will be offered to them via mail or e-
mail prior to the day of surgery to allow ample time to review and consider the patient's participation in 
the study.  On the day of surgery, information about the study will be reiterated by an anesthesia provider 
and all questions will be ansered prior to randomization.
10.7  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using DocuSign or another E-Signature system
Click through a link in a survey or email after reading about the study and then complete the study 
online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree to 
participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that is placed 
in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the case of a 
critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk research or 
greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior (waiver of 
consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent text in 
the Informed Consent Documents section of the Initial Review Submission 
Packet Form.
10.8  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study. For online and electronic consent, explain that process in 
detail: (REQUIRED)        
 
If there are multiple groups being consented differently, provide details 
about the consent process for each group. If you are relying on verbal or implied consent, provide 
        
details about how that will happen.
 
We encourage researchers to review UC Irvine's excellent 
 .
guidance on obtaining informed consent
Potential patients meeting the inclusion/non-inclusion criterias will be contacted via telephone prior to their 
day of surgery by a member of the research team.  At this time, the research team will introduce 
themselves, confirm the surgery type and surgery day and any other clarifying information regarding the 
patient's past medical information as it is relevant to the study. If there are no contraindications for the 
patient for the study, the patient will be introduced to the study.  We will discuss the study's goals, risks 
and benefits.  If the patient agrees to be a participant, the research team will offer to send them a consent 
via mail or email prior to the date of surgery.  A formal written consent will be obtained the day of surgery.
 
Potential study participatnets will be introduced to the study after their routine pre-operative anesthesia 
evaluation verbally.  They will also be offered a written copy of the consent form via mail or email prior to 
the day of surgery.  This consent form includes the name and contact information of the study 
investigator.  On the day of surgery, an anesthesia attending will review this information, answer any 
questions, and assure that there is a written consent prior to randomization.
 

 It is important that the people obtaining consent are qualified to do so. Briefly 
*
describe the training and experience these individuals have in obtaining informed 
consent: (REQUIRED)
All study personel involved in the enrollment process have prior experience in enrolling patients for clinical 
studies. They are either fully trained, board certified anesthesiologists, anesthesia residents involved in the 
design of this study (P.S), or study coordinators currently enrolling patients in other ongoing clinical 
studies done by our department.
10.9  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)        
 
Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider using 
UCSD's Brief Assessment of Capacity to Consent (UBACC), and review UC Irvine's guidance on 
 
Subject Consent Assessment for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended questions about 
the nature of the study or the experimental treatment, the risks and benefits of participating, and the 
voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their understanding of the 
study purpose, procedures, risks and benefits, as well as the voluntary nature of participation 
(especially appropriate when the consent process happens online or through a mobile health app)
Other method (describe below):
10.13  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
An initial phone call to the patient to introduce the study to the patient will take approximately 10 
minutes.  We will offer the informed consent form to eligible patients via mail or e-mail prior to the day of 
surgery.  On the day of surgery, additional time may be allotted if needed to answer any additional 
questions from the patient. Epidural placement will follow pre-established ERAS protocol as per institution 
guidelines and should not distrupt the current work flow of the perioperative setting. Follow up with 
regards to pain scores, hypotension, amount of adjunct analgesics will be obtained via chart biopsy. 
Patient satisfcation will be obtained at the time of discontinuation of the epidural, which should take 
approximal 5 minutes.  Total face-time will be approximately 15 minutes.  Epidurals are removed typically 
on the morning of post-operative day 2, however some may be removed earlier or later pending clinical 
scenario.
11.0
 Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when medical records may be reviewed to 
determine eligibility for recruitment.
11.1  
Study personnel need to access 
* PRACTICABILITY OF OBTAINING CONSENT PRIOR TO ACCESS: 
protected health information (PHI) during the recruitment process and it is not practicable to obtain 
informed consent until potential subjects have been identified: (REQUIRED)
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
11.2  
 
A waiver for screening of health records to identify potential subjects poses no 
* RISK TO PRIVACY: 
more than minimal risk to privacy for participants:
Yes 

If 
, a waiver of authorization can NOT be granted.
no
11.3  
Screening health records prior to obtaining consent will not adversely affect 
* RIGHTS/WELFARE: 
subjects' rights and welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
11.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* IDENTIFIERS: 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
11.5  
 
Describe any health information that will be collected prior to obtaining 
* HEALTH INFORMATION: 
informed consent:
All study investigators have access to the surgery schedule at the UCSF Mission Bay.  Patient that are 
potential research participants (scheduled for surgeries with pre-existing ERAS pathways) will be 
identified.  Research members will then collect the patient's name, medical record number, date of 
surgery.  The patient's medical record will then be reviewed to screen for inclusion and exclusion criteria. 
If the patient is a potential candidate for enrollment, based on our inclusion/noninclusion criteria, will will 
retrieve the contact information to contact the patient.
Note: HIPAA requires that you collect the minimum necessary.
11.6  
escribe your plan to destroy any identifiable data 
* DATA RETENTION/DESTRUCTION PLAN: D
collected to determine eligibility for recruitment. This should be done at the earliest opportunity. If 
you plan to retain identifiable recruitment data, provide the justification for doing so:
All identifying information will be destroyed at the earliest opportunity upon completion of the study.
12.0
 Risks and Benefits
12.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 

to participants that may need to be disclosed in the consent form:
For interventional studies, risk that the regimen may be more harmful or less effective than other 
available interventions
Risks associated with radiation exposure for imaging studies specifically for research purposes
Risks associated with the administration of contrast agent for imaging studies
Risks associated with withholding of treatment or discontinuation of current treatment (e.g., washout 
period is required by the study protocol)
For randomized, placebo-controlled trials, possible temporary or permanent health consequences from 
the deprivation of effective therapies during the placebo administration period
For studies involving a sham surgical procedure, the risk that participants may experience increased 
morbidity without the possibility of benefit
Risks associated with modification or extension of a surgical procedure primarily for research purposes 
(e.g. risks associated with prolonging anesthesia, time in the operating room, etc.)
Risk of pain or physical discomfort caused by the research intervention
Possible personal discomfort due to sensitive topics (stress, embarassment, trauma)
For any boxes checked above, describe how you will minimize these risks and 
* 
discomforts, e.g., adding or increasing the frequency of monitoring, additional 
screening to identify and exclude people with diminished kidney or liver function, 
or modification of procedures such as changing imaging studies to avoid giving 
contrast agent to people who are more likely to suffer side effects from it, etc.: 
(REQUIRED)
Participants in the study have the risk that their study intervention (local anesthesic administration by 
bolus application or continuous infusion) results in inferior pain control. To ameliorate this risk we are 
firstly offering all patients the ability to obtain addtional (demand) bolus administrations of local anesthetic 
and fentanyl through their epidural catheter. Secondly, all patients will have additional analgesics ordered 
in case they require additional pain control. We expect that all patients will be offered excellent pain 
control. For this reason, we did not choose pain scores as primary endpoint (we don't expect any 
differences here), but the need to administer additional analgesics.
12.2  
Describe any anticipated risks and discomforts not listed above:
RISKS: 
There are risks associated with the placement and use of epidural anesthesia. However, this study will only 
performed in patients who have already consented to the current standard of care in the ERAS pathways. 
ERAS pathways routinely includes the use of epidural anesthesia.  Patients in this study will be seen daily 
by the study investigators as well as the acute pain service at Mission Bay. They will routinely be asked for 
side effects of regional anesthesia such as hypotension, itching and the catheter site will be inspected. In 
case of hypotension with a mean arterial blood pressure <60 mmHg, nursing orders to contact the primary 
service and the acute pain service for appropriate clinical response remain in place.
 
 
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
There will be no interference with the care of the patient. The treatment of enrolled patients is not 
different from patients who do not participate in the study. We have already been using the programmed 
intermittent bolus function successfully in these patients, but it always happened at the descretion of the 
ordering anesthesia provider.
All procedures will be performed by or under direct supervision of an anesthesiology attending as per 
current institutional protocol.  Medication changes to the epidural solution will be handled by physicians 
only as per current institutional protocol.  

Patient data remains confidential and de-identified. Only encrypted computers will be used for data 
collection and management.
12.4  
Describe the resources in place to conduct this study in a way that assures protection 
RESOURCES: 
of the rights and welfare of participants:   These resources typically include appropriately trained 
and qualified personnel (in terms availability, number, expertise and experience), funding, space, 
  
equipment, and time to devote to study activities.  Depending on the nature of the research study, 
investigators should consider the proximity or availability of critical resources that may be essential 
to the safety and welfare of participants, such as
the proximity of an emergency facility for care of participant injury
availability of psychological support after participation
resources for participant communication, such as language translation services
The treatment of study patients does not deviate from our current clinical practice. The additional riks to 
the wellfare of the patients should be minimal.
The use of a study coordinator facilitates patient enrollment and should minimize delays in the clinical care 
of the patients. All procedures the patients are undergoing are part of their regular medical care. The only 
additional study interventions are the programming of the pump, the follow visits and the follow up 
interview.
To protect the patient's privacy and medical information, all study documentation will be secured in a 
locked file cabinet.  Data will be collected using RedCap. Only encrypted computer will be used.
 
12.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or alleviation 
of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
12.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
The treatment of study patients does not deviate from our current clinical practice. The additional riks to 
the wellfare of the patients should be minimal.
13.0
 
Data and Safety Monitoring Plan
13.2  
DATA AND SAFETY MONITORING PLAN: 
* 
(REQUIRED)
All greater than minimal risk studies are required to provide a plan. Lack 
of an adequate plan is one of the most common reasons why IRB approval 
is delayed.
 
Instructions:

Describe the plan for monitoring data quality and participant safety. Key areas that 
should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, and 
safety
A description of who will perform the monitoring and at what frequency (e.g., 
the PI only, a contract research organization, a Data and Safety Monitoring 
Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse events, 
breaches of confidentiality, unanticipated problems involving risk to 
participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the UCSF 
IRB, the study sponsor, and other appropriate entities
Assurance that the research team will adhere to the UCSF IRB reporting 
requirements
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study interventions
Patients will be monitored as per routine nursing care as well as followed by the acute pain service for the 
management of the epidural catheter.  Any adverse events occuring in a study participant will be managed 
by the acute pain service and be brought immediately to the principal investigator for review.  Given that 
epidural is routinely performed for the ERAS pathway, we consider this a low-risk study.
 
Serious or unexpected adverse events will be reported to the CHR within 10 working days in accordance 
with CHR guidelines.
We are also planning on perfoming an interims analysis after 44 patients have completed the study to 
investigate whether there are any differences in outcomes as well as adverse events reported between 
study groups.
 
 
13.3  
Will a Data and Safety Monitoring Board (DSMB) 
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
be established: (REQUIRED)
Yes 
No 
Guidelines
A Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) 
is a formal, independent committee that is specifically established to conduct 
interim monitoring, oversight and analysis of study information and data to assure 
the continuing safety, efficacy, appropriateness, relevance, and integrity of the 
study.
 
The UCSF IRB reserves the right to request a DSMB/DMC for any study. However, 
the following are factors that the IRB will consider when making this determination:
There is a significant likelihood of a serious adverse event to subjects
The study is conducted at multiple sites and the level of risk is greater than 
minimal
The study generates data that are blinded or randomized
The study involves a large number of patients randomized to one of two or 
more interventions

A study for which the performance of an interim analysis is crucial for the 
protection of the subjects
First use in humans
First use in children
The study involves gene transfer, stem cell therapy, or other novel 
interventions for which long-term outcome data are not known or available
14.0
 Confidentiality, Privacy, and Data Security
14.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be called, can 
messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added to their 
medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
  Yes   
  No
14.3  
Could a breach of privacy or 
CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
confidentiality  result in any significant consequences to participants, such as criminal or civil 
liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
  Yes   
  No
14.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:
All patient identifiers will be decoupled from the remainder of the data as soon as possible to minimize loss 
of confidentiality through the study.
14.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes   
  No
14.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
  Yes   
  No
14.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes   
  No
14.8  
Will personal identifiers be included in research records: 
IDENTIFIERS: 
* 
(REQUIRED)

 Yes   
 No
Check all the identifiers that may be included:
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
Could study records include 
 photos or images (even 'unidentifiable' ones): 
* 
ANY
(REQUIRED)
  Yes   
  No
14.9  
 
Will identifiable information be shared with outside groups:
DATA DISCLOSURE: 
  Yes   
  No
14.11  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)
Collection methods:
Paper-based (surveys, logs, diaries, etc.)
Electronic case report forms (CRFs), such as OnCore or another clinical trial management portal
Web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Wearable devices
Audio/video recordings
Other:
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
UCSF
SF VAMC
Amazon (Amazon Cloud)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
14.12  
Indicate how data are kept secure and protected from improper use and 
DATA SECURITY: 

disclosure (check all that apply):   NOTE: Whenever possible, do not store subject identifiers on 
laptops, PDAs, or other portable devices. If you collect subject identifiers on portable devices, 
you MUST encrypt the devices.
Data are stored securely in My Research
Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
14.13  
  
Confirm below that you will keep data confidential: 
* DATA SECURITY: 
(REQUIRED)  I will keep 
any data sets that include identifiers secure and protected from improper use and disclosure by 
using methods such as:
Physical Security – Keeping data in locked file cabinets, locked offices, locked suites, and 
physically securing computers and servers.
Electronic Security – Following UCSF minimum security standards for electronic information 
, which includes (but is not limited to): not storing identifiers on portable devices 
resources
like laptops or flash drives if they are unencrypted, encrypting portable devices, and storing 
data in password-protected files and on secure networks.
 
Yes 
14.15  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED) 
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service (THREDS) at 
SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
In addition to signing a consent form, each subject will have to sign the 
 
UCSF Research Subject Authorization Form (HIPAA Form).
NEW REQUIREMENT - This form should be uploaded in the Other Study 
Documents section of the Initial Review Submission Packet Form. Failure 
to have the signed HIPAA Authorization is one of the most common 
and can result in a Serious 
findings from QIU Routine Site Visits 
Noncompliance determination. Please call the IRB office at 415-476-1814 
if you have questions about HIPAA research requirements.  
14.16  
Does the research require access to any of 
HIPAA - PERMISSION TO ACCESS SENSITIVE DATA: 
* 
the following types of health information from the medical record: (check all that apply) 
(REQUIRED)

Drug or alcohol abuse, diagnosis or treatment
HIV/AIDS testing information
Genetic testing information
Mental health diagnosis or treatment
None of the above
Important note: Ensure that participants DO NOT initial any of the lines in 
Section C of the HIPAA authorization form during the consent process. 
   
15.0
 Financial Considerations
15.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
  Yes   
  No
15.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
  Yes   
  No
16.0
 Qualifications of Key Study Personnel
16.1    NOTE: This information is required and your application will be considered 
incomplete without it. If this study involves invasive or risky procedures, or 
procedures requiring special training or certification, please identify who will 
be conducting these procedures and provide details about their qualifications 
and training. Also identify each person who will be involved in the consent 
 
process. Click the orange question mark for more information and examples.
Under qualifications, please include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
  November, 2015 - NEW Definition of Key Study Personnel and CITI 
 
Training Requirements:
include the Principal Investigator, other 
UCSF Key Study Personnel 
investigators and research personnel who are directly involved in conducting 
research with study participants or who are directly involved in using study 
participants’ identifiable private information during the course of the research. 
Key Personnel also include faculty mentors/advisors who provide direct 
oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI 
  
on the IRB application.  The IRB requires that all Key Study Personnel 
complete Human Subjects Protection Training through 
 
CITI prior to approval of 
a new study, or a modification in which KSP are being added. More information 
 
on the CITI training requirement can be found on our website.     
Description of Study 
Responsibilities - Briefly 
describe what will each person 
be doing on the study. If there 

KSP Name
are procedures requiring special 
expertise or certification, 
identify who will be carrying 
these out. Also identify who will 
be obtaining informed consent.
Qualifications, Licensure, and 
Training
Behrends, Matthias, MD
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, data analysis, 
patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Chen, Lee-Lynn
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Naidu, Ramana K
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, data analysis, 
patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Su, Po-Yi Paul
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
anesthesia resident, CITI 
trained

these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, data analysis, 
patient follow up
Aleshi, Pedram
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Siegmueller, Claas
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Haight, Matthew J
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
board certified 
anesthesiologist,
Delgado, Adrian C
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
UCSF research coordinator, 
CITI trained

these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
Latronica, Mark
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
Patient enrollment, data 
collection, patient follow up
board certified 
anesthesiologist, PI status, 
CITI trained
Ladd, Michael J
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
UCSF research coordinator, 
CITI trained
Clelland, Elle N
Briefly describe what will 
each person be doing on 
the study. If there are 
procedures requiring 
special expertise or 
certification, identify 
who will be carrying 
these out. Also identify 
who will be obtaining 
informed consent.
patient enrollment, data 
collection, patient follow up
UCSF research coordinator, 
CITI trained
17.0
 Other Approvals and Registrations
17.1  
 
Does this study involve administration of vaccines 
* ADMINISTRATION OF RECOMBINANT DNA: 
produced using recombinant DNA technologies to human subjects 
: 
(Help Link added Aug '15)
(REQUIRED)
  Yes   
  No

17.2  
Does this study involve human gene transfer (NOTE: Requires NIH 
* HUMAN GENE TRANSFER: 
Recombinant DNA Advisory Committee (RAC) review prior to CHR approval): (REQUIRED)
  Yes   
  No
17.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
18.0
 End of Study Application
18.1  End of Study Application Form   To continue working on the Study 
: Click on the section you need to edit in the left-hand menu. Remember to save 
Application
  
through the entire Study Application after making changes.  If you are done working on the 
: Click Save and Continue. If this is a new study, you will automatically 
Study Application
enter the Initial Review Submission Packet form, where you can attach consent forms or 
other study documents. Review the 
 for a list of required 
Initial Review Submission Checklist
 
attachments.   Answer all questions and attach all required documents to speed up your 
approval.