Clinical trial NCT03302936
Conditions: Urinary Retention
Keywords: Midurethral sling Pyridium
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2017-10-24; Completion date: 2019-07-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.

Detailed description:
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.

Arms: arm 1: Phenazopyridine 200mg tablet, once prior to surgery arm 2: No intervention in this group. Routine perioperative care.
Interventions: intervention 1: Phenazopyridine
Intervention descriptions: intervention 1: to be given preoperatively

Protocol documents:
Prot_SAP_000.pdf: 
Icahn School of Medicine at Mount Sinai
Mount Sinai Beth Israel
Mount Sinai Brooklyn
The Mount Sinai Hospital
Mount Sinai Queens
New York Eye and Ear Infirmary
of Mount Sinai
Mount Sinai St. Luke's
Mount Sinai West
Program for the Protection
of Human Subjects
Institutional Review Boards
Mount Sinai Health System
One Gustave L. Levy Place, Box
 1081
New York, NY 10029-6574
T 212-824-8200
F 212-876-6789
irb@mssm.edu
icahn.mssm.edu/pphs
Amendment
IRB-17-01796
Charles Ascher-Walsh
Table of Contents
1. Modification.............................................................................................................................................................................1
2. Summary - Title.....................................................................................................................................................................2
3. Summary - Setup..................................................................................................................................................................3
4. Summary - Background......................................................................................................................................................5
5. Research Personnel.............................................................................................................................................................6
6. Sites.......................................................................................................................................................................................... 7
7. Subjects - Enrollment.......................................................................................................................................................... 8
8. Subjects - Populations........................................................................................................................................................ 9
9. Subjects - Participation.....................................................................................................................................................10
10. Procedures - Narrative...................................................................................................................................................11
11. Procedures - Genetic Testing......................................................................................................................................12
12. Procedures - Details....................................................................................................................................................... 13
13. Procedures - Compensation.........................................................................................................................................14
14. Consent - Obtaining Consent.......................................................................................................................................15
15. Consent - Documents.....................................................................................................................................................16
16. Data - Collection...............................................................................................................................................................17
17. Data - HIPAA.................................................................................................................................................................... 18
18. Data - Storage.................................................................................................................................................................. 19
19. Data - Safety Monitoring................................................................................................................................................21
20. Financial Administration................................................................................................................................................. 22
21. Attachments....................................................................................................................................................................... 23


IRB-17-01796
Amendment
Charles Ascher-Walsh
1. Modification
Summary of the Modification Request
I would like to give the control group a B12 vitamin prior to surgery to act as a placebo.
Justification for the Modification
After consideration of both groups and discussion with Attendings, we feel it would be less biased if the control
 group received a by mouth pill prior to surgery.  I am proposing a vitamin as the pill given to the control group. The
 B12 vitamin I am proposing is over the counter and in some people changes the color of urine to orange, similar to
 pyridium. Hence it will increase the placebo affect on the patient's end. 
This Modification Changes
 the Consent Document or
 Information that May Affect
 Subjects’ Willingness to Continue
 to Participate in the Research
Yes
Description of Changes in the Consent Document or Information that May Affect Subjects’ Willingness to
 Continue to Participate in the Research
In the areas where is it stated that the control group will receive nothing, it will be changed to them receiving a
 vitamin. 
Subjects Will Be Re-Consented or
 Provided with the New Information
Yes
Proposed Plan to Re-Consent Subjects or to Provide Them with the New Information
The patients already enrolled as controls did not receive vitamin B12, and have completed the intervention of the
 study. Therefore, re-consent is not necessary.
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2. Summary - Title
Protocol Title
A randomized control trial assessing pyridium for post-sling urinary retention
Principal Investigator
Charles Ascher-Walsh
When the application is complete, it will be sent to the PI for submission
When the application is complete, it will be sent to the PI for submission
Primary Department
Obstetrics/Gynecology
When the application is complete, it will be sent to the PI for submission
Application Initiated By
Annacecilia Peacher-Seaney
Lay Summary
Patients with stress urinary incontinence have the option of undergoing surgical intervention with a midurethral
 sling to improve if not cure their incontinence.  One of the major complications of this procedure is urinary retention
 postoperatively.  If a patient is not able to void on their own postoperatively they are required to go home from the
 hospital with a foley for bladder rest, and return to the clinic in 2-3 days to attempt a void trial once again.  At our
 institution the rate of urinary retention after midurethral sling requiring discharge with an indwelling foley is 25% of
 patients who undergo this procedure.  
 Pyridium is a medication widely used and of low risk to the subject. It is a urinary numbing medication often used
 in patients with urinary tract infections. At the discretion of the physician, medication is given prior to midurethral
 sling and/or other urogynecologic procedures requiring cystoscopy to confirm bilateral ureteral jet efflux. The
 most common medication administered in the past was indigo carmine, now that this medication is off the market.
 Physicians have been using alternatives for visualization of ureteral jets on cystoscopy such a methylene blue,
 fluorescein, or pyridium.  In this study patients undergoing midurethral slings will be randomized to one of two
 groups. The first group will receive pyridium preoperatively; the second will receive one 100mcg tablet of vitamin
 B12 as a placebo pill.  The main goal of the study is to assess whether the group of patients who receive pyridium
 preoperatively have a lower rate of urinary retention postoperatively versus the control group.  The secondary goal of
 the study is short term postoperative pain.
IF Number
IF2052990
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IRB-17-01796
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Charles Ascher-Walsh
3. Summary - Setup
Funding Has Been Requested /
 Obtained
No
Application Type
Request to Rely on Mount Sinai IRB
Research Involves
Prospective Study ONLY
Consenting Participants
Yes
Requesting Waiver or Alteration
 of Informed Consent for Any
 Procedures
No
Humanitarian Use Device (HUD)
 Used Exclusively in the Course of
 Medical Practice
No
Use of an Investigational Device to
 Evaluate Its Safety or Effectiveness
No
Banking Specimens for Future
 Research
No
Cancer Related Research that
 Requires Approval from the
 Protocol Review and Monitoring
 Committee (PRMC).
No
   Is this Cancer Related Research?  Cancer Related Research is defined as research that
 has cancer endpoints or has a cancer population as part of or all of its targeted population.
 This includes protocols studying patients with cancer or those at risk for cancer.
  
Clinical Trial
Yes
   
   * A prospective biomedical or behavioral research study of human subjects that is
 designed to answer specific questions about biomedical or behavioral interventions
 (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). 
   *  Used to determine whether new biomedical or behavioral interventions are safe,
 efficacious, and effective.    
  
Drugs / Biologics 
No
   
   * Drugs / Biologics That Are Not a Part of Standard Practice 
   * Controlled Substances 
   * Drugs / Biologics Supplied by the Research Sponsor or Purchased with Study Funds 
  
   Ionizing Radiation for imaging or therapy, including X-Ray, Fluoroscopy, CT, Nuclear
 Medicine, PET andor Radiation Therapy:
  
* Purely for standard of care:
No
* In frequency or intensity that
 exceeds what is necessary for
 standard of care:
No
Hazardous Materials
No
   * Recombinant DNA 


   * Viral Vectors 
   * Plasmids 
   * Bacterial Artificial Chromosomes 
   * Toxic Chemicals, Potentially Toxic Medications, Carcinogens 
   * Autologous Cell Lines 
  
Request Use of Clinical Research
 Unit Resources
No
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4. Summary - Background
Objectives
To assess if there is a statistically significant difference in urinary retention after midurethral slings for stress urinary
 incontience in a group that receives preoperative pyridium versus a control.
Background
 The prevalence of pelvic floor disorders in the United States is estimated to be 24%, with 16% of women
 experiencing urinary incontinence. Pelvic floor disorders affect a significant amount of women, and this increases
 with age.(3) Approximately 30% of women in the United States undergo corrective surgery, with a majority including
 incontinence surgery.  The frequency of diagnosis of urinary tract infection after a sling procedure is 34% in the
 first three months, and 50% in the first year following a sling procedure.(1) Patients who are discharged with an
 indwelling foley after midurethral sling placement, undergo a risk of urinary tract infection that reaches 30%.(2)
1. Anger JT, Litwin MS, Wang Q, et al. Complications of sling surgery among female Medicare beneficiaries. Obstet
 Gynecol. 2007;109:707-714.
2. Dieter AA, Amundsen CL, Visco AG, et al. Treatment for urinary tract infection after midurethral sling: a
 retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a
 void trial on the day of surgery. Female Pelvic Med Reconstr Surg.  2012; 18(3): 175-178.
3. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. Jama.
 2008;300: 1311-1316.
Primary and Secondary Study Endpoints
Primary outcome: To evaluate if there is a statistical difference in urinary retention postoperatively after  midurethral
 sling placement in patients who receive preoperative pyridium versus  patients who receive routine perioperative
 care.
Secondary outcomes: Pain after surgery.  
Pain Visual analog scale with documented log of pain postoperatively (starting at 2hrs-ending at 8hrs)(Half life of
 pyridium 8hr).
Protocol Was Already Approved
 by the Icahn School of Medicine at
 Mount Sinai (ISMMS) Institutional
 Review Board (IRB) Under a
 Different Principal Investigator
No
Protocol Was Previously Submitted
 to an External(non-ISMMS) IRB
No
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Charles Ascher-Walsh
5. Research Personnel
Name/Department
Role/Status
Contact
Access
Signature
 Authority
Phone
Email
Charles Ascher-
Walsh / Obstetrics/
Gynecology
Principal
 Investigator / 
Signature
 Authority
Annacecilia Peacher-
Seaney / 
CI / 
Signature
 Authority
John Andrew Fantl / CI / 
Edit
 Access
Woojin Chong-
Kaufman / 
CI / 
Edit
 Access
Janine Doneza / 
CI / 
Edit
 Access
 
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6. Sites
Site Name
The Mount Sinai Hospital
Other External Site Name
Contact Details
Approved
Approval Document
Funded By Mount Sinai
Other IRB
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7. Subjects - Enrollment
Site Name
The Mount Sinai Hospital
Subjects To Be Enrolled
98
Total Number of Subjects to be
 Enrolled Across All Listed Sites
 Above (Auto Populated)
98
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Charles Ascher-Walsh
8. Subjects - Populations
Inclusion Criteria
Any  female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or
 gynecological surgery.
Exclusion Criteria
Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring
 indwelling catheter, acute bleeding requiring indwelling catheter for accurate urine output calculation, patients
 undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid
 residual >150cc, or spinal anesthesia. Women who are pregnant, including women of childbearing age who test
 positive on preoperative urine pregnancy test.
Enrollment Restrictions Based
 Upon Gender, Pregnancy,
 Childbearing Potential, or Race
Yes
Justify Restriction(s)
As part of the urogynecology specialty, I am only interested in analyzing  female patients undergoing midurethral
 slings for stress urinary incontinence.
Age Range(s)
18 to 64 Years, 65 Years and Over
Targeted Population(s)
Adults - Patients 
Other Aspects that Could Increase Subjects Vulnerability
None to be noted, if a patient declines randomized medication prior to surgery they will receive the same
 perioperative care as all other patients. 
Safeguards to protect Subjects rights and welfare
The patients' rights and welfare will be protected to the same standards as all patients undergoing surgery by our
 Urogynecology department at Mount Sinai Hospital. 
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9. Subjects - Participation
Duration of an Individual Subjects Participation in the Study
Approximately 1-2 days, starting with day of surgery and ending with Visual Analog Score 2-8 hours postoperatively
Duration Anticipated to Enroll All Study Subjects
Approximately 9 months according to 3-5 midurethral slings being performed at Mount Sinai Hospital per week. This
 is taking into consideration patient volume and subjects meeting inclusion/exclusion criteria.
Estimated Date for the Investigators
 to Complete This Study
Within two years
Procedures for Subjects to Request Withdrawal
A patient can withdraw completely from the study by informing the principal investigator. They can call and ask to
 speak to Dr. Ascher-Walsh at FPA, or they can email Dr. Ascher-Walsh or Dr. Peacher-Seaney and let us know of
 their wish to withdraw.
Procedures for Investigator to Withdraw Subjects
It is not anticipated that patients will be withdrawn from the study by the research team.  If a patient undergoes
 a complication in surgery necessitating an indwelling foley, or undergoes spinal anesthesia for their procedure,
 they will be removed from the study.  When the voiding trial cannot be performed as it should, because of these
 constraints, it will be explained to the patient that they may have been in the treatment arm and received pyridium,
 however, due to the exclusion criteria of the study, their data cannot be used towards conclusions for the study.
Participants Will Be Recruited
Yes
Recruitment Method(s)
Clinical Practice
How Participants Will Be Identified
Any patients that are being consented for a midurethral sling procedure at FPA will be asked if they would like to
 participate in the study.
During a patient's preoperative visit, they will be screened to see if they meet inclusion/exclusion criteria. If they
 do, we will discuss how a cystoscopy is performed at the end of a case including a mid-urethral sling to inspect for
 bladder injury and uretheral patency.  It will be discussed what medications can be given to aid in visualization of
 ureteral jets, and how pyridium is one medication that is often used for this.  Then we will discuss that we want to test
 this medication to see if it decreases risks of urinary retention postoperatively.  Then we will ask if they are interested
 in participating in the study. 
Who Will Initially Approach
 Potential Participants
Study Personnel
How Research Will Be Introduced to Participants
The research team approaching the patient asking if they are interested in the study will either be the surgeon, or
 fellow who will be participating in their surgery. If it is the fellow, they will be meeting the patient at the preoperative
 visit and discussing the study with them, in addition to being involved in the patient's surgical history and physical.
It will be discussed that pyridium at times is used as standard of care during a urogynecologic procedure for
 visualization of ureteral patency during cystoscopy.  In this study it will also be used to assess if it decreases the rate
 of urinary retention after midurethral sling procedure.
How Participants Will Be Screened
Patients who are having a midurethral sling procedure, who have not previously undergone an anti-incontinence
 procedure will be asked if they would like to participate.
Patients will be asked if they would like to participate in the study if they meet inclusion and exclusion criteria. 
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10. Procedures - Narrative
Description of the Study Design
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98
 patients. Patients will be randomized with a block randomization schedule generated by computerized random
 numbers using a 1:1 allocation to pyridium and vitamin B12 placebo.  The study is powered to see a difference in
 incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical
 sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha
 0.05. 
Description of Procedures Being Performed
This study will use two study groups. One group will be given Pyridium 200mg po one hour prior to surgery.  The
 second group will receive one 100mcg vitamin B12 tablet as a placebo pill. Patients will be randomized to either
 study group.  After the patient's surgery, including a midurethral sling, they will have an active voiding trial performed
 as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If they cannot
 tolerate 300cc, they will be filled to maximum capacity. They will be allowed 20 minutes to void.  The patient must
 void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial.  The
 timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of
 concomitant surgery, the patient being alert, ambulating, with tolerable pain. 
Description of the Source Records that Will Be Used to Collect Data About Subjects 
The electronic medical record Epic will be used to gather demographic information about patients.
Description of Data that Will Be Collected Including Long-Term Follow-Up
Demographics will be gathered on patients, including: age, race, BMI, preoperative urodynamics and/ or simple
 cystometrics, obstetrical and gynecologic history, medical and surgical history.
Surgical procedures performed, if a patient passed or failed their active voiding trial.
 Visual Analog Scale with documented log of pain postoperatively (starting at 2hrs-ending at 8hrs)(Half life of pyridium
 8hr).
Research Requires HIV Testing
No
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11. Procedures - Genetic Testing
Genetic Testing Will Be Performed
No
Guidance and Policies > Future Use Data Sharing and Genetic Research
  
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Charles Ascher-Walsh
12. Procedures - Details
Surveys or Interviews
Yes
Type of Instruments Being Used
Standardized
Names of Standardized Instruments
Visial Analog Scale for pain
Audio / Photo / Video Recording
No
Deception
No
Results of the Study Will Be Shared
 with Subjects or Others
No
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Charles Ascher-Walsh
13. Procedures - Compensation
Compensation for Participation
No
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Charles Ascher-Walsh
14. Consent - Obtaining Consent
Consent Process
Adult Consent
Where and When Consent Will Be Obtained
The consent will be obtained during the patient's preoperative visit or at an earlier visit if a specific surgical plan has
 been discussed prior to the preoperative visit at FPA.
Waiting Period for Obtaining Consent
A patient has the option of deciding about participation in the study and returning to clinic with the signed consent
 prior to their surgical date.
SOP HRP-090 Informed Consent
 Process for Research Is Being
 Used
Yes
PPHS Worksheets, Checklists and SOPs
  
Process to Document Consent in
 Writing
Will Use Standard Template
Non-English Speaking Participants
 Will Be Enrolled
Yes
What Languages Other Than English Will Be Used
Spanish
What Process Will Be Used
Long Form
  
  The consent document must be translated into the language of the potential subject, and
 approved by the IRB, before you can go through the consent process with the non-English
 speaking person. If, after the project is approved, a short form consent process is needed,
 please see the PPHS policy and submit a modification.
     
 
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15. Consent - Documents
Consent Documents
Type
Version 6.6.17
Name
Version 6.6.17
Upload
IDEATE Version 6.6.17 clean.doc
Consent Templates
  
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Charles Ascher-Walsh
16. Data - Collection
Health Related Information Will Be
 Viewed, Recorded, or Generated
Yes
Description of Health Information That Will Be Viewed, Recorded, or Generated
Age, race, BMI, preoperative urodynamics and/ or simple cystometrics, obstetrical and gynecologic history, medical
 and surgical history.
Surgical procedures performed, if a patient passed or failed their active voiding trial.
Non-Health Related Information Will
 Be Viewed or Recorded
No
HIV / AIDS Related Information Will
 Be Viewed or Recorded
No
Data That Will Be Viewed,
 Recorded, or Generated Contains
 ANY of the Following Directly
 Identifiable Information
Yes
Will Be Viewed
Name, Medical Record Number, Telephone
 number, Email Address
Will Be Recorded
Name, Medical Record Number
Data Collection Sheet
        
        A Data Collection Sheet is required if you are either performing a retrospective review,
 or your study meets the category of exempt 4 research, or your study meets the category
 of expedited 5 research. Please upload it here.
        
    
Data Collection Source(s)
Participant, Medical Chart (Paper or
 Electronic)
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17. Data - HIPAA
Obtaining HIPAA Authorization
Yes
How PHI Will Be Protected from Improper Use or Disclosure
PHI will be saved on the password protected Mount Sinai desktop of the principal investigator.
PHI Will Be Destroyed at the
 Earliest Opportunity Consistent
 with the Research
Yes
When and How PHI Will Be Destroyed 
When statistical analysis is completed for this study, the PHI will be permanently deleted from the hard drive of the
 prinicpal investigator's computer.
PHI Will Be Shared
No
  PI must attest to the following.
  * I assure that the protected health information (PHI) will not be disclosed to any other
 person or entity not listed on this form except where required by law or for the authorized
 oversight of this research project. If at any time I want to reuse this PHI for other purposes
 or disclose it to other individuals or entities I will seek approval from the IRB. 
  
 
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18. Data - Storage
Location Where Data Will Be Stored
The data will be stored on the password protected Mount Sinai desktop of the principal investigator.
How will the data be stored?
With a Code That Can Be Linked to the
 Identity of the Participant
Research Personnel Responsible
 for:
Charles Ascher-Walsh
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Yes
Research Personnel Responsible
 for:
Annacecilia Peacher-Seaney
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
John Andrew Fantl
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Woojin Chong-Kaufman
Accessing Data
No
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Janine Doneza
Accessing Data
No
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Duration Data Will Be Stored
Until statistical analysis of the study is complete.
Steps That Will Be Taken to Secure the Data During Storage, Use, and Transmission
The data will be kept on the hard drive of the principal investigator's password protected Mount Sinai desktop.
Power Analysis/Data Analysis Plan (Including Any Statistical Procedures)
This is a two arm randomized controlled trial aimed to compare the rate of post-operative urinary retention between
 subjects given pyridium versus a control group. The primary outcome is the incidence of urinary retention measured
 prior to hospital discharge.  
 The rate of urinary retention is expected to be 25% in the control group.  The proportion of subjects experiencing a
 primary outcome event will be compared between the groups using a two-sided T-tests of proportions.  Assuming the
 proportion of patients experiencing post-op urinary retention is 25% in the control group a sample size of 48 in each
 group would give 80% power to detect a 20 percentage point reduction in urinary retention in the pyridium group. 
 Patients will be randomized using a 1:1 allocation to pyridium and control. The secondary analyses is considered


 exploratory and will be tested at the 0.05 significance level.VAS scores (ranging from 1-10) will be collected at 2- 6
 hours post-operatively.  Median score between the groups will be compared using a Wilcoxon test.
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19. Data - Safety Monitoring
More Than the Minimum Data
 Safety Monitoring Will Be Done
No
  
  The following minimum requirements apply to all projects, including retrospective
 reviews of medical records, use of tissue samples, and many minimal risk studies, such
 as observational and survey research. Because these minimum requirements apply to
 all studies, a specific written DSMP will not usually be required for projects that do not
 pose greater than minimal risk to subjects. The MSSM PPHS may alter the required level of
 monitoring if appropriate. 
  For all projects, the principal investigator must have a plan to assure that data integrity
 will be maintained during its collection, storage and analysis. All research projects
 must adhere to MSSM recommendations on the storage of research data. Loss of data
 containing identifiable information is reportable to the IRB within 5 business days.
  Any problems concerning the consent process and any subject complaints should be
 monitored by the investigator. Reports of such problems must be made at least annually.
 The discretion of the protocol director will guide the need to report these problems
 immediately or more frequently.
  The principal investigator is, typically, the monitoring entity for the minimum DSMP. When
 a principal investigator is not a faculty member, the supervising faculty member must be
 responsible for the data and safety monitoring aspect of the protocol.
     
 
Will the Research Include Data
 Coordinating Center Activities?
No
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20. Financial Administration
  This information will help the Financial Administration of Clinical Trials Services (FACTS)
 office determine whether a Medicare Coverage Analysis (MCA) is needed for the research
 study. If you have any questions while completing this form, please contact the FACTS
 office at (212) 731-7067 or FACTS@mssm.edu.
  
 
Clinical Research Study Category
Investigator Initiated
  Payment Options: 
  * Option 1:  No protocol-required services will be billed to patients or third-party payers.
 Does Not Need MCA 
  * Option 2:  Protocol-required services (i.e., routine care services) will be billed to patients
 or third-party payers. Must Have MCA 
  * Option 3:  Study is initiated and federally funded by a Government Sponsored
 Cooperative Group who will only pay for services that are solely conducted for research
 purposes and other protocol-required services (i.e., routine care services) will be billed to
 patients or third-party payers. Billing Grid Only Required, NO MCA 
  * Option 4:  Study involves only data collection and has no protocol-required clinical
 services. Does Not Need MCA 
  * Option 5:  Study is not described in any of the above options. Please describe the study
 and specify whether External Sponsor (i.e., industry, government, or philanthropic source)
 and/or patient/third party payer will pay for protocol required services. MCA MAY Be
 Required 
  
 
Payment Option
Option 1
  
  No MCA is needed per option selected above. 
  
 
  
  Payment Option 1: 
  * Option 1A:  Department/collaborating departments will act as internal sponsor paying for
 all protocol-required services and no protocol-required services will be billed to patients or
 third party payers. 
  * Option 1B:  Study involves protocol-required clinical services and an External Sponsor
 (i.e., industry, government, or philanthropic source) will pay for all protocol-required
 services. 
  
 
Payment Option 1
Option 1A
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21. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Consent - Consent
 Document
Version 9.26
1
New
IDEATE Version 9.26
 clean.doc
09/28/2017
 
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