Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Conditions: Pelvic Organ Prolapse
Sponsor: Coloplast A/S

 
AXIS Protocol  
Cover Page 
NCT01541748 
Axis Allograft Dermis for female Pelvic Floor Repair: a Prospective Post Market 
Study  
Most recent version 24Oct2011 
 

Coloplast Corporation 
Confidential 
Investigation ID: CP009SU 
 
 
 24 October 2011 
Page 1 of 32 
 
 
 
 
 
 
 
 
 
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective 
Post Market Study 
 
 
 
Clinical Investigational Plan (CIP) 
 
 
 
 
 
 
 
Investigational Plan #: CP009SU 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This confidential document is the property of Coloplast Corp. No unpublished information contained 
herein may be disclosed without written approval of Coloplast Corp. 
 
 

Coloplast Corporation 
Confidential 
Investigation ID: CP009SU 
 
 
                         
 2011 
              Page 3 of 32 
 
 
Table of Contents 
 
Signature page ................................................................................................................ 2 
1  Protocol Summary ...................................................................................................... 4 
2  Background ................................................................................................................. 4 
3  Product Description .................................................................................................... 6 
4  Study Purpose and Design ......................................................................................... 6 
5  Objectives .................................................................................................................... 6 
6  Study Population......................................................................................................... 7 
7  Enrollment ................................................................................................................... 7 
8  Procedures .................................................................................................................. 8 
9  Study Product ........................................................................................................... 10 
10  Protocol Deviations ................................................................................................ 11 
11  Adverse Events ....................................................................................................... 11 
12  Withdrawal / Study Exit ........................................................................................... 13 
13  Electronic Case Report Forms (eCRFs)................................................................. 13 
14  Statistical Methods ................................................................................................. 13 
15  Data Quality Assurance .......................................................................................... 14 
16  Regulations and Guidances ................................................................................... 15 
17  Publication ............................................................................................................... 16 
18  Records and Retention ........................................................................................... 16 
19  
.............................................................................................................. 18 
Appendix A:  
 ......................................... 20 
Attachment 1: 
 .............................................. 22 
Appendix B:  Patient Questionnaires .......................................................................... 24 
 
 

Coloplast Corporation 
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Investigation ID: CP009SU 
 
 
                         24 October 2011 
              Page 4 of 32 
 
1  Protocol Summary 
Title 
Axis™ Allograft Dermis for female pelvic organ prolapse repair: a post market study  
Sponsor 
Coloplast Corp. 
1601 W. River Road 
Minneapolis, MN 55411 
Product 
Axis Allograft Dermis 
Study Design 
A prospective, single arm, multi-center, post market study of the efficacy of Axis™ 
Allograft Dermis for anterior, posterior or combined female pelvic floor repair. 
Primary 
Objective 
POP-Q Stage improvement from baseline at 1 year post operatively, categorized as 
cure, improved or failed. 
Secondary 
Objective 
 
POP-Q Stage at 6 weeks, 6 months, 2 year, and 3 year follow-up 
 
Brief Entrance 
Criteria 
 
Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or 
higher as determined by POP-Q prolapse grading requiring surgical 
intervention in the anterior, posterior or combined (anterior and posterior) 
compartment. 
 
Must be willing and able to complete all follow-up visits and procedures 
indicated in this protocol 
 
No prior prolapse implant or procedure 
 
No concurrent surgical treatment of prolapse using anything other than Axis  
 
No history of previous pelvic radiation 
 
No severe urogenital atrophy 
 
No immunosuppression and/or current systemic steroid use 
 
No contraindication to the surgical procedure 
Visit Schedule 
Study visits will take place at baseline, implant/hospitalization, 6 weeks, 6 months, 1 
year, 2 years, and 3 years post operatively. 
Scope 
This study will target enrollment of 70 to 100 subjects at 5 to 10 US investigative 
sites. 
2  Background 
A woman's organs can shift position overtime as she ages or, in some cases, it can happen without any 
notice or warning.  Pregnancy, childbirth, genetic predisposition, menopause, prior pelvic surgery, 
connective tissue disorders, and factors associated with elevated intra-abdominal pressure such as 
obesity, chronic constipation, and excessive straining can stretch and weaken the muscles that support 
the pelvic organs.  A sheet of muscles, ligaments, and connective tissue called the pelvic floor supports 

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                         24 October 2011 
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the uterus, small intestine, colon and bladder.  If pelvic floor muscles are weak, the organs may drop, 
protruding into the vagina causing a Pelvic Organ Prolapsed (POP). 
 
This condition affects millions of women and with the advancing age of the U.S. population, health care 
providers are likely to encounter women with pelvic organ prolapse with greater frequency.  A woman’s 
lifetime risk (up to the age of 80 years) for undergoing prolapse surgery has been estimated at 11 
percent1.  Approximately 200,000 inpatient procedures for prolapse are performed annually in the United 
States alone2.   
 
Pelvic organ prolapse can be categorized into four areas: 
 
Cystocele or anterior prolapse:  When the vaginal wall weakens and allows the bladder to 
protrude into the vagina from above. 
 
Vaginal vault or uterine prolapse:  When the top of the vagina loses its support and drops. 
 
Rectocele or posterior prolapse:  When the back of the vagina weakens and allows the rectum to 
protrude into the vagina. 
 
Enterocele:  When the small intestine drops and protrudes into the vagina.  This usually occurs in 
conjunction with one or more of the other types of prolapse listed above. 
 
Depending on the severity and stage of prolapse, many women do not need treatment.  Some women 
find that their symptoms are relieved through special pelvic muscle exercises call Kegel Exercises, which 
are used to strengthen the muscles that surround the opening of the urethra, vagina, and rectum.  Making 
dietary changes, maintaining a healthy weight, not smoking, and avoiding heavy lifting and straining also 
help to relieve symptoms.  Medication is available to help treat urinary and bowel symptoms of POP.  
Further, a device called a pessary can be inserted into the vagina to support the pelvic organs.  For 
women who can be fitted properly and whose pelvic organ support can be maintained with a pessary, this 
form of treatment has a high probability of success. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 

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                         24 October 2011 
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3  Product Description 
Coloplast’s Axis™ Allograft Dermis consists of 
, preserved human 
collagen.  
 
 
 
 
 
 
 
   
4  Study Purpose and Design 
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ 
Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse 
repair.  Target enrollment is 70-100 subjects enrolled at 5 to 10 investigational sites in the United States.  
 
5  Objectives 
5.1  Primary Objective 
The primary objective of this study is to evaluate efficacy of the Axis Dermis graft used for soft tissue 
repair, replacement, reconstruction, or augmentations in the correction of POP as assessed by POP-Q 
Stage improvement based upon an objective grading of prolapse of the anterior, posterior or combined 
anterior and posterior (assessed individually) compartment(s) compared between baseline and one year.  
Grading of the prolapse will be categorized as follows: 
 
Cured:  POP-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline 
 
Improved:  POP-Q Stage > 1, but improved by 1 stage from baseline 
 
Failed:  POP-Q Stage stayed the same or increased in severity from baseline 
 
5.2  Secondary Objectives 
Secondary objectives will assess POP-Q Stage and patient satisfaction at 6 weeks, 6 months, 2 years, 
and 3 years post implant, as follows: 
 
Change in prolapse stage from baseline as determined objectively by POP-Q prolapse 
grading at 6 weeks, 6 months, 2 year, and 3 year follow-ups. Change in patient satisfaction 
from baseline and quality of life measured through validated questionnaires (PDFI-20 and 
PFIQ-7)6 
 
Change in patient sexual satisfaction from baseline measured through a validated 
questionnaire (PISQ-12)7 
 
Summary of Patient Global Impression of Improvement (PGI-I) for urogenital prolapse9 
results 
 
Summary of The Institute for Female Pelvic Medicine & Reconstructive Surgery Surgical 
Satisfaction Questionnaire (SSQ-8) results10 
 
Change in Pelvic and Sexual Health Institute Visual Analog Scale (VAS)11 results 
 
Surgical revision rate of the index prolapse(s) 
 
Summary of all mild, moderate, and serious product and/or procedure related adverse events 

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6  Study Population 
6.1  Participant Population 
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage > 2 that are 
clinically indicated for surgical intervention with Axis human tissue in the anterior, posterior or combined 
(anterior and posterior) compartments at the institutions designated for this study.  All study candidates 
must be able to understand the nature of the procedure, provide written informed consent, and be 
available for follow-up at an approved investigational site.   
 
6.2  Number of Participants 
This study will target enrollment at 70-100 subjects at 5 to 10 investigational sites in the US. 
 
6.3  Inclusion Criteria 
Patients must meet all of the following criteria to be included in the study: 
1. Adult female at least 18 years of age. 
2. Willing and able to provide written informed consent. 
3. Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse 
grading requiring surgical intervention in the anterior, posterior or combined (anterior and 
posterior) compartment. 
4. Willing and able to complete all follow-up visits and procedures indicated in this protocol. 
 
6.4  Exclusion Criteria 
Patients who meet any of the following criteria are excluded from entry into the study: 
 
1. Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.  
[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is 
allowed]. 
2. Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a 
compartment that is not being repaired in the same procedure.  (Concurrent POP-Q Stage 1 
repair is at the physician’s discretion.) 
3. Previous pelvic organ prolapse repair using biologic, or synthetic grafts.  [Note: previous mid-
urethral sling for treatment of stress urinary incontinence is allowed] 
4. Pregnant or a desire to become pregnant in the future. 
5. Previous radiation or other treatments for cancer in the pelvic area. 
6. Severe urogenital atrophy. 
7. Immunosuppression and/or current systemic steroid user. 
8. Any contraindication to the surgical procedure. 
7  Enrollment 
After it has been determined that a potential study participant meets the entrance criteria and prior to data 
being collected, an informed consent must be obtained.  There is no formal screening process outside of 
standard of care procedures required to determine participant eligibility. 
 
 
Once it is determined the 
participant meets all of the inclusion and none of the exclusion criteria, they are considered enrolled in the 
study.  When they are enrolled they will receive a subject number.   
 

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                         24 October 2011 
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8  Procedures 
Clinical data will be collected at baseline, implant, 6 weeks, 6 months, 1 year, 2 years, and 3 years post-
operatively.  The Data Collection Schedule below provides an outline of what clinical and participant data 
is collected at each visit (Table 1). 
 
 
8.1  Data Collection Schedule  
8.2  Baseline 
The following will be collected at baseline: 
 
Consent Form Obtained 
The signed and dated consent form will be obtained prior to any study information being 
collected at the Baseline Visit. 
 
Entrance Criteria Verified 
The inclusion/exclusion criteria will be verified at the Baseline Visit. 

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Demographics, Medical History 
Participant demographics, medical history related to pelvic organ prolapse, and other 
relevant medical history will be collected. 
 
Subject evaluation/examination required within 6 months of the implant procedure 
 
Objective POP-Q prolapse grading 
 
 
Clinical exam 
 
Other Symptoms 
 
Urinary symptoms 
 
Colo-rectal symptoms 
 
Incontinence measures, if applicable and standard of care (Uroflowmetry, 
Cystoscopy) 
 
Participant Questionnaires required within 6 months of the implant procedure.  
 
Pelvic Floor Distress Inventory Short Form (PFDI-20) 
 
Pelvic Organ Prolapse/ Urinary Incontinence Sexual Function Questionnaire (PISQ-
12) [for sexually active subjects] 
 
Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) 
 
Pelvic and Sexual Health Institute Visual Analog Scale (VAS) 
8.3  Implant Procedure 
The surgical technique for POP repair using tissue is widely variable and dependant on physician training 
female anatomy, and preference.  
 
 
 
 
     
 
The implant of Axis will be documented on the Procedure Form. In addition, study product or procedure 
related adverse events will be recorded. 
 
The Initial Implant Procedure Form should be entered into the database within 72 hours after the implant 
is completed. 
 
8.4  Follow-Up Schedule 
Follow-up visits are required at 6 weeks, 6 months, 1 year, 2 years, and 3 years post implant.  If the 
participant misses any required follow-ups, a Study Deviation Form must be completed.   Every attempt 
should be made to complete the visit, however, if the subject cannot be seen in person the required 
questionnaires should be mailed to the participant with a postage paid return envelope.  If a scheduled 
visit is not within the follow-up window, the visit should still be completed as soon as possible and a Study 
Deviation Form completed. 
 
Table 2 Follow-up Schedule & Visit Windows 
Follow-Up 
Window Start 
Target Day 
Window End 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
   
 
 
 
 

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8.5  Follow-Up Visits 
 
 
 
 
8.6  Revision Procedure 
If during the follow up period a subject requires urogynecological surgery (i.e. additional or revision POP 
repair, mid-urethral sling, hysterectomy, etc.), complete the Revision Form.  If a revision procedure is 
performed as the result of an adverse event (e.g. infection, rejection, pain), complete the Adverse Event 
form in addition to the Revision form. 
 
 
 
9  Study Product 
All investigative sites will be required to maintain an adequate stock of Axis Dermis. The lot number and 
size of each product used will be recorded on the Procedure Form. 

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10  Protocol Deviations 
A protocol deviation is defined as an event where the clinical investigator or site personnel did not 
conduct the study according to the clinical investigational plan or the investigator agreement.  All protocol 
deviations must be documented on a Study Deviation Case Report Form. 
 
Reporting of protocol deviations should comply with local IRB policies and/or local laws.   
11  Adverse Events 
11.1 Adverse Event Definitions 
An Adverse Event (AE) is any undesirable clinical occurrence in a participant regardless of whether or not 
it is related to the product or procedure.  Any pre-existing condition that exhibits a change in nature, 
severity, or degree of incidence is also considered an AE. 
 
A Serious Adverse Event (SAE) is an Adverse Event that results in one or more of the following 
outcomes: 
 
Life Threatening: The participant was at eminent risk of dying at the time of the adverse 
event. 
 
Permanent Impairment: An adverse event that resulted in permanent impairment of a 
body function or permanent damage to a body structure. 
 
Necessitates Intervention: An adverse event that resulted in a condition that necessitates 
medical or surgical intervention to preclude permanent impairment of a body function or 
damage to a body structure. 
 
Hospitalization/Prolongs Hospitalization: Requires inpatient hospitalization or prolongs an 
existing hospitalization. 
 
Results in Death: An adverse event that results in the participant’s death. 
 
 
An Adverse Reaction (AR) is a noxious and unintended response to any Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps) for which there is a reasonable possibility that the HCT/P 
caused the response.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11.2 Adverse Event Classification 
The investigator will be asked to assess the relationship of the event to the implanted product, the implant 
procedure, and the presence or performance of the tissue itself for each adverse event reported. 
 
A product related adverse event is an Axis Dermis related adverse event that results from the presence or 
performance of the product.  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A procedure related adverse event is an adverse event that occurs due to the implant procedure.  
Procedure related events can include, but are not limited to: 
 
Adhesion 
 
Anaesthesia reaction 
 
De Novo dyspareunia 
 
Fistula formation 
 
Hematoma 
 
Infection 
 
Inflammation 
 
Major nerve supply injury 
 
Major vascular injury 
 
Nerve injury or damage 
 
Pain (lasting >6 weeks post-operatively) 
 
Perforation (e.g. bladder, urethra, ureter, and bowel) 
 
Urinary Retention directly related to the procedure and requiring surgical intervention 
and/ or prolonged catheterization lasting greater than 28 days 
 
Voiding dysfunction not including urinary retention (e.g. Dysuria or obstruction) 
 
Wound dehiscence 
 
11.3 Adverse Event Reporting Requirements 
Any mild, moderate, or severe adverse events possibly or probably related to the product and/or 
procedure, including Adverse Reactions, must be reported for purposes of this study protocol.    
 
Any Serious Adverse Events, including Adverse Reactions, possibly related to the product and/or 
procedure must be reported to the Sponsor within 10 working days.  
 

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11.4  Adverse Event Review 
An Independent Medical Advisor will review all Serious Adverse Events and Adverse Reactions on a 
periodic basis to be determined by nature and number of reported serious adverse events. 
12  Withdrawal / Study Exit 
In the event that a participant is unable or unwilling to continue participation in the study, notify Coloplast 
as soon as possible.   
 
If a participant expresses the desire to withdraw from the study, a Withdrawal / Study Exit Case Report 
Form must be completed.  The reason for participant withdrawal must be documented on this form.   
 
In the case that the participant fails to comply with the follow-up schedule, the study site must make 
multiple attempts to contact the participant (e.g. telephone, registered mail).  Each attempt to contact the 
participant must be documented in the participant’s records.  In the case that the participant is determined 
to be lost to follow-up, a Withdrawal / Study Exit Case Report Form must also be completed.   
 
Participants will be considered to have completed the study after their two year follow up visit has been 
completed and all outstanding adverse events have been resolved or are permanently ongoing. 
13  Electronic Case Report Forms (eCRFs) 
The eCRFs are designed to accommodate the specific features of the study design and will be used to 
capture study specific data and store in a secured FDA 21 CFR 11 compliant database.  Training will be 
provided for all study personnel entering data into the electronic database prior to being given access to 
the database.   
 
Sites will enter data on eCRFs using Electronic Data Capture (EDC).  All visit information will be captured 
in the EDC system.  
 
  
 
The data from the questionnaires will be entered by the site into the EDC system after 
completion. 
 
The investigator or relevant staff member who has signed the eCRF Authorization Log may complete the 
eCRF. The investigator will review all eCRFs for completeness and electronically sign the forms. 
14  Statistical Methods  
The key endpoints are specified below: 
 
Efficacy:  Efficacy metrics will include objective POP-Q prolapse grading as well as patient 
satisfaction (as measured by subject questionnaires) post-operatively at 
 
 
 
Safety:  Safety will be measured through procedural and product related adverse events.  
Procedural complications will be collected during hospitalization.  Serious product and procedure 
related events will be collected through 3 years post implant via the Adverse Event Form.  
 
 
 

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14.1 Sample Size 
In the absence of predefined hypotheses, the desired sample size is based on the precision of estimates 
and half-widths of confidence intervals. The target enrollment cohort of 70 to 100 will provide between 60 
and 85 evaluable subjects at month 12 
 
 
   
 
Table 3 Sample Size Calculations 
14.2 Statistical Analysis 
 
 
  
 
  
 
 
 
 
  Results will be 
compared to competitive products from the available literature. 
 
The primary analyses will include all subjects enrolled and followed. Additional analyses will be conducted 
where results are tabulated separately for subjects who require a revision procedure in one or both 
compartments and receive a product other than Axis Dermis and those who do not receive any additional 
product other than Axis Dermis during study follow-up.  
15  Data Quality Assurance 
15.1  Data Management 
Coloplast will be responsible for data management and statistical analysis.  Edit checks will be created for 
quality control of all data collected.  Data will be subjected to initial inspection for omitted data, data 
inconsistencies, and deviations.  The resolution of any inconsistencies will be resolved through Data 
Query Forms (DQFs).  The site will be asked to review and respond to the DQFs generated by Coloplast. 
 

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15.2  Monitoring 
It is the responsibility of Coloplast to ensure that proper monitoring of this investigation is conducted.  
Appropriately trained personnel appointed by the study sponsor will perform all monitoring that is done 
and will ensure that the investigation is conducted in accordance with the Monitoring Plan, the signed 
Investigator Agreement, and applicable laws. 
 
During the period of the investigation, monitoring will be performed at the study site to assure compliance 
with study protocol.  The monitor must be allowed access to the participant’s files.  The monitor will review 
the participant’s records and consent forms and regulatory and study management documents to assess 
the accuracy of the data and study progress.  Any concerns that result from this review will be 
documented and discussed with site personnel.  The site investigator or delegated research staff will work 
with the monitor to resolve all queries.  Resolution of these items and completion of assigned tasks will be 
documented by the monitor. 
 
Monitoring visits will occur based on enrollment rates, duration of the study, site compliance, and data 
quality at each investigative site.  Monitoring visits will be performed at least once at all enrolling sites.  
For sites that do not enroll participants, a telephone closeout visit will be completed. 
 
15.3  
 
 
 
 
 
 
16  Regulations and Guidances  
 
 
 
  
 
 
 
  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
    
Further, this study will be registered on www.ClinicalTrials.gov. 
 
16.1  Consent 
All participants will be required to sign an Informed Consent Form for participation in this study.  In order 
to obtain informed consent, each participant must be informed about the investigation, acknowledge that 
participation is voluntary, and sign and date a consent agreement prior to collection of any study-related 
data. The Informed Consent should be provided to the participant in a language that he/she can read and 
understand.  After the information contained in the Informed Consent document has been reviewed with 
each participant, the participant must sign and date the document, indicating willingness to participate in 

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the clinical study.  In the event the participant cannot read, witnessed informed consent will be allowed.  
The participant should be given a copy of the Consent Form. 
 
16.1.1  Requirements 
A sample informed consent document suitable for use in this study, including the elements of informed 
consent in conformance with 21 CFR Part 50 will be provided by the sponsor.  Iterations of this document 
must also include the elements of informed consent in conformance with 21 CFR Part 50 and should be 
approved by the sponsor prior to IRB review.  Participants must be presented with the most current, IRB 
approved version of the consent form for signature and enrollment. 
 
16.2  Institutional Review Board 
This protocol and/or other relevant documents should be submitted to the appropriate local Institutional 
Review Board (IRB).  Written approval must be obtained before commencement of the investigation. 
Approval obtained from the local IRB should document the version of the protocol and consent for that is 
being approved. 
 
Any amendment to the protocol that impacts the conduct of the study will also be submitted to the same 
IRB. 
 
16.3  Data Protection 
All information collected during the course of this investigation will be kept strictly confidential. Any 
information that could identify a participant will remain with the investigator where it will be archived with 
study documents. Participants will remain anonymous for the purposes of data analysis.  Data collected 
for the purposes of this study should be made available for Coloplast at all monitoring visits. 
 
Should the investigation require future review, it may be necessary to allow limited access to Coloplast 
and regulatory authorities for audit purposes only. 
17  Publication  
Coloplast will form a publication committee that includes at a minimum the Study Principal Investigator 
and at least one other participating investigator. The committee will develop a publication strategy in 
collaboration with Coloplast. The scientific validity and timing of publications will be evaluated in order to 
maximize the benefits derived from the publication of the clinical data of the study. 
18  Records and Retention 
18.1  Sponsor Responsibilities 
Coloplast, the study sponsor will maintain the following records: 
 
All correspondence which pertains to the investigation 
 
Signed Investigator Agreements, financial disclosure information, and current curriculum 
vitae 
 
IRB approval correspondence 
 
Adverse events, deaths, and complaints 
 
All case report forms submitted by investigator, samples of informed consents/ applicable 
privacy protection authorizations, investigational plan and report of prior investigations 
 
Study training records for all site personnel  

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Monitoring reports 
 
Study reports 
 
 
18.1.1  Sponsor Reports 
The following table details submission requirements for each report.  
 
Table 4 Sponsor Reports 
Report 
Submit To 
Description 
 
Adverse Reaction 
Investigators’ IRBs and 
FDA, as applicable 
Notification within 15 working days after 
the sponsor first learns of the effect. 
 
Withdrawal of Local 
IRB approval 
Investigators’ IRBs 
Notification within 5 working days. 
Recall and product 
disposition 
Investigators’ 
IRBs, as applicable 
FDA/ Applicable 
Competent Authorities 
Notification within 30 working days; will 
include the reasons for any request that 
an investigator return, repair, or otherwise 
dispose of any products. 
Progress Reports 
 
Investigators’ 
IRB, as applicable 
Annually 
Final report 
Investigators’ 
IRB, as applicable 
Coloplast will notify the investigators of 
the completion or termination of the 
investigation.  Investigators will, in turn, 
inform their IRBs.  A final report will be 
submitted to the investigators and IRBs 
within six months after completion or 
termination of this study. 
 
18.12  Records Retention 
The sponsor will archive and retain all remaining documents pertaining to the investigation for a minimum 
of 10 years. 
 
18.2  Investigator Responsibilities  
In addition to the requirements stated in the investigator agreement, the investigator is responsible for the 
preparation (review and signature) and retention of the records cited below.  All of the records below, with 
the exception of case history records, should be kept in the Investigator Site File (i.e., the study binder 
provided to the investigator).  The following records are subject to inspection and must be retained 
according to the agreed upon timeframe in the investigator agreement (or longer as local law or hospital 
administration requires) after study closure. 
 
All substantial correspondence that pertains to the conduct of the investigation.  Any 
correspondence describing rationale for decisions made affecting participant safety and 
privacy or data collection and reporting is considered substantial correspondence. 
 
Participant's case history records including: signed informed consent/applicable privacy 
protection authorization form; observations of adverse events/adverse device effects; 
medical history; implant and follow-up data; documentation of the dates and rationale for 
any deviation from the protocol. 

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Appendix B:  Patient Questionnaires 
 
 
 
 

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