P4 008 - Formative Human Factors Study for a Pre-filled Pen (PFP)


KDA Marktforschung GmbH

Bruchstraße 5

60594 Frankfurt, Germany

 

Phone: +49 69 973077-0

Fax: +49 69 973077-20

E-Mail: info@kdagmbh.de

Website: https://kdagmbh.de

 

 

 

 

INFORMED CONSENT TO TAKE PART IN A RESEARCH STUDY

 

TITLE OF STUDY:               P4 008 - Formative Human Factors Study for a Pre-filled Pen (PFP)

 

INVESTIGATOR:                 KDA Marktforschung GmbH, Thomas Jahnke

TELEPHONE:                     +49 69 9730 77 11

SPONSOR:                         Sanofi

You are being asked to participate in a research study. It is important that you read the following explanation of what we plan to do in this study and how it might affect you. The investigator or a member of the investigator team will review the study procedures and answer any questions you have about the study or the consent form.

When you feel you understand the study well enough, you will be asked if you agree to take part. If you agree, you will be asked to sign this consent form. You will be given a signed and dated copy of this consent form to take home with you.

Your participation in this study is voluntary. You can quit the study at any time without affecting any future medical care or losing any benefits to which you are entitled.

 

Purpose: The purpose of this study is to evaluate a study device to be used for injecting a medication to treat chronic disease. This study is NOT testing you or your skills or knowledge. The study sponsor wants to understand if the device will work well for actual users.

 

Procedure:

Your study session, that will take about 60 minutes. We will ask you to complete a series of tasks using the device and associated instructions and then ask your opinions about the device and your experience.  Up to 75 people will take part in this study. You will:

  • Receive an introduction to the study
  • Sign and date this consent and non-disclosure form
  • Answer some questions about yourself
  • You will perform a simulated injection into an injection pad as if you were at home giving the injection to yourself or a person you take care off for the first time on your own.
  • Following the injection, you will be asked some questions about the instructions for use.

 

PLEASE NOTE CAREFULLY:

You will NOT receive or give an injection to yourself or to any other person during this study. The device you will use in this study does not contain active medication.  

 

The device you will use will contain a needle. You will not be injecting yourself or anyone else with this study device. You will perform the injections into a plastic injection pad. 

 

Again, you will never be asked to actually inject yourself or others.

 

To further understand your thoughts about a new device, sponsor representatives may observe your participation in the study interviews either on site or via audio/video transmission.

 

You do not have to answer every question or complete every task. However, we would like you to take the questions and complete the tasks seriously as you would do in your daily life.

 

Confidential Research: This study is confidential. That means that only members of the research team, the study sponsor, its collaborators in the research study, and their affiliates, representatives, and agents (including laboratories and other third-party contractors working in connection with the study), have access to the information you gave. Any information you provide will be kept strictly confidential: your name will not be associated with this information. Instead a unique identification number will be assigned to each participant as a means of identification. During our analysis, and in any reports or other presentations of this research, your data will be identified with that number only.

 

Risks: The devices you will use in this study does not contain drug and they have real needles attached. Because the devices will have needles, there is a chance that you could get stuck with the needle. Accidental needlestick can possibly lead to pain, bleeding, and infection. However, the investigator and team will take care to keep this from happening. The device will not contain real medication. If accidental contact does occur, notify the study team as the area needs to be washed immediately.

There is a risk that your personal information could be shared by accident or stolen but this is unlikely.

 

Compensation: You will be compensated for your time and will receive a monetary honorarium for your participation. This will be

  • $125 for participating in a 60 minutes study session including the preparation and recruitment.
  • $100 maximum per hour as an additional reimbursement for your travel time if needed.

Full payment will be made if early withdrawal occurs at the discretion of the Manufacturer/Sponsor.

 

Benefits: As a research participant, you will not benefit directly from this research.

 

Alternatives to Participation: Since this study is not intended to provide any therapeutic or other health-related benefit, your other choice is not to participate in this study.

 

Costs: There are no direct costs to you for taking part in this study.

 

Compensation for Injury: If you are injured by being in this research study, you will be referred to your physician or the nearest medical facility for medical treatment. You or your insurance will be billed for the cost of treatment by the medical facility where you receive treatment. Neither the study Manufacturer/Sponsor nor KDA will pay for any necessary medical costs related to the treatment of your injury (related to taking part in this research or otherwise) that is not paid by your insurance or any other payor. If you are injured, there is no money set aside for lost wages, discomfort, disability, etc. Please inform the Investigator or staff immediately if you believe you have been injured because of your participation in this study.

 

Inventions, Discoveries, Non-disclosure, and Improvements: You agree that you will not disclose any information to a third party or use information for your own benefit. You agree that you will not disclose any ideas, concepts, or designs relating to any products or potential products, methods, client identities, business leads, and relationships, intellectual property of various kinds, or other confidential information of the study’s sponsor, which you might learn over the course of this study.

 

Data Privacy: During the sign-up process you have provided personal data, and possibly will provide more personal data, about your age, medical conditions, experience with injections, etc. Your personal data will be part of information that the investigator and investigator team will collect over the course of the study. It will be used for the purposes of this study only. This information is secured to protect your privacy. Any information you provide us, will not be shared with others, except for research, quality assurance, and/or legal purposes, as described below. Your name will not be associated with your personal data. Instead, the investigator and investigator team will assign you a unique ID number to keep your identity private. No one will be able to link your study data to your name or other identifying information.

The sponsor needs your data and information to check whether study data is valid and accurate, for example when the results of this study are presented to government authorities, e.g. the U.S. Food and Drug Administration (FDA), may request to see these records and they may retain copies of them.

At any time, you are allowed to see, correct, and limit access to your personal data.

If you have complaints about personal data privacy, you can send your complaint to: Centralized Case Management Operations, U.S. Department of Health and Human Services, 200 Independence Avenue, S.W., Room 509F HHH Bldg., Washington, D.C. 20201. (https://www.hhs.gov/hipaa/filing-a-complaint/complaint-process/index.html )

 

Future Use and Retention: The data collected during this study will be stored with other documents for the development of the sponsor’s healthcare product(s). Your data and some of the background information you gave us (such as age- and experience with injections) will only be labeled with your participant number. After the study report is finalized, the investigator will permanently remove all links between your personal information and your participant number. After that time, the study data will be anonymous because it will not be possible to connect the data with your name anymore. The investigator and team will keep your name and contact information in case an injury occurs so that they can follow up with you afterward if needed, but they will not keep a record of what your participant number was.

 

Audio and Video Recording:  You will be videotaped during the study interview sessions. You may decide not to give permission for audio and video recording of your session. In that case, you will not be able to participate in the study. This is because the investigator and team would not be able to collect the data needed to evaluate the device. 

During the interview sessions, cameras will be set up in a way to protect your identity. Every attempt will be made to not capture your face. All videos will be reviewed within four (4) weeks after the study is completed for instances of identifying information. If any identifying information is visible in the video, that video will be either de-identified or it will be deleted permanently.

If you do allow the investigator and team to audio and videotape your interview session, these recordings may be used for later review and analysis (if necessary). Your comments will not be transcribed, and the recordings will be labeled with the date of the session and your participant number only (not your name). The recordings will be digitally stored on a password-protected computer(s). The computer(s) will be accessible only to the investigator and team.

 

Termination of Your Participation by investigator or sponsor: The investigator or the sponsor can ask you to leave the study if:

  • you do not meet the study requirements,
  • the study is cancelled by the sponsor, or
  • for any other reason.

 

Whom to Contact About this study: During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns, or complaints about the study, please contact the investigator at the telephone number listed on the first page of this consent document.  If you seek emergency care, or hospitalization is required, alert the treating physician that you are/were participating in this research study. 

 

An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects.  If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, contact: Core Human Factors IRB at (610) 668-CORE (2673) or irb@corehf.com. Core Human Factors IRB has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean Core Human Factors IRB has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

 

Volunteer’s Statement

Based on my understanding of the requirements and risks of this research:

I understand that I will not be asked to inject anything into my body or anyone else’s body.

I understand that if I am injured, I must immediately notify the investigator, who will assist me in seeking medical attention.

I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction.

I understand that my participation in this research project is voluntary. I know that I may quit the study at any time without affecting my future medical care or losing any benefits to which I am entitled. I also understand that the investigator in charge of this study may decide at any time that I should no longer take part in this study.

 

I agree that I will not disclose to any third party, or use for my own benefit, any ideas, concepts, designs, or any information relating to any products or potential products, methods, client identities, business leads, and relationships, intellectual property of various kinds, or other confidential information of the study’s sponsor, which may be disclosed to me over the course of this study.

 

If I have any questions about my rights as a research subject in this study, I may contact KDA

 

By signing this form, I have not waived any of my legal rights.

 

I have read the above information. I agree to participate in this study. I will be given a copy of this signed and dated form for my own records.

 

 

 

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Zertifikat
Document name: P4 008 - Formative Human Factors Study for a Pre-filled Pen (PFP)
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5. August 2024 16:39 CETP4 008 - Formative Human Factors Study for a Pre-filled Pen (PFP) Uploaded by KDA Marktforschung - consent@kdagmbh.de IP 37.24.207.110
5. August 2024 18:07 CETKDA GMBH - consent@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:51ea:79db:4a1d:24c7
7. August 2024 17:15 CETKDA GMBH - consent@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
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20. September 2024 18:51 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:80e:4ea6:a2a:dec
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20. September 2024 18:51 CETSue LaGrippe - sue@lagripperesearch.com added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:80e:4ea6:a2a:dec
24. September 2024 15:43 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
24. September 2024 15:43 CETChimezie Amaefule - Chimezie.amaefule@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
24. September 2024 15:43 CETSue LaGrippe - sue@lagripperesearch.com added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
27. September 2024 12:07 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:807f:462c:618e:e53a
27. September 2024 12:07 CETChimezie Amaefule - Chimezie.amaefule@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:807f:462c:618e:e53a
27. September 2024 12:07 CETMaggie Barber - maggie@lagripperesearch.com added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 2a02:908:192:fa80:807f:462c:618e:e53a
9. October 2024 10:14 CETJoshua Valentin - joshua.valentin@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. October 2024 10:14 CETChimezie Amaefule - Chimezie.amaefule@kdagmbh.de added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
9. October 2024 10:14 CETMaggie Barber - maggie@lagripperesearch.com added by KDA Marktforschung - consent@kdagmbh.de as a CC'd Recipient Ip: 37.24.207.110
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