LinkId Text Definition Answer consent-form-populate-exampleQR QuestionnaireResponse c1 Research Study c1.1 Study Title Study of Drug A for arthritis c1.2 IRB Protocol Number PRO098765 c38 Study Site ExternalDataFor_c38.1 External Data For linkId c38.1 c38.1 Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below. [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA c38.2 Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI? expandedYes-NoIndicator N: No c40 Study Site Principal Investigator and Study Site c40.1 Multi-site statement This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed. c40.3 Statement for Consent Form at Relying Site (not Lead PI Site) This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site. c40.5 Principal Investigator at Study Site c40.5.2 First Name Xi-Yang c40.5.1 Last Name Lee c40.5.6 Suffix Jr. c40.5.3 Degree(s) MD, PhD c40.5.4 Associated Institution Test Example University c40.5.8 Contact Information c40.5.8.20 Phone 6781233456 c40.5.8.21 Email XiYangLee@teu.med.edu c40.9 Study Site Institution c40.9.1 Institution Name Test Example University c40.9.2 Address c40.9.2.10 Street Address 200 Test Example Circle c40.9.2.11 City Example c40.9.2.12 State MA c40.9.2.13 Zip Code 67890 c40.9.2.14 Country United States c49 Lead Principal Investigator and Lead Principal Investigator Site c49.1 Statement about Lead PI and Lead PI Site for Consent Form at Relying Site In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information. c49.2 Lead Principal Investigator c49.2.2 First Name Jane c49.2.1 Last Name Doe c49.2.3 Degree(s) MD c49.2.5 Contact Information c49.2.5.20 Phone 567-123-1234 c49.2.5.21 Email drjanedoe@sampleuniversity.edu c49.5 Lead Principal Investigator Institution c49.5.1 Name Sample University Medical Center c49.5.2 Address c49.5.2.10 Street Address 105 Sample University Ct. c49.5.2.11 City Sample City c49.5.2.12 State NC c49.5.2.13 Zip Code 27612 c49.5.2.14 Country United States c4 Sponsor or Funding Source ExternalDataFor_c4.1 External Data For linkId c4.1 c4.1 Sponsor Name c6 Is this consent an eConsent? expandedYes-NoIndicator N: No c7 Summary Text c7.1 Summary Text Statement This field should contain a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. c8 Introduction and Statement of Research c8.1 About Consent Form This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate. c9 Purpose c9.1 Reason for Research This study is to determine the efficacy of Drug A for arthritis and whether it is more effective than the standard of care treatment. c9.2 Interactions with others Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures. c9.3 Invited Participants Candidates for this study include patients suffering from arthritis. c9.4 Total expected study enrollment 500 c9.5 Additional Enrollment Text Additional Text can be inserted here. c9.6 What is involved in the study? This study will involve an initial visit for collection of health history and demographic data, a baseline clinical visit, a follow up visit and an end of study clinical visit. c10 Assessments c10.1 Assessment List c10.1.1 Name of the Assessment Initial health history and demographic data survey c10.1.2 Description of Assessment Participants will be asked about health history and demographic background c10.1 Assessment List c10.1.1 Name of the Assessment Baseline Blood Draw c10.1.2 Description of Assessment 4 tubes of blood will be drawn c10.1 Assessment List c10.1.1 Name of the Assessment Recurring monthly blood draws c10.1.2 Description of Assessment 2 tubes of blood will be drawn c10.1 Assessment List c10.1.1 Name of the Assessment End of Study Blood Draw c10.1.2 Description of Assessment 4 tubes of blood will be drawn c10.2 Assessment Supplemental Text Additional Text about the assessments can be included here. c10.3 Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire? expandedYes-NoIndicator N: No c11 Visits and Procedures c11.1 Visit Introductory Text explain any additional detail or information about the visit schedule. c11.2 Visit List c11.2.1 Visit Type Initial visit c11.2.2 Visit Description Collection of health history and demographic data c11.2.3 Visit Duration 2 c11.2.4 Visit Duration Units Unified Code for Units of Measure (UCUM) h: h c11.2.5 Number of Visits 1 c11.2 Visit List c11.2.1 Visit Type Baseline Visit c11.2.2 Visit Description Collection of baseline measures c11.2.3 Visit Duration 1 c11.2.4 Visit Duration Units Unified Code for Units of Measure (UCUM) h: h c11.2.5 Number of Visits 1 c11.2 Visit List c11.2.1 Visit Type Follow up Visit c11.2.2 Visit Description Recurring monthly visits for blood draw and weight check c11.2.3 Visit Duration 30 c11.2.4 Visit Duration Units Unified Code for Units of Measure (UCUM) min: min c11.2.5 Number of Visits 6 c11.2 Visit List c11.2.1 Visit Type End of study visit c11.2.2 Visit Description Collection of end of study measures c11.2.3 Visit Duration 1 c11.2.4 Visit Duration Units Unified Code for Units of Measure (UCUM) h: h c11.2.5 Number of Visits 1 c11.6 Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire? expandedYes-NoIndicator N: No c11.3 Procedure List c11.3.1 Name of Procedure Weight check c11.3.2 Common Term of Procedure Weight check c11.3.3 Description of a Procedure Participants will be weighed on a scale c11.3.4 Experimental Procedure Indicator expandedYes-NoIndicator N: No c11.3.5 Research Indicator Temporary Codes STDCR: Standard of Care c11.3.6 Frequency At baseline visit, at end of study visit and at monthly follow up visits c11.3.9 Procedure Duration (minutes) 1 c11.3 Procedure List c11.3.1 Name of Procedure Baseline visit and End of Study visit Venipuncture c11.3.2 Common Term of Procedure Blood Draw c11.3.3 Description of a Procedure Phelebotomist will draw 4 tubes of blood at Baseline visit and End of Study visit c11.3.4 Experimental Procedure Indicator expandedYes-NoIndicator N: No c11.3.5 Research Indicator Temporary Codes STDCR: Standard of Care c11.3.6 Frequency At Baseline visit and End of Study visit c11.3.9 Procedure Duration (minutes) 20 c11.3 Procedure List c11.3.1 Name of Procedure Recurring monthly Venipuncture c11.3.2 Common Term of Procedure Blood Draw c11.3.3 Description of a Procedure Phelebotomist will draw 2 tubes of blood monthly c11.3.4 Experimental Procedure Indicator expandedYes-NoIndicator N: No c11.3.5 Research Indicator Temporary Codes STDCR: Standard of Care c11.3.6 Frequency monthly c11.3.9 Procedure Duration (minutes) 15 c11.4 Procedure Supplemental Text Additional Text can be captured here c11.9 Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire? expandedYes-NoIndicator N: No c11.5 Total Duration of Study Participation 7 months c12 Risks c12.1 Risk List c12.1.1 Name of the risk Bruising c12.1.2 Description of Risk Blood draw may cause some mild bruising c12.1.3 Risk Category Temporary Codes PHYS: Physical c12.9 Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire? expandedYes-NoIndicator N: No c12.2 Risk Supplemental Text Additional risk text can be included here c12.3 Fetal Risks expandedYes-NoIndicator N: No c13 Alternative Procedures c13.1 Alternative Procedure Text Participants are free to not participate at no additional risk. c14 Benefits c14.1 Benefits List c14.1.1 Name of Benefit Societal Benefit of additional knowledge c14.1.2 Description of Benefit Societal Benefit c14.1.3 Benefit to you expandedYes-NoIndicator N: No c14.1.4 Benefit to society expandedYes-NoIndicator Y: Yes c14.9 Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire? expandedYes-NoIndicator N: No c15 Compensation c15.1 Will there be compensation for participation? expandedYes-NoIndicator Y: Yes c15.2 Compensation Supplemental Text Description of compensation can be included c15.3 Compensation List c15.3.1 What types of visits or milestones will I be compensated for? Baseline c15.3.2 How many visits or milestones of this type will there be compensation for? 1 c15.3.3 How much will be paid per that type of visit? 100 c15.3 Compensation List c15.3.1 What types of visits or milestones will I be compensated for? Followup c15.3.2 How many visits or milestones of this type will there be compensation for? 6 c15.3.3 How much will be paid per that type of visit? 25 c15.3 Compensation List c15.3.1 What types of visits or milestones will I be compensated for? End of Study visit c15.3.2 How many visits or milestones of this type will there be compensation for? 1 c15.3.3 How much will be paid per that type of visit? 100 c15.5 Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire? expandedYes-NoIndicator N: No c17 Participant Rights and whom to contact for answers c17.2 Site IRB Contact Information c17.2.8 IRB Name X Pharmaceutical Research IRB c17.2.10 Street Address 210 Research Drive c17.2.11 City Sample City c17.2.12 State NC c17.2.13 Zip Code 27612 c17.2.14 Country United States c17.3 Study Coordinator Contact Information c17.3.1 Study Coordinator Name [Study Coordinator Contact Information] c17.3.8 Study Coordinator Institution or Organization [Study Coordinator Contact Information] c17.3.9 Department Name or Division [Study Coordinator Contact Information] c17.3.10 Street Address [Study Coordinator Contact Information] c17.3.11 City [Study Coordinator Contact Information] c17.3.12 State [Study Coordinator Contact Information] c17.3.13 Zip Code [Study Coordinator Contact Information] c17.3.14 Country [Study Coordinator Contact Information] c17.3.20 Phone [Study Coordinator Contact Information] c17.3.21 Email [Study Coordinator Contact Information] c17.4 Site Principal Investigator Contact Information c17.4.1 Site Principal Investigator Name Xi-Yang Lee, Jr., MD, PhD c17.4.8 Site Principal Investigator Institution Test Example University c17.4.10 Street Address 200 Test Example Circle c17.4.11 City Example c17.4.12 State MA c17.4.13 Zip Code 67890 c17.4.14 Country United States c17.4.20 Phone 6781233456 c17.4.21 Email XiYangLee@teu.med.edu c18 Participation c18.1 Voluntary Permission Statement Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. c18.2 What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent. Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions. c19 Early Withdrawal c19.1 Are there consequences to participant for early withdrawal? expandedYes-NoIndicator Y: Yes c19.2 Are there Emotional Consequences of Withdrawal expandedYes-NoIndicator N: No c19.3 Are there Physical Consequences of Withdrawal expandedYes-NoIndicator N: No c19.4 What are the consequences of withdrawal? Consequences of withdrawal should be included here. c20 Confidentiality of Records c20.1 Will HIPAA content be included within this document? expandedYes-NoIndicator Y: Yes c20.2 Medical information and billing statement Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care. c20.3 Will confidentiality be protected? expandedYes-NoIndicator Y: Yes c20.5 Are there data security or policies that need to be included in the consent, particularly around device use (optional) expandedYes-NoIndicator N: No c20.7 Who can use or see participant information? c20.7.1 Role or group who will have access to data Temporary Codes OTHINSTRES: Researchers at other institutions c20.7.2 Description of Information Disclosed Deidentified demographic data c20.7 Who can use or see participant information? c20.7.1 Role or group who will have access to data Temporary Codes THISINSTRES: Researchers outside the study team at this institution c20.7.2 Description of Information Disclosed Deidentified demographic data c20.8 Will the data be released for future use? expandedYes-NoIndicator Y: Yes c20.9 Will the future use data be deidentified? expandedYes-NoIndicator Y: Yes c20.10 Deidentification detail Only demographic data will be shared c20.11 Required text disclosure surrounding future use. Temporary Codes DEIDUSED: Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent. c21 Specimen Management c21.1 Were specimens collected as part of this study? expandedYes-NoIndicator Y: Yes c21.2 Is whole genome sequencing being conducted? expandedYes-NoIndicator N: No c21.3 Sharing or no Sharing of samples. expandedYes-NoIndicator Y: Yes c21.4 Conditions of sharing Deidentified samples will be shared with other investigators at this institution. c21.5 Will participant share in profit with commerical use? expandedYes-NoIndicator N: No c21.6 Description of Collection and Storage Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion. c21.7 Can consent for sample use be revoked? expandedYes-NoIndicator N: No c22 Will there be Broad Consent for Storage, maintenance and secondary research use? expandedYes-NoIndicator N: No c23 Can the study team contact you for future research? expandedYes-NoIndicator Y: Yes c23.1 Conditions about contact for additional sample use, information not currently described or future research Participants can be called for up to 1 year after conclusion of the study c24 Will participants share in commercial profit? expandedYes-NoIndicator N: No c25 Will the study team contact you with new information that may affect your willingness to remain in the study expandedYes-NoIndicator N: No c26 Will the study team disclose clinically relevant study results to you? expandedYes-NoIndicator N: No c27 Clinical Trials.gov statement A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. c28 Is this study covered under a Certificate of Confidentiality? (default Y in NIH) expandedYes-NoIndicator N: No c30 Statement of PHI Authorization Revocation Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared. c31 Signature c31.1 Indicator to include Participant Signature and Date/Time expandedYes-NoIndicator Y: Yes c31.2 Indicator to include Assent Signature and Date/Time expandedYes-NoIndicator N: No c31.3 Indicator to include Legally Authorized Representative Signature and Date/Time expandedYes-NoIndicator Y: Yes c31.5 Indicator to include a Witness Signature and Date/Time expandedYes-NoIndicator Y: Yes c31.6 Indicator to include Parent 1 Signature and Date/Time expandedYes-NoIndicator N: No c31.7 Indicator to include Parent 2 Signature and Date/Time expandedYes-NoIndicator N: No c32 Consent Version c32.1 Consent Version Number 2 c32.2 sIRB Version Date of Consent 2021-08-10 c32.3 Relying Site Version Date of Consent 2021-08-10 c32.6 Expiration Date of Consent 2024-08-01T03:59:59.846Z ADMIN00 Administrative Use Only ADMIN01 Link ID prefix c ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any initiate-study-populate-exampleQR ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any ResearchStudyExample-sIRB Documentation for this format
Sample University Medical Center | | Jane Doe, MD | Sample City, NC
Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
Central Campus Test University | | Maria Smith, PhD | Central, MI
Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.
Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?
Study Site Principal Investigator and Study Site
This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed.
Statement for Consent Form at Relying Site (not Lead PI Site)
This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site.
Lead Principal Investigator and Lead Principal Investigator Site
Statement about Lead PI and Lead PI Site for Consent Form at Relying Site
In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information.
Organization of Arthritis Patients Foundation
This field should contain a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate.
This study is to determine the efficacy of Drug A for arthritis and whether it is more effective than the standard of care treatment.
Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures.
Candidates for this study include patients suffering from arthritis.
This study will involve an initial visit for collection of health history and demographic data, a baseline clinical visit, a follow up visit and an end of study clinical visit.
Initial health history and demographic data survey
Participants will be asked about health history and demographic background
Additional Text about the assessments can be included here.
Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?
explain any additional detail or information about the visit schedule.
Collection of health history and demographic data
Recurring monthly visits for blood draw and weight check
Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?
At baseline visit, at end of study visit and at monthly follow up visits
Baseline visit and End of Study visit Venipuncture
Phelebotomist will draw 4 tubes of blood at Baseline visit and End of Study visit
At Baseline visit and End of Study visit
Phelebotomist will draw 2 tubes of blood monthly
Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?
Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?
Additional risk text can be included here
Participants are free to not participate at no additional risk.
Societal Benefit of additional knowledge
Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?
Will there be compensation for participation?
Description of compensation can be included
What types of visits or milestones will I be compensated for?
How many visits or milestones of this type will there be compensation for?
How much will be paid per that type of visit?
Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?
Participant Rights and whom to contact for answers
Study Coordinator Institution or Organization
Site Principal Investigator Contact Information
Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.
Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions.
Are there consequences to participant for early withdrawal?
Are there Emotional Consequences of Withdrawal
Are there Physical Consequences of Withdrawal
What are the consequences of withdrawal?
Consequences of withdrawal should be included here.
Will HIPAA content be included within this document?
Medical information and billing statement
Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.
Are there data security or policies that need to be included in the consent, particularly around device use (optional)
Who can use or see participant information?
Role or group who will have access to data
Researchers outside the study team at this institution
Will the data be released for future use?
Will the future use data be deidentified?
Required text disclosure surrounding future use.
Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
Were specimens collected as part of this study?
Is whole genome sequencing being conducted?
Deidentified samples will be shared with other investigators at this institution.
Will participant share in profit with commerical use?
Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion.
Will there be Broad Consent for Storage, maintenance and secondary research use?
Can the study team contact you for future research?
Conditions about contact for additional sample use, information not currently described or future research
Participants can be called for up to 1 year after conclusion of the study
Will participants share in commercial profit?
Will the study team contact you with new information that may affect your willingness to remain in the study
Will the study team disclose clinically relevant study results to you?
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Is this study covered under a Certificate of Confidentiality? (default Y in NIH)
Statement of PHI Authorization Revocation
Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.
Indicator to include Participant Signature and Date/Time
Indicator to include Assent Signature and Date/Time
Indicator to include Legally Authorized Representative Signature and Date/Time
Indicator to include a Witness Signature and Date/Time
Indicator to include Parent 1 Signature and Date/Time
Indicator to include Parent 2 Signature and Date/Time
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any