# entry[].resource.text.div
            Comorbidity? YES
              Cardial Comorbidity? YES
                Angina? YES
                MI? NO
              Vascular Comorbidity?
                (no answers)
              ...
            Histopathology
              Abdominal
                pT category: 1a
              ...

# entry[].resource.item[].item[].answer[].valueString
A phase II, randomized, double-blind, placebo-controlled, multi-center study of the effects of XXXX on infarct size in participants with diabetes mellitus presenting with acute myocardial infarction.

# entry[].resource.item[].item[].answer[].valueString
A phase II, randomized, double-blind, placebo-controlled, multi-center study of the effects of XXXX on infarct size in participants with diabetes mellitus presenting with acute myocardial infarction.

# entry[].resource.item[].answer[].valueCoding.display
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical Practice (ICH GCP) and the following: tUnited States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must be obtained before any participant is consented. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.

# entry[].resource.item[].item[].item[].answer[].valueString
A phase II, randomized, double-blind, placebo-controlled, multi-center study of the effects of XXXX on infarct size in participants with diabetes mellitus presenting with acute myocardial infarction.

# entry[].resource.item[].item[].item[].answer[].valueString
A phase II, randomized, double-blind, placebo-controlled, multi-center study of the effects of XXXX on infarct size in participants with diabetes mellitus presenting with acute myocardial infarction.

# entry[].resource.item[].item[].item[].answer[].valueString
This a a A phase II, randomized, double-blind, placebo-controlled, multi-center study of the effects of XXXX on infarct size in participants with diabetes mellitus presenting with acute myocardial infarction.

# entry[].resource.item[].item[].item[].text
Accrual Ceiling/Number of Participants (projected-for all sites)

# entry[].resource.item[].item[].item[].text
Statistical Analysis/Methodology (Limit discussion to primary end point and the main secondary endpoint)

# entry[].resource.item[].item[].item[].text
Data and Safety Monitoring Plan (who will be responsible for the data quality management and ongoing safety of subjects?)

# entry[].resource.item[].item[].item[].text
Describe the relevant literature and the specific gaps in current knowledge that this study intends to address

# entry[].resource.item[].item[].item[].answer[].valueString
This section should contain a background discussion of the target disease state to which the investigational product(s) hold promise and any pathophysiology relevant to potential study treatment action.Provide an overview of the literature and data relevant to the trial, which help to support the rationale for the trial. Discuss importance of the study and anyrelevant treatment issues or controversies.Also include the relevant literature establishing the validity of any scales, evaluation tools, etc. which may be used in the study to assess study endpoints. References should be listed in section 17.

# entry[].resource.item[].item[].item[].text
Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge:

# entry[].resource.item[].item[].item[].text
Is this is the first time the study drug, device, or intervention/procedure will be used in humans.

# entry[].resource.item[].item[].item[].text
If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date:

# entry[].resource.item[].item[].item[].text
Name and Description of the Investigational Product

# entry[].resource.item[].item[].item[].item[].answer[].valueString
name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable.

# entry[].resource.item[].item[].item[].item[].item[].text
Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment:

# entry[].resource.item[].item[].item[].item[].item[].text
Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study.

# entry[].resource.item[].item[].item[].item[].item[].text
Is the active control an established effective intervention?

# entry[].resource.item[].item[].item[].text
State the problem or question (e.g., describe the population, disease, current standard of care, if one exists, and limitations of knowledge or available therapy) and the reason for conducting the clinical trial

# entry[].resource.item[].item[].item[].item[].text
List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the subjects related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks:

# entry[].resource.item[].item[].item[].item[].text
State which study interventions may have unknown risks:

# entry[].resource.item[].item[].item[].item[].text
State which study interventions may have risks to an embryo or fetus (if a subject is or becomes pregnant) or to a nursing infant of a study subject:

# entry[].resource.item[].item[].item[].item[].text
Describe risks to people other than the participating subject, e.g., risks to family members, friends, others or risks to the community:

# entry[].resource.item[].item[].item[].item[].text
Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?

# entry[].resource.item[].item[].item[].item[].text
Describe the potential benefits that individual subjects may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits:

# entry[].resource.item[].item[].item[].item[].answer[].valueString
Subject may realize better health outcomes.

# entry[].resource.item[].item[].item[].item[].text
Describe any benefit to the population from which the subject is drawn:

# entry[].resource.item[].item[].item[].item[].text
Describe any benefit to science, society, and humanity in general:

# entry[].resource.item[].item[].item[].item[].text
Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.):

# entry[].resource.item[].item[].item[].item[].text
Describe the standard clinical care that may be an alternative:

# entry[].resource.item[].item[].item[].item[].text
Describe how the subject can receive the research procedures/drug/device used in this study in a non-research setting:

# entry[].resource.item[].item[].item[].text
Assessment of Potential Risks and Benefits

# entry[].resource.item[].text
STUDY PURPOSE, OBJECTIVES OR SPECIFIC AIMS

# entry[].resource.item[].item[].text
Describe the purpose, specific aims, or objectives of the study (i.e. the reason for performing the study in terms of the scientific question to be answered):    Note: Specify which are the primary or secondary aims or objectives of this study as applicable. The primary objective is the main question. Secondary objectives are goals that will provide further information for the study

# entry[].resource.item[].item[].text
Explanation of Study design. (e.g., randomized placebo-controlled, cross-over, cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/ randomization/blinding scheme

# entry[].resource.item[].item[].text
Phase II (if applicable include and add details about open label study phase)

# entry[].resource.item[].item[].text
Provide precise definitions of the study endpoints and criteria for evaluation; if the primary outcomes are derived from several measurements (i.e., composite variables) or if endpoints are based composite variables, then describe precisely how the composite variables are derived.

# entry[].resource.item[].item[].item[].text
Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.

# entry[].resource.item[].item[].item[].text
Category/Group (eg. Adults, controls, parents, children)

# entry[].resource.item[].item[].item[].text
Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)

# entry[].resource.item[].item[].item[].text
Number Expected to Complete the Study or Needed to Address the Research Question

# entry[].resource.item[].item[].item[].text
Overall study sample size (if multisite)

# entry[].resource.item[].item[].item[].item[].text
Describe the criteria that define who will be included in the study as a numbered list: Indicate specifically whether you will include any of the following special populations: (You may not include members of the populations listed below as subjects in your research unless you indicate them in your inclusion criteria.

# entry[].resource.item[].item[].item[].item[].text
Describe the criteria that define who will be excluded in the study as a numbered list

# entry[].resource.item[].item[].item[].item[].text
Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination):

# entry[].resource.item[].item[].item[].item[].text
State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study:

# entry[].resource.item[].item[].item[].item[].text
Can study subjects participate in another research study while participating in this research study:

# entry[].resource.item[].item[].item[].text
If eligibility is based on age, gender, pregnancy/childbearing potential, social/ethnic group, or language spoken (e.g., English Speakers only), provide a scientific rationale.

# entry[].resource.item[].item[].item[].item[].item[].text
Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses:

# entry[].resource.item[].item[].item[].item[].item[].text
Are there any risk to the fetus from the study interventions or procedures.

# entry[].resource.item[].item[].item[].item[].item[].text
Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus

# entry[].resource.item[].item[].item[].item[].item[].text
If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe the biomedical knowledge that is expected to result from this research for this population:

# entry[].resource.item[].item[].item[].item[].item[].text
How any risk of this research is the least possible for achieving the objectives of the research:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate:

# entry[].resource.item[].item[].item[].item[].item[].text
Check to confirm that no inducements, monetary or otherwise, will be offered to terminate a pregnancy and that in the case of a fetus, the fetus is not the subject of a planned abortion.

# entry[].resource.item[].item[].item[].item[].text
Can or will the research involve neonates of uncertain viability or non-viable neonates?

# entry[].resource.item[].item[].item[].item[].text
Can or will subjects who are not yet adults (neonates, children, teenagers) be enrolled?

# entry[].resource.item[].item[].item[].item[].text
Can or will minors who are: I)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or    iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs  be approached for study participation for either themselves or their child?

# entry[].resource.item[].item[].item[].item[].text
Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?

# entry[].resource.item[].item[].item[].item[].text
Can or will students and/or employees be enrolled in this research?

# entry[].resource.item[].item[].item[].item[].text
Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)?

# entry[].resource.item[].item[].text
Strategies for Recruitment and Retention

# entry[].resource.item[].item[].item[].item[].text
Describe when, where, and how potential subjects will be recruited

# entry[].resource.item[].item[].item[].item[].text
When subjects respond to recruitment material, describe the information that will be provided to them about the study and the information that will be collected from subjects (e.g. name, telephone number, etc.). Describe also, how many times you will attempt to respond to call the subject back / leave a voice message:

# entry[].resource.item[].item[].item[].item[].item[].text
Check to confirm that a script for both the telephone conversation and the voice message is included with the submission.

# entry[].resource.item[].item[].item[].item[].text
Describe source of subjects (for example, patient population, local community, etc.):

# entry[].resource.item[].item[].item[].item[].text
Describe methods that will be used to identify potential subjects:

# entry[].resource.item[].item[].item[].item[].text
If recruitment material is being mailed or otherwise distributed, submit the proposed material and describe where/how the distribution list will be obtained:

# entry[].resource.item[].item[].text
Duration of Study Participation. (If there are sub-studies, include duration of participation in each sub-study.)

# entry[].resource.item[].item[].item[].text
Handling of Participant Withdrawal or Termination

# entry[].resource.item[].item[].text
Premature Termination or Suspension of Study

# entry[].resource.item[].text
Study Agent (Study drug, device, biologic, vaccine, etc.)

# entry[].resource.item[].item[].item[].text
Formulation, Appearance of Control Product

# entry[].resource.item[].item[].item[].text
Formulation and Appearance of Test Product

# entry[].resource.item[].item[].item[].text
Starting Dose and Dose Escalation Schedule

# entry[].resource.item[].item[].text
Study Agent Accountability Procedures / Return or Destruction of Investigational Product

# entry[].resource.item[].item[].item[].text
Procedures for Training of Clinicians on Procedural Intervention

# entry[].resource.item[].item[].item[].text
Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention

# entry[].resource.item[].item[].text
Measures to Minimize Bias: Randomization and Blinding

# entry[].resource.item[].item[].text
Study Intervention / Experimental Manipulation Adherence

# entry[].resource.item[].item[].item[].text
Specimen Preparation, Handling, and Storage

# entry[].resource.item[].item[].item[].text
Does your study involve the exposure to radiation, radiotracers and/or radiological imaging modalities?

# entry[].resource.item[].item[].item[].text
Does your study include pregnant women?(See Pregnancy Clause and Justification)

# entry[].resource.item[].item[].item[].text
Does your study involve Research Radiation?

# entry[].resource.item[].item[].item[].text
Does your study involve Research CT Scans?

# entry[].resource.item[].item[].item[].text
Does your study involve Nuclear Medicine Regulated Research procedures?

# entry[].resource.item[].item[].item[].text
Does your research study involve Pathology and Lab Medicine?

# entry[].resource.item[].item[].item[].text
Is your study linked to Department of Defense

# entry[].resource.item[].item[].item[].text
Does your study involve Pregnant Women, Neonates, and/or Placenta or Fetal Material?

# entry[].resource.item[].item[].item[].text
Data Collection and Follow Up for Withdrawn Subjects

# entry[].resource.item[].item[].text
Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).

# entry[].resource.item[].item[].text
Rescue Medications, Treatments, and Procedures

# entry[].resource.item[].item[].text
Participant Access to Study Agent at Study Closure

# entry[].resource.item[].item[].text
Phase 2 of the Study (if applicable provide details, for example open label phase

# entry[].resource.item[].item[].item[].text
Describe the sites / locations where your research team will conduct the research:

# entry[].resource.item[].item[].item[].text
Describe the steps the research team will take to ensure that a subject is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.):

# entry[].resource.item[].item[].item[].text
Describe the roles/tasks of each research team member

# entry[].resource.item[].item[].item[].text
Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead:

# entry[].resource.item[].item[].item[].text
Describe the coverage plan to address any issues (including subject safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI:

# entry[].resource.item[].item[].item[].text
Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities:

# entry[].resource.item[].item[].item[].text
Are medical or psychological resources that subjects might need, such as for emergencies or medical issues, are available for the study?

# entry[].resource.item[].item[].item[].text
Check to confirm that an appropriate IRB , registered with the OHRP ,review and approve this study.

# entry[].resource.item[].item[].item[].text
Check to confirm that  any amendments to the protocol or informed consent documents be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to subjects?

# entry[].resource.item[].item[].text
Community-based Participatory Research / Field Research

# entry[].resource.item[].item[].item[].text
Can or will this study involve community-based participatory research?

# entry[].resource.item[].item[].item[].item[].item[].text
Research Activity that will occur at each site (if they will do all the activities described in the protocol state that)

# entry[].resource.item[].item[].item[].item[].item[].text
Name of IRB overseeing the research at each site

# entry[].resource.item[].item[].item[].item[].text
The plan for tracking IRB approval of documents and consent forms for each site:

# entry[].resource.item[].item[].item[].item[].text
Name of the sponsor and Contract Research Organization (CRO):

# entry[].resource.item[].item[].item[].item[].text
The training that will be provided to the enrolling sites  staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented:

# entry[].resource.item[].item[].item[].item[].text
The plan for ensuring that amendments to the Coordinating Centertemplate protocol and template consent forms will be communicated to all sites:

# entry[].resource.item[].item[].item[].item[].text
The plan for ensuring that all sites have the most current version of the protocol and consent forms:

# entry[].resource.item[].item[].item[].item[].text
The plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed).  If available, please provide the Data Sharing Plan or Policy:

# entry[].resource.item[].item[].item[].item[].text
The plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.):

# entry[].resource.item[].item[].item[].item[].item[].text
Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?:

# entry[].resource.item[].item[].item[].item[].text
The plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA):

# entry[].resource.item[].item[].item[].item[].text
The plan for handling of the investigational product (drug/device/biologic) at each site (if applicable) as follows:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe how they will be provided to each enrolling site:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe how dispensing will be monitored:

# entry[].resource.item[].item[].item[].item[].item[].text
Describe what investigational product accountability procedures will be implemented:

# entry[].resource.item[].item[].item[].item[].text
The procedures for study closures and early site termination:

# entry[].resource.item[].item[].item[].item[].text
Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution):

# entry[].resource.item[].item[].item[].text
Definition of Serious Adverse Events (SAE)

# entry[].resource.item[].item[].item[].text
Relationship to Study Intervention / Experimental Manipulation

# entry[].resource.item[].item[].text
Time Period and Frequency for Event Assessment and Follow-up

# entry[].resource.item[].item[].item[].text
Analysis of the Primary Efficacy Endpoint(s)

# entry[].resource.item[].item[].item[].item[].text
Breaking the Study Blind/Participant Code

# entry[].resource.item[].item[].text
Regulatory, Ethical, and Study Oversight Considerations

# entry[].resource.item[].item[].item[].item[].text
Consent/Assent and Other Informational Documents Provided to Participants

# entry[].resource.item[].item[].item[].item[].item[].text
Specify how the research team will assure that subjects have sufficient time to consider whether to participate in the research

# entry[].resource.item[].item[].item[].item[].item[].text
Describe the parental permission process and the child assent process. (If study involves children)

# entry[].resource.item[].item[].item[].item[].item[].text
Some subjects may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals

# entry[].resource.item[].item[].item[].item[].item[].text
Methods of Informed Consent for non-English Speakers

# entry[].resource.item[].item[].item[].item[].item[].item[].text
Subject's Capacity to Give Legally Effective Consent

# entry[].resource.item[].item[].item[].item[].text
Indicate where the consent process will take place.

# entry[].resource.item[].item[].item[].item[].text
Research Use of Stored Human Samples, Specimens, or Data

# entry[].resource.item[].item[].item[].text
Future Use of Stored Human Specimens and Data

# entry[].resource.item[].item[].item[].text
Confidentiality of Research Biospecimens / Data

# entry[].resource.item[].item[].item[].text
Source Documents and Access to Source Data / Documents

# entry[].resource.item[].item[].item[].text
Certificate of Confidentiality (if applicable)

# entry[].resource.item[].item[].item[].text
Collections of Photographs, or Audio/Video Recording

# entry[].resource.item[].item[].text
Resources Available [(training, experience, oversight) as required to perform the research.]

# entry[].resource.item[].item[].item[].text
Data Collection and Management Responsibilities

# entry[].resource.item[].item[].item[].text
Provisions to Protect the Privacy of Subjects:

# entry[].resource.item[].answer[].valueString
A Randomized Clinical Trial on the combinative use of letters A and B.

# entry[].resource.item[].item[].text
Site Principal Investigator Professional Degrees

# entry[].resource.item[].item[].text
Site Principal Investigator Contact Information

# entry[].resource.item[].item[].answer[].valueString
XXX-XXX-XXXX Smith Building Room 14, College Circle, XX

# entry[].resource.item[].item[].answer[].valueString
This is the Mandated paragraph that describes the basic purpose, procedures and reasons behind the research in easily understood prose. To be set off from other text in a box.

# entry[].resource.item[].item[].answer[].valueString
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.  You may take this consent form home to think about and discuss with family or friends.

# entry[].resource.item[].item[].answer[].valueString
This study is being conducted to better understand the relationship between A and B, and the effects on people who use these letters.  In addition, this study will also generate data that may be applicable to all letter based conditions.

# entry[].resource.item[].item[].text
Who will the subjects be interacting with during the course of the study?

# entry[].resource.item[].item[].answer[].valueString
Each participant will be working with a specific research coordinator.  This RC will be your point of contact for the study, and be responsible for scheduling procedures and followup.

# entry[].resource.item[].item[].answer[].valueString
This study is open to all people who are users of specifically A and B in combination.  Users of A and B in isolation will not be enrolled.

# entry[].resource.item[].item[].answer[].valueString
Visits will be scheduled monthly +/- 5 days.  Other information about the visit schedule can be included here.

# entry[].resource.item[].item[].item[].answer[].valueString
Vitals, Venipuncture, Respiratory testing bank, Bone DXA scan, EQOL

# entry[].resource.item[].item[].item[].answer[].valueString
Vitals, Venipuncture, Respiratory testing bank

# entry[].resource.item[].item[].item[].answer[].valueString
These tests will consist of 5 different tests measuring breathing rate, vital capacity and 3 other tests.  Some tests will not require any procedure other than observation by the study coordinator.  Vital capacity will involve taking a very deep breath and completely exhaling into a tube in order to measure total volume.  Another test will involve walking on a treadmill while wearing a mask and several different speeds on the treadmill.

# entry[].resource.item[].item[].item[].answer[].valueString
This procedure will involve wearing a hospital gown and laying still in a large machine.  The amount of x-rays used is equivalent to the amount absorbed on a transcontinental flight.

# entry[].resource.item[].item[].answer[].valueString
There may be additional information about procedures to capture here that applies to all or some of the procedures listed.  Other comparisons or warnings can be detailed here.

# entry[].resource.item[].item[].text
Total Duration of Study Participation (units)

# entry[].resource.item[].item[].answer[].valueString
This section would not be relevant in an observational study, but would otherwise detail alternatives to the active treatment in an interventional study.

# entry[].resource.item[].item[].answer[].valueString
Information from this study will be used to inform policy and refine current understanding and treatment for patients who use both A and B.  In addition, this study will also provide increased understanding of all letters.

# entry[].resource.item[].item[].text
Will there be compensation for participation?

# entry[].resource.item[].item[].answer[].valueString
Participants will receive $100 for completing the baseline visit, $25 for each follow up visit they complete and $200 for completing they study in full.

# entry[].resource.item[].item[].item[].text
What types of visits or milestones will I be compensated for?

# entry[].resource.item[].item[].item[].text
How many visits or milestones of this type will there be compensation for?

# entry[].resource.item[].item[].item[].text
How much will be paid per this type of visit or milestone?

# entry[].resource.item[].item[].item[].text
What types of visits or milestones will I be compensated for?

# entry[].resource.item[].item[].item[].text
How many visits or milestones of this type will there be compensation for?

# entry[].resource.item[].item[].item[].text
How much will be paid per this type of visit or milestone?

# entry[].resource.item[].item[].item[].text
What types of visits or milestones will I be compensated for?

# entry[].resource.item[].item[].item[].text
How many visits or milestones of this type will there be compensation for?

# entry[].resource.item[].item[].item[].text
How much will be paid per this type of visit or milestone?

# entry[].resource.item[].item[].text
What are the costs of participation, if any?

# entry[].resource.item[].item[].text
Will there be reimbursement for other study visit costs incurred?

# entry[].resource.item[].item[].text
Who will pay for medical treatment if research related injury occurs?

# entry[].resource.item[].item[].text
Additional description of treatment coverage

# entry[].resource.item[].item[].answer[].valueString
No additional treatment coverage is expected.

# entry[].resource.item[].text
Participant Rights and whom to contact for answers

# entry[].resource.item[].item[].answer[].valueString
Subjects can expect study staff to update them on any changes to the study

# entry[].resource.item[].item[].text
Contact Information for IRB contact for questions regarding participant rights

# entry[].resource.item[].item[].text
Contact Information for Study Cooridinator for questions regarding study procedures

# entry[].resource.item[].item[].text
Contact Information for PI for research-related injury

# entry[].resource.item[].text
Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefitsto which the subject is otherwise entitled.

# entry[].resource.item[].item[].text
What are the anticipated circumstances under which subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent.

# entry[].resource.item[].item[].answer[].valueString
If the participant is not able to complete the procedures are described, they may be deemed ineligible for the study and terminated prior to study conclusion.

# entry[].resource.item[].item[].text
Are there consequences for early withdrawal?

# entry[].resource.item[].item[].text
Are there Emotional Consequences of Withdrawal

# entry[].resource.item[].item[].text
Are there Physical Consequences of Withdrawal

# entry[].resource.item[].item[].text
What are the consequences of withdrawal?

# entry[].resource.item[].item[].answer[].valueString
If there had been consequences for withdrawal, they could have been captured here.

# entry[].resource.item[].item[].answer[].valueString
All study records will be captured with a generic study ID.  Only the study coordinator will have the key to lookup individual participant data in the source system, and will not enter this into the clinical database.

# entry[].resource.item[].item[].text
Are there data security or policies that need to be included in the consent, particularly around device use (optional)

# entry[].resource.item[].item[].text
Describe any data security policies and processes protecting the data

# entry[].resource.item[].item[].text
Who can use or see participant information?

# entry[].resource.item[].item[].item[].text
Role or group who will have access to data

# entry[].resource.item[].item[].item[].answer[].valueString
Governmental auditors will have access to data as part of auditing procedures, but will not have access to the key linking the data to the original data storage system.

# entry[].resource.item[].item[].text
Will the data be released for future use?

# entry[].resource.item[].item[].text
Will the future use data be deidentified?

# entry[].resource.item[].item[].answer[].valueString
Data released to other researchers will not be

# entry[].resource.item[].item[].text
Required text disclosure surrounding future use.

# entry[].resource.item[].item[].answer[].valueCoding.display
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.

# entry[].resource.item[].item[].text
Were specimens collected as part of this study?

# entry[].resource.item[].item[].text
Is whole genome sequencing being conducted?

# entry[].resource.item[].item[].answer[].valueString
These are the conditions under which samples may be shared with other entities

# entry[].resource.item[].item[].text
Will participant share in profit with commerical use?

# entry[].resource.item[].item[].answer[].valueString
This is the description of how samples are collected and stored in a way that facilitates their retrieval.

# entry[].resource.item[].text
Will there be Broad Consent for Storage, maintenance and secondary research use?

# entry[].resource.item[].text
Can the study team contact you for future research?

# entry[].resource.item[].text
Will participants share or not share in commercial profit?

# entry[].resource.item[].text
Will the study team contact you with new information that may affect your willingness to remain in the study

# entry[].resource.item[].text
Will the study team disclose clinically relevant study results to you?

# entry[].resource.item[].answer[].valueString
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.

# entry[].resource.item[].text
Is this study covered under a Certificate of Confidentiality? (default Y in NIH)

# entry[].resource.item[].text
When will the PHI Authorization Expire based on date or time past an event

# entry[].resource.item[].answer[].valueString
Authorization will expire 5 years past final study visit.

# entry[].resource.item[].text
Statement of PHI Authorization Revocation

# entry[].resource.item[].answer[].valueString
Particpants 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.

# entry[].resource.item[].item[].text
Indicator to include Subject Signature and Date

# entry[].resource.item[].item[].text
Indicator to include Assent Signature and Date

# entry[].resource.item[].item[].text
Indicator to include Legally Authorized Representative Signature and Date

# entry[].resource.item[].item[].text
Indicator to include a Witness Signature and Date

# entry[].resource.item[].item[].text
Indicator to include Parent 1 Signature and Date

# entry[].resource.item[].item[].text
Indicator to include Parent 2 Signature and Date

# entry[].resource.text.div
            Comorbidity? YES
              Cardial Comorbidity? YES
                Angina? YES
                MI? NO
              Vascular Comorbidity?
                (no answers)
              ...
            Histopathology
              Abdominal
                pT category: 1a
              ...

# entry[].resource.contained[].text.div
Identifier | A34442332
Date of birth | 30 November 1972

# entry[].resource.item[].text
DO YOU BELIEVE YOUR EATING HABITS ARE THE CAUSE OF YOUR OBESITY CONDITION?

# entry[].resource.item[].text
Are you a resident of, or do you travel frequently to, an area with active Zika transmission?

# entry[].resource.item[].text
Are you a resident of, or do you travel frequently to, an area with active Zika transmission?

# entry[].resource.item[].text
평소 내 생활에 기본적으로 만족한다.

# entry[].resource.item[].text
활동과 흥미가 많이 줄었다.

# entry[].resource.item[].text
평소 내 생활에 기본적으로 만족한다.

# entry[].resource.item[].text
활동과 흥미가 많이 줄었다.

# entry[].resource.item[].item[].answer[].valueString
Comparison Chart Review of Pediatric Inpatients.

# entry[].resource.text.div
            Comorbidity? YES
              Cardial Comorbidity? YES
                Angina? YES
                MI? NO
              Vascular Comorbidity?
                (no answers)
              ...
            Histopathology
              Abdominal
                pT category: 1a
              ...

# entry[].resource.contained[].text.div
Identifier | A34442332
Date of birth | 30 November 1972