Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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: M11 Report Section 9 (Adverse Events) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Investigators are responsible for monitoring the safety of patients who have entered this study and for alerting Lilly or its designee to any event that seems unusual, even if this event may be considered an unanticipated benefit to the patient. The investigator is responsible for the appropriate medical care of patients during the study. Investigators must document their review of each laboratory safety report. The investigator remains responsible for following, through an appropriate health care option, AEs that are serious or otherwise medically important, considered related to the investigational product or the study, or that caused the patient to discontinue the investigational product before completing the study. The patient should be followed until the event resolves, stabilizes with appropriate diagnostic evaluation, or is reasonably explained. The frequency of follow-up evaluations of the AE is left to the discretion of the investigator. After the informed consent form is signed, study site personnel will record, via CRF, the occurrence and nature of each patient’s preexisting conditions, including clinically significant signs and symptoms of the disease under treatment in the study. Additionally, site personnel will record any change in the condition(s) and the occurrence and nature of any AEs. The investigator will interpret and document whether or not an AE has a reasonable possibility of being related to study treatment, medical device, or a study procedure, taking into account the disease, concomitant treatment, or pathologies. A “reasonable possibility” means that there is a potential cause and effect relationship between the investigational product, medical device, and/or study procedure and the AE. Planned surgeries should not be reported as AEs unless the underlying medical condition has worsened during the course of the study.</p></div>"
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>An SAE is any AE from this study that results in one of the following: • death • initial or prolonged inpatient hospitalization • a life-threatening experience (that is, immediate risk of dying) • persistent or significant disability/incapacity • congenital anomaly/birth defect • important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above • when a condition related to the medical device necessitates medical or surgical intervention to preclude either permanent impairment of a body function or permanent damage to a body structure, the serious outcome of “required intervention” will be assigned. Study site personnel must alert the Lilly CRP/CP, or its designee, of any SAE as soon as practically possible. Additionally, study site personnel must alert Lilly Global Patient Safety, or its designee, of any SAE within 24 hours of investigator awareness of the event via a sponsor-approved method. If alerts are issued via telephone, they are to be immediately followed with official notification on study-specific SAE forms. This 24-hour notification requirement refers to the initial SAE information and all follow-up SAE information. Although all AEs are recorded in the CRF after signing informed consent, SAE reporting to the sponsor begins after the patient has signed informed consent and has received investigational product. However, if an SAE occurs after signing informed consent, but prior to receiving investigational product, AND is considered reasonably possibly related to a study procedure then it MUST be reported. Investigators are not obligated to actively seek AEs or SAEs in patients once they have discontinued from and/or completed the study (the patient summary CRF has been completed). However, if the investigator learns of any SAE, including a death, at any time after a patient has been discharged from the study, and he/she considers the event reasonably possibly related to the study treatment or study participation, the investigator must promptly notify Lilly. Pregnancy (maternal or paternal exposure to investigational product) does not meet the definition of an AE. However, to fulfill regulatory requirements any pregnancy should be reported following the SAE process to collect data on the outcome for both mother and fetus. 9.1.2.1 Suspected Unexpected Serious Adverse Reactions Suspected unexpected serious adverse reactions (SUSARs) are serious events that are not listed in the IB and that the investigator reports as related to investigational product or procedure. Lilly has procedures that will be followed for the recording and expedited reporting of SUSARs that are consistent with global regulations and the associated detailed guidances</p></div>"
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Adverse Event Monitoring with a Systematic Questionnaire Before administering the Nasal and Non-nasal Score Questionnaire (see Appendix 6) and Edinburgh Hypoglycemia Scale (see Appendix 7), study site personnel will question the patient about any change in the preexisting condition(s) and the occurrence and nature of any AEs. Study site personnel will explain the possibility to the patient of AEs associated with the study and that these AEs will be captured during the study through the use of the Nasal and Non-nasal Score Questionnaire and Edinburgh Hypoglycemia Scale. Nonserious AEs obtained through the questionnaire are recorded and analyzed separately. Only SAEs elicited through the Nasal and Non-nasal Score Questionnaire and Edinburgh Hypoglycemia Scale are to be recorded as AEs via CRF and reported to Lilly or its designee within 24 hours as SAEs</p></div>"
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                {
                  "title" : "Identification",
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                    "status" : "additional",
                    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The Lilly CP or CRP/scientist will monitor safety data throughout the course of the study. Lilly will review SAEs within time frames mandated by company procedures. The Lilly CP or CRP will periodically review the following data: • trends in safety data • laboratory analytes • AEs including monitoring of nasal cavity and IM injection site When appropriate, the Lilly CP or CRP will consult with the functionally independent Global Patient Safety therapeutic area physician or clinical research scientist. See Separate Reporting Form Instructions.</p><p>Safety Monitoring The Lilly CP or CRP/scientist will monitor safety data throughout the course of the study. Lilly will review SAEs within time frames mandated by company procedures. The Lilly CP or CRP will periodically review the following data: • trends in safety data • laboratory analytes • AEs including monitoring of nasal cavity and IM injection site When appropriate, the Lilly CP or CRP will consult with the functionally independent Global Patient Safety therapeutic area physician or clinical research scientist. 8.4.5.1 Hypoglycemic Event Reporting Episodes of hypoglycemia (plasma glucose ≤ 70 mg/dL) that occur after the patient’s PG level returns to≥ 100 mg/dL (at least after 30 minutes post study dose) at post study treatment on Day 1, will be described using the following definitions: Documented Glucose Alert Level (Level 1) Plasma glucose ≤ 70 mg/dL • Documented symptomatic hypoglycemia: with typical symptoms of hypoglycemia. • Documented asymptomatic hypoglycemia: without typical symptoms of hypoglycemia. • Documented unspecified hypoglycemia: with no information about symptoms of hypoglycemia available. (This has also been called unclassifiable hypoglycemia.) Documented Clinically Significant Hypoglycemia (Level 2) Similar criterion as for Level 1, except for threshold PG &lt; 54 mg/dL • Level 2 documented symptomatic hypoglycemia • Level 2 documented asymptomatic hypoglycemia • Level 2 documented unspecified hypoglycemia Severe Hypoglycemia (Level 3) Patient had altered mental status and could not assist in their own care, was semiconscious or unconscious, or experienced coma with or without seizures, and the assistance of another person was to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of PG concentration to normal is considered sufficient evidence that the event was induced by a low PG concentration (PG ≤ 70 mg/dL) Other Hypoglycemia • Nocturnal hypoglycemia: Any documented hypoglycemic event (including severe hypoglycemia) that occurs at night and presumably during sleep. This is captured as hypoglycemia that occurs between bedtime and waking. This definition is more useful than the commonly used approximately 00:00 to 06:00 definition which does not take patients’ individual sleep times into consideration, and is consistent with the American Diabetes Association recommendations of reporting events that occur during sleep (ADA 2005). It is also important to collect the actual time when a hypoglycemic event occurred to allow further characterization of hypoglycemia timing (eg, to allow analysis of frequency of events occurring across a 24-hour clock). Nocturnal hypoglycemia may occur at severity Levels 1, 2, or 3. • Relative hypoglycemia (also referred to as pseudohypoglycemia [Seaquist et al. 2013]): An event during which typical symptoms of hypoglycemia occur, that does not require the assistance of another person and is accompanied by PG ≥ 70 mg/dL. The PG value of patients with chronically poor glycemic control can decrease so rapidly that patients may report symptoms of hypoglycemia before their PG concentration falls below 70 mg/dL. Events with PG ≤ 70 mg/dL should not be categorized as relative hypoglycemia. Evaluation and statistical analysis of this category is optional. However, if a patient reports a relative hypoglycemia event where assistance from another person was received or the patient experienced significant symptoms, the study team should clarify the circumstances to ensure the event is not a severe hypoglycemia event, and report it appropriately. • Probable symptomatic hypoglycemia: Symptoms of hypoglycemia were present, but PG measurement was not reported. • Overall (or total) hypoglycemia: This optional category combines most cases of hypoglycemia (documented hypoglycemia and probable symptomatic hypoglycemia, including severe hypoglycemia). It does not include relative hypoglycemia. Nocturnal and severe hypoglycemia are special cases of documented or probable hypoglycemia. If an event of hypoglycemia falls into multiple subcategories, that event should only be counted once in the category of overall (or total) hypoglycemia. Hypoglycemia episodes will be recorded on specific CRF pages. Only severe hypoglycemic episodes will be reported separately as AEs. If a hypoglycemic event meets the criteria of severe, it needs to be recorded as serious in the CRF (that is, recorded as an SAE). In the case of a hypoglycemic event (other than severe), the actual glucose value, if measured, should be recorded in the CRF, with any treatments administered, and not be recorded as an AE. Cases of hypoglycemia may be treated with foods rich in carbohydrate such as fruit, juice, skimmed milk, or energy bars. All episodes of hypoglycemia that are determined by the investigator to constitute severe hypoglycemia according to the definition above should be reported as SAEs. 8.4.5.2 Hepatic Safety If a study patient experiences elevated alanine aminotransferase (ALT) ≥ 3× upper limit of normal (ULN), alkaline phosphatase (ALP) ≥ 2× ULN, or elevated total bilirubin (TBL) ≥ ≥2× ULN, liver tests (Appendix 4) should be repeated within 3 to 5 days including ALT, aspartate aminotransferase, ALP, TBL, direct bilirubin, gamma-glutamyl transferase, and creatinine kinase to confirm the abnormality and to determine if it is increasing or decreasing. If the abnormality persists or worsens, clinical and laboratory monitoring should be initiated by the investigator based on consultation with the Lilly CP or CRP. Monitoring should continue until levels normalize and/or are returning to approximate baseline levels. Additional safety data should be collected if 1 or more of the following conditions occur: • elevation of serum ALT to ≥ 5× ULN on 2 or more consecutive blood tests • elevated serum TBL to ≥ 2× ULN (except for cases of known Gilbert’s syndrome) • elevation of serum ALP to ≥ 2× ULN on 2 or more consecutive blood tests • patient discontinued from treatment due to a hepatic event or abnormality of liver tests • hepatic event considered to be an SAE.</p></div>"
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            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"
          },
          "section" : [
            {
              "title" : "Participants Who Become Pregnant During the Trial",
              "code" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C218622",
                    "display" : "ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial"
                  }
                ],
                "text" : "section9.3.1-pregnant"
              },
              "text" : {
                "status" : "additional",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not Applicable.</p></div>"
              }
            },
            {
              "title" : "Participants Whose Partners Become Pregnant During the Trial",
              "code" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C218623",
                    "display" : "ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial"
                  }
                ],
                "text" : "section9.3.2-pregnant-partner"
              },
              "text" : {
                "status" : "additional",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not Applicable.</p></div>"
              }
            }
          ]
        },
        {
          "title" : "Special Safety Situations",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218624",
                "display" : "ICH M11 Protocol Section 9.4 Special Safety Situations"
              }
            ],
            "text" : "section9.4-special-safety-situations"
          },
          "text" : {
            "status" : "empty",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Specify special safety situations associated with the trial intervention(s) that do not qualify as an AE or SAE, but require regulatory reporting. Examples include: • misuse or abuse • off-label use (if applicable) • medication error (prescription or dispensing error) • occupational exposure • use outside of what is foreseen in the protocol • unintended exposure of embryo, foetus, or child via maternal exposure (pregnancy or breastfeeding) or via paternal exposure (semen) • lack of therapeutic efficacy; this is not applicable for studies that measure efficacy as a study endpoint • suspected transmission of an infectious agent; this is only applicable for injected or biologic medicinal products • product complaint, including falsified or counterfeit products • suspected drug-food or drug-drug interaction]</div>"
          }
        }
      ]
    }
  ]
}