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changes.mady.by.user Christine Connolly

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  1. Prior treatmentsinterventions, including prior medications and procedures, should be submitted in an appropriate dataset from the Interventions class (e.g., Concomitant/Prior Medications (CM) or Procedures (PR)).
  2. MH description and coding
    1. MHTERM is the topic variable and captures the verbatim term collected for the condition or event or the prespecified term used to collect information about the occurrence of any of a group of conditions or events. MHTERM is a required variable and must have a value.
    2. MHMODIFY is a permissible variable and should be included if the applicant’s procedure permits modification of a verbatim term for coding. The modified term is listed in MHMODIFY. The variable should be populated as per the applicant’s procedures; null values are permitted.
    3. If the applicant codes the reported term (MHTERM) using a standard dictionary, then MHDECOD will be populated with the preferred term derived from the dictionary.
    4. MHBODSYS is the system organ class (SOC) from the coding dictionary associated with the adverse event by the applicant. This value may differ from the primary SOC designated in the coding dictionary's standard hierarchy.
    5. If a CRF collects medical history by prespecified body systems and the applicant also codes reported terms using a standard dictionary, then MHDECOD and MHBODSYS are populated using the standard dictionary. MHCAT and MHSCAT should be used for the prespecified body systems.
  3. Additional categorization and grouping
    1. MHCAT and MHSCAT may be populated with the applicant's predefined categorization of medical history events, which are often prespecified on the CRF. Note that even if the applicant uses the body system terminology from the standard dictionary, MHBODSYS and MHCAT may differ; MHBODSYS is derived from the coding system, whereas MHCAT is effectively assigned when the investigator records a condition under the prespecified category.
      1. This categorization should not group all records (within the MH domain) into one generic group such as “Medical History” or “General Medical History” because this is redundant information with the domain code. If no smaller categorization can be applied, then it is not necessary to include or populate this variable.
      2. Examples of MHCAT could include “General Medical History“ (see above assumption; if “General Medical History” is an MHCAT value, then there should be other MHCAT values), “Allergy Medical History, “ and “Reproductive Medical History”.
    2. MHGRPID may be used to link (or associate) different records together to form a block of related records at the subject level within the MH domain. It should not be used in place of MHCAT or MHSCAT, which are used to group data across subjects. For example, if a group of syndromes reported for a subject were related to a particular disease, then the MHGRPID variable could be populated with the appropriate text.
  4. Prespecified terms; presence or absence of events
    1. Information on medical history is generally collected in 2 different ways, either by recording free text or using a prespecified list of terms. The solicitation of information on specific medical history events may affect the frequency at which they are reported; therefore, the fact that a specific medical history event was solicited may be of interest to reviewers. MHPRESP and MHOCCUR are used together to indicate whether the condition in MHTERM was prespecified and whether it occurred, respectively. A value of “Y” in MHPRESP indicates that the term was prespecified.
    2. MHOCCUR is used to indicate whether a prespecified medical condition occurred; a value of "Y" indicates that the event occurred and "N" indicates that it did not.
    3. If a medical history event was reported using free text, the values of MHPRESP and MHOCCUR should be null. MHPRESP and MHOCCUR are permissible fields and may be omitted from the dataset if all medical history events were collected as free text.
    4. MHSTAT and MHREASND provide information about prespecified medical history questions for which no response was collected. MHSTAT and MHREASND are permissible fields and may be omitted from the dataset if all medications were collected as free text or if all prespecified conditions had responses in MHOCCUR.
      Include Page
      SDTM MH Assumption 4d table
      SDTM MH Assumption 4d table
    5. When medical history events are collected with the recording of free text, a record may be entered into the data management system to indicate “no medical history” for a specific subject or prespecified body system category (e.g., gastrointestinal). For these subjects or categories within subject, do not include a record in the MH dataset to indicate that there were no events.
  5. Timing variables
    1. Relative timing assessments such as “Ongoing” or "Active" are common in the collection of MH information. MHENRF may be used when this relative timing assessment is coincident with the start of the study reference period for the subject represented in the Demographics (DM) dataset (RFSTDTC). MHENRTPT and MHENTPT may be used when "Ongoing" is relative to another date such as the screening visit date.
    2. Additional timing variables (e.g., MHSTRF) may be used when appropriate.
  6. MH event date type
    1. MHEVDTYP is a domain-specific variable that can be used to indicate the aspect of the event that is represented in the event start and/or end date/times (MHSTDTC and/or MHENDTC). If a start date and/or end date is collected without further specification of what constitutes the start or end of the event, then MHEVDTYP is not needed. However, when data collection specifies how the start or end date is to be reported, MHEVDTYP can be used to provide this information. For example, when collecting the date of diagnosis, it would be used to populate MHSTDTC; MHEVDTYP would be populated with "DIAGNOSIS". If MHEVDTYP is not needed for any collected data, it need not be included in the dataset. If MHEVDTYP is included in the dataset, it should be populated only when the data collection specifies the aspect of the event that is to be used to populate the start and/or end date; otherwise, it should be null. 
    2. When data collected about an event includes 2 different dates that could be considered the start or end of an event, then an MH record will be created for each. For example, if data collection included both a date of onset of symptoms and a date of diagnosis, there would be 2 records for the event, one with MHSTDTC the date of onset of symptoms and MHEVDTYP = "SYMPTOMS" and a second with MHSTDTC the date of diagnosis and MHENDTYP = "DIAGNOSIS". In such a case, it is recommended that the 2 records be linked by means such as a common value of MHSPID or MHGRPID.
  7. Any identifiers, timing variables, or Events general observation-class qualifiers may be added to the MH domain, but the following Qualifiers would generally not be used: --SER, --ACN, --ACNOTH, --REL, --RELNST, --OUT, --SCAN, --SCONG, --SDISAB, ‑‑SDTH, --SHOSP, --SLIFE, --SOD, --SMIE.