Free Text from Case Report Forms (CRFs)

For the TIG Product Impact on Individual Health use case, applicants may collect free-text data on a CRF to supplement a standard field. A common example is collection using a list of choices accompanied by a field to collect "Other, specify". In such cases, collected free-text will be populated in the domain based on the role of the tabulation variable used to represent data from the standard field.

When free-text information is collected to supplement a standard non-result qualifier field, the free-text value should be placed in the SUPP-- dataset described in Section 8.4, Relating Non-standard Variable Values to a Parent Domain. When applicable, controlled terminology should be used for SUPP-- field names (QNAM) and their associated labels (QLABEL; see Section 8.4, Relating Non-standard Variable Values to a Parent Domain, and Appendix C1, Supplemental Qualifiers Name Codes).
For example, when a description of "Other Medically Important Serious Adverse Event" category is collected on a CRF, the free-text description should be stored in the SUPPAE dataset.

• AESMIE = "Y"
• SUPPAE QNAM = "AESOSP", QLABEL = "Other Medically Important SAE", QVAL = "HIGH RISK FOR ADDITIONAL THROMBOSIS"

Another example is a CRF that collects reason for dose adjustment with additional free-text description:

The free-text description should be stored in the SUPPEX dataset.

• EXADJ = "NONMEDICAL REASON"

• SUPPEX QNAM = "EXADJDSC", QLABEL = "Reason For Dose Adjustment Description", QVAL = "PATIENT MISUNDERSTOOD INSTRUCTIONS"
  Note that QNAM references the "parent" variable name with the addition of "DSC". Likewise, the label is a modification of the parent variable label.

When the CRF includes a list of values for a qualifier field that includes "Other" and the "Other" is supplemented with a "Specify" free-text field, then the manner in which the free-text "Specify" value is submitted will vary based on the sponsor's coding practice and analysis requirements.

For example, consider a CRF that collects the indication for an analgesic concomitant medication (CMINDC) using a list of prespecified values and an "Other, specify" field :

An investigator has selected "OTHER" and specified "Broken arm". Several options are available for submission of this data:

1. If the sponsor wishes to maintain controlled terminology for the CMINDC field and limit the terminology to the 5 prespecified choices, then the free text is placed in SUPPCM.

   CMINDC
   OTHER

   QNAM	QLABEL	QVAL
   CMINDOTH	Other Indication	BROKEN ARM

2. If the sponsor wishes to maintain controlled terminology for CMINDC but will expand the terminology based on values seen in the "Other, specify" field, then the value of CMINDC will reflect the sponsor's coding decision and SUPPCM could be used to store the verbatim text.

   
   

   CMINDC
   FRACTURE

   QNAM	QLABEL	QVAL
   CMINDOTH	Other Indication	BROKEN ARM

   Note that the sponsor might choose a different value for CMINDC (e.g., "BONE FRACTURE") depending on the sponsor's coding practice and analysis requirements.

   
   

3. If the sponsor does not require that controlled terminology be maintained and wishes for all responses to be stored in a single variable, then CMINDC will be used and SUPPCM is not required.

   CMINDC
   BROKEN ARM