Adding new clinical data

To add new clinical data to an existing subject at a site, use the PATIENTDATA element with the following attributes:

Table 3-4 Adding new clinical data attributes and definitions

Attribute	Definition
PATIENTINITIALS	Initials of the subject that is being enrolled. Either PATIENTINITIALS or PATIENTNUMBER is required.
PATIENTNUMBER	Subject number of the subject that is being enrolled. Either PATIENTINITIALS or PATIENTNUMBER is required.
SITEMNEMONIC	Mnemonic of the site at which the subject is being screened. Either SITEMNEMONIC or SITENAME is required.
SITENAME	Name of the site at which the subject is enrolled. Either SITEMNEMONIC or SITENAME is required.
FORMSETREFNAME	RefName of the visit to which you are importing data.
FORMSETINDEX	Indicates to which visit instance to add the data.
FORMREFNAME	Specifies the RefName of the CRF to which you are importing data.
REASONINCOMPLETE	This attribute may apply to either the form or item level. The value is one of the values in the radio group control. This attribute will be ignored if the form or item is complete. To add an incompletion reason at the form level, do not include a DATA element in the PATIENTDATA group.
FORMINDEX	(Optional) If not present, then a new repeating form instance will be created (if FORMREFNAME is a repeating form). If present, the value indicates to which form instance the new data will be added.
ASSOCIATION	Indicates that an association exists.
ITEMSETINDEX	Row number for the row to add to an itemset. For an Add Entry itemset: Specify one row number at a time. Adds a single row to an Add Entry itemset. You can use the ITEMSETINDEX attribute with the PATIENTDATA tag or the DATA sub-tag. For a Repeating Data itemset: Specify one or more rows at a time. Creates all rows for a Repeating Data itemset. For a Repeating Data itemset, you must use the ITEMSETINDEX attribute with the DATA sub-tag. Note: You cannot specify the ITEMSETINDEX attribute on both the PATIENTDATA and DATA tags. ITEMSETINDEX is an optional attribute of the PATIENTDATA tag and the DATA sub-tag.

• Adding a row to an Add Entry itemset
  
• Creating rows for a Repeating Data itemset
  
• Adding data to an unscheduled visit
  
• Adding a comment
  
• Example: Adding data to a form
  
• Example: Adding a row to an Add Entry itemset
  
• Example: Creating rows for a Repeating Data itemset
  
• Example: Adding data to an unscheduled visit
  
• Example: Specifying REASONINCOMPLETE
  
• Example: Creating a new association instance