Creating a data and map file

The data and map file that are used in the direct import method must be a text file. You can use any text editor that creates plain text files, or develop a conversion utility that automatically formats your raw data.

You can direct the data in the file to target controls on more than one CRF; however, you must use separate files for each itemset into which you are importing rows of data, and data that you import into CRF itemsets must be in a separate file from data that you import into regular CRF items.

The import file must have the following characteristics.
  • Each import row must include either of the following:
    • A field that specifies the subject number and initials in the following format:
      subject_number (subject_initials)

      If it is possible that more than one subject could have the same subject number and initials, you must also include a field for the site mnemonic of the subject.

    • The database ID of the subject.
  • All import fields must be separated by a pipe character ( | ).
  • Do not include double quotation marks (") in the data file.
Additionally, some types of data must be presented in specific ways. The following sections describe how to set up the following fields and controls for import:
  • Date fields
    Dates must consist of three fields in month|day|year format, using a 4-digit year. Observe these formatting considerations:
  • Time fields
    Times must consist of three fields in hour|minute|second format, using a 24-hour clock. Observe these formatting considerations:
  • DateTime fields
    Dates must consist of three fields: month, day, and year. The year must use four digits, and times must use a 24-hour clock.
  • Nested Controls
    Nested controls must consist of a field for each control separated by a pipe character ( | ). Only one of these fields will contain information for each row of data.
  • Checkboxes and multiple-selection drop-down lists
    Checkboxes and multiple-selection drop-down lists must consist of a field with a list of zero or more controls separated by a comma.
  • Units
    A field that contains units must immediately follow the value that it describes.
  • Item comments
    Item comments must consist of a field that contains the text comment for the item.

Parent topic: Specifying a data and map file

Date fields

Dates must consist of three fields in month|day|year format, using a 4-digit year. Observe these formatting considerations:

  • If a date is missing a component, include a null field, as in the following example: 
    month||year
  • If a component of a date is unknown, use the keyword UNK, as in the following example:
    month|UNK|year

Parent topic: Creating a data and map file

Time fields

Times must consist of three fields in hour|minute|second format, using a 24-hour clock. Observe these formatting considerations:

  • If a time is missing a component, include a null field, as in the following example:
    hour|minute|
  • If a component of a time is unknown, use the keyword UNK, as in the following example:
    hour|UNK|UNK

Parent topic: Creating a data and map file

DateTime fields

Dates must consist of three fields: month, day, and year. The year must use four digits, and times must use a 24-hour clock.

Observe these formatting considerations:

  • By default, the date order format must match the order specified in the study configuration. If data is entered in a date order format that is different from the study configuration setting, you can override the setting by using the -datetimeformat command line parameter during import. For more information, see Running the PFConsole utility from the command line.
  • If a datetime data item is missing a component, include a null field.
  • If a component of a datetime item is unknown, use the keyword UNK.

    Example:

    PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|Clinical Chemistry:|AG Ratio|XGR|Nov|UNK|1998|0.8-2||2.0|N|||
    PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|Clinical Chemistry:|ALAT(SGPT)|XGP|Nov|UNK|1998|0-48|U/L|42|N|||
    PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|Clinical Chemistry:|Albumin|XAL|Nov|UNK|1998|3.2-5|G/DL|4.3|N|||
    PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|Clinical Chemistry:|Alkaline Phosphatase|XLK|Nov|UNK|1998|20-125|U/L|63|N|||

Parent topic: Creating a data and map file

Nested Controls

Nested controls must consist of a field for each control separated by a pipe character ( | ). Only one of these fields will contain information for each row of data.

Example:
PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|hematology|||
PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA||urinalysis||
PF|001 (CJB)|Sep|23|1975|1|1|215210|LABDATA|||toxicology|

Parent topic: Creating a data and map file

Checkboxes and multiple-selection drop-down lists

Checkboxes and multiple-selection drop-down lists must consist of a field with a list of zero or more controls separated by a comma.

Example:
PF|001 (CJB)|Sep|23|1975|LABDATA|Sinus Tachycardia, Premature Ectopic Junctional Beats, Sinus Bradycardia, Premature Ectopic Atrial Beats|

Parent topic: Creating a data and map file

Units

A field that contains units must immediately follow the value that it describes.

The example shows weight in pounds. The number value of the weight (177) is contained in one field, and the unit value (pounds) is contained in the following field.
PF|001 (CJB)|Sep|23|1975|70|in|177|lb|

Parent topic: Creating a data and map file

Item comments

Item comments must consist of a field that contains the text comment for the item.

Example:
PF|001 (CJB)|Sep|23|1975|70|177|weight measured with shoes and socks

Parent topic: Creating a data and map file