DF_ICkeys

DF_ICkeys — Check key fields (id,visit,plate) and subject initials

Synopsis

DF_ICkeys {study} [-P #, #-#] [-K IVP] [-R status] [-V vsp] [-I #] [-L sc]

Description

DF_ICkeys checks each id for consistency with the sites database, each visit with the visit map, each plate with the list of legal plates, and optionally checks the consistency of subject initials across all database records within subject.

DF_ICkeys exports the keys for each database record and checks them as follows:

  • Ids are counted as errors if they do not appear in the source (i.e., study schema, sites database, or both) specified for legal range definitions. When -L c is specified, all subject IDs specified in the sites database are considered legal for all plates defined for the study. With -L s, only the study schema is used, where different legal subject IDs may be specified for each plate. If no legal ID specifications are defined for a plate, no legal ID checking is performed on that plate. With -L sc, both schema and sites database are consulted, but if a legal range is defined for a plate in the study schema, that definition takes precedence and the sites database is ignored. This allows users to set specific legal criteria at the plate level that override the general specifications in the sites database. This might be useful for side studies where certain CRF forms are only completed at those clinical sites participating in the side study.

  • Visit/sequence numbers are counted as errors if they are inconsistent with one or more specifications. The specifications to use can be chosen, using -V vsp from the visit map, schema, and/or page map. When the visit map is used, the legal visit/sequence numbers for each plate are those visits for which the plate is specified as required, optional or a missed visit notification plate. When the schema is used, the legal values are those defined in field 6 of each record (this is always the visit/sequence number in a DFdiscover database). When the page map is used, the legal values are those visits for which a visit and plate pair appears in the file. When more than one file is selected, the priority order is: visit map first, then schema, and then page map. If there are no legal visit/sequence numbers specified for a plate, visit checking is disabled for that plate.

  • Plate numbers are counted as errors if they differ from the plate data file that contains them (this would be very rare and likely a serious error).

  • When -I is used to check subject initials, the initials read from the first record (the lowest plate number) read for each subject are saved and compared with the initials on all subsequent records for the same id. If the lowest plate number should not be used as the source of correct subject initials, -P can be used to alter the plate selection order so that another plate number will be used as the source.

By default, DF_ICkeys checks all 3 keys (id,visit and plate) in records of all statuses (primary, secondary and missed) in all study plates, except for plate 501. It does not check initials by default because there is no default field in which subject initials can always be found.

A subset of the defined plates can be checked using -P #, #-#. This option can also be used to change the order in which plates are checked. This is important when used in conjunction with -I # because that option uses the first selected plate as the source of the correct subject initials. Queries can be checked for consistency of keys by including plate 511 in the list of plates in -P #, #-#, but subject initials will never be checked on that plate.

By default, each of the id, visit, and plate keys is checked. However, by using -K, a subset of the keys can be selected by including combinations (with no intervening spaces or commas) of the letters I for id, V for visit, and/or P for plate, in the option string.

-V is used to select the source(s) of legal visit/sequence numbers for each plate to use. Any combination (with no intervening spaces or commas) of the letters v, s, and p may be used but they must be specified as a single string. The letter v specifies that the legal visit/sequence numbers for each plate can be determined from the study visitmap. Similarly, s indicates that the legal range from the study schema should be used, and p indicates that the entries in the study page map should be used. When more than one source is used, the combination of sources is used with precedence given first to visit map, then schema and then page map, when a conflict occurs.

By default, records of all statuses are selected. Use -R to select only records of specified statuses. Any legal status keyword from the list: final, incomplete, pending, missed, all may be used. Multiple keywords must be separated by spaces and the entire string enclosed in "".

DF_ICkeys creates a DRF named [3] which lists the records, if any, that had key inconsistencies. This file can be used in DFexplore Data View to retrieve and review the problem records. The specific error (id, visit, plate or initials) is written to the 5th field of each record in .

[Note]Note

DF_ICkeys reports the number of records with errors for each plate and also reports the number of errors in ids, visit numbers, plates and initials. Some plates may have more than one type of error, and as a result, the number of plates with errors may be less than the sum of the the different types of errors.

Options

-P #, #-#

Select the plates to be checked (default=all). This option can also be used to change the order of checked plates (this is useful in conjunction with -I #).

-R status

Select only records with one of the specified status codes. Valid codes are from the list: final, incomplete, pending, missed, all

-K IVP

Select the key fields to be checked (default=all), from the list: I=id, V=visit, P=plate

-V vsp

Determine the legal visit/sequence numbers for each plate using the specifications in the:

v, visit map
s, legal ranges from schema
p, page map

or a combination thereof.

-I #

In addition to the selected key fields, also check the subject initials that can be found in field # on selected plates.

-L sc

Determine the source for legal subject IDs from:

s, study schema
c, sites database
sc, both schema and sites database

Examples

Example 2.12. Check key fields and initials (found in field 8) on plates 1-3

-P 1~3 -I 8
DF_ICkeys: Check Key Fields (ID,SEQ,PLT,Initials) DFstudy 7. Apr 22,2017 23:44

Plate 001:    26 errors in  1664 records (26 Initials)
Plate 002:    60 errors in  1675 records (60 Initials)
Plate 003:    44 errors in  1333 records (1 Seqs, 43 Initials)

    Total:   130 errors in  4672 records
Use DF_ICkeys.drf to review problem records.

Example 2.13. Check key fields and initials on final and missed records for plates 1-10

-R "final missed" -P 1~10
DF_ICkeys: Check Key Fields (ID,SEQ,PLT,Initials) DFstudy 7. Apr 22,2017 23:48

Plate 001:     0 errors in  1143 records
Plate 002:     0 errors in  1106 records
Plate 003:     1 errors in  1139 records (1 Seqs)
Plate 004:     0 errors in  1092 records
Plate 005:     0 errors in  1096 records
Plate 006:     0 errors in  1147 records
Plate 007:     0 errors in  1143 records
Plate 008:     0 errors in  4242 records
Plate 009:     0 errors in  1123 records
Plate 010:     0 errors in  1079 records

    Total:     1 errors in 14310 records
Use DF_ICkeys.drf to review problem records.

Example 2.14. Check initials but not the keys on all primary records of plates 11-20

Notice the use of -K "" to disable checking on the key fields.

The header line of the output is a standard line and does not reflect the subset of keys selected for the current run.

-I 8 -K "" -R "primary" -P 11~20
DF_ICkeys: Check Key Fields (ID,SEQ,PLT,Initials) DFstudy 7. Apr 22,2017 23:51

Plate 011:     0 errors in  1101 records
Plate 012:     4 errors in  1101 records (4 Initials)
Plate 013:    14 errors in  1063 records (14 Initials)
Plate 014:    30 errors in  1974 records (30 Initials)
Plate 015:    19 errors in   914 records (19 Initials)
Plate 016:     8 errors in   926 records (8 Initials)
Plate 017:    11 errors in   926 records (11 Initials)
Plate 018:    10 errors in   923 records (10 Initials)
Plate 019:    16 errors in   921 records (16 Initials)
Plate 020:     1 errors in    57 records (1 Initials)

    Total:   113 errors in  9906 records
Use DF_ICkeys.drf to review problem records.

Example 2.15. Check key fields on plates 1-2 using only the study schema as the source for legal subject IDs.

-P 1~2 -L s
DF_ICkeys: Check Key Fields (ID,SEQ,PLT,Initials) DFstudy 253. Feb 11,2017 15:07
Plate 001:    30 errors in    53 records (30 IDs)
Plate 002:    11 errors in    26 records (11 IDs)

    Total:    41 errors in    79 records
Use DF_ICkeys.drf to review problem records.

Limitations

It is not possible to compare subject initials across plates where the subject initials variable is not the same variable number on each checked plate.



[3] This file is overwritten each time that DF_ICkeys is executed.