## Warning: One or more parsing issues, call `problems()` on your data frame for details,
## e.g.:
## dat <- vroom(...)
## problems(dat)
## Rows: 26324 Columns: 35
## ── Column specification ────────────────────────────────────────────────────────
## Delimiter: ","
## chr (20): extid, firstname, lastname, fullname_id, hhid, read_sign_name, pa...
## dbl (7): cluster, safety_age, safety_cl, efficacy_age, efficacy_cl, age, p...
## lgl (2): pk_errors, pk_pages
## date (6): safety_date, efficacy_date, pk_date, safety_verification_date, ef...
##
## ℹ Use `spec()` to retrieve the full column specification for this data.
## ℹ Specify the column types or set `show_col_types = FALSE` to quiet this message.
## Rows: 26698 Columns: 100
## ── Column specification ────────────────────────────────────────────────────────
## Delimiter: ","
## chr (51): device_id, member_select, study_select, fullname_id, extid, first...
## dbl (15): archivist_select, hhid, cluster, safety_age, safety_cl, efficacy_...
## lgl (26): note_form_title, pk_age, note_not_in_study, note_cl_id, note_fa_i...
## dttm (3): SubmissionDate, start_time, end_time
## date (5): todays_date, safety_date, efficacy_date, pk_date, date
##
## ℹ Use `spec()` to retrieve the full column specification for this data.
## ℹ Specify the column types or set `show_col_types = FALSE` to quiet this message.
Report 1. Confirming the total number of Missing (Physical) ICFs per
cohort
Brief Description: The following tables display the total number of
Informed Consent Forms (ICFs) signed in each cohort and their status in
the ICF database. Once an ICF is entered into the archive, it is
assigned a status, which can be one of the following:
- Archived: ICFs that have been verified and have no outstanding
queries.
- Rectification: ICFs that have been verified but have been identified
as having queries that need to be resolved.
- Resolved-Archived: ICFs that were previously identified as having
queries, which have since been resolved.
- Unresolved: ICFs that still have queries after being sent for
resolution more than two times without successful resolution.
- Missing: Any ICF that has not been logged in the ICF database is
labeled as “Missing,” indicating that the ICF is potentially lost.
Safety cohort
|
safety_icf_status
|
Count
|
Percentage
|
|
Archived
|
21755
|
94.28
|
|
Resolved-Archived
|
908
|
3.93
|
|
Physical Missing ICF
|
402
|
1.74
|
|
Rectification
|
10
|
0.04
|
|
Unresolved
|
1
|
0.00
|
|
Total
|
23076
|
100.00
|
Efficacy cohort
|
efficacy_icf_status
|
Count
|
Percentage
|
|
Archived
|
2482
|
95.8
|
|
Resolved-Archived
|
82
|
3.2
|
|
Physical Missing ICF
|
26
|
1.0
|
|
Total
|
2590
|
100.0
|
PK cohort
|
pk_icf_status
|
Count
|
Percentage
|
|
Archived
|
71
|
100
|
|
Total
|
71
|
100
|
ICF verification status by ICF type in Safety cohort
|
ICF Status
|
ICF Type
|
Count
|
Total
|
Percentage
|
|
Archived
|
Adult
|
11145
|
21753
|
51.2
|
|
Archived
|
Parent Legal Guardian
|
7187
|
21753
|
33.0
|
|
Archived
|
Assent and parent Legal Guardian
|
3421
|
21753
|
15.7
|
|
Missing ICFs
|
Parent Legal Guardian
|
343
|
402
|
85.3
|
|
Missing ICFs
|
Adult
|
49
|
402
|
12.2
|
|
Missing ICFs
|
Assent and parent Legal Guardian
|
10
|
402
|
2.5
|
|
Rectification
|
Parent Legal Guardian
|
6
|
10
|
60.0
|
|
Rectification
|
Adult
|
2
|
10
|
20.0
|
|
Rectification
|
Assent and parent Legal Guardian
|
2
|
10
|
20.0
|
|
Resolved-Archived
|
Assent and parent Legal Guardian
|
499
|
908
|
55.0
|
|
Resolved-Archived
|
Adult
|
215
|
908
|
23.7
|
|
Resolved-Archived
|
Parent Legal Guardian
|
194
|
908
|
21.4
|
|
Unresolved
|
Parent Legal Guardian
|
1
|
1
|
100.0
|
|
Total
|
Total
|
23074
|
23074
|
100.0
|
ICF verification status by ICF type in Efficacy cohort
|
ICF Status
|
ICF Type
|
Count
|
Total
|
Percentage
|
|
Archived
|
Parent Legal Guardian
|
1817
|
2482
|
73.2
|
|
Archived
|
Asset and parent Legual Guardian
|
665
|
2482
|
26.8
|
|
Missing ICFs
|
Parent Legal Guardian
|
15
|
26
|
57.7
|
|
Missing ICFs
|
Asset and parent Legual Guardian
|
11
|
26
|
42.3
|
|
Resolved-Archived
|
Asset and parent Legual Guardian
|
62
|
82
|
75.6
|
|
Resolved-Archived
|
Parent Legal Guardian
|
20
|
82
|
24.4
|
|
Total
|
Total
|
2590
|
2590
|
100.0
|
ICF verification status by ICF type in PK cohort
|
ICF Status
|
ICF Type
|
Count
|
Total
|
Percentage
|
|
Archived
|
Adult
|
71
|
71
|
100
|
|
Total
|
Total
|
71
|
71
|
100
|