- Updated ADFACE template and vignette as per new SDTM mapping of Investigator assessment for eDiary data, as recommended by CBER. The collection of the Investigator assessment can happen when data reported by the participants was deemed incorrect or the participant did not complete the eDiary. In these two scenarios, the Investigator assessment is collected within the eDiary platform as a separate record from the original data reported by the participant (if this is allowed by eCOA system) or in the study eCRF. This leads to a change in Solicited Adverse Event SDTM structure (FACE and VS). Additional records coming from Investigator assessment are added, which can be identified through an evaluator variable (FAEVAL/VSEVAL). An update in ADFACE has been provided in order to reflect these changes in SDTM. (#243)
-
Removed
dataset_supp
anddataset_suppex
arguments fromderive_vars_merged_vaccine()
as we are not combining parental with supplementary domains inside the function, but can be optionally combined in the ADCE, ADFACE and ADIS templates usingcombine_supp()
function from {metatools}. (#246) -
Included an argument
filter_add
inderive_diam_to_sev_records()
to pass the subset condition to consider the particular diameter record for convert them to severity records. (#243)
-
Included a step to derive ANL01FL in ADFACE template, to flag the records which would be considered for analysis purpose. (#243)
-
Supplementary domains are now optionally combined with parental domains in ADFACE and ADIS templates. (#246)
-
Included a step to derive ANL01FL in ADFACE vignette, to flag the records which would be considered for analysis purpose. (#243)
-
Supplementary domains are now optionally combined with parental domains n ADFACE and ADIS vignettes. (#246)
- {metatools} was added to 'Suggests'. (#246)
-
Modified calls to
derive_vars_joined()
in ADCE, ADFACE and ADIS templates in line with the updates to this function in the new version of the{admiral}
package. Thejoin_type
argument is now always specified and populated as'all'
(#229). -
Modified calls to
derive_extreme_records()
in ADFACE template in line with the updates to this function in the new version of the{admiral}
package. Thefilter
argument is now renamed tofilter_add
and the argumentdataset_add
is now always specified. (#229).
-
Modified calls to
derive_vars_joined()
in ADCE, ADFACE and ADIS vignettes in line with the updates to this function in the new version of the{admiral}
package. Thejoin_type
argument is now always specified and populated asall
(#229). -
Modified calls to
derive_extreme_records()
in ADFACE vignette in line with the updates to this function in the new version of the{admiral}
package. Thefilter
argument is now renamed tofilter_add
and the argumentdataset_add
is now always specified. (#229). -
All dummy SDTM data used in the package, have been replaced with data available in
{pharmaversesdtm}
package (#228).
-
Website now has button/links to Slack channel and GitHub Issues (#225).
-
Lee Armishaw was added as a contributor (#225).
- Created SDTM dummy data
IS
,SUPPIS
forADIS
(#31, #26) - Created SDTM dummy data
DM
,CE
,EX
,FACE
,VS
forADCE
ANDADFACE
. - Developed new functionalities for
ADFACE
,ADIS
andADIS
domain. - Added
metatools
,metacore
packages instaged_dependencies.yaml
file. - Created template for
ADSL
.
- Created
ADIS
vignette. - Created
ADCE
vignette. - Created
ADSL
vignette. - Created
ADFACE
vignette.