From 9e209e54041338403e3b40a45eda76f4a15a5c4f Mon Sep 17 00:00:00 2001
From: Samuel Johnson <sfjohnson24@gmail.com>
Date: Fri, 13 Feb 2026 14:33:08 -0500
Subject: [PATCH 1/4] rule type, builder changes

---
 .../domain_list_with_define_builder.py        |   6 +++---
 .../enums/domain_presence_values.py           |   1 +
 cdisc_rules_engine/enums/sensitivity.py       |   1 +
 cdisc_rules_engine/models/actions.py          |   6 ++++++
 cdisc_rules_engine/rules_engine.py            |  18 +++++++++++++++++-
 resources/schema/rule/Rule_Type.md            |   4 ++--
 resources/schema/rule/Sensitivity.json        |   3 +++
 resources/schema/rule/Sensitivity.md          |   4 ++++
 resources/templates/report-template.xlsx      | Bin 20694 -> 20500 bytes
 9 files changed, 37 insertions(+), 6 deletions(-)

diff --git a/cdisc_rules_engine/dataset_builders/domain_list_with_define_builder.py b/cdisc_rules_engine/dataset_builders/domain_list_with_define_builder.py
index 180603763..8ec2741c3 100644
--- a/cdisc_rules_engine/dataset_builders/domain_list_with_define_builder.py
+++ b/cdisc_rules_engine/dataset_builders/domain_list_with_define_builder.py
@@ -31,11 +31,11 @@ def build(self):
         records = []
         for define_item in all_define_metadata:
             domain_name = define_item.get("define_dataset_name", "")
+            filename = domain_files.get(domain_name)
             record = {
-                "domain": domain_name,
-                "filename": domain_files.get(domain_name),
                 **define_item,
+                "domain": domain_name if filename is not None else None,
+                "filename": filename,
             }
             records.append(record)
-
         return self.dataset_implementation.from_records(records)
diff --git a/cdisc_rules_engine/enums/domain_presence_values.py b/cdisc_rules_engine/enums/domain_presence_values.py
index bdd5b687c..5e664c05f 100644
--- a/cdisc_rules_engine/enums/domain_presence_values.py
+++ b/cdisc_rules_engine/enums/domain_presence_values.py
@@ -4,3 +4,4 @@
 class DomainPresenceValues(BaseEnum):
     DATASET = "STUDY"
     RECORD = ""
+    DOMAIN = "N/A"
diff --git a/cdisc_rules_engine/enums/sensitivity.py b/cdisc_rules_engine/enums/sensitivity.py
index 4d2189129..7ff7ea376 100644
--- a/cdisc_rules_engine/enums/sensitivity.py
+++ b/cdisc_rules_engine/enums/sensitivity.py
@@ -5,3 +5,4 @@ class Sensitivity(BaseEnum):
     DATASET = "Dataset"
     RECORD = "Record"
     GROUP = "Group"
+    STUDY = "Study"
diff --git a/cdisc_rules_engine/models/actions.py b/cdisc_rules_engine/models/actions.py
index 331a62ed7..60f493af9 100644
--- a/cdisc_rules_engine/models/actions.py
+++ b/cdisc_rules_engine/models/actions.py
@@ -65,8 +65,10 @@ def generate_dataset_error_objects(self, message: str, results: pd.Series):
         )
         if "domain presence" in self.rule.get("rule_type", "").lower():
             error_object.dataset = DomainPresenceValues.DATASET.value
+            error_object.domain = DomainPresenceValues.DOMAIN.value
             for error in error_object.errors:
                 error.dataset = DomainPresenceValues.DATASET.value
+                error.domain = DomainPresenceValues.DATASET.value
                 error.row = DomainPresenceValues.RECORD.value
         self.output_container.append(error_object.to_representation())
 
@@ -177,6 +179,10 @@ def generate_targeted_error_object(  # noqa: C901
             errors_list = self._generate_errors_by_target_presence(
                 data, targets_not_in_dataset, all_targets_missing, errors_df
             )
+        elif self.rule.get("sensitivity") == Sensitivity.STUDY.value:
+            errors_list = self._generate_errors_by_target_presence(
+                data, targets_not_in_dataset, all_targets_missing, errors_df
+            )
         elif self.rule.get("sensitivity") == Sensitivity.GROUP.value:
             grouping_variables = self.rule.get("grouping_variables", [])
 
diff --git a/cdisc_rules_engine/rules_engine.py b/cdisc_rules_engine/rules_engine.py
index 05666741d..50f36b009 100644
--- a/cdisc_rules_engine/rules_engine.py
+++ b/cdisc_rules_engine/rules_engine.py
@@ -1,6 +1,8 @@
 from copy import deepcopy
 from typing import Iterable, List, Union
 from dateutil.parser._parser import ParserError
+import traceback
+
 from business_rules import export_rule_data
 from business_rules.engine import run
 from cdisc_rules_engine.config import config as default_config
@@ -58,7 +60,7 @@
     ExternalDictionariesContainer,
 )
 from cdisc_rules_engine.models.sdtm_dataset_metadata import SDTMDatasetMetadata
-import traceback
+from cdisc_rules_engine.enums.sensitivity import Sensitivity
 
 
 class RulesEngine:
@@ -174,6 +176,8 @@ def validate_single_rule(self, rule: dict, datasets: Iterable[SDTMDatasetMetadat
                     )
                     if limit_reached:
                         break
+        if rule.get("sensitivity") == Sensitivity.STUDY.value:
+            results = self._collapse_to_study_result(results)
         return results
 
     def _update_total_errors_and_check_limit(
@@ -671,3 +675,15 @@ def handle_validation_exceptions(  # noqa
             message=message,
             status=ExecutionStatus.EXECUTION_ERROR.value,
         )
+
+    def _collapse_to_study_result(self, results: dict) -> dict:
+        """
+        For study sensitivity rules, collapse all per-dataset results into a single
+        study-level result using the first non-skipped result as the representative.
+        """
+        for key, dataset_results in results.items():
+            for result in dataset_results:
+                if result.get("executionStatus") != ExecutionStatus.SKIPPED.value:
+                    return {"study": [result]}
+        first_key = next(iter(results))
+        return {"study": results[first_key]}
diff --git a/resources/schema/rule/Rule_Type.md b/resources/schema/rule/Rule_Type.md
index 9556730f6..6d534755b 100644
--- a/resources/schema/rule/Rule_Type.md
+++ b/resources/schema/rule/Rule_Type.md
@@ -192,8 +192,8 @@ all:
 
 One row per dataset defined in Define-XML:
 
-- `domain`
-- `filename` - The file name if dataset exists, null otherwise
+- `domain` - The domain if the dataset exists, empty otherwise
+- `filename` - The file name if dataset exists, empty otherwise
 - `define_dataset_name`
 - `define_dataset_label`
 - `define_dataset_location`
diff --git a/resources/schema/rule/Sensitivity.json b/resources/schema/rule/Sensitivity.json
index 08c68d6bd..ba331d1a6 100644
--- a/resources/schema/rule/Sensitivity.json
+++ b/resources/schema/rule/Sensitivity.json
@@ -10,6 +10,9 @@
     },
     {
       "const": "Group"
+    },
+    {
+      "const": "Study"
     }
   ],
   "markdownDescription": "Determines what level of granularity issues should be generated within the report"
diff --git a/resources/schema/rule/Sensitivity.md b/resources/schema/rule/Sensitivity.md
index 3229a521f..45ffb9d92 100644
--- a/resources/schema/rule/Sensitivity.md
+++ b/resources/schema/rule/Sensitivity.md
@@ -1,3 +1,7 @@
+## Study
+
+Will report once per submitted data study. Lends itself to Domain Presence Check rule types as these are cross-study checks that do not involve within-dataset checks. Reports one result per failing row in the dataset generated by the rule type, collapsed to a single study-level result.
+
 ## Dataset
 
 Report one result per dataset generated by the `Rule Type`, where a dataset or record within the dataset matches the rule failure criteria
diff --git a/resources/templates/report-template.xlsx b/resources/templates/report-template.xlsx
index 41b3eb81a5674513832c80179777143cbbc205a0..227cdd1e74e22f6873af4f354a25e1534275a30e 100644
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From 25aa36ead3915449c7851f6c7973ee7dda39bc1d Mon Sep 17 00:00:00 2001
From: Samuel Johnson <sfjohnson24@gmail.com>
Date: Fri, 13 Feb 2026 15:07:28 -0500
Subject: [PATCH 2/4] tests

---
 .../test_domain_presence_define_builder.py     | 18 +++++++++++-------
 1 file changed, 11 insertions(+), 7 deletions(-)

diff --git a/tests/unit/test_dataset_builders/test_domain_presence_define_builder.py b/tests/unit/test_dataset_builders/test_domain_presence_define_builder.py
index 70ccb61c3..3005e31cc 100644
--- a/tests/unit/test_dataset_builders/test_domain_presence_define_builder.py
+++ b/tests/unit/test_dataset_builders/test_domain_presence_define_builder.py
@@ -199,7 +199,7 @@
                         ],
                     },
                     {
-                        "domain": "SE",
+                        "domain": None,
                         "filename": None,
                         "define_dataset_name": "SE",
                         "define_dataset_label": "Subject Elements",
@@ -241,7 +241,7 @@
             pd.DataFrame(
                 [
                     {
-                        "domain": "AE",
+                        "domain": None,
                         "filename": None,
                         "define_dataset_name": "AE",
                         "define_dataset_label": "Adverse Events",
@@ -260,7 +260,7 @@
                         ],
                     },
                     {
-                        "domain": "DM",
+                        "domain": None,
                         "filename": None,
                         "define_dataset_name": "DM",
                         "define_dataset_label": "Demographics",
@@ -279,7 +279,7 @@
                         ],
                     },
                     {
-                        "domain": "SE",
+                        "domain": None,
                         "filename": None,
                         "define_dataset_name": "SE",
                         "define_dataset_label": "Subject Elements",
@@ -293,7 +293,7 @@
                         "define_dataset_variables": ["STUDYID", "USUBJID", "SESEQ"],
                     },
                     {
-                        "domain": "EC",
+                        "domain": None,
                         "filename": None,
                         "define_dataset_name": "EC",
                         "define_dataset_label": "Exposure as Collected",
@@ -344,7 +344,11 @@ def test_domain_list_with_define_dataset_builder(
     if expected_results.empty:
         assert result_df.empty, f"Expected empty DataFrame for {test_description}"
     else:
-        assert list(result_df.columns) == list(
+        assert set(result_df.columns) == set(
             expected_results.columns
         ), f"Columns do not match for {test_description}"
-        pd.testing.assert_frame_equal(result_df, expected_results, check_dtype=False)
+        pd.testing.assert_frame_equal(
+            result_df.reindex(columns=expected_results.columns),
+            expected_results,
+            check_dtype=False,
+        )

From 3c5df3f69f7a3db3e859abf7caaf22b4ad1144a9 Mon Sep 17 00:00:00 2001
From: Samuel Johnson <sfjohnson24@gmail.com>
Date: Fri, 13 Feb 2026 15:41:46 -0500
Subject: [PATCH 3/4] last test

---
 tests/unit/test_rules_engine.py | 2 +-
 1 file changed, 1 insertion(+), 1 deletion(-)

diff --git a/tests/unit/test_rules_engine.py b/tests/unit/test_rules_engine.py
index a068ac9a7..62a4bd040 100644
--- a/tests/unit/test_rules_engine.py
+++ b/tests/unit/test_rules_engine.py
@@ -1050,7 +1050,7 @@ def test_rule_with_domain_prefix_replacement(mock_get_dataset: MagicMock):
                 {
                     "executionStatus": ExecutionStatus.ISSUE_REPORTED.value,
                     "dataset": "STUDY",
-                    "domain": "AE",
+                    "domain": "N/A",
                     "variables": ["AE"],
                     "message": "Domain AE exists",
                     "errors": [

From d79c3de14aeb6515cbc45bdab96d1c38518ab9aa Mon Sep 17 00:00:00 2001
From: Samuel Johnson <sfjohnson24@gmail.com>
Date: Mon, 16 Feb 2026 09:21:32 -0500
Subject: [PATCH 4/4] docs

---
 cdisc_rules_engine/models/actions.py | 1 -
 resources/schema/rule/Rule_Type.md   | 4 ++--
 2 files changed, 2 insertions(+), 3 deletions(-)

diff --git a/cdisc_rules_engine/models/actions.py b/cdisc_rules_engine/models/actions.py
index 60f493af9..2150d94c6 100644
--- a/cdisc_rules_engine/models/actions.py
+++ b/cdisc_rules_engine/models/actions.py
@@ -68,7 +68,6 @@ def generate_dataset_error_objects(self, message: str, results: pd.Series):
             error_object.domain = DomainPresenceValues.DOMAIN.value
             for error in error_object.errors:
                 error.dataset = DomainPresenceValues.DATASET.value
-                error.domain = DomainPresenceValues.DATASET.value
                 error.row = DomainPresenceValues.RECORD.value
         self.output_container.append(error_object.to_representation())
 
diff --git a/resources/schema/rule/Rule_Type.md b/resources/schema/rule/Rule_Type.md
index 6d534755b..bbf184d8f 100644
--- a/resources/schema/rule/Rule_Type.md
+++ b/resources/schema/rule/Rule_Type.md
@@ -192,8 +192,8 @@ all:
 
 One row per dataset defined in Define-XML:
 
-- `domain` - The domain if the dataset exists, empty otherwise
-- `filename` - The file name if dataset exists, empty otherwise
+- `domain` - The domain if the dataset exists, null otherwise
+- `filename` - The file name if dataset exists, null otherwise
 - `define_dataset_name`
 - `define_dataset_label`
 - `define_dataset_location`