tblCEP - Clinical Events and Procedures
holds type and date of clinical events and procedures including serious non-AIDS conditions. Former known as tblAE (adverse event).
Core Fields
Note: Fields marked bold form the unique identifier for a record of the table.
| Field name | Format | Description |
|---|---|---|
| EVENT_ID | numeric | Unique Event Identifier (foreign key to the different event tables) |
| PATIENT | character (or numeric if possible) | Code to identify patient (Cohort Patient ID) |
| CEP_D | yyyy-mm-dd | date of event |
| CEP_ID | character. see coding table for valid codings. | identifies type of event |
| CEP_SPEC | character. see coding table for valid codings. | further specification |
| CEP_V | numeric. See coding table for interpretation. | Depending on CEP_ID and CEP_SPEC: value of given event |
| SRCDOC_Y | numeric:
|
whether the source documentation is available |
| SRCDOC_D | yyyy-mm-dd | date for source documentation verification |
| VERIFY_Y | numeric:
|
Has the monitor verified the source documentation? |
| VERIFY_D | yyyy-mm-dd | date for monitor verification |
| APPROV_Y | numeric:
|
final verification/approval |
| APPROV_D | yyyy-mm-dd | final verification date |
| APPROV_S | character | signature for final verification |
Additional Fields
| Field name | Format | Description |
|---|---|---|
| CEP_Y | numeric:
|
has the patient had an event? |
| CEP_NAME | character | full name of the event |
| CEP_DESCRIP | character | full description of the event |
| CEP_R_Y | numeric:
|
relation to treatment |
QA Checks
| Table | Crosstable | Error Code | Description | Study specific | Is HICDEP |
|---|---|---|---|---|---|
| AllTables | CrossTable | ATC001 | any date in database after DEATH_D in tblLTFU | Yes | |
| AllTables | CrossTable | ATC002 | any date in database after DROP_D in tblLTFU | Yes | |
| AllTables | CrossTable | ATC003 | any date in database before BIRTH_D in tblBAS | Yes | |
| AllTables | CrossTable | ATC004 | any date in database in the future | Yes | |
| AllTables | CrossTable | ATC005 | patients submitted previously who have been missed out | Yes | |
| AllTables | CrossTable | ATC006 | Any fields not coded as coding lists on table definition | Yes |