For a single patient one SAE Encounter Row in import CSV file can represent entire SAE Form.
TB drug treatment section columns set of "TB Drug", "TB Drug:Final Action", "TB Drug:related?" can be repeated based on no of sections to be imported.
To remove a particular TB drug treatment section from multiple sections, remove it from the import file.
Every SAE import keeps the sections only from import and remove the sections that are not present in import file.
Following are the columns of the sample file.
Key
Description
Possible Values
Registration Number
Reg num/Treatment ID of a patient
Any String
SAE case number
SAE case number
Any String
Date of SAE Report
Date of SAE Report
yyyy-mm-dd
SAE term
SAE that the patient is suffering
any SAE term concept
Other SAE term
Can only be given when SAE term is 'other'
Any String (Case-Sensitive)
Date of SAE onset
Date of SAE onset
yyyy-mm-dd
Maximum Severity of SAE
Maximum Severity of SAE
Number, 1
Number, 2
Number, 3
Number, 4
Date of SAE outcome
Date of SAE outcome
yyyy-mm-dd
SAE outcome
SAE outcome
Fatal/Not Resolved/Resolved/
Resolved with sequel SAE/Resolving/
Unknown
SAE related to TB drugs?
Is the SAE related to TB drugs?
TRUE/FALSE
TB Drug
TB Drug (Can be given only when SAE related is true)
any TB drug concept
TB Drug:Final Action
Final Action taken on the TB drug above
(Can be given only when SAE related is true)
Dose maintained/Dose reduced/
Drug permanently withdrawn/Unknown
TB Drug:related?
is SAE related to given TB drug
(Can be given only when SAE related is true)
TRUE/FALSE
Non-TB drug
The Non-TB drugs that might be a possible other reason
for the SAE
List of all the drugs that apply for the
treatment separated by "|" e.g. drug1|drug2|drug3
Co-morbidity
The co morbidity that might be a possible other reason
for the SAE
List of all the co-morbidities that apply for the
treatment separated by "|" e.g. cm1|cm2|cm3
Other causal factor
Any other possible reason for the SAE
List of all the other reasons that apply for the
treatment separated by "|" e.g. reason1|reason2|reason3
What happens when import fails ?
If the import fails, an error file is generated, indicating the errors. Errors are usually generated, if the data in the import is not of the possible values as in the table above or if the import doesn't have a match in the system.
Solving the import error
When there is an error, download the file. Then rectify the errors and upload it again.