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convert a dataset from sdtm to adam

Pre-Conversion Steps

Identify the SDTM dataset(s) to be converted to ADaM.

Review SDTM dataset specifications/documentation.

Determine the ADaM dataset(s) to be created.

Review ADaM dataset specifications/documentation.

Validate data mapping and variable mappings between SDTM and ADaM datasets.

Ensure all necessary SDTM datasets are available and complete.

Prepare a detailed conversion plan.

Data Conversion Steps

Create ADaM dataset shells based on ADaM dataset specifications.

Identify and extract relevant data from the SDTM datasets.

Transform and map SDTM variables to ADaM variables.

Perform any necessary calculations or derivations for ADaM variables.

Apply any necessary data validation or cleaning rules.

Populate the ADaM dataset shells with the transformed and mapped data.

Perform quality checks on the converted ADaM datasets.

Metadata and Documentation

Update metadata documents to reflect the converted ADaM datasets.

Generate and update data definition documents for ADaM variables.

Document any transformations or derivations made during the conversion.

Prepare documentation on any data validation or cleaning rules applied.

Review and update the study data reviewer's guide.

Validation and Review

Validate the converted ADaM datasets against predefined validation rules.

Perform cross-dataset consistency checks between ADaM and other datasets.

Review the converted ADaM datasets for accuracy and completeness.

Conduct a peer review or validation review of the ADaM datasets.

Address any identified issues or discrepancies.

Documentation and Submission

Generate final ADaM datasets in appropriate file formats (e.g., SAS datasets, CSV).

Create submission-ready documentation for the ADaM datasets.

Include any necessary metadata and documentation for FDA submission.

Prepare a data reviewer's guide specific to the ADaM datasets.

Archive the converted ADaM datasets and associated documentation.

Please note that this checklist provides a general outline of the steps involved in converting SDTM to ADaM, and it may vary depending on the specific requirements and processes followed by the software development organization.

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