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DISC DTM Implementation Guide for Associated Persons (Version 0.5) Study Data Tabulation Model Implementation Guide: Associated Persons Prepared by the DISC Submission Data Standards Team Principal

How to fill out sdtmig-ap

How to fill out sdtmig-ap:

1. Familiarize yourself with the SDTM Implementation Guide for Animal Pharmacology (sdtmig-ap) to understand its structure and content.
2. Gather the necessary data from animal pharmacology studies, including study design, study samples, treatment information, efficacy data, safety data, and any other relevant variables.
3. Review the SDTMIG Variable Terminology (sdtmigterms-ap) to ensure proper naming conventions and standardization of variables in your datasets.
4. Map your study data to the appropriate domains and variables specified in the sdtmig-ap. This involves identifying and assigning data points to the corresponding variables based on the study design and specific variables described in the guide.
5. Define the datasets according to the SDTMIG standards. This includes creating datasets such as study-level, subject-level, disposition, efficacy, adverse events, laboratory test results, and any other required datasets based on the nature of your study data.
6. Populate the datasets with the collected study data, ensuring that the data is accurately assigned to the correct variables and domains as per the sdtmig-ap specifications.
7. Validate the datasets to ensure compliance with the SDTM standards and the sdtmig-ap guidelines. This involves verifying the completeness, accuracy, and consistency of the data within the datasets.
8. Generate the necessary documentation, including a data definition document, a data mapping document, and any other relevant documents required to record and describe the SDTM implementation process.
9. Ensure the proper submission of your sdtmig-ap-compliant datasets to regulatory authorities or other relevant parties as per their specific requirements.

Who needs sdtmig-ap:

1. Pharmaceutical companies conducting animal pharmacology studies and intending to submit their research data to regulatory authorities.
2. Contract research organizations (CROs) responsible for managing and analyzing animal pharmacology data on behalf of pharmaceutical sponsors.
3. Regulatory authorities requiring consistent and standardized submission of animal pharmacology study data for evaluation and review purposes.
4. Researchers and scientists involved in animal pharmacology studies who wish to adhere to industry standards and best practices in organizing, analyzing, and reporting their research findings.
5. Software developers and vendors creating tools and software that support the implementation of sdtmig-ap standards and facilitate the transformation of study data into SDTM-compliant datasets.

For pdfFiller’s FAQs

What is sdtmig-ap?

SDTMIG-AP stands for Study Data Tabulation Model Implementation Guide - Analysis Dataset. It is a document that provides guidance on creating analysis datasets for clinical trials following CDISC standards.

Who is required to file sdtmig-ap?

Sponsors, researchers, and organizations conducting clinical trials are required to file SDTMIG-AP.

How to fill out sdtmig-ap?

SDTMIG-AP should be filled out following the guidelines provided in the document by mapping data from the clinical trial to CDISC standards.

What is the purpose of sdtmig-ap?

The purpose of SDTMIG-AP is to standardize the format of analysis datasets in clinical trials to ensure consistency and facilitate data analysis and regulatory submissions.

What information must be reported on sdtmig-ap?

SDTMIG-AP must include information on variables, datasets, metadata, and annotations related to the analysis datasets in a clinical trial.

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