CTA - CTD to CTR conversion: basic steps outline

Converting CTD to CTR in the CTIS: Basic steps

1. Access CTIS Platform:

2. Select "Create New Application":

Within CTIS, choose the option to create a new application for a clinical trial under the Clinical Trial Regulation (CTR).

3. Basic Trial Information:

Provide general details about the clinical trial, such as its title, phase, and objectives.

4. CTD to CTR Mapping:

Map the content of your existing CTD submission to the corresponding sections in the CTR application within CTIS.

5. CTR Application Modules:

Review the required modules for the CTR application. These may include Protocol, Investigator's Brochure, IMPD (Investigational Medicinal Product Dossier), etc.

6. Data Entry and Upload:

For each module in the CTR application, enter data that corresponds to the information you provided in your CTD.
Upload documents as required, such as PDFs of your CTD sections.

7. Document Formatting:

Ensure that the uploaded documents and entered data are formatted according to the CTIS specifications.

8. Validation Check:

Utilize the validation tools provided by CTIS to check for errors, inconsistencies, or missing information.

9. Review and Verification:

Review the entered data and uploaded documents to ensure accuracy and completeness.

10. Finalize CTR Application:

Once you're satisfied with the content and the application passes validation, finalize the CTR application.

11. Submission:

12. Regulatory Authority Review:

The regulatory authority will review the CTR application within the CTIS platform.

Important Notes:

The actual process might involve specific steps unique to the CTIS platform, which you can find in official user guides or handbooks.
Ensure that your data accurately reflects the information provided in the original CTD submission.
Formatting, document naming, and other technical aspects must comply with CTIS requirements.

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